DICLOFENAC SODIUM AND MISOPROSTOL tablet, delayed release

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:

Preferred Pharmaceuticals Inc.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 75 mg

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: Risk Summary Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women [see Contraindications (4)] . If a woman becomes pregnant while taking diclofenac sodium and misoprostol delayed-release tablets, 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 and misoprostol in pregnant women; however, there is information available about the active drug c

Product summary:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as a tablet in dosage strengths of either 50 mg diclofenac sodium, USP/200 mcg misoprostol, USP or 75 mg diclofenac sodium, USP/200 mcg misoprostol, USP. The 75 mg/200 mcg dosage strength is supplied as white to off-white, round shaped, biconvex tablets debossed with “AN” on one side and “438” on the other side. They are available as follows: Bottles of 60:                          NDC 68788-7103-6 Bottles of 30:                         NDC 68788-7103-3 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE FOR DICLOFENAC
SODIUM AND MISOPROSTOL DELAYED-
RELEASE TABLETS, USP
Diclofenac Sodium (dye kloe' fen ak soe' dee um) and Misoprostol
(mye'' soe pros' tol)
Delayed-Release Tablets, USP
for oral use
What is the most important information I should know about diclofenac
sodium and misoprostol delayed-
release tablets?
Diclofenac sodium and misoprostol delayed-release tablets 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 and misoprostol delayed-release tablets
if you are pregnant.
•
Tell your healthcare provider if you become pregnant or think you may
be pregnant during
treatment with diclofenac sodium and misoprostol delayed-release
tablets. If you are able to become
pregnant, your healthcare provider should do a pregnancy test before
you start treatment with
diclofenac sodium and misoprostol delayed-release tablets. Females who
are able to become
pregnant should use an effective form of birth control (contraception)
during treatment with
diclofenac sodium and misoprostol delayed-release tablets.
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:
•
with increasing doses of NSAIDs
•
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

Summary of Product characteristics

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, DELAYED RELEASE
PREFERRED 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._
•
•
•
•
•
INDICATIONS AND USAGE
Diclofenac sodium and misoprostol delayed-release tablets are a
combination of diclofenac sodium, a
non-steroidal anti-inflammatory drug, and misoprostol, a
prostaglandin-1 (PG E1) 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:
•
•
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 ARE 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
CONTRAINDI