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ARTHROTEC® (misoprostol, diclofenac sodium)
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ARTHROTEC® Quick Finder
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS
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1 INDICATIONS AND USAGE
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...
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage Information
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- Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before...
3 DOSAGE FORMS AND STRENGTHS
Delayed-release tablets:
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- 50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with four "A's" encircling a "50" in the...
4 CONTRAINDICATIONS
ARTHROTEC is contraindicated in the following patients:
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- Pregnancy. Use of misoprostol, a component of ARTHROTEC, during pregnancy can result in maternal and fetal harm, including...
5 WARNINGS AND PRECAUTIONS
5.1 Uterine Rupture, Abortion, Premature Birth, or Birth Defects with Misoprostol and Embryo-Fetal Toxicity with NSAIDs
...6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
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- Cardiovascular Thrombotic Events [see Warnings...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
ARTHROTEC is...
10 OVERDOSAGE
Manage patients with symptomatic and supportive care following an acute NSAID overdosage. There are no specific antidotes. It is advisable to contact a poison control center (1-800-222-1222) to determine the...
11 DESCRIPTION
ARTHROTEC is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. ARTHROTEC tablets...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
ARTHROTEC is a combination product containing diclofenac sodium, an NSAID with analgesic, anti-inflammatory and...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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14 CLINICAL STUDIES
Osteoarthritis
Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be...
16 HOW SUPPLIED/STORAGE AND HANDLING
ARTHROTEC (diclofenac sodium and misoprostol delayed-release tablets) are supplied as:
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- 50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to...
This Medication Guide has been approved by the U.S. Food and Drug Administration. | ... |
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