CLANZA CR- aceclofenac tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Aceclofenac (UNII: RPK779R03H) (Aceclofenac - UNII:RPK779R03H)
Available from:
United Douglas Pharm., Inc.
INN (International Name):
Aceclofenac
Composition:
Aceclofenac 200 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
INDICATIONS CLANZA CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism. 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. USE IN CHILDREN The dosage and indication is not established yet for children with less than 6 years old.
Product summary:
PACKAGE 10 Blister Packs with 10 Tablets in each Blister Pack
Authorization status:
Export only
Authorization number:
65697-450-20, 65697-450-21, 65697-450-22

CLANZA CR- aceclofenac tablet, film coated

United Douglas Pharm., Inc.

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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 30 C.

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

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 56 9 7-450

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceclo fena c (UNII: RPK779 R0 3H) (Aceclo fenac - UNII:RPK779 R0 3H)

Ac e c lo fe na c

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

La cto se Mo no hydra te (UNII: EWQ57Q8 I5X)

Cellulo se, Micro crysta lline (UNII: OP1R32D6 1U)

So dium Ca rbo na te (UNII: 45P326 1C7T)

Co llo ida l Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Cro spo vido ne (UNII: 6 8 40 19 6 0 MK)

Po lo xa mer 4 0 7 (UNII: TUF2IVW3M2)

United Douglas Pharm., Inc.

Ma g nesium Stea ra te (UNII: 70 0 9 7M6 I30 )

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Hypro mello se 2 2 0 8 ( 150 0 0 MPA.S) (UNII: Z78 RG6 M2N2)

Ca rbo mer 9 4 1 (UNII: F6 8 VH75CJC)

Hypro mello se 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Methylene Chlo ride (UNII: 58 8 X2YUY0 A)

Hypro mello se 2 9 10 ( 5 MPA.S) (UNII: R75537T0 T4)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

Ethylcellulo ses (UNII: 7Z8 S9 VYZ4B)

Diethyl Phtha la te (UNII: UF0 6 4M0 0 AF)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL (Film-co ated white o blo ng tablet)

S iz e

15mm

Flavor

Imprint Code

UT;CR;CT

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 56 9 7-450 -20

1 in 1 PACKET

2

NDC:6 56 9 7-450 -22

10 in 1 CARTON

2

NDC:6 56 9 7-450 -21

10 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Expo rt o nly

0 5/12/20 11

Labeler -

United Douglas Pharm., Inc. (001444350)

Registrant -

United Douglas Pharm., Inc. (001444350)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

United Do uglas Pharm., Inc.

0 0 1444350

pack, label

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ko rea United Pharm Inc.

6 8 8 0 16 534

ma nufa c ture

Revised: 11/2011

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