Monday, July 30, 2012

MyKidz Iron Suspension


Pronunciation: muhl-tee-VYE-ta-min/EYE-urn
Generic Name: Multivitamin with Iron
Brand Name: MyKidz Iron

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children and away from pets. In case of accidental ingestion, call a doctor or poison control center right away.





MyKidz Iron Suspension is used for:

Treating or preventing low levels of vitamins and iron in the body.


MyKidz Iron Suspension is a vitamin and iron supplement. It works by providing extra vitamins and iron to the body when you do not get enough from your diet.


Do NOT use MyKidz Iron Suspension if:


  • you are allergic to any ingredient in MyKidz Iron Suspension

  • you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.



Before using MyKidz Iron Suspension:


Some medical conditions may interact with MyKidz Iron Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have bowel problems (eg, colitis, Crohn disease, diverticulitis), certain blood problems (eg, hemolytic anemia, porphyria, thalassemia), or peptic ulcers

  • if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with MyKidz Iron Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Acitretin because the risk of its side effects may be increased by MyKidz Iron Suspension

  • Doxycycline, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by MyKidz Iron Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if MyKidz Iron Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use MyKidz Iron Suspension:


Use MyKidz Iron Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take MyKidz Iron Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • MyKidz Iron Suspension may be taken by mouth directly or mixed with fruit juice, cereal, or other food.

  • Use the dropper that comes with MyKidz Iron Suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • Shake well before each use.

  • Avoid taking MyKidz Iron Suspension with dairy products; they may interfere with the absorption of the iron in MyKidz Iron Suspension.

  • Do not take an antacid within several hours before or after you take MyKidz Iron Suspension.

  • Many medicines (eg, used for infection, blood pressure, low blood platelets, osteoporosis) should not be taken at the same time as MyKidz Iron Suspension; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of MyKidz Iron Suspension should be separated from your dose of any of your other medicines.

  • If you miss a dose of MyKidz Iron Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use MyKidz Iron Suspension.



Important safety information:


  • Do not take large doses of vitamins while you take MyKidz Iron Suspension unless your doctor tells you to.

  • Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.

  • MyKidz Iron Suspension may discolor the stools. This is normal and not a cause for concern.

  • MyKidz Iron Suspension has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking MyKidz Iron Suspension, contact your doctor. You will need to discuss the benefits and risks of taking MyKidz Iron Suspension while you are pregnant. It is not known if MyKidz Iron Suspension is found in breast milk. If you are or will be breast-feeding while you take MyKidz Iron Suspension, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of MyKidz Iron Suspension:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dark or discolored stools; diarrhea; nausea; stomach upset.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent nausea, vomiting, or diarrhea; stomach pain or cramping.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: MyKidz Iron side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; bloody vomit; fast heartbeat; paleness of the skin; seizures; severe diarrhea, nausea, vomiting, or stomach pain; shallow, rapid breathing; sluggishness; unusual drowsiness; weakness.


Proper storage of MyKidz Iron Suspension:

Store MyKidz Iron Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep MyKidz Iron Suspension out of the reach of children and away from pets.


General information:


  • If you have any questions about MyKidz Iron Suspension, please talk with your doctor, pharmacist, or other health care provider.

  • MyKidz Iron Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about MyKidz Iron Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More MyKidz Iron resources


  • MyKidz Iron Side Effects (in more detail)
  • MyKidz Iron Use in Pregnancy & Breastfeeding
  • MyKidz Iron Drug Interactions
  • MyKidz Iron Support Group
  • 0 Reviews for MyKidz Iron - Add your own review/rating


Compare MyKidz Iron with other medications


  • Anemia
  • Vitamin/Mineral Supplementation and Deficiency

Sunday, July 29, 2012

trimethoprim



trye-METH-oh-prim


Commonly used brand name(s)

In the U.S.


  • Primsol

  • Proloprim

  • Trimpex

Available Dosage Forms:


  • Tablet

  • Solution

Therapeutic Class: Antibiotic


Pharmacologic Class: Folic Acid Antagonist


Uses For trimethoprim


Trimethoprim is used to treat infections of the urinary tract. It may also be used for other problems as determined by your doctor. It will not work for colds, flu, or other virus infections.


Trimethoprim is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, trimethoprim is used in certain patients for the following medical conditions:


  • Prevention of urinary tract infections

  • Treatment of Pneumocystis carinii pneumonia (PCP)

For patients taking trimethoprim for prevention of urinary tract infections:


  • Your doctor may have prescribed trimethoprim to prevent infections of the urinary tract. It is usually given once a day and may be given for a long time for this purpose. If you have any questions about this, check with your doctor.

Before Using trimethoprim


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For trimethoprim, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to trimethoprim or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


trimethoprim has been used in a limited number of children 2 months of age or older, and tested in children 12 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems in children than it does in adults.


Geriatric


Elderly people may be more sensitive to the effects of trimethoprim. Blood problems may be more likely to occur in elderly patients who are taking diuretics (water pills) along with trimethoprim.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking trimethoprim, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using trimethoprim with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Bepridil

  • Cisapride

  • Dofetilide

  • Levomethadyl

  • Mesoridazine

  • Pimozide

  • Terfenadine

  • Thioridazine

Using trimethoprim with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acecainide

  • Ajmaline

  • Amiodarone

  • Amisulpride

  • Amitriptyline

  • Amoxapine

  • Aprindine

  • Arsenic Trioxide

  • Astemizole

  • Azimilide

  • Bretylium

  • Chloral Hydrate

  • Chloroquine

  • Chlorpromazine

  • Clarithromycin

  • Desipramine

  • Dibenzepin

  • Disopyramide

  • Dolasetron

  • Doxepin

  • Droperidol

  • Eltrombopag

  • Enflurane

  • Erythromycin

  • Flecainide

  • Fluconazole

  • Fluoxetine

  • Foscarnet

  • Gemifloxacin

  • Halofantrine

  • Haloperidol

  • Halothane

  • Hydroquinidine

  • Ibutilide

  • Imipramine

  • Isoflurane

  • Isradipine

  • Lidoflazine

  • Lorcainide

  • Mefloquine

  • Methotrexate

  • Nortriptyline

  • Octreotide

  • Pentamidine

  • Pirmenol

  • Prajmaline

  • Probucol

  • Procainamide

  • Prochlorperazine

  • Propafenone

  • Pyrimethamine

  • Quetiapine

  • Quinidine

  • Risperidone

  • Sematilide

  • Sertindole

  • Sotalol

  • Spiramycin

  • Sultopride

  • Tedisamil

  • Telithromycin

  • Trifluoperazine

  • Trimipramine

  • Vasopressin

  • Zotepine

Using trimethoprim with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Anisindione

  • Didanosine

  • Digoxin

  • Enalaprilat

  • Enalapril Maleate

  • Fosphenytoin

  • Phenytoin

  • Quinapril

  • Repaglinide

  • Rosiglitazone

  • Tolbutamide

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using trimethoprim with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use trimethoprim, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of trimethoprim. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia—Patients with anemia may have an increased chance of side effects affecting the blood

  • Kidney disease—Patients with kidney disease may have an increased chance of side effects

  • Liver disease—Patients with liver disease may have an increased chance of side effects

Proper Use of trimethoprim


Do not give trimethoprim to infants or children under 12 years of age unless otherwise directed by your doctor.


