AccessPak for HIV PEP Expanded with Viracept

Generic Name: emtricitabine, nelfinavir, and tenofovir (em trye SYE ta been, nel FIN a veer, ten OF oh vir)

Brand Names: AccessPak for HIV PEP Expanded with Viracept

What is AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

Emtricitabine, nelfinavir, and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in your body.

The combination of emtricitabine, nelfinavir, and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

Emtricitabine, nelfinavir, and tenofovir may also be used for purposes not listed in this medication guide.

What is the most important information I should know about AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

You should not take this medication if you have severe liver or kidney disease, or if you are allergic to emtricitabine (Emtriva, Atripla), nelfinavir (Viracept), or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other drugs that can cause serious or life threatening medical problems if you take them together with this medication. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Some people develop lactic acidosis while taking emtricitabine or tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What should I discuss with my healthcare provider before taking AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

You should not take this medication if you have severe liver or kidney disease, or if you are allergic to emtricitabine (Emtriva, Atripla), nelfinavir (Viracept), or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other drugs that can cause serious or life threatening medical problems if you take them together with emtricitabine, nelfinavir, and tenofovir. The following drugs should not be used while you are taking this medication:

• 
  

  amiodarone (Cordarone, Pacerone);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  pimozide (Orap);

  
  


• 
  

  midazolam (Versed) or triazolam (Halcion); or

  
  


• 
  

  an ergot medicine such as D.H.E. 45, Ergomar, Cafergot, Ergotrate, Methergine, Migergot, or Migranal.

  
  

To make sure you can safely take emtricitabine, nelfinavir, and tenofovir, tell your doctor if you have any of these other conditions:

• 
  

  diabetes;

  
  


• 
  

  a bleeding or blood-clotting disorder such as hemophilia;

  
  


• 
  

  high cholesterol or triglycerides (a type of fat in the blood);

  
  


• liver or kidney disease;


• 
  

  osteopenia (low bone mineral density); or

  
  


• 
  

  if you also have hepatitis B infection.

  
  

Some people develop a life-threatening condition called lactic acidosis while taking emtricitabine or tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. FDA pregnancy category B. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to a child younger than 2 years old without medical advice.

How should I take AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

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.

This medicine works best if you take it with food.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your kidney and liver function or bone density may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking emtricitabine, nelfinavir, and tenofovir, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using the medicine. Do not miss any follow-up visits to your doctor.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet of moisture-absorbing preservative that comes with this medicine.

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.

What should I avoid while taking AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

If you also take didanosine, take it 1 hour before or 2 hours after you take emtricitabine, nelfinavir, and tenofovir.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. Call your doctor at once if you have a serious side effect such as:

• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  increased thirst, urinating less than usual or not at all;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath; or

  
  


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  signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

  
  

Less serious side effects may include:

• 
  

  vomiting, diarrhea, bloating;

  
  


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  headache, tired feeling, dizziness, depressed mood;

  
  


• 
  

  sleep problems (insomnia), strange dreams;

  
  


• 
  

  runny or stuffy nose, cough; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

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 AccessPak for HIV PEP Expanded with Viracept (emtricitabine, nelfinavir, and tenofovir)?

Emtricitabine, nelfinavir, and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• 
  

  lithium (Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others;

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

You may need dose adjustments or special tests when taking any of these medications together with emtricitabine, nelfinavir, and tenofovir.

Many other drugs can interact with emtricitabine, nelfinavir, and tenofovir. Below is just a partial list:

• 
  

  antiviral medications for herpes or HIV;

  
  


• 
  

  antifungal medicine;

  
  


• 
  

  cholesterol-lowering medicines;

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  seizure medications; or

  
  


• 
  

  medicines to treat erectile dysfunction.

  
  

This list is not complete and other drugs may interact with emtricitabine, nelfinavir, and tenofovir. 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 AccessPak for HIV PEP Expanded with Viracept resources

• AccessPak for HIV PEP Expanded with Viracept Drug Interactions
• 0 Reviews for AccessPak for HIV PEP Expanded with Viracept - Add your own review/rating

Compare AccessPak for HIV PEP Expanded with Viracept with other medications

• HIV Infection

Where can I get more information?

• Your pharmacist can provide more information about emtricitabine, nelfinavir, and tenofovir.

Yariba Tablets

1. Name Of The Medicinal Product

YARIBA™ TABLETS

2. Qualitative And Quantitative Composition

Kola nut 250 mg.

3. Pharmaceutical Form

Round, slightly glossy film coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

A traditional herbal remedy used as a pick-me-up in temporary tiredness.

4.2 Posology And Method Of Administration

To be taken by mouth.

Adults and the elderly: One or two tablets three times a day.

Children under 14: Not recommended.

4.3 Contraindications

Do not use if sensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep medicines away from children. Because it contains glucose monohydrate, patients with rare glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Not recommended.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None reported.

4.9 Overdose

Occasionally slight insomnia. In emergency withdraw treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Kola is a stimulant, with the action of caffeine which it contains.

5.2 Pharmacokinetic Properties

No special information.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glucose Monohydrate; Maltodextrin; Sodium Starch Glycollate; Talc; Ethylcellulose; Magnesium Stearate; Sodium Chlorophyllin.

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

White plastic container with tamper-evident cap, containing 50 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Diomed Herbals

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

8. Marketing Authorisation Number(S)

17418/0012.

9. Date Of First Authorisation/Renewal Of The Authorisation

29 January 2006.

10. Date Of Revision Of The Text

April 2008.

AN-DTPA

pentetate calcium trisodium

Dosage Form: injection

AN-DTPA Description

AN-DTPA® Kit for the Preparation of Technetium Tc 99m Pentetate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pentetate Injection for diagnostic use by intravenous injection.

Each 10 mL reaction vial contains 20.6 mg pentetate calcium trisodium, 0.15 mg minimum stannous tin as stannous chloride dihydrate and 0.30 mg maximum total tin as stannous chloride dihydrate in lyophilized form and sealed under nitrogen. The pH is adjusted to 3.9-4.1 with sodium hydroxide and/or hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present.

The active agent is a Technetium Tc 99m complex of pentetate calcium trisodium. The chemical names and structure for pentetate calcium trisodium are: (1) Calciate (3-), [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]-,trisodium;(2)Trisodium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]-calciate(3-).

When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection is added to the vial, Technetium Tc 99m Pentetate Injection is formed. The product so derived is intended for intravenous injection within 6 hours of the time of reconstitution. The precise structure of Technetium Tc 99m Pentetate Injection if not known at this time.

Physical Characteristics

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1.

Table 1. Principal Radiation Emission Data

Radiation	Mean Percent Per Disintegration	Mean Energy (keV)
Gamma-2	89.07	140.5

 1Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981

External Radiation

The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1 cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm	Coefficient of Attenuation
0.017	0.5
0.08	10-1
0.16	10-2
0.25	10-3
0.33	10-4

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart: Tc 99m, half-life 6.02 hours

Hours	Fraction Remaining	Hours	Fraction Remaining
0*	1.000	7	0.447
1	0.891	8	0.398
2	0.794	9	0.355
3	0.708	10	0.316
4	0.631	11	0.282
5	0.562	12	0.251
6	0.501

*Calibration time

AN-DTPA - Clinical Pharmacology

Following its intravenous administration. Technetium Tc 99m Pentetate Injection rapidly distributes itself throughout the extracellular fluid space from which it is promptly cleared from the body by glomerular filtration. There should be little or no binding of the chelate by the renal parenchyma. A variable percentage of the Technetium Tc 99m Pentetate binds to the serum proteins; this ranges from 3.7% following a single injection to approximately 10% if the material is continuously infused. Although the chelate gives useful information on the glomerular filtration rate, the variable percent which is protein bound leads to a measured clearance rate which is lower than that determined by inulin clearance.

