DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL- diclofenac sodium/misoprostol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1), MISOPROSTOL (UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57)

Available from:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] . Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: - Pregnancy. Use of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.1)] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnin

Product summary:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as a uncoated tablets in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol.   The dosage strengths are supplied in: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL-
DICLOFENAC SODIUM/MISOPROSTOL TABLET
MICRO LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM
AND MISOPROSTOL DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE
TABLETS.
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1997
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH
DEFECTS;
SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ADMINISTRATION OF MISOPROSTOL, A COMPONENT OF DICLOFENAC SODIUM AND
MISOPROSTOL
DELAYED-RELEASE TABLETS, TO PREGNANT WOMEN CAN CAUSE UTERINE RUPTURE,
ABORTION,
PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS OCCURRED WHEN
MISOPROSTOL
WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR AN ABORTION. (
4, 5.1, 8.1)
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS ARE
CONTRAINDICATED IN
PREGNANCY AND IS NOT RECOMMENDED IN WOMEN OF CHILDBEARING POTENTIAL.
PATIENTS
MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE
THE DRUG TO
OTHERS. ( 5.1, 8.3)
INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING
MYOCARDIAL
INFARCTION AND STROKE, WHICH CAN BE FATAL. ( 5.2)
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS ARE
CONTRAINDICATED IN
THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ( 4, 5.2)
INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS
INCLUDING BLEEDING,
ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES, WHICH CAN BE
FATAL AND CAN
OCCUR AT ANY TIME AND WITHOUT WARNING SYMPTOMS. ELDERLY PATIENTS AND
PATIENTS WITH
A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT
GREATER RISK. ( 5.3)
INDICATIONS AND USAGE
Diclofenac sodium and misoprostol delayed-release tablets are a
combination of diclofenac sodium, a
non-ste