Trimethoprim may be taken on an empty stomach or, if it upsets your stomach, it may be taken with food.


To help clear up your infection completely, keep taking trimethoprim for the full time of treatment even if you begin to feel better after a few days. If you stop taking trimethoprim too soon, your symptoms may return.


trimethoprim works best when there is a constant amount in the body. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 2 doses a day, the doses should be spaced about 12 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.


Dosing


The dose of trimethoprim will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of trimethoprim. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For the treatment of urinary tract infections :
    • Adults and children 12 years of age and older: 100 milligrams every twelve hours for ten days, or 200 milligrams once a day for ten days.

    • Children up to 12 years of age: Dose must be determined by the doctor.


Missed Dose


If you miss a dose of trimethoprim, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using trimethoprim


It is important that your doctor check your progress at regular visits if you will be taking trimethoprim for a long time. This will allow your doctor to check for any unwanted effects that may be caused by trimethoprim.


If your symptoms do not improve within a few days, or if they become worse, check with your doctor.


If trimethoprim causes anemia, your doctor may want you to take folic acid (a vitamin) every day to help clear up the anemia. If so, it is important to take folic acid every day along with trimethoprim; do not miss any doses.


Trimethoprim may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.


Some people who take trimethoprim may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn or skin rash, redness, itching, or discoloration. When you begin taking trimethoprim:


  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.

  • Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.


trimethoprim Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Skin rash or itching

Rare
  • Black, tarry stools

  • blood in urine or stools

  • bluish fingernails, lips, or skin

  • changes in facial skin color

  • chills

  • difficult breathing or shortness of breath

  • fever with or without chills

  • general feeling of discomfort or illness

  • headache

  • joint or muscle pain

  • nausea

  • neck stiffness

  • pale skin

  • pinpoint red spots on skin

  • redness, blistering, burning, tenderness, peeling, or loosening of skin or mucous membranes

  • redness, swelling, or soreness of tongue

  • red skin lesions, often with a purple center

  • sore throat

  • swelling

  • thickened or scaly skin

  • unusual bleeding or bruising

  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Diarrhea

  • loss of appetite

  • nausea or vomiting

  • stomach cramps or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: trimethoprim side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More trimethoprim resources


  • Trimethoprim Side Effects (in more detail)
  • Trimethoprim Use in Pregnancy & Breastfeeding
  • Drug Images
  • Trimethoprim Drug Interactions
  • Trimethoprim Support Group
  • 0 Reviews for Trimethoprim - Add your own review/rating


  • trimethoprim Concise Consumer Information (Cerner Multum)

  • Trimethoprim Prescribing Information (FDA)

  • Trimethoprim Monograph (AHFS DI)

  • Trimethoprim MedFacts Consumer Leaflet (Wolters Kluwer)

  • Primsol Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Proloprim Prescribing Information (FDA)



Compare trimethoprim with other medications


  • Bladder Infection
  • Otitis Media
  • Pneumocystis Pneumonia
  • Prevention of Bladder infection

Saturday, July 28, 2012

Magmilax Bolus





Dosage Form: FOR ANIMAL USE ONLY
Magmilax Bolus

INDICATIONS


INDICATIONS: For oral administration as an aid in the treatment of digestive disturbances requiring  an antacid or a mild laxative in cattle.



Magmilax Bolus Dosage and Administration


DOSAGE AND ADMINISTRATION: Two to four boluses depending on size and condition of animal.  Three boluses are equivalent to one quart of milk of magnesia.  Lubricate boluses with mineral oil or other non-irritating lubricants before administering.


M-0079-02; Rev. 12-08






EACH BOLUS CONTAINS


EACH BOLUS CONTAINS:

Magnesium Oxide ..... 276 grs.

(Equivalent to Magnesium Hydroxide, 400 grs.)

In a flavored base



Store in a cool dry place.;Keep tightly closed when not in use.;TAKE TIME TO OBSERVE LABEL DIRECTIONS;LOT NO.:, EXP. DATE:









Magmilax Bolus 
magnesium oxide  tablet










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)58005-079
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM OXIDE (MAGNESIUM OXIDE)MAGNESIUM OXIDE276 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Colorpink ( PINK)Score2 pieces
ShapeOVAL (OBLONG)Size8mm
FlavorImprint Code2
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
158005-079-0250 BOLUS In 1 BOXNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/1996


Labeler - Sparhawk Laboratories, Inc. (958829558)
Revised: 12/2009Sparhawk Laboratories, Inc.



Thursday, July 26, 2012

PCE


Pronunciation: e-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: PCE


PCE is used for:

Treating infections caused by certain bacteria. It is also used to prevent attacks of rheumatic fever in certain patients. It may also be used for other conditions as determined by your doctor.


PCE is a macrolide antibiotic. It works by killing or slowing the growth of sensitive bacteria.


Do NOT use PCE if:


  • you are allergic to any ingredient in PCE

  • you are taking astemizole, cisapride, diltiazem, dofetilide, dronedarone, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, tolvaptan, toremifene, vandetanib, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.



Before using PCE:


Some medical conditions may interact with PCE. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have diarrhea

  • if you have a history of kidney or liver disease, heart problems, a fast or irregular heartbeat, myasthenia gravis, or the blood disease porphyria

  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with PCE. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Astemizole, cisapride, diltiazem, dofetilide, dronedarone, halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, toremifene, vandetanib, or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur. Check with your doctor if you have questions about which medicines may affect your heartbeat

  • Eletriptan, ergot alkaloids (eg, dihydroergotamine, ergotamine), or tolvaptan because the risk of their side effects may be increased by PCE

  • Many prescription and nonprescription medicines (eg, used for aches and pains, allergies, blood thinning, breathing problems, cancer, diabetes, erection problems, gout, irregular heartbeat or other heart problems, high blood calcium levels, high blood pressure, high cholesterol, HIV infection, inflammation, infections, low blood sodium levels, migraine, mood or mental problems, nausea and vomiting, overactive bladder, Parkinson disease, prevention of organ transplant rejection, seizures, stomach problems, trouble sleeping), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with PCE. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with PCE

This may not be a complete list of all interactions that may occur. Ask your health care provider if PCE may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use PCE:


Use PCE as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.


  • Take PCE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Swallow PCE whole. Do not break, crush, or chew before swallowing.

  • Do not eat grapefruit or drink grapefruit juice while you use PCE.

  • PCE works best if taken at the same times each day.

  • To clear up your infection completely, take PCE for the full course of treatment. Keep taking it even if you feel better in a few days.

  • If you miss a dose of PCE, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use PCE.



Important safety information:


  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

  • PCE only works against bacteria; it does not treat viral infections (eg, the common cold).

  • Be sure to use PCE for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Long-term or repeated use of PCE may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • Tell your doctor or dentist that you take PCE before you receive any medical or dental care, emergency care, or surgery.

  • Rarely, patients taking PCE have developed reversible hearing loss. The risk is greater if you have kidney problems or you take high doses of PCE. Contact your doctor if you develop decreased hearing or hearing loss.

  • PCE may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking PCE.

