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ARTHROTEC®(misoprostol, diclofenac sodium)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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
Boxed Warning
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS
...
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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 adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and...
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Dosage and Administration
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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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
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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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see Warnings and...
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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...
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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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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 either 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 www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.