The images of the kidneys obtained in the first few minutes after administration of Technetium Tc 99m Pentetate Injection represent the vascular pool within the kidney. Subsequent images of the kidneys represent radioactivity which is in the urine of both the collecting system and the renal pelvis.

Technetium Tc 99m Pentetate Injection tends to accumulate in intracranial lesions with excessive neovascularity or an altered blood-brain barrier. It does not accumulate in the choroid plexus.

Indications and Usage for AN-DTPA

Technetium Tc 99m Pentetate Injection may be used to perform kidney imaging, brain imaging, to assess renal perfusion and to estimate glomerular filtration rate.

Contraindications

None known.

Warnings

None.

Precautions

General

The components of the kit are sterile and non-pyrogenic. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.

Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Pentetate Injection and are NOT to be administered directly to the patient.

The contents of the kit before preparation are not radioactive. However, after the Sodium Pertechnetate Tc 99m Injection is added, adequate shielding of the final preparation must be maintained.

The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. Hence, Sodium PertechnetateTc 99m Injection containing oxidants should not be employed.

To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately after the examination and as often thereafter as possible for the next 4-6 hours.

The image quality may be adversely affected by impaired renal function. Literature reports indicate that the target to non-target ratio for intracranial lesions may take several hours to develop fully, and the possibility of missing certain lesions when imaging is restricted to the early period after injection should be borne in mind.

Technetium Tc 99m Pentetate Injection should be formulated within six (6) hours prior to clinical use for brain and kidney imaging, and for assessing renal perfusion. For estimating glomerular filtration rates, Technetium Tc 99m Pentetate Injection should be used within one (1) hour after formulation. The preparation contains no bacteriostatic preservative and should be stored at 15-30° C.

High background counts, poor images and erroneous clearance results have been observed with use of kits exceeding expiration time, owing to inadequate labeling.

AN-DTPA® contains no preservative.

Vials are sealed under nitrogen: air or oxygen is harmful to the contents of the vials and the vials should not be vented.

The components of the AN-DTPA® are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals for sterile, non-pyrogenic containers should be used during addition of the pertechnetate solution and the withdrawal of doses for patient administration.

No special handling is required for the non-radioactive drug product.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Technetium Tc 99m Pentetate Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Pentetate Injection affects fertility in males and females. Mutagenesis studies have not been conducted.

Pregnancy Category C

Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Pentetate Injection. It is also not known whether Technetium Tc 99m Pentetate Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc 99m Pentetate Injection should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula feeding should be substituted for breast feeding.

GERIATRIC USE

Clinical studies of AN-DTPA® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Pyrogenic and allergic reactions to Technetium Tc 99m Pentetate Injection preparations have been reported in the literature.

AN-DTPA Dosage and Administration

Shielding should be utilized when preparing Technetium Tc 99m Pentetate Injection.

The suggested dose range of Technetium Tc 99m Pentetate Injection for intravenous administration, after reconstitution with oxidant-free Sodium Pertechnetate Tc 99m Injection to be administered to the average adult patient (70 kg) is:

Kidney imaging and glomerular

filtration rate estimation                             111 - 185 megabecquerels

                                                                     (3 - 5 mCi)

Brain imaging or assessment of

renal perfusion                                           370 - 740 megabecquerels

                                                                     (10 - 20 mCi)

Safety and effectiveness have not been established for doses of the drug containing more than 25 mg of pentetate calcium trisodium and 0.275 mg stannous chloride complexed with 740 megbequerels (20 millicuries) of Technetium Tc 99m.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should not be used if cloudy, discolored, or found to contain particulate matter.

Radiation Dosimetry

The estimated absorbed radiation doses2 to an average ADULT patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Pentetate Injection are shown in Table 4.