  • Lab tests, including liver or kidney function and complete blood cell counts, may be performed while you use PCE. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use PCE with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval).

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using PCE while you are pregnant. PCE is found in breast milk. If you are or will be breast-feeding while you use PCE, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of PCE:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Loss of appetite; mild diarrhea; nausea; stomach pain; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; changes in the amount of urine produced; decreased hearing or hearing loss; irregular heartbeat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain; stomach cramps; symptoms of liver problems (eg, yellowing of the skin or eyes; pale stools; severe or persistent nausea, vomiting, or loss of appetite; dark urine).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: PCE side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.


Proper storage of PCE:

Store PCE at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep PCE out of the reach of children and away from pets.


General information:


  • If you have any questions about PCE, please talk with your doctor, pharmacist, or other health care provider.

  • PCE is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about PCE. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More PCE resources


  • PCE Side Effects (in more detail)
  • PCE Use in Pregnancy & Breastfeeding
  • Drug Images
  • PCE Drug Interactions
  • PCE Support Group
  • 0 Reviews for PCE - Add your own review/rating


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  • Bacterial Endocarditis Prevention
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  • Dental Abscess
  • Legionella Pneumonia
  • Lyme Disease
  • Lymphogranuloma Venereum
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Prestim Tablets





1. Name Of The Medicinal Product



Prestim Tablets


2. Qualitative And Quantitative Composition



Each tablet contains timolol maleate 10 mg and bendroflumethiazide 2.5 mg



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Tablet.



White, flat, oval-shaped tablets with a score mark on one side, and engraved on the other side with “V PRE”



4. Clinical Particulars



4.1 Therapeutic Indications



Prestim tablets are indicated for the treatment of mild to moderate hypertension.



4.2 Posology And Method Of Administration



Posology



The recommended dosage range is 1 to 4 tablets daily. The dosage can be taken in the morning or in two divided doses, morning and evening.



If blood pressure control is not achieved on 4 tablets daily, consideration should be given to titrating timolol and bendroflumethiazide separately or adding another agent with hypotensive activity.



Dosage in the elderly



Initiate treatment with 1 tablet daily and thereafter adjust according to response.



Paediatric population



The safety and efficacy of Prestim in children has not been established. No data are available.



Method of administration



Prestim tablets are for oral use



4.3 Contraindications



Hypersensitivity to timolol maleate and/or bendroflumethiazide or to any of the excipients



Anuria. Prestim should not be used in patients with renal failure.



Uncontrolled heart failure, bradycardia, cardiogenic shock, history of bronchospasm, bronchial asthma, chronic obstructive pulmonary disease, patients receiving adrenergic augmenting drugs (monoamine oxidase inhibitors and tricyclic antidepressants), sick sinus syndrome (including sino-atrial block), Prinzmetals angina, untreated phaeochromocytoma, second to 3rd degree heart block, metabolic acidosis, hypotension, and severe peripheral circulatory disturbances.



Anaesthesia with agents that produce myocardial depression, such as chloroform and ether.



Prestim is contraindicated in pregnancy.



4.4 Special Warnings And Precautions For Use



Cardiovascular



The continued depression of sympathetic drive through beta-blockade may lead to cardiac failure. All patients should be observed for evidence of cardiac failure, and if it occurs, digitalisation should be considered.



Beta blockers should not be used in patients with untreated congestive heart failure. This condition should first be stabilised



In patients with ischaemic heart disease, treatment should not be discontinued suddenly. The dosage should gradually be reduced, i.e. over 1-2 weeks. If necessary, replacement therapy should be initiated at the same time, to prevent exacerbation of angina pectoris.



Beta blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced.



In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), beta blockers should be used with great caution as aggravation of these disorders may occur.



Metabolic/endocrine



Caution should be exercised in patients with diabetes mellitus, spontaneous hypoglycaemia, impaired renal or hepatic function



Beta blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia.



Other warnings



Patients with a history of psoriasis should take beta blockers only after careful consideration.



Beta blockers may increase sensitivity to allergens and the seriousness of anaphylactic reactions.



The following statement will appear on the label of this product: `Do not take this medicine if you have a history of wheezing or asthma'.



There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable, cessation of therapy with the beta-blocker should be gradual.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



As with other diuretics, Prestim should not be administered concurrently with lithium salts. Diuretics can reduce lithium clearance resulting in high serum levels of lithium.



The depressant effect of beta blocking drugs on myocardial contractility and on intracardiac conduction may be increased by concomitant use with other drugs having similar effects. Serious effects have been reported with verapamil, disopyramide, lignocaine and tocainide and may be anticipated with diltiazem, quinidine, amiodarone and any of the class 1 antiarrhythmic agents. Special care is necessary when any of these agents are given intravenously in patients who are receiving beta-blockers.



Concurrent administration of digitalis glycosides may increase the atrio-ventricular conduction time.



Beta blockers increase the risk of `rebound hypertension' when taken with clonidine. When clonidine is used in conjunction with non selective beta blockers such as timolol, treatment with clonidine should be continued for some time after treatment with the beta blocker has been discontinued.



Concomitant administration of tricyclic antidepressants, barbiturates and phenothiazines, dihydropyridine derivatives such as nifedipine or antihypertensive agents may increase the blood pressure lowering effect.



Beta blockers may intensify the blood sugar lowering effect of insulin and oral antidiabetic drugs.



Anaesthesia



The anaesthesiologist should be informed when the patient is receiving a beta blocking agent. Concomitant use of beta blockers and anaesthetics may attenuate reflex tachycardia and increase the risk of hypotension.



The withdrawal of beta blocking drugs prior to surgery is not necessary in the majority of patients. If beta blockade is interrupted in preparation for surgery, therapy should be discontinued at least 24 hours beforehand.



Continuation of beta blockade reduces the risk of arrhythmias during induction and intubation, however the risk of hypertension may be increased. Anaesthetic agents such as ether, cyclopropane and trichloroethylene should not be used whereas halothane, isoflurane, nitrous oxide, intravenous induction agents, muscle relaxants, narcotic analgesics and local anaesthetic agents are all compatible with beta adrenergic blockade. Local anaesthetics with added vasoconstrictors, e.g. adrenaline, should be avoided. The patient may be protected against vagal reactions by intravenous administration of atropine.



The bioavailability of beta-blockers will be increased by co-administration with cimetidine or hydralazine and reduced with rifampicin.



Alcohol induces increased plasma levels of hepatically metabolised beta blockers such as timolol.



Some prostaglandin synthetase inhibiting drugs have been shown to impair the antihypertensive effect of beta blocking drugs.



The effect of sympathomimetic agents, e.g. isoprenaline, salbutamol, will be reduced by concomitant use of beta blockers. In addition, sympathomimetics may counteract the effect of beta blocking agents.



Caution is recommended when administering to patients on catecholamine depleting drugs such as reserpine or guanethidine.



4.6 Pregnancy And Lactation



Prestim is contraindicated during pregnancy. (See section 4.3).Both constituents cross the placenta and appear in breast milk therefore breastfeeding is not recommended.



Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.



4.7 Effects On Ability To Drive And Use Machines



None known. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.



