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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; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
ARTHROTEC CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO...
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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 patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before deciding to use ARTHROTEC. Use the lowest effective dosage for the shortest duration consistent...
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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...
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Contraindications
4 CONTRAINDICATIONS
ARTHROTEC is contraindicated in the following patients:
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium and misoprostol, other...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Thrombotic Events
Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three...
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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
6.1 Clinical Trials...
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Drug Interactions
7 DRUG INTERACTIONS
See
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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 effective...
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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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Medication Guide
| Medication Guide for Arthrotec A combination of... |
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