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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC)

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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.

DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) 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; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

DICLOFENAC SODIUM/MISOPROSTOL CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION...

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1 INDICATIONS AND USAGE

Diclofenac sodium/misoprostol 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...

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2 DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol and other treatment options before deciding to use diclofenac sodium/misoprostol. Use the lowest effective...

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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

Diclofenac sodium/misoprostol is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium...
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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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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...

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7 DRUG INTERACTIONS

See

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

8.1 Pregnancy

Risk Summary

Diclofenac sodium/...

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10 OVERDOSAGE

The toxic dose of diclofenac sodium/misoprostol has not been determined. However, signs of overdosage from the components of the product have been described.

...
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11 DESCRIPTION

Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1)...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, an NSAID with analgesic, anti-...

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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 effective...

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16 HOW SUPPLIED/STORAGE AND HANDLING

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 tablets...
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