Table 4. Estimated Absorbed Radiation Doses and Effective Dose Equivalent Technetium Tc 99m Pentetate

Target Organ	mGy/740 MBq	rads/20 mCi
Kidneys	4.3	0.4
Urinary Bladder Wall	53.3	5.4
Testes	2.8	0.3
Ovaries	4.1	0.4
Effective Dose Equivalent	5.9 mSv	0.6 rem

2 Doses calculated using the model in MIRD Dose Estimate Report No. 12 (Journal Nuclear Medicine 24:503-505, 1984)

Radiation Doses to Hospital Personnel

The typical total body exposure to a person administering a maximum dose of 740 megabecquerels (20 mCi) of Technetium Tc 99m to a patient is about 0.02 mR.3

3Barrall RC, Smith SI: Personnel radiation exposure and protection from 99m Tc radiations. In Biophysical Aspects of the Medical Use of Technetium 99m, Kereiakes JG, Corey KR, eds, American Association of Physicists in Medicine, Monograph No 1, 1976, p77

How is AN-DTPA Supplied

The AN-DTPA®Kit for the Preparation of Technetium Tc 99m Pentetate Injection is supplied as a set of either 5 or 30 sterile, non-pyrogenic and capped 10mL vials. Each nitrogen-flushed vial contains in lyophilized form 20.6 mg pentetate calcium trisodium, 0.15 mg minimum stannous tin as stannous chloride dihydrate and 0.30 mg maximum total tin as stannous chloride dihydrate. The pH is adjusted to 3.9-4.1 with NaOH and/or HCl prior to lyophilization. Included in each 5-vial kit are one package insert and 10 radiation labels. Included in each 30-vial kit are one package insert and 60 radiation labels. Store the kit as packaged at 15-30° C.

Directions for Use

Technetium Tc 99m Pentetate Injection is prepared from AN-DTPA® by the following aseptic procedure:

1. Waterproof gloves should be worn during the preparation procedure. Remove the flip-off plastic cap from the AN-DTPA® vial and swab the top of the vial closure with alcohol to sterilize the surface.


2. Complete the radiation label and affix to the vial. Place the vial in an appropriate lead-capped radiation shield labeled and identified.


3. With a sterile shielded syringe, aseptically obtain 1-8 mL of a suitable, oxidant-free, sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection containing from 0.11-5.92 gigabecquerels (3-160 millicuries). Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial.


4. Swirl the contents of the vial for about one minute, or until the contents are completely dissolved, and let stand for 1-2 minutes.


5. Record time and date of preparation.


6. The radiochemical purity of the prepared radiopharmaceutical should be checked prior to patient administration.


7. Visually examine the vial contents to ascertain that it is free of particulates and discoloration prior to injection.


8. Withdrawals for administration must be made aseptically using a sterile shielded syringe. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.


9. The finished preparation should be discarded after six (6) hours, or, if used solely for the estimation of glomerular filtration rate, after one (1) hour. Store the reconstituted vial at 15-30°C.


10. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

NDC # 45567-0010-1 for 5 vial kits

NDC # 45567-0010-2 for 30 vial kits

This reagent kit for preparation of a radiopharmaceutical is approved for use by persons

licensed pursuant to Section 120.533, Code of Massachusetts Regulation 105, or under

equivalent license of the U.S. Nuclear Regulatory Commission of an Agreement State.

Manufactured by

CIS-US, INC.

5 DeAngelo Drive

Bedford, MA 01730

June 2003

RM 2A-001

AN-DTPA  pentetate calcium trisodium  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45567-0010 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Pentetate Calcium Trisodium (Pentetate Calcium Trisodium) Active 20.6 MILLILITER  In 1 VIAL stannous tin Inactive 0.15 MILLIGRAM  In 1 VIAL total tin Inactive 0.30 MILLIGRAM  In 1 VIAL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45567-0010-2 30 VIAL In 1 KIT contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the KIT (45567-0010-2) 2 45567-0010-1 5 VIAL In 1 KIT contains a VIAL 2 1 VIAL In 1 VIAL This package is contained within the KIT (45567-0010-1)

Revised: 03/2007CIS-US, INC.

More AN-DTPA resources

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

Compare AN-DTPA with other medications

• Radiation Emergency

Pulmicort Respules

Generic Name: budesonide (Inhalation route)

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.

• Pulmicort


• Pulmicort Flexhaler


• Pulmicort Respules


• Pulmicort Turbuhaler

In Canada

• Pulmicort Nebuamp


• Rhinocort Turbuhaler

Available Dosage Forms:

• Suspension


• Powder


• Solution


• Aerosol Powder


• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Pulmicort Respules

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

This medicine is available only with your doctor's prescription.

Before Using Pulmicort Respules

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 this medicine, 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 this medicine 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.

• Boceprevir


• Bupropion


• Telaprevir

Using this medicine 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.

• Erythromycin


• Itraconazole


• Ketoconazole

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or


• Measles or


• Herpes simplex virus infection of the eye or


• Infections (virus, bacteria, or fungus) or


• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

Proper Use of budesonide

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Pulmicort Respules. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.


• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.


• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.


• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.


• You do not have to prime it again after this, even if you have not used it for a long time.


• After the inhaler is primed, twist the cover and lift it off.


• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.


• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.


• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.


• Do not chew or bite on the mouthpiece.


• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.


• Repeat these steps if more than one dose is needed.


• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.


• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.


• Do not use a spacer with the Pulmicort Flexhaler™.


• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.


• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.


• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.


• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.


• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.


• Do not mix this liquid with other medicines.


• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.


• Each container has one dose of medicine.


• Place the unused containers back in the foil pouch. This will protect the medicine from light.


• Shake the container in a circular motion before using it.


• Hold the container upright and open it by twisting off the cap.


• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.


• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.


• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.


• After the dose is completed, wash your child's face to prevent skin irritation.


• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine 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 this medicine. 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 preventing an asthma attack:
  
  • For inhalation dosage form (powder inhaler):
    
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation dosage form (suspension in a nebulizer):
    
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    
    
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

Precautions While Using Pulmicort Respules

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pulmicort Respules 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:

More common

• Body aches or pain


• chills


• congestion


• cough


• diarrhea


• dryness or soreness of the throat


• fever


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• pain or tenderness around the eyes and cheekbones


• shivering


• shortness of breath or troubled breathing


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tender, swollen glands in the neck


• tightness of the chest or wheezing


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting

Less common

• Bruising


• darkening of the skin


• depression


• dizziness


• earache


• excessive muscle tone


• fainting


• fractures


• large, flat, blue, or purplish patches in the skin


• lower back or side pain


• muscle stiffness


• muscle tension or tightness


• painful or difficult urination


• redness or swelling in the ear


• skin rash


• sore mouth or tongue


• white patches in the mouth or on the tongue

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:

More common

• Back pain

Less common

• Acid or sour stomach


• belching


• change in taste or bad, unusual, or unpleasant (after) taste


• difficulty with breathing


• difficulty with moving


• dry mouth


• ear congestion


• headache, severe and throbbing


• heartburn


• indigestion


• muscle cramping


• neck pain


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep


• unexplained runny nose or sneezing


• weakness

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: Pulmicort 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 Pulmicort Respules resources

• Pulmicort Respules Side Effects (in more detail)
• Pulmicort Respules Use in Pregnancy & Breastfeeding
• Pulmicort Respules Drug Interactions
• Pulmicort Respules Support Group
• 1 Review for Pulmicort - Add your own review/rating

• Pulmicort Respules Concise Consumer Information (Cerner Multum)


• Pulmicort Respules Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Budesonide Professional Patient Advice (Wolters Kluwer)


• budesonide Concise Consumer Information (Cerner Multum)


• Budesonide Monograph (AHFS DI)


• Budesonide Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Entocort EC Prescribing Information (FDA)


