Clanza CR

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

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label test

CLANZA  CR
aceclofenac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65697-450
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aceclofenac (Aceclofenac) Aceclofenac 200 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate  
Cellulose, Microcrystalline  
Sodium Carbonate  
Colloidal Silicon Dioxide  
Crospovidone  
Poloxamer 407  
Magnesium Stearate  
Alcohol  
Hypromellose 2208 (15000 MPA.S)  
Carbomer 941  
Hypromellose 2910 (6 MPA.S)  
Alcohol  
Methylene Chloride  
Hypromellose 2910 (5 MPA.S)  
Titanium Dioxide  
Ethylcelluloses  
Diethyl Phthalate  
Product Characteristics
Color white Score no score
Shape OVAL (Film-coated white oblong tablet) Size 15mm
Flavor Imprint Code UT;CR;CT
Contains         
Packaging
# Item Code Package Description
1 NDC:65697-450-20 1 TABLET, FILM COATED (TABLET) in 1 PACKET
2 NDC:65697-450-22 10 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 NDC:65697-450-21 10 TABLET, FILM COATED (PACKET) in 1 BLISTER PACK
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
Revised: 11/2011
 
United Douglas Pharm., Inc.



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