Diclofenac sodium and Misoprostol 50 mg/1
Diclofenac sodium and Misoprostol · TABLET, FILM COATED · Mylan Pharmaceuticals Inc.
This medication combines diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), with misoprostol, a prostaglandin analog, and is used to reduce the risk of stomach ulcers in patients taking NSAIDs for pain and inflammation. It is taken by mouth as a film-coated tablet.
Key Facts
- Brand Name
- Diclofenac sodium and Misoprostol
- Generic Name
- Diclofenac sodium and Misoprostol
- NDC Code (Product)
59762-0028- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA020607
- Drug Class
- Prostaglandin E1 Analog [EPC]
- Marketing Start
- 11/01/2012
Recall History
Actavis Inc
Failed Tablet/Capsule Specifications: Broken tablets
Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Physicians Total Care, Inc.
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Watson Laboratories, Inc.-(Actavis) - Florida
Failed Tablet/Capsule Specifications: Broken tablets
Exela Pharma Sciences LLC
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Watson Laboratories, Inc.-(Actavis) - Florida
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Diclofenac sodium/misoprostol 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 their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ] . Diclofenac sodium/misoprostol is a combination of diclofenac sodium, a non‑steroidal anti‑inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID‑induced gastric and duodenal ulcers and their complications. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Osteoarthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three times daily. A dosage of diclofenac higher than 150 mg/day is not recommended. ( 2.2 ) Rheumatoid Arthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three or four times daily A dosage of diclofenac higher than 200 mg/day is not recommended. ( 2.3 ) For dosage modifications due to intolerance, see the full Prescribing Information. ( 2.2 , 2.3 ) 2.1 Important Dosage Information 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 dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ]. After observing the response to initial therapy with diclofenac sodium/misoprostol, the dose and frequency should be adjusted to suit …
Contraindications
4 CONTRAINDICATIONS Diclofenac sodium/misoprostol is contraindicated in the following patients: Pregnancy. Use of misoprostol, a component of diclofenac sodium/misoprostol, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2) ] Active gastrointestinal bleeding [see Warnings and Precautions (5.3) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.8 , 5.9) ] Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium and misoprostol, other prostaglandins, or any components of the drug product [see Warnings and Precautions (5.8 , 5.10) ] Pregnancy ( 4 ) In the setting of CABG surgery ( 4 ) Active gastrointestinal bleeding ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAID…
Drug Interactions
7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with diclofenac and misoprostol. Table 1: Clinically Significant Drug Interactions with Diclofenac and Misoprostol Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac sodium/misoprostol with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [see Warnings and Precautions (5.12) ] . Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical stud…
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 Precautions (5.2) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Hypertension [see Warnings and Precautions (5.5) ] Heart Failure and Edema [see Warnings and Precautions (5.6) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.7) ] Anaphylactic Reactions [see Warnings and Precautions (5.8) ] Serious Skin Reactions [see Warnings and Precautions (5.10) ] Hematologic Toxicity [see Warnings and Precautions (5.12) ] Most common adverse reactions (>2%) are: abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, dizziness, alanine aminotransferase increased, hematocrit decreased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug …
Frequently Asked Questions
What is Diclofenac sodium and Misoprostol used for?
This medication combines diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), with misoprostol, a prostaglandin analog, and is used to reduce the risk of stomach ulcers in patients taking NSAIDs for pain and inflammation. It is taken by mouth as a film-coated tablet.
Is Diclofenac sodium and Misoprostol a controlled substance?
Diclofenac sodium and Misoprostol is not classified as a controlled substance by the DEA.
What is the generic name for Diclofenac sodium and Misoprostol?
The generic name for Diclofenac sodium and Misoprostol is Diclofenac sodium and Misoprostol. There are 11 other brand versions of Diclofenac sodium and Misoprostol.
What is the NDC code for Diclofenac sodium and Misoprostol 50 mg/1?
The NDC (National Drug Code) for Diclofenac sodium and Misoprostol 50 mg/1 is 59762-0028, listed by Mylan Pharmaceuticals Inc..
Other Diclofenac Brands
See all →- Diclofenac Sodium Misoprostol50 mg/171205-865
- Diclofenac sodium and Misoprostol DR75 mg/180425-0272
- Diclofenac Sodium and Misoprostol75 mg/171335-1183
- Diclofenac Sodium Misoprostol50 mg/172162-2518
- Diclofenac Sodium Misoprostol50 mg/175834-264
- Diclofenac Sodium and Misoprostol50 mg/10591-0397
- Diclofenac Sodium and Misoprostol75 mg/10591-0398
- ARTHROTEC75 mg/10025-1421
- Diclofenac Sodium Misoprostol75 mg/172162-2519
- Diclofenac Sodium and Misoprostol75 mg/142291-233
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)