Drugplain

Diclofenac Sodium Misoprostol 50 mg/1

diclofenac sodium and misoprostol · TABLET, DELAYED RELEASE · Nivagen Pharmaceuticals, Inc.

No Recall History
Plain English

Diclofenac Sodium Misoprostol is a tablet, delayed release containing diclofenac sodium and misoprostol at 50 mg/1, taken oral. Manufactured by Nivagen Pharmaceuticals, Inc..

Key Facts

Brand Name
Diclofenac Sodium Misoprostol
Generic Name
diclofenac sodium and misoprostol
NDC Code (Product)
75834-264
Manufacturer
Nivagen Pharmaceuticals, Inc.
Strength
50 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA205143
Drug Class
Prostaglandin E1 Analog [EPC]
Marketing Start
07/15/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Diclofenac sodium and misoprostol delayed-release tablets are 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 and misoprostol delayed-release tablets are 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 and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. 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 and …

Contraindications

4 CONTRAINDICATIONS Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: Pregnancy. Use of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, 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 o…

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 and misoprostol delayed-release tablets 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 NSA…

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 Micro Labs USA Inc. at 1-855-839-8195 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 …

Frequently Asked Questions

What is Diclofenac Sodium Misoprostol used for?

Diclofenac Sodium Misoprostol contains diclofenac sodium and misoprostol. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Diclofenac Sodium Misoprostol a controlled substance?

Diclofenac Sodium Misoprostol is not classified as a controlled substance by the DEA.

What is the generic name for Diclofenac Sodium Misoprostol?

The generic name for Diclofenac Sodium Misoprostol is diclofenac sodium and misoprostol. There are 8 other brand versions of diclofenac sodium and misoprostol.

What is the NDC code for Diclofenac Sodium Misoprostol 50 mg/1?

The NDC (National Drug Code) for Diclofenac Sodium Misoprostol 50 mg/1 is 75834-264, listed by Nivagen Pharmaceuticals, Inc..

Product NDC

75834-264

Package NDC

75834-264-60

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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