ARTHROTEC- diclofenac sodium and misoprostol tablet, film coated

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:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ARTHROTEC is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult 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 (5.3)] . ARTHROTEC is contraindicated in the following patients: Risk Summary ARTHROTEC is contraindicated in pregnant women [see Contraindications (4)]. If a woman becomes pregnant while taking ARTHROTEC, discontinue the drug and advise the woman of the potential risks to her and to a fetus. There are no adequate and well-controlled studies of ARTHROTEC in pregnant women; however, there is information available about the active drug components of ARTHROTEC, diclofenac sodium and misoprostol. Administration of misoprostol to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions (5.1)] . Co

Product summary:

ARTHROTEC (diclofenac sodium and misoprostol delayed-release tablets) are supplied as: The dosage strengths are supplied in: ARTHROTEC 50 50 mg diclofenac sodium and 200 mcg misoprostol 0025-1411-60 bottle of 60 0025-1411-90 bottle of 90 ARTHROTEC 75 75 mg diclofenac sodium and 200 mcg misoprostol 0025-1421-60 bottle of 60 Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

Pfizer Laboratories Div Pfizer Inc
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: August 2022
MEDICATION GUIDE
Medication Guide for
ARTHROTEC (ARTH' roe-tek)
(diclofenac sodium and misoprostol delayed- release tablets) for oral
use
What is the most important information I should know about ARTHROTEC?
ARTHROTEC contains diclofenac (a nonsteroidal anti-inflammatory drug
(NSAID)) and misoprostol, and
can cause uterus to tear (uterine rupture), abortion, premature birth,
or birth defects. 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 ARTHROTEC if you are pregnant.
•
Tell your healthcare provider if you become pregnant or think you may
be pregnant during treatment
with ARTHROTEC. If you are able to become pregnant, your healthcare
provider should do a
pregnancy test before you start treatment with ARTHROTEC. Females who
are able to become
pregnant should use an effective form of birth control (contraception)
during treatment with
ARTHROTEC.
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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
with

Summary of Product characteristics

ARTHROTEC- DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED
PFIZER LABORATORIES DIV PFIZER INC
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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 DELAYED-RELEASE TABLETS),
FOR ORAL USE
INITIAL U.S. APPROVAL:1997
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH
DEFECTS;
SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
INDICATIONS AND USAGE
ARTHROTEC is a combination of diclofenac sodium, a non-steroidal
anti-inflammatory drug, and
misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the
treatment of signs and symptoms of
osteoarthritis or rheumatoid arthritis in adult patients at high risk
of developing NSAID-induced gastric and
duodenal ulcers and their complications. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets:
•
•
CONTRAINDICATIONS
•
•
®
ADMINISTRATION OF MISOPROSTOL, A COMPONENT OF ARTHROTEC, TO PREGNANT
WOMEN
CAN CAUSE UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, OR BIRTH
DEFECTS. UTERINE
RUPTURE HAS OCCURRED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT
WOMEN TO
INDUCE LABOR OR AN ABORTION. (4, 5.1, 8.1)
ARTHROTEC IS CONTRAINDICATED IN PREGNANCY AND IS NOT RECOMMENDED IN
WOMEN OF
CHILDBEARING POTENTIAL. PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT
PROPERTY AND
WARNED NOT TO GIVE THE DRUG TO OTHERS. (5.1, 8.3)
INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING
MYOCARDIAL
INFARCTION AND STROKE, WHICH CAN BE FATAL. (5.2)
ARTHROTEC IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT
(CABG) SURGERY. (4, 5.2)
INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS
INCLUDING BLEEDING,
ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES, WHICH CAN BE
FATAL AND
CAN OCCUR AT ANY TIME AND WITHOUT W