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ARTHROTEC® (misoprostol, diclofenac sodium)

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ARTHROTEC® Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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

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Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before...
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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...
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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...
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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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Cardiovascular Thrombotic Events [see Warnings...
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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...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

ARTHROTEC is...

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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...

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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:

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50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to...
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This Medication Guide has been approved by the U.S. Food and Drug Administration.

...
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Call (800) 438-1985

Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985

Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.