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

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1), Misoprostol (UNII: 0E43V0BB57) (Misoprostol - UNII:0E43V0BB57)

Доступна с:

Proficient Rx LP

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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: Risk Summary Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women [see Contraindications (4)] . There are no adequate and well-controlled studies of diclofenac sodium and misoprostol delayed-release tablets in pregnant women; however, there is information available about the active drug components of diclofenac sodium and misoprostol delayed-release tablets, diclofenac sodium and misoprostol. Administration of misoprostol to pregnant women can cause abort

Обзор продуктов:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as: The dosage strengths are supplied in: 50 mg diclofenac sodium and 200 mcg misoprostol 71205-865-30 71205-865-60 71205-865-90 71205-865-00 71205-865-72 71205-865-64 71205-865-55 30 60 90 100 120 240 500 75 mg diclofenac sodium and 200 mcg misoprostol 71205-866-30 71205-866-60 71205-866-90 71205-866-00 71205-866-72 71205-866-64 71205-866-55 30 60 90 100 120 240 500 Store in a dry area at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

Proficient Rx LP
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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?
Diclofenac sodium and misoprostol delayed-release tablets contain
diclofenac (a nonsteroidal anti-
inflammatory drug (NSAID)) and misoprostol, and can cause abortion,
premature birth, birth defects, and
the uterus to tear (uterine rupture). 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.
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
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", "antiplatelet drugs",
"anticoagulants", "SSRIs", or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
•
older age
•
poor health
•
advanced liver disease
•
drinking alcohol
bleeding problems
NSAID containing medicines shou

Характеристики продукта

DICLOFENAC SODIUM MISOPROSTOL- DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, DELAYED RELEASE
PROFICIENT RX LP
----------
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, BIRTH
DEFECTS, OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN
MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO
INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING
GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN
DELIVERY. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS
SHOULD NOT BE TAKEN BY PREGNANT WOMEN (4, 5.11, 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:
•
•
•
•
CARDIOVASCULAR THROMBOTIC EVENTS RISK
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION RISK
•
RECENT MAJOR CHANGES
HAS HAD A NEGATIVE SERUM PREGNANCY TEST WITHI