DICLOFENAC SODIUM AND MISOPROSTOL tablet, film coated

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:

Greenstone LLC

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac sodium/misoprostol is 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/misoprostol is contraindicated in the following patients: Risk Summary Diclofenac sodium/misoprostol is contraindicated in pregnant women [see Contraindications (4)] . If a woman becomes pregnant while taking diclofenac sodium/misoprostol, discontinue the drug and advise the woman of the potential risks to her and to a fetus. There are no adequate and well-controlled studies of diclofenac sodium/misoprostol in pregnant women; however, there is information available about the active drug components of diclofenac sodium/misoprostol, diclofenac sodium and misoprostol. Administration of misoprostol to pregnan

Product summary:

Diclofenac sodium and misoprostol delayed-release tablets are supplied as: The dosage strengths are supplied in: Diclofenac sodium/misoprostol 50 50 mg diclofenac sodium and 200 mcg misoprostol 59762-0028-1 bottle of 60 59762-0028-2 bottle of 90 Diclofenac sodium/misoprostol 75 75 mg diclofenac sodium and 200 mcg misoprostol 59762-0029-1 bottle of 60 Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Greenstone LLC
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MEDICATION GUIDE
MEDICATION GUIDE FOR
DICLOFENAC SODIUM/MISOPROSTOL
(DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS)
FOR ORAL USE
What is the most important information I should know about diclofenac
sodium/misoprostol?
Diclofenac sodium/misoprostol contains diclofenac (a nonsteroidal
anti-inflammatory drug (NSAID)) and
misoprostol, and can cause uterus to tear (uterine rupture), abortion,
premature birth, or birth defects. The
risk of uterine rupture increases as your pregnancy advances, if you
have given birth to 5 or more children,
and if you have had surgery on the uterus, such as a cesarean
delivery.
Do not take diclofenac sodium/misoprostol if you are pregnant.
•
Tell your healthcare provider if you become pregnant or think you may
be pregnant during treatment
with diclofenac sodium/misoprostol. If you are able to become
pregnant, your healthcare provider
should do a pregnancy test before you start treatment with diclofenac
sodium/misoprostol. Females
who are able to become pregnant should use an effective form of birth
control (contraception) during
treatment with diclofenac sodium/misoprostol.
What is the most important information I should know about medicines
containing Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o
with increasing doses of NSAIDs
o
with longer use of NSAIDs
Do not take NSAID containing medicines right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
Avoid taking NSAID containing medicines after a recent heart attack,
unless your healthcare provider tells
you to. You may have an increased risk of another heart attack if you
take NSAIDs after a recent heart
attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
o
anytime during use
MEDICA

Summary of Product characteristics

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, FILM COATED
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC
SODIUM/MISOPROSTOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DICLOFENAC
SODIUM/MISOPROSTOL.
DICLOFENAC SODIUM/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._
•
•
•
•
•
INDICATIONS AND USAGE
Diclofenac sodium/misoprostol is a combination of diclofenac sodium, a
non‑steroidal anti‑inflammatory
drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for
the treatment of 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.
(1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets:
•
•
CONTRAINDICATIONS
ADMINISTRATION OF MISOPROSTOL, A COMPONENT OF DICLOFENAC
SODIUM/MISOPROSTOL, 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/MISOPROSTOL IS 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/MISOPROSTOL IS 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, A