Rotec 50™

[Diclofenac Sodium + Misoprostol]

Rotec 50

Active Ingredients

  • Diclofenac Sodium 50 mