Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

I am a U.S. Healthcare ProfessionalYes, I am a U.S. Healthcare Professional
SelectI am a U.S. Healthcare ProfessionalYes, I am a U.S. Healthcare Professional
I am a U.S. Patient / CaregiverNo, go back to the patient portal
SelectI am a U.S. Patient / CaregiverNo, go back to the patient portal
Non-US residents click here.

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.
Not a healthcare professional? Go to the patient or caregiver website.
Please note that while Pfizer continues to support Medical Information requests for this product at this time, it is now a Viatris product.

DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC)

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.

DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) Quick Finder

Download Prescribing Information
Show All Hide All

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
Read more
Did you find an answer to your question? Yes No

WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

...
Read more
Did you find an answer to your question? Yes No

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...

Read more
Did you find an answer to your question? Yes No

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...

Read more
Did you find an answer to your question? Yes No

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...
Read more
Did you find an answer to your question? Yes No

4 CONTRAINDICATIONS

Diclofenac sodium/misoprostol is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium...
Read more
Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have...

Read more
Did you find an answer to your question? Yes No

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...

Read more
Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

See

...
Table 1: Clinically Significant Drug Interactions with Diclofenac and Misoprostol
Read more
Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Diclofenac sodium/...

Read more
Did you find an answer to your question? Yes No

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.

...
Read more
Did you find an answer to your question? Yes No

11 DESCRIPTION

Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal...

Read more
Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, a nonsteroidal anti-...

Read more
Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

Read more
Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

Osteoarthritis

Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be effective...

Read more
Did you find an answer to your question? Yes No

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...
Read more
Did you find an answer to your question? Yes No
Show All Hide All
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information. 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event
Pfizer Safety

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:

Pfizer Safety Reporting Site

*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.

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 https://vaers.hhs.gov or call (800) 822-7967.