4.8 Undesirable Effects























































System Organ Class




Rare






Frequency Not Known




Blood and lymphatic system disorders



 


Blood dyscrasias (including thrombocytopenia, granulocytopenia, aplastic anaemia), haemolytic anaemia




Metabolism and nutrition disorders



 


Electrolyte depletion and dehydration; hypokalaemia; hyperglycaemia (in diabetic and other susceptible patients); hyperuricaemia




Psychiatric disorders




Withdrawal syndrome (Abrupt withdrawal may precipitate angina in susceptible patients or cause rebound hypertension -see section 4.4.)




Hallucination; depression; disorientation; confusional state; nightmare; insomnia




Nervous system disorders



 


Coma (may be precipitated in hepatic cirrhosis); paraesthesia; dizziness; headache; sedation




Eye disorders




Dry eye




Aggravation of pre-existing myopia; visual impairment




Ear and labyrinth disorders



 


Vertigo




Cardiac disorders



 


Atrioventricular block; bradycardia; cardiac failure; cyanosis




Vascular disorders



 


Necrotising vasculitis; hypotension; Raynaud's phenomenon; increase of an existing intermittent claudication, peripheral coldness




Respiratory, thoracic and mediastinal disorders



 


Dyspnoea; bronchospasm (Bronchospasm is generally observed in patients with pre-existing asthma or obstructive airways disease.)




Gastrointestinal disorders




Retroperitoneal fibrosis




Acute pancreatitis; dyspepsia; vomiting; nausea; diarrhoea




Skin and subcutaneous tissue disorders




Allergic dermatitis; psoriasiform dermatitis; erythematous rash




Rash with associated photosensitivity




Musculoskeletal and connective tissue disorders




Arthralgia




Muscle pain




Renal and urinary disorders



 


Oliguria; glucosuria (in diabetic and other susceptible patients)




Reproductive system and breast disorders



 


Erectile dysfunction




General disorders and administration site conditions



 


Fatigue; weakness; thirst




Investigations



 


Increased blood urea (most pronounced in patients with renal disease and pre-existing retention of nitrogen); increased antinuclear antibody



Thiazide diuretics may cause excessive depletion of fluid and electrolytes during prolonged or intense use. Symptoms are muscle pain or fatigue, thirst and oliguria. With thiazide diuretics hypokalaemia is more severe in patients already depleted of potassium, as in renal or hepatic insufficiency.



4.9 Overdose



The most common signs of overdosage are bradycardia, hypotension, bronchospasm and acute cardiac failure. Suggested treatments are as follows:












Severe bradycardia:




IV atropine sulphate 0.25 - 2 mg. If bradycardia persists, IV isoprenaline 25 micrograms may be given.




Severe hypotension:




IV noradrenaline or adrenaline




Bronchospasm:




isoprenaline hydrochloride, orciprenaline or salbutamol.




Acute cardiac failure:




digitalis, diuretics and oxygen. In refractory cases, IV aminophylline and IV glucagon 0.5 - 1mg have been reported useful.



General measures should be taken to restore blood volume, maintain blood pressure and correct electrolyte imbalance.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Cardiovascular system, Beta blocking agents, non-selective and thiazides ATC code: C07BA06



Timolol maleate is a non-selective Beta-adrenoceptor antagonist with marked hypotensive activity.



Bendroflumethiazide is a thiazide diuretic, which has a moderate duration of activity.



It has been shown that beta-blocking agents used in combination with a thiazide diuretic potentiates the effects of this diuretic giving an enhanced antihypertensive effect. This may be due to the inhibition of renin release or concomitant regional haemodynamic changes. This means that a relatively lower dose of the beta-blocker is required.



5.2 Pharmacokinetic Properties



Timolol maleate is well absorbed, extensively metabolised in the liver and eliminated through the kidney with a half-life of 2.5 to 5 hours (the biological half-life is somewhat longer). The beta-blocking effect of timolol is apparent within 30 minutes of administration and has been shown to last for up to 24 hours. It has low to moderate lipid solubility. Protein binding is reported to be low. It crosses the placenta and appears in breast milk.



Bendroflumethiazide has been reported to be completely absorbed from the gastro-intestinal tract and to have a plasma half-life of about 3 or 4 hours. It is highly bound to plasma protein. There is evidence that bendroflumethiazide is fairly extensively metabolised; about 30% is excreted unchanged in the urine. The diuretic effect of bendroflumethiazide is usually complete in 12-18 hours.



5.3 Preclinical Safety Data



There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Microcrystalline cellulose, starch, magnesium stearate.



6.2 Incompatibilities



None known.



6.3 Shelf Life



The shelf life of Prestim tablets is three years.



6.4 Special Precautions For Storage



Store below 25°C.



6.5 Nature And Contents Of Container



Glass bottles of 30 tablets, 100 and 500 tablets.



Glass bottle of 14 tablets (sample pack).



Not all pack sizes may be marketed



6.6 Special Precautions For Disposal And Other Handling



No special requirements.



7. Marketing Authorisation Holder



Meda Pharmaceuticals Ltd



Skyway House



Parsonage Road



Takeley



Bishop's Stortford



CM22 6PU



UK



8. Marketing Authorisation Number(S)



PL 15142/0025



9. Date Of First Authorisation/Renewal Of The Authorisation



31 December 2000



10. Date Of Revision Of The Text



24 November 2011




Wednesday, July 25, 2012

Avelox



Generic Name: moxifloxacin (moxi FLOX a sin)

Brand Names: Avelox


What is moxifloxacin?

Moxifloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-o-KWIN-o-lones). Moxifloxacin fights bacteria in the body.


Moxifloxacin is used to treat different types of bacterial infections.


Moxifloxacin may also be used for purposes not listed in this medication guide.


What is the most important information I should know about moxifloxacin?


You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to moxifloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

Before taking moxifloxacin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, a history of seizures, low levels of potassium in your blood (hypokalemia), muscle weakness or trouble breathing, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.


Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 8 hours before or 4 hours after you take moxifloxacin. These other medicines can make moxifloxacin much less effective when taken at the same time.

Taking moxifloxacin can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.


Moxifloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking moxifloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you do.

What should I discuss with my healthcare provider before taking moxifloxacin?


You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to moxifloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

To make sure you can safely take moxifloxacin, tell your doctor if you have any of these other conditions:



  • heart rhythm disorder, especially if you take quinidine (Quin-G), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace);




  • a history of allergic reaction to an antibiotic;




  • joint problems;




  • kidney or liver disease, cirrhosis;




  • epilepsy or a history of seizures;




  • muscle weakness or trouble breathing;




  • low levels of potassium in your blood (hypokalemia); or




  • a personal or family history of "Long QT syndrome."




FDA pregnancy category C. It is not known whether moxifloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether moxifloxacin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using moxifloxacin. Moxifloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking moxifloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you do.

How should I take moxifloxacin?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Take moxifloxacin with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking moxifloxacin.

Moxifloxacin may be taken with or without food, but take it at the same time each day.


Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Moxifloxacin will not treat a viral infection such as the common cold or flu. Store at room temperature away from moisture and heat.

See also: Avelox dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tremors, nausea, vomiting, diarrhea, and seizures (convulsions).


What should I avoid while taking moxifloxacin?


