Your browser does not support JavaScript! CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]
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CLANZA CR (aceclofenac) tablet, film coated
[United Douglas Pharm., Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Export only
Drug Label Sections

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 Package Label

CLANZA  CR
aceclofenac tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:65697-450
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aceclofenac (Aceclofenac) Aceclofenac200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVAL (Film-coated white oblong tablet) Size15mm
FlavorImprint Code UT;CR;CT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65697-450-201 in 1 PACKET
2NDC:65697-450-2210 in 1 CARTON
2NDC:65697-450-2110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only05/12/2011
Labeler - United Douglas Pharm., Inc. (001444350)
Registrant - United Douglas Pharm., Inc. (001444350)
Establishment
NameAddressID/FEIBusiness Operations
United Douglas Pharm., Inc.001444350pack, label
Establishment
NameAddressID/FEIBusiness Operations
Korea United Pharm Inc.688016534manufacture

Revised: 11/2011
 
United Douglas Pharm., Inc.

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