ARTHROTEC- diclofenac sodium and misoprostol tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

PD-Rx Pharmaceuticals, Inc.

INN（国际名称）:

DICLOFENAC SODIUM

组成:

DICLOFENAC SODIUM 50 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

ARTHROTEC is 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)] . ARTHROTEC 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)] 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

產品總結:

ARTHROTEC (diclofenac sodium/misoprostol) is 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 four "A's" encircling a "50" in the middle on one side and "SEARLE" and "1411" on the other. Bottles of 15 (NDC 55289-406-15) Bottles of 30 (NDC 55289-406-30) Store at or below 25°C (77°F), in a dry area.

授权状态:

New Drug Application

资料单张

PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR ARTHROTEC
A COMBINATION OF DICLOFENAC A NONSTEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID) AND MISOPROSTOL A
GI MUCOSAL PROTECTIVE PROSTAGLANDIN E 1 ANALOG
What is the most important information I should know about Arthrotec?
Do not take Arthrotec if you are pregnant. Arthrotec 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:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
MEDICATION GUIDE FOR ARTHROTEC
A COMBINATION OF DICLOFENAC A NONSTEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID) AND MISOPROSTOL A
GI

产品特点

ARTHROTEC- DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARTHROTEC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ARTHROTEC.
ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL 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._
ARTHROTEC 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. ARTHROTEC 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. ARTHROTEC 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, ARTHROTEC 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
CONTRACEPTION FAILURE, AND THE DANGER TO OTHER WOMEN OF CHILDBEARING
POTENTIAL SHOULD THE DRUG BE
TAKEN BY MISTAKE.
WILL BEGIN ARTHROTEC ONLY ON THE SECOND OR THIRD DAY OF THE NEXT
NORMAL MENSTRUAL PERIOD.
CARDIOVASCULAR THROMBOTIC EVENTS RISK
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS CARDIOVASCULAR
THROMBOTIC EVENTS,