DICLOFENAC SODIUM MISOPROSTOL- diclofenac sodium and misoprostol tablet, delayed release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Nivagen Pharmaceuticals, Inc.

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 Warnings and Precautions (5.2)] - Active gastrointestinal bleeding [see Warnings and Precautions (5.3)] - History of

leaflet_short:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as: The dosage strengths are supplied in: Store in a dry area at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

PIL

Nivagen Pharmaceuticals, Inc.
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.
Revised: 3/2023
Document Id: ec6c28fc-0909-4a33-818c-77ead8538bcc
34391-3
Set id: 2acf46ac-8ba8-444d-b421-19d5ad49644c
Version: 3
Effective Time: 20230302
Nivagen Pharmaceuticals, Inc.

SPC

DICLOFENAC SODIUM MISOPROSTOL - DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, DELAYED RELEASE
NIVAGEN PHARMACEUTICALS, INC.
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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-steroid