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ARTHROTEC®(misoprostol, diclofenac sodium)
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ARTHROTEC® Quick Finder
Highlights
Boxed Warning
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS
...
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Indications and Usage
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage Information
- Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before deciding to...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Delayed-release tablets:
- 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 middle on one...
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Contraindications
4 CONTRAINDICATIONS
ARTHROTEC is contraindicated in the following patients:
- Pregnancy. Use of misoprostol, a component of ARTHROTEC, during pregnancy can result in maternal and fetal harm, including uterine...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Uterine Rupture, Abortion, Premature Birth, or Birth Defects with Misoprostol and Embryo-Fetal Toxicity with NSAIDs
...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see Warnings and...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
ARTHROTEC is...
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Overdosage
10 OVERDOSAGE
The toxic dose of ARTHROTEC has not been determined. However, signs of overdosage from the components of the product have been described.
...
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Description
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...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
ARTHROTEC is a combination product containing diclofenac sodium, an NSAID with analgesic, anti-inflammatory and...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
Osteoarthritis
Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
ARTHROTEC (diclofenac sodium and misoprostol delayed-release tablets) are supplied as:
- 50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white...
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