• Entocort EC Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Pulmicort Flexhaler Prescribing Information (FDA)


• Pulmicort Turbuhaler Powder MedFacts Consumer Leaflet (Wolters Kluwer)

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Drugs associated with Borderline Personality Disorder

The following drugs and medications are in some way related to, or used in the treatment of Borderline Personality Disorder. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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• Symptoms and treatment for Borderline Personality Disorder

Drug List:

Abilify

Abilify-Discmelt-Orally-Disintegrating-Tablets

Clozaril

Deplin

Duleek-Dp

Fazaclo

Latuda

Seroquel

Seroquel-Xr-Sustained-Release-Tablets

Zervalx

Zyprexa

Zyprexa-Zydis-Orally-Disintegrating-Tablets

Cipro HC

Generic Name: ciprofloxacin and hydrocortisone otic (sih pro FLOCK sah sin and hye droe CORE tih sone OH tic)

Brand Names: Cipro HC

What is Cipro HC (ciprofloxacin and hydrocortisone otic)?

Ciprofloxacin is a fluoroquinolone antibiotic. Ciprofloxacin fights bacteria in the body.

Hydrocortisone is a steroid. It is used with ciprofloxacin to reduce inflammation caused by an infection.

Together, ciprofloxacin and hydrocortisone are used to treat ear infections.

Ciprofloxacin and hydrocortisone otic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Cipro HC (ciprofloxacin and hydrocortisone otic)?

Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and hydrocortisone otic is intended for use in the ears only. Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

What should I discuss with my healthcare provider before using Cipro HC (ciprofloxacin and hydrocortisone otic)?

Do not use ciprofloxacin and hydrocortisone otic if the ear drum (tympanic membrane) has ruptured (broken). It may be dangerous for medicine to get into the inner ear. A ruptured ear drum usually causes a considerable amount of pain. A decrease in hearing may also occur. Call your doctor if you suspect a ruptured ear drum. Your doctor will know if the ear drum is ruptured by looking into the ear with a special device (otoscope). Do not use ciprofloxacin and hydrocortisone otic without first talking to your doctor if you have had a previous allergic reaction to it or to another similar oral or topical medication such as:

• 
  

  a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), sparfloxacin (Zagam), or trovafloxacin (Trovan);

  
  


• 
  

  an oral or injectable steroid such as cortisone (Cortef, Cortone), dexamethasone (Decadron), hydrocortisone (Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone), and others; or

  
  


• 
  

  a topical steroid such as betamethasone (Diprosone, Diprolene), clobetasol (Temovate, Olux), fluocinolone (Synalar, Synemol, Fluonid), fluocinonide (Lidex), fluticasone (Cutivate), halobetasol (Ultravate), mometasone (Elocon), triamcinolone (Aristocort), and others.

  
  

You may not be able to use ciprofloxacin and hydrocortisone otic, or you may require a dosage adjustment or special monitoring during treatment.

Ciprofloxacin and hydrocortisone otic is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use ciprofloxacin and hydrocortisone otic without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether ciprofloxacin and hydrocortisone otic passes into breast milk. Do not use ciprofloxacin and hydrocortisone otic without first talking to your doctor if you are breast-feeding a baby.

How should I use Cipro HC (ciprofloxacin and hydrocortisone otic)?

Use ciprofloxacin and hydrocortisone otic exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you. Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and hydrocortisone otic is intended for use in the ears only.

In general, ciprofloxacin and hydrocortisone otic should be used as follows:

• 
  

  Warm the drops slightly by holding them in the hands for 1 or 2 minutes. Administration of cold drops into the ear may cause dizziness.

  
  


• 
  

  Have another person administer the drops whenever possible. Have the affected person lie on their side or tilt the ear up to make administering a drop easier.

  
  


• Gently shake the drops just before administration.


• 
  

  For adults, hold the earlobe up and back. For children, hold the earlobe down and back. This will allow the drops to run into the ear canal. Carefully instill the prescribed number of drops in the first ear.

