DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE- 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:

Yung Shin Pharmaceutical Industrual Co., Ltd.

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 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 (5.2)] . Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium/misoprostol, other prostaglandins, or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)] - In the setting of coronary artery bypass g

Product summary:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as a film-coated tablet in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. The 50 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with “YSP 167”. The 75 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with “YSP 168”. 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

Patient Information leaflet

MISOPROSTOL TABLET, DELAYED RELEASE
Yung Shin Pharmaceutical Industrual Co., Ltd.
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MEDICATION GUIDE FOR DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE
TABLETS
A COMBINATION OF DICLOFENAC A NONSTEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID) AND MISOPROSTOL A GI
MUCOSAL PROTECTIVE PROSTAGLANDIN E1 ANALOG
What is the most important information I should know about diclofenac
sodium and misoprostol delayed-
release tablets?
Do not take diclofenac sodium and misoprostol delayed-release tablets
if you are pregnant. Diclofenac
sodium and misoprostol delayed-release tablets can cause abortion,
premature birth, birth defects, and
uterine rupture.
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 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:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAID containing medicines should only be used:
MEDICAT

Summary of Product characteristics

DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE- DICLOFENAC SODIUM
AND
MISOPROSTOL TABLET, DELAYED RELEASE
YUNG SHIN PHARMACEUTICAL INDUSTRUAL CO., LTD.
----------
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; AND
SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS CONTAIN
DICLOFENAC
SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE
PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS.
UTERINE RUPTURE
HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN
TO INDUCE
LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY.
DICLOFENAC
SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS SHOULD NOT BE TAKEN BY
PREGNANT
WOMEN (4, 5.10, 8.1).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT
TO GIVE THE
DRUG TO OTHERS. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE
TABLETS SHOULD NOT BE USED IN
WOMEN OF CHILDBEARING POTENTIAL UNLESS THE PATIENT REQUIRES
NONSTEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID) THERAPY AND IS AT HIGH RISK OF DEVELOPING GASTRIC OR DUODENAL
ULCERATION OR FOR DEVELOPING
COMPLICATIONS FROM GASTRIC OR DUODENAL ULCERS ASSOCIATED WITH THE USE
OF THE NSAID. IN SUCH PATIENTS,
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS MAY BE
PRESCRIBED IF THE PATIENT:
HAS HAD A NEGATIVE SERUM PREGNANCY TEST WITHIN 2 WEEKS PRIOR TO
BEGINNING THERAPY (8.3).
IS CAPABLE OF COMPLYING WITH EFFECTIVE CONTRACEPTIVE MEASURES.
HAS RECEIVED BOTH ORAL AND WRITTEN WARNINGS OF THE HAZARDS OF
MISOPROSTOL, THE RISK OF POSSIBLE
CONTRAC