You may be taking certain other medicines that should not be taken at the same time as moxifloxacin. Avoid taking the following medicines within 8 hours before or 4 hours after you take moxifloxacin. These other medicines can make moxifloxacin much less effective when taken at the same time:

  • antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids);




  • the ulcer medicine sucralfate (Carafate);




  • didanosine (Videx) powder or chewable tablets; or




  • vitamin or mineral supplements that contain iron or zinc.




Avoid exposure to sunlight or tanning beds. Moxifloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking moxifloxacin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


Moxifloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Moxifloxacin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using moxifloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;




  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;




  • diarrhea that is watery or bloody;




  • confusion, hallucinations, depression, insomnia or nightmares, unusual thoughts or behavior, feeling light-headed;




  • seizure (convulsions);




  • severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;




  • pale or yellowed skin, dark colored urine, fever, weakness;




  • urinating less than usual or not at all;




  • easy bruising or bleeding;




  • numbness, tingling, or unusual pain anywhere in your body;




  • the first sign of any skin rash, no matter how mild; or




  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.



Less serious side effects may include:



  • nausea, mild diarrhea;




  • headache, dizziness;




  • blurred vision;




  • feeling nervous, anxious, or agitated;




  • mild skin itching.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect moxifloxacin?


Tell your doctor about all other medicines you use, especially:



  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), or pentamidine (NebuPent, Pentam);




  • an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), or desipramine (Norpramin);




  • anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam);




  • medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);




  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);




  • narcotic medication such as methadone (Methadose, Diskets, Dolophine);




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or




  • steroid medication (prednisone and others).



This list is not complete and other drugs may interact with moxifloxacin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Avelox resources


  • Avelox Side Effects (in more detail)
  • Avelox Dosage
  • Avelox Use in Pregnancy & Breastfeeding
  • Drug Images
  • Avelox Drug Interactions
  • Avelox Support Group
  • 96 Reviews for Avelox - Add your own review/rating


  • Avelox Prescribing Information (FDA)

  • Avelox Consumer Overview

  • Avelox Advanced Consumer (Micromedex) - Includes Dosage Information

  • Avelox MedFacts Consumer Leaflet (Wolters Kluwer)

  • Avelox Monograph (AHFS DI)

  • Avelox I.V. Advanced Consumer (Micromedex) - Includes Dosage Information

  • Avelox I.V.



Compare Avelox with other medications


  • Anthrax
  • Anthrax Prophylaxis
  • Bacterial Infection
  • Bronchitis
  • Intraabdominal Infection
  • Pneumonia
  • Prostatitis
  • Sinusitis
  • Skin and Structure Infection
  • Skin Infection
  • Tuberculosis, Active


Where can I get more information?


  • Your pharmacist can provide more information about moxifloxacin.

See also: Avelox side effects (in more detail)


Monday, July 23, 2012

Methylprednisolone Sodium Succinate



Class: Adrenals
Note: This monograph also contains information on Methylprednisolone, Methylprednisolone Acetate
ATC Class: H02AB04
VA Class: HS051
CAS Number: 83-43-2
Brands: A-methaPred, Depo-Medrol, Medrol, Medrol Dosepak, Meprolone Unipak, Solu-Medrol

Introduction

Synthetic glucocorticoid; minimal mineralocorticoid activity.b c d


Uses for Methylprednisolone Sodium Succinate


Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.c d


Usually, inadequate alone for adrenocortical insufficiency because of minimal mineralocorticoid activity.c


Adrenocortical Insufficiency


Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.a c


Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.a c d m


If methylprednisolone is used, must also administer a mineralocorticoid (fludrocortisone), particularly in infants.a c d


In suspected or known adrenal insufficiency, parenteral therapy may be used preoperatively or during serious trauma, illness, or shock unresponsive to conventional therapy.d e m


In shock unresponsive to conventional therapy, IV therapy in conjunction with other therapy for shock is essential; hydrocortisone is preferred, but a synthetic glucocorticoid like methylprednisolone can be substituted.c e


Adrenogenital Syndrome


Lifelong glucocorticoid treatment of congenital adrenogenital syndrome.a c


In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; a mineralocorticoid may be necessary in conjunction through at least 5–7 years of age.c


A glucocorticoid, usually alone, for long-term therapy after early childhood.c


In hypertensive forms, a “short-acting” glucocorticoid with minimal mineralocorticoid activity (e.g., methylprednisolone, prednisone) is preferred;c avoid long-acting glucocorticoids (e.g., dexamethasone) because of tendency toward overdosage and growth retardation.c


Hypercalcemia


Treatment of hypercalcemia associated with malignancy.a c d m


Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.c


Most effective long-term treatment for hypercalcemia associated with breast cancer in postmenopausal women.c


Efficacy varies in other malignancies.c


Treatment of hypercalcemia associated with sarcoidosis.c


Treatment of hypercalcemia associated with vitamin D intoxication.c


Not effective for hypercalcemia caused by hyperparathyroidism.c


Thyroiditis


Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.a c d m


Anti-inflammatory actions relieves fever, acute thyroid pain, and swelling.c


May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).c


Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.c


Rheumatic Disorders and Collagen Diseases


Short-term palliative treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, Reiter syndrome, rheumatic fever [especially with carditis]) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, dermatomyositis [polymyositis], polyarteritis nodosa, vasculitis) refractory to more conservative measures.a c d l m


Relieves inflammation and suppresses symptoms but not disease progression.c


Rarely indicated as maintenance therapy.c


May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.a b c d


Glucocorticoid withdrawal is extremely difficult if used for maintenance; relapse and recurrence usually occur with drug discontinuance.c


Local injection can provide dramatic relief initially for articular manifestations of rheumatic disorders (e.g., rheumatoid arthritis) that involve only a few persistently inflamed joints or for inflammation of tendons or bursae;c inflammation tends to recur and sometimes is more intense after drug cessation.c


Local injection used for the management of cystic tumors of an aponeurosis or tendon (ganglia).d


Local injection can prevent invalidism by facilitating movement of joints that might otherwise become immobile.c


Controls acute manifestations of rheumatic carditis more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and no better than salicylates for long-term treatment.c


Adjunctively for severe systemic complications of Wegener’s granulomatosis, but cytotoxic therapy is the treatment of choice.c


Primary treatment to control symptoms and prevent severe, often life-threatening complications in patients with dermatomyositis and polymyositis, polyarteritis nodosa, relapsing polychondritis, polymyalgia rheumatica and giant-cell (temporal) arteritis, or mixed connective tissue disease syndrome.a c High dosage may be required for acute situations; after a response has been obtained, drug must often be continued for long periods at low dosage.c


Polymyositis associated with malignancy and childhood dermatomyositis may not respond well.c


Rarely indicated in psoriatic arthritis, diffuse scleroderma (progressive systemic sclerosis), acute and subacute bursitis, or osteoarthritis; risks outweigh benefits.a c d m


In osteoarthritis, intra-articular injections may be beneficial but should be limited in number as joint damage may occur.c d


Dermatologic Diseases


Treatment of pemphigus and pemphigoid, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczema, cutaneous sarcoidosis, mycosis fungoides, lichen planus, lichen simplex chronicus (neurodermatitis), severe psoriasis, and severe seborrheic dermatitis.a c d e