  
  


• 
  

  Keep the ear tilted for approximately 30 to 60 seconds to allow the medication to penetrate the ear.

  
  


• 
  

  Repeat the process in the other ear if prescribed.

  
  

Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated. If you do not use all of the medication prescribed, the condition could return or worsen.

It is important to use ciprofloxacin and hydrocortisone otic regularly to get the most benefit.

Notify your doctor if the condition does not improve or appears to worsen.

Avoid getting water inside of the affected ear(s) during treatment with ciprofloxacin and hydrocortisone. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare provider.

Store ciprofloxacin and hydrocortisone otic at room temperature or in the refrigerator, away from moisture, heat, and direct light. Keep the bottle properly capped. Do not allow the medication to freeze.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of ciprofloxacin and hydrocortisone otic unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected or if the medication has been ingested.

Symptoms of a ciprofloxacin and hydrocortisone otic overdose are not known.

What should I avoid while using this medication?

Ear infections may sometimes cause dizziness or a loss of balance. Use caution when driving, operating machinery, or performing other hazardous activities if you experience dizziness or a loss of balance. Avoid getting water inside of the affected ear(s) during treatment with ciprofloxacin and hydrocortisone. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare provider.

Cipro HC (ciprofloxacin and hydrocortisone otic) side effects

Stop using ciprofloxacin and hydrocortisone otic and seek emergency medical attention or notify your doctor if you experience:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  skin rash; or

  
  


• 
  

  ear drainage, discharge, or worsening pain.

  
  

Other less serious side effects may also occur such as headache or itching in the ear. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my Cipro HC (ciprofloxacin and hydrocortisone otic)?

Do not use other ear drops during treatment with ciprofloxacin and hydrocortisone otic without first talking to your doctor.

Drugs other than those listed here may also interact with ciprofloxacin and hydrocortisone otic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Cipro HC resources

• Cipro HC Side Effects (in more detail)
• Cipro HC Dosage
• Cipro HC Use in Pregnancy & Breastfeeding
• Cipro HC Support Group
• 0 Reviews for Cipro HC - Add your own review/rating

• Cipro HC Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Cipro HC with other medications

• Acute Otitis Externa

Where can I get more information?

• Your pharmacist has more information about ciprofloxacin and hydrocortisone otic written for health professionals that you may read.

See also: Cipro HC side effects (in more detail)

Pram

Generic Name: chloroxylenol and pramoxine otic (KLOR oh ZYE le nol and pra MOX een OH tik)

Brand Names: Pramotic, Uni-Otic Ear Drops

What is Pram (chloroxylenol and pramoxine otic)?

Chloroxylenol is an antibiotic that fights bacteria in your body.

Pramoxine is an anesthetic. It is used to reduce itching and pain caused by ear infections.

The combination of chloroxylenol and pramoxine otic (for the ears) is used to treat ear infections.

Chloroxylenol and pramoxine otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about my Pram (chloroxylenol and pramoxine otic)?

You should not use this medication if you are allergic to it, or if you have a ruptured ear drum. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive or do anything that requires you to be awake and alert. Do not use other ear drops during treatment with chloroxylenol and pramoxine otic unless your doctor tells you to. Call your doctor if your infection does not improve, or if you have ear pain, burning or itching, hearing problems, or ear drainage or discharge.

What should I discuss with my healthcare provider before using Pram (chloroxylenol and pramoxine otic)?

You should not use this medication if you are allergic to it, or if you have a ruptured ear drum. Do not use chloroxylenol and pramoxine otic without telling your doctor if you are pregnant. Do not use chloroxylenol and pramoxine otic without telling your doctor if you are breast-feeding.

How should I use Pram (chloroxylenol and pramoxine otic)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down with your head tilted for at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out. Follow your doctor's instructions about the use of cotton.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your infection does not improve.

