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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC)
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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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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
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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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...
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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
Diclofenac sodium/...
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Overdosage
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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Description
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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Clinical Pharmacology
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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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
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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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.