Usually reserved for acute exacerbations unresponsive to conservative therapy.c


Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid, and high or massive doses may be required.c


For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) intractable to adequate trials of conventional treatment.a d e f m


Chronic skin disorders seldom an indication for systemic glucocorticoids.c


Intralesional or sublesional injections occasionally indicated for localized chronic skin disorders, keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, granuloma annulared m unresponsive to topical therapy.c


Rarely indicated for psoriasis;c if used, exacerbation may occur when the drug is withdrawn or dosage is decreased.c


Rarely indicated systemically for alopecia (areata, totalis, or universalis).c May stimulate hair growth, but hair loss returns when the drug is discontinued.c


Allergic Conditions


For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment and control of acute manifestations, including anaphylactic and anaphylactoid reactions, angioedema, acute noninfectious laryngeal edema, serum sickness, allergic symptoms of trichinosis, asthma, urticarial transfusion reactions, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.a c d e f m


Systemic therapy usually reserved for acute conditions and severe exacerbations.c


For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).c


Reserve prolonged treatment of chronic allergic conditions for disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.c


Ocular Disorders


To suppress a variety of allergic and nonpyogenic ocular inflammations.c


To reduce scarring in ocular injuries.c


For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, anterior segment inflammation, optic neuritis, sympathetic ophthalmia, temporal arteritis).a c d e f m


Acute optic neuritis optimally treated with initial high-dose IV therapy followed by chronic oral therapy. Assists in recovery of vision and slows progression to clinically definite multiple sclerosis.


Less severe allergic and inflammatory allergic conditions of the eye are treated with topical (to the eye) corticosteroids.g


Topically applied glucocorticoids appear to be as effective as systemic steroids for the treatment of most anterior ocular inflammations.c


Systemically in stubborn cases of anterior segment eye disease and when deeper ocular structures are involved.c


Asthma


Adjunctively for moderate to severe exacerbations of asthma and for maintenance in persistent asthma.c g


Systemically (oral or IV) for treatment of moderate to severe acute exacerbations of asthma (oral prednisone usually preferred); speeds resolution of airflow obstruction and reduces rate of relapse.g


Because onset of effects is delayed, do not use alone for emergency treatment.c


Early systemic glucocorticoid therapy particularly important for asthma exacerbations in infants and children.g


In hospital management of an acute asthma exacerbation, may give systemic adjunctive glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids were used as self-medication prior to hospitalization, or if the episode is severe.c


For severe persistent asthma once initial control is achieved, high dosages of inhaled corticosteroids are preferable to oral glucocorticoids for maintenance because inhaled corticosteroids have fewer systemic effects.


Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment for adults and children with mild persistent asthmac (i.e., patients with daytime symptoms of asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma more than twice per month).b


Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations of asthma when response to a short-acting inhaled β2-agonist is not prompt or sustained after 1 hour or in those who have a history of severe exacerbations.c


Oral glucocorticoids with minimal mineralocorticoid activity and relatively short half-life (e.g., prednisone, prednisolone, methylprednisolone) are preferred.


COPD


For severe exacerbations of COPD, a short (e.g., 1–2 weeks) course of oral glucocorticoids can be added to existing therapy.


Effects in stable COPD are much less dramatic than in asthma, and role of glucocorticoids in the management of stable COPD is limited to very specific indications.


Croup


Adjunctive treatment of croup in pediatric patients.g


Decreases edema in laryngeal mucosa.g


Reduces need for hospitalization, shorter duration of hospitalization, and reduces need for subsequent interventions (e.g., epinephrine).g


Sarcoidosis


Management of symptomatic sarcoidosis.a c d e f m


Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.c


Advanced Pulmonary and Extrapulmonary Tuberculosis


Systemically as adjunctive therapy with effective antimycobacterial agents (e.g., streptomycin, isoniazid) to suppress manifestations related to the host’s inflammatory response to the bacillus (Mycobacterium tuberculosis) and ameliorate complications in severe pulmonary or extrapulmonary tuberculosis.a m


Adjunctive glucocorticoid therapy may enhance short-term resolution of disease manifestations (e.g., clinical and radiographic abnormalities) in advanced pulmonary tuberculosis and also may reduce mortality associated with certain forms of extrapulmonary disease (e.g., meningitis, pericarditis).


Systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment) and/or improve survival in moderate to severe tuberculous meningitis; used in the treatment of tuberculous meningitis with subarachnoid block or impending block concurrently with appropriate antituberculous chemotherapy.a d e f m


Systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably through control of hemodynamically threatening effusion) in acute tuberculous pericarditis.


Hastens the resolution of pain, dyspnea, and fever associated with tuberculous pleurisy.c


Lipid Pneumonitis


Promotes the breakdown or dissolution of pulmonary lesions and eliminates sputum lipids in lipid pneumonitis.c


Pneumocystis jiroveci Pneumonia


Systemic adjunctive glucocorticoids decrease the likelihood of deterioration of oxygenation, respiratory failure, and/or death in moderate to severe Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia in AIDS.


Prevents early deterioration in oxygenation associated with antipneumocystis therapy; initiate adjunctive glucocorticoid therapy as early as possible in moderate to severe pneumocystis pneumonia.


Not known whether patients with mild pneumocystis pneumonia (arterial oxygen pressure >70 mm Hg or arterial-alveolar gradient <35 mm Hg on room air) will have clinically important benefit with adjunctive glucocorticoid therapy.


Oral prednisone or parenteral methylprednisolone generally is preferred.


Loeffler’s Syndrome


Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.a f


Berylliosis


Symptomatic relief of acute manifestations of berylliosis.a d f m


Aspiration Pneumonitis


Symptomatic relief of acute manifestations of aspiration pneumonitis.a d f


Anthrax


Adjunct to anti-infective therapy in the treatment of anthrax in an attempt to ameliorate toxin-mediated effects associated with Bacillus anthracis infections.


For cutaneous anthrax if there are signs of systemic involvement or extensive edema involving the neck and thoracic region, anthrax meningitis, and inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism if extensive edema, respiratory compromise, or meningitis is present.


Hematologic Disorders


Management of acquired (autoimmune) hemolytic anemia, pure red cell aplasia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or congenital (erythroid) hypoplastic anemia.a d e f m


High or even massive dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.c


Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for moderate to severe ITP, depending on the extent of bleeding involved.


May not affect or prevent renal complications in Henoch-Schoenlein purpura.c


Insufficient evidence of effectiveness in aplastic anemia in children, but widely used.c


Shock


Although IV glucocorticoids may be life-saving in shock secondary to adrenocortical insufficiency (see Adrenocortical Insufficiency under Uses), the value of the drugs in the treatment of shock resulting from other causes is controversial.c


Management of shock should be based on specific treatment of the primary cause and secondary abnormalities, and glucocorticoids, if used, should be regarded only as adjunctive supportive treatment.c


Value in adjunctive treatment of septic shock is particularly controversial. Conflicting evidence regarding effects of high-dose regimens on morbidity and mortality in septic shock. In a clinical study, methylprednisolone was ineffective in the treatment of sepsis syndrome and septic shock, and may increase the risk of mortality in certain patients (i.e., patients with increased Scr or those who develop secondary infections after treatment).e


Pericarditis


To reduce the pain, fever, and inflammation of pericarditis, including that associated with MI.c


Glucocorticoids can provide effective symptomatic relief, but aspirin considered the treatment of choice for post-MI pericarditis because of greater evidence establishing benefit.


