DICLOFENAC SODIUM AND MISOPROSTOL tablet, delayed release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

AvKARE

DCI (Dénomination commune internationale):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 50 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 is 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

Descriptif du produit:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied in dosage strengths of either 50 mg diclofenac sodium/0.2 mg misoprostol or 75 mg diclofenac sodium/0.2 mg misoprostol. The 50 mg/0.2 mg dosage strength are white to off white, round, biconvex tablets, plain on one side and debossed with “ 0397 ” on the other side. The 75 mg/0.2 mg dosage strength are white to off white, round, biconvex tablets, plain on one side and debossed with “ 0398 ” on the other side. The dosage strengths are supplied in: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature], in a dry area.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND MISOPROSTOL
TABLET, DELAYED
RELEASE
AvKARE
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Medication Guide for
Diclofenac Sodium (dye kloe’ fen ak soe’ dee um) and Misoprostol
(mye’ soe pros’ tol)
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 can cause abortion, premature birth, birth
defects, and uterine rupture.
What is the most important information I should know about medicines
containing NonsteroidalAnti-
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
•
NSAID containing medicines should only be used:
○ exactly as prescribed
○ at the lowest dose possible for your treatment
○ for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions such
as different types of arthritis, menstrual cramps, and other types of
short-term pain.
Who should not take NSAID containing medicines?
Do n

Résumé des caractéristiques du produit

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, DELAYED RELEASE
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS, USP
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 CONTAINS
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