DICLOENAC SODIUM and MISOPROSTOL DR 75 mg/1
DICLOENAC SODIUM and MISOPROSTOL · TABLET · Advanced Rx Pharmacy of Tennessee, LLC
DICLOENAC SODIUM and MISOPROSTOL DR is a tablet containing dicloenac sodium and misoprostol at 75 mg/1, taken oral. Manufactured by Advanced Rx Pharmacy of Tennessee, LLC.
Key Facts
- Brand Name
- DICLOENAC SODIUM and MISOPROSTOL DR
- Generic Name
- DICLOENAC SODIUM and MISOPROSTOL
- NDC Code (Product)
80425-0273- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Strength
- 75 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204355
- Drug Class
- Prostaglandin E1 Analog [EPC]
- Marketing Start
- 02/16/2023
Recall History
No Recall HistoryFull Prescribing Information
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)] .
Dosage & Administration
2. Dosage and Administration 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 misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. Diclofenac sodium and misoprostol delayed-release tablets are not recommended for patients who would not receive the appropriate dosage of both active ingredients. Diclofenac sodium and misoprostol delayed-release tablets, a fixed combination product, is administered as diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg (50 mg diclofenac sodium and 200 mcg misoprostol) or diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg (75 mg diclofenac sodium and 200 mcg misoprostol). 2.2 Recommended Dosage in Patients with Osteoarthritis T…
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)]
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)] 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reaction information for diclofenac sodium and misoprostol delayed-release tablets is derived from multinational controlled clinical trials in over 2,000 patients receiving diclofenac sodium and misoprostol de…
Frequently Asked Questions
What is DICLOENAC SODIUM and MISOPROSTOL DR used for?
DICLOENAC SODIUM and MISOPROSTOL DR contains DICLOENAC SODIUM and MISOPROSTOL. It is a tablet taken oral. Consult your doctor for specific uses.
Is DICLOENAC SODIUM and MISOPROSTOL DR a controlled substance?
DICLOENAC SODIUM and MISOPROSTOL DR is not classified as a controlled substance by the DEA.
What is the generic name for DICLOENAC SODIUM and MISOPROSTOL DR?
The generic name for DICLOENAC SODIUM and MISOPROSTOL DR is DICLOENAC SODIUM and MISOPROSTOL. There are no other listed brand versions of DICLOENAC SODIUM and MISOPROSTOL.
What is the NDC code for DICLOENAC SODIUM and MISOPROSTOL DR 75 mg/1?
The NDC (National Drug Code) for DICLOENAC SODIUM and MISOPROSTOL DR 75 mg/1 is 80425-0273, listed by Advanced Rx Pharmacy of Tennessee, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)