DICLOFENAC SODIUM AND MISOPROSTOL tablet, delayed release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Bryant Ranch Prepack

INN (Kansainvälinen yleisnimi):

DICLOFENAC SODIUM

Koostumus:

DICLOFENAC SODIUM 75 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 tablets are contraindicated in the following patients: ● Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium and 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 bypas

Tuoteyhteenveto:

NDC: 63629-4970-1: 20 Tablets in a BOTTLE NDC: 63629-4970-2: 14 Tablets in a BOTTLE NDC: 63629-4970-3: 60 Tablets in a BOTTLE NDC: 63629-4970-4: 30 Tablets in a BOTTLE NDC: 63629-4970-5: 10 Tablets in a BOTTLE

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Bryant Ranch Prepack
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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?
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
•
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 c

Valmisteyhteenveto

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, DELAYED RELEASE
BRYANT RANCH PREPACK
----------
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 CONTAINS
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 CHILDBEARINGPOTENTIAL 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 ORA