ARTHROTEC® Principal Display Panel (misoprostol, diclofenac sodium) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 50 mg Tablet Label

Arthrotec® 50

50 mg diclofenac sodium/
200 mcg misoprostol

Distributed by
G.D. Searle LLC
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Label

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1411-60

Arthrotec® 50
diclofenac sodium and misoprostol
delayed-release tablets

50 mg/200 mcg

DOSAGE AND USE
See accompanying prescribing information.

60 Tablets
Rx only

20688084

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Label

Arthrotec® 75

75 mg diclofenac sodium/
200 mcg misoprostol

Distributed by
G.D. Searle LLC
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Label

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0025-1421-60

Arthrotec® 75
diclofenac sodium and misoprostol
delayed-release tablets

75 mg/200 mcg

DOSAGE AND USE
See accompanying prescribing information.

60 Tablets
Rx only

20688086

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label

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.

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Resources

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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

Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before deciding to...

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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

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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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:

Cardiovascular Thrombotic Events [see Warnings and...

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7 DRUG INTERACTIONS

See Table 1 for clinically significant drug interactions with diclofenac and misoprostol.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

ARTHROTEC is...

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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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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:

50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white...

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This Medication Guide...

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LAB-0061-30.0

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Report Adverse Event

Pfizer Safety

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:

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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.