Important to distinguish between pain caused by pericarditis and that caused by ischemia since management will differ.


Consider possibility that cardiac rupture may account for recurrent pain since use of glucocorticoids may be a risk factor in its development.


Glucocorticoids may cause thinning of developing scar and myocardial rupture.


Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses.)


GI Diseases


Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis, regional enteritis (Crohn's disease), and celiac disease.a c d e f m


Do not use if a probability of impending perforation, abscess, or other pyogenic infection.e


Rarely indicated for maintenance therapy in chronic GI diseases (e.g., ulcerative colitis, celiac disease) since does not prevent relapses and may produce severe adverse reactions with long-term administration.c


Occasionally, low dosages, in conjunction with other supportive therapy, may be useful for disease unresponsive to the usual therapy indicated for chronic conditions.c


Management of mildly to moderately active and moderately to severely active Crohn's disease .


Parenteral glucocorticoids recommended for patients with severe fulminant Crohn's disease. Once patients respond to parenteral therapy, they should gradually be switched to an equivalent regimen of an oral glucocorticoid.


Some experts state that glucocorticoids should not be used for the management of mildly to moderately active Crohn's disease because of the high incidence of adverse effects and their use should be reserved for patients with moderately to severely active disease.


Glucocorticoids should not be used for maintenance therapy of chronic GI diseases (e.g., ulcerative colitis, Crohn's disease) because they usually do not prevent relapses and the drugs may produce severe adverse effects with long-term administration.a c


Glucocorticoids have been used in the management of moderately to severely active Crohn’s disease and in mild esophageal or gastroduodenal Crohn's disease in pediatric patients.


Neoplastic Diseases


Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).a d e f m


Treatment of breast cancer; glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.c


Glucocorticoids alone or as a component of various combination chemotherapeutic regimens for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate cancer.


Cancer Chemotherapy-induced Nausea and Vomiting


Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.


Cerebral Edema


To decrease cerebral edema associated with brain tumors and neurosurgery.c d m


Cerebral edema associated with pseudotumor cerebri may also benefit, but efficacy of glucocorticoids is controversial and remains to be established.c


Edema resulting from brain abscesses is less responsive than that resulting from brain tumors.c


Pharmacologic management of cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.c d f


Head Injury


Efficacy of glucocorticoid therapy is not established in patients with head injury; such therapy can be detrimental and is associated with a substantial increase in risk of death. Use to improve outcome or reduce intracranial pressure not recommended in patients with head injury.


Cerebral Malaria


Glucocorticoids are not effective and can have detrimental effects in the management of cerebral malaria caused by Plasmodium falciparum; no longer recommended for this condition.c


Acute Spinal Cord Injury


Some evidence indicates that large IV doses of glucocorticoids (i.e., methylprednisolone) can improve motor and sensory function in patients with acute spinal cord injury when treatment is initiated promptly following injury (within 8 hours). It is not known whether improvement in neurologic function with such therapy will routinely lead to specific improvements in disability.


Low Back Pain


Has been used epidurally (alone or combined with a local anesthetic and/or an opiate analgesic) for symptomatic relief of low back pain; although use remains controversial and convincing evidence of efficacy is lacking, most experts consider such therapy an option for short-term relief of acute, subacute, or chronic radicular pain in patients with low back pain and radiculopathy associated with disk disease or herniation or spinal stenosis when more conservative therapies (e.g., rest, analgesics, physical therapy) fail and as a means of potentially avoiding surgery.


Limited evidence suggests that therapeutic facet joint and intradiscal glucocorticoid injections are minimally effective or ineffective in the treatment of low back pain, although facet joint injections may be useful in some patients with facet arthropathy. Inclusion of a glucocorticoid in trigger point injections does not appear to be beneficial.


Sacroiliac joint injections performed using fluoroscopic guidance may provide temporary pain relief in some patients when the principal source of spinal pain is the sacroiliac joint.


Oral glucocorticoids have been used; however, they do not appear to be effective and evidence supporting such use is lacking.


Bacterial Meningitis


Limited data in animals suggest that dexamethasone may be superior to methylprednisolone in reversing certain CSF abnormalities (e.g., intracranial hypertension, elevated lactate concentrations) associated with bacterial meningitis, and experience is insufficient to allow recommendation of glucocorticoids other than dexamethasone for adjunctive therapy in bacterial meningitis.


Short-term IV adjunctive therapy with dexamethasone is preferred.


Multiple Sclerosis


Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosisa d m and have replaced corticotropin as the therapy of choice because of a more rapid onset of action, more consistent effects, and fewer adverse effects.


Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.


Shortens the duration of relapse and accelerates recovery; remains to be established whether the overall degree of recovery improves or the long-term course is altered.


Myasthenia Gravis


Management of myasthenia gravis, usually when there is an inadequate response to anticholinesterase therapy.


Parenterally for the treatment of myasthenic crisis.


Organ Transplants


In massive dosage, used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs.c


Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.c


Trichinosis


Treatment of trichinosis with neurologic or myocardial involvement.a d e f


Nephrotic Syndrome and Lupus Nephritis


Treatment of idiopathic nephrotic syndrome without uremia.a d e f


Can induce diuresis and remission of proteinuria in nephrotic syndromea c d e f m secondary to lupus erythematosus or primary renal disease, especially when there is minimal renal histologic change.b d m


Treatment of lupus nephritis.a d e


Carpal Tunnel Syndrome


Local injection of glucocorticoids (e.g., methylprednisolone, betamethasone) into the tissue near the carpal tunnel has been used in a limited number of patients to relieve symptoms (e.g., pain, edema, sensory deficit) of carpal tunnel syndrome.


Methylprednisolone Sodium Succinate Dosage and Administration


General



  • Route of administration and dosage depend on the condition being treated and the patient response.a



Alternate-day Therapy



  • Alternate-day therapy in which a single dose (twice the usual daily dosage) is administered every other morning is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions.a c This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.a c




  • If alternate-day therapy is preferred, only use a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., methylprednisolone, prednisone, prednisolone).c




  • Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.c



Discontinuance of Therapy



  • A steroid withdrawal syndrome consisting of lethargy, fever, and myalgia can develop following abrupt discontinuance.c Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).c




  • If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.c




  • Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs following long-term therapy with pharmacologic dosages.c d e m (See Adrenocortical Insufficiency under Warnings.)




  • Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.c




  • Many methods of slow withdrawal or “tapering” have been described.c




  • In one suggested regimen, decrease by 2–4 mg every 3–7 days of until the physiologic dose (4 mg) is reached.c




  • Other recommendations state that decrements usually should not exceed 2 mg every 1–2 weeks.c




  • When a physiologic dosage has been reached, single 20-mg oral morning doses of hydrocortisone can be substituted for whatever glucocorticoid the patient has been receiving.c After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily is reached.c




  • For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute exacerbations of chronic allergic conditions, glucocorticoids may be administered short term (e.g., for 6 days).c Administer an initially high dose on the first day of therapy, and then withdraw therapy by tapering the dose over several days.c



Administration


Administer orally, by IV injection or infusion, or IM injection.a d e f m


Administer for local effect by intra-articular, intralesional, intrasynovial, soft-tissue, or epidural injection.c d m


Generally reserve IM or IV therapy for patients who are not able to take the drug orally or for use in an emergency situation.d e After the initial emergency period, a longer-acting injectable corticosteroid preparation or oral administration of a corticosteroid should be considered.b


Methylprednisolone acetate injections (in multiple-dose vials) contain benzyl alcohol; do not administer intrathecally because of reports of severe adverse events with such use.m


Oral Administration


Methylprednisolone

Administer orally as tablets.a


IV Administration


Methylprednisolone Sodium Succinate

Administer by IV injection or infusion.e


Reconstitution of Methylprednisolone Sodium Succinate

Reconstitute by pressing on a plastic activator to force the diluent provided from the manufacturer from an upper compartment of a 2-compartment vial to a lower compartment containing sterile powder.e Alternately, use bacteriostatic water for injection with benzyl alcohol for reconstitution.e


Dilution of Methylprednisolone Sodium Succinate

When administered by IV infusion, the drug can be added to 5% dextrose, or 0.9% sodium chloride, or 5% dextrose in sodium chloride injection.e


Rate of Administration of Methylprednisolone Sodium Succinate

Direct IV injection: Administer over a period of several minutes.e


IM Administration


Do not administer IM for conditions prone to bleeding (e.g., idiopathic thrombocytopenic purpura [ITP]).e


Methylprednisolone Acetate

Administer by IM injection.d m


Because it is slowly absorbed, IM administration is not indicated when an immediate effect of short duration is required.d


Commercially available single-dose vials are for single use only.d m Although initially sterile, multiple use of a single-dose vial may result in contamination, unless strict aseptic technique is observed.m


Methylprednisolone Sodium Succinate

Administer by IM injection.e


Absorption from IM injection sites is rapid.b


Intra-articular, Intralesional, and Soft Tissue Administration


Methylprednisolone Acetate

Administer by intra-articular, intralesional, intrasynovial, or soft tissue injection.b d m (See Dermatologic Effects under Cautions.)


May infiltrate the tissue surrounding the joint with a local anesthetic (e.g., procaine hydrochloride) before administration of methylprednisolone acetate.b d


Examine joint fluid to exclude sepsis and avoid injection into an infected site; if joint sepsis is evident, institute appropriate antibacterial therapy.c d m Symptoms of septic arthritis include local swelling, further restriction of joint motion, fever, or malaise.c d m Do not inject glucocorticoids into unstable joints and caution patients not to overuse joints in which the inflammatory process still is active despite symptomatic improvement.c


Epidural Administration


Long-acting injectable suspension has been administered by epidural injection, although safety of epidural injections using preserved formulations is controversial and epidural administration of these formulations is not recommended by the manufacturer.c Limited evidence suggests that large particles in glucocorticoid suspensions may cause embolic vascular occlusion following inadvertent intra-arterial injection.


Inject into the epidural space near the site where the nerve roots pass before entering the intervertebral foramen.


Epidural injections may be performed by caudal, interlaminar, or transforaminal approaches; the transforaminal approach requires the smallest injection volume and appears to be the most specific and possibly most effective route.


Because of the potential for complications related to improper needle placement or drug administration, many experts state that epidural injections should be performed by an experienced clinician using fluoroscopic guidance and contrast control to ensure that the needle is correctly positioned and that the injection is not performed intravascularly, intrathecally, or into tissues other than the epidural space.


Optimal technique, dosage, timing of initial injection, injection frequency, and maximum number of injections remain to be established.


Dosage


Available as methylprednisolone, methylprednisolone acetate, and methylprednisolone sodium succinate.a b d e m Dosage of methylprednisolone sodium succinate or methylprednisolone acetate is expressed in terms of methylprednisolone or methylprednisolone acetate, respectively.d e m


After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.a b e


Monitor patients continually for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).b


High dosages may be required for acute situations of certain rheumatic disorders and collagen diseases; after a response has been obtained, drug often must be continued for long periods at low dosage.c


High or massive dosages may be required in the treatment of pemphigus, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides.c Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris.c Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.c d m


Massive dosages may be required for treatment of shock.b


Increase dosage of rapidly acting corticosteroids in patients subjected to any unusual stress before, during, and after the stressful situation.a d e m


Pediatric Patients


Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.b e


Usual Dosage

Oral

0.117–1.66 mg/kg daily or 3.3–50 mg/m2 daily, administered in 3 or 4 divided doses.b


IM

Methylprednisolone sodium succinate: 0.03–0.2 mg/kg or 1–6.25 mg/m2 IM 1–2 times daily has been used.b


Asthma

Oral

To gain prompt control of asthma in infants and children ≤4 years of age with very poorly controlled, moderate-to-severe asthma (i.e., >3 exacerbations per year requiring oral corticosteroids) and in children 5–11 years of age with asthma of comparable control and severity (i.e., ≥2 exacerbations per year requiring oral corticosteroids): Methylprednisolone 1–2 mg/kg daily (maximum 60 mg daily) may be added to existing asthma therapy.


In children ≤11 years of age undergoing emergency department treatment for moderate-to-severe acute asthma exacerbations not controlled with an inhaled β2-adrenergic agonist: May add methylprednisolone 1–2 mg/kg daily in 2 divided doses (maximum 60 mg daily). Continue treatment until patient achieves a PEF of 70% of predicted or personal best.


Allergic Conditions

IM

Methylprednisolone acetate: For control of severe or incapacitating allergic conditions (e.g., bronchial asthma, seasonal or perennial allergic rhinitis) intractable to adequate trials of conventional therapy, initially, 1–2 mg/kg.


To gain prompt control of asthma in infants and children ≤4 years of age or children ≥5 years of age with very poorly-controlled, moderate-to-severe asthma (as an alternative to a short course of an oral corticosteroid) who are vomiting or noncompliant with oral corticosteroid therapy: 7.5 mg/kg or 240 mg as a single dose of methylprednisolone acetate, respectively. Relief of asthma symptoms should occur within 6–48 hours and persist for several days to 2 weeks.d


Relief of coryzal symptoms of allergic rhinitis should occur within 6 hours and persist for several days to 3 weeks.d


IV

Methylprednisolone sodium succinate: For control of severe or incapacitating allergic conditions (e.g., bronchial asthma) intractable to adequate trials of conventional therapy, initially, 1–2 mg/kg.


Croup

IV

Methylprednisolone sodium succinate: Initialy, 1–2 mg/kg.


Pneumocystis jiroveci Pneumonia

IV

Methylprednisolone sodium succinate in children >13 years of age with AIDS and moderate to severe Pneumocystis jiroveci pneumonia: 30 mg twice daily for 5 days, followed by 30 mg once daily for 5 days, and then 15 mg once daily for 11 days (or until completion of the anti-infective regimen). Initiate within 24–72 hours of initial antipneumocystis therapy.


Acute Spinal Cord Injury

IV

Methylpred