Store chloroxylenol and pramoxine otic at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of chloroxylenol and pramoxine otic is not likely to cause life-threatening symptoms.

What should I avoid while using this medication?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive or do anything that requires you to be awake and alert. Do not use other ear drops during treatment with chloroxylenol and pramoxine otic unless your doctor tells you to.

Pram (chloroxylenol and pramoxine otic) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  ear pain, burning, or itching;

  
  


• 
  

  hearing problems;

  
  


• 
  

  ear drainage or discharge; or

  
  


• 
  

  worsening pain, irritation, or rash.

  
  

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 my Pram (chloroxylenol and pramoxine otic)?

It is not likely that other drugs you take orally or inject will have an effect on chloroxylenol and pramoxine used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Pram resources

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

Compare Pram with other medications

• Otitis Externa

Where can I get more information?

• Your pharmacist can provide more information about chloroxylenol and pramoxine otic.

See also: Pram side effects (in more detail)

Neomycin,Polymyxin B,Gramicidin

Dosage Form: ophthalmic solution
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)

Rx only

DESCRIPTION:

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP is a sterile antimicrobial solution for ophthalmic use.

EACH mL CONTAINS: ACTIVES: Neomycin Sulfate, (equivalent to 1.75 mg neomycin base), Polymyxin B Sulfate equal to 10,000 Polymyxin B units, Gramicidin, 0.025 mg; INACTIVES: Sodium Chloride, Alcohol (0.5%), Poloxamer 188, Propylene Glycol, Purified Water. Hydrochloric Acid and/ or Ammonium Hydroxide may be added to adjust pH (4.7- 6.0).

PRESERVATIVE ADDED: Thimerosal 0.001%.

Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.

The structural formulae are:

Polymyxin B Sulfate is the sulfate salt of polymyxin Bl and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:

Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillusbrevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:

CLINICAL PHARMACOLOGY:

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.

Microbiology:

Neomycin sulfate, polymyxin B sulfate and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

INDICATIONS AND USAGE:

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

CONTRAINDICATIONS:

This product is contraindicated in those persons who have shown hypersensitivity to any of its components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.

The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter. (See PRECAUTIONS, General).

PRECAUTIONS:

General:

As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to this product may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or other allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or gramicidin. Treatment of cultured lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C. Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

DOSAGE AND ADMINISTRATION:

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW

HOW SUPPLIED:

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP is supplied in a plastic squeeze bottle with a controlled drop tip in the following size:

10 mL – Prod. No. 03409

Storage:

Store between 15° – 30° C (59°– 86° F).

PROTECT FROM LIGHT.

KEEP OUT OF REACH OF CHILDREN.

Revised August 2007

Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

9113400 (Folded)

9113500 (Flat)

PRINCIPAL DISPLAY PANEL

NDC 24208-790-62

Bausch & Lomb

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP

(Sterile)

Rx only

[icon- eye] [icon- solution] [icon- 10 mL]

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN  neomycin sulfate, polymyxin b sulfate and gramicidin  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-790 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 1.75 mg  in 1 mL POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [USP'U]  in 1 mL GRAMICIDIN (GRAMICIDIN) GRAMICIDIN 0.025 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-790-62 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-790-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064047	01/31/1996

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Xellia Pharmaceuticals		305814345	ANALYSIS, MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Xellia Pharmaceuticals		401172630	ANALYSIS, MANUFACTURE

Revised: 03/2011Bausch & Lomb Incorporated

More Neomycin,Polymyxin B,Gramicidin resources

• Neomycin,Polymyxin B,Gramicidin Side Effects (in more detail)
• Neomycin,Polymyxin B,Gramicidin Use in Pregnancy & Breastfeeding
• Neomycin,Polymyxin B,Gramicidin Support Group
• 0 Reviews for Neomycin,Polymyxin B,Gramicidin - Add your own review/rating

Compare Neomycin,Polymyxin B,Gramicidin with other medications

• Conjunctivitis, Bacterial