Generic Name: aceclofenac
Dosage Form: tablet, film coated
DESCRIPTION
White, oblong, film-coated tablet, engraved with "UT" on one side and "CL CR" on the other side.
INDICATIONS
Clanza CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.
Dosage and Administration
Adults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours). However, the dose and dose frequency of Clanza CR can be modified under the supervison of physician or pharmacist.
CONTRAINDICATIONS
Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.
CAUTIONS
Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastroulceration. Patients with severe hepatic impairment or cardiac or renal impairment. Patients under the medication of diuretics. Patients in recovery after surgical treatment.
ADVERSE REACTIONS
The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness. To report suspected adverse reactions, call 1-800-FDA-1088.
GENERAL PRECAUTIONS
Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.
DRUG INTERACTIONS
There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics.
USE IN PREGNANCY AND NURSING MOTHERS
Since there is no information on the safe use of Clanza CR during pregnancy and lactation, the use of Clanza CR should therefore be avoided in pregnancy and lactation.
USE IN CHILDREN
The dosage and indication is not established yet for children with less than 6 years old.
OVERDOSAGE
There are no human data available on the consequences of Clanza CR overdosage. If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.
STORAGE
Preserve in tight containers. Store at room temperature not exceeding 30oC.
SHELF LIFE
Three (3) years from manufacturing date. Do not exceed the expiry date for use printed on the box.
PACKAGE
10 Blister Packs with 10 Tablets in each Blister Pack
Enter section text here
label test
| CLANZA CR aceclofenac tablet, film coated | ||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Export only | 05/12/2011 | ||
| Labeler - United Douglas Pharm., Inc. (001444350) |
| Registrant - United Douglas Pharm., Inc. (001444350) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| United Douglas Pharm., Inc. | 001444350 | pack, label | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Korea United Pharm Inc. | 688016534 | manufacture | |
No comments:
Post a Comment