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ARTHROTEC®(misoprostol, diclofenac sodium)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

ARTHROTEC® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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...

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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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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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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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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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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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7 DRUG INTERACTIONS

See Table 1 for clinically significant drug interactions with diclofenac and misoprostol.

Table 1: Clinically Significant Drug Interactions with...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

ARTHROTEC is...

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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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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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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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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...

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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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This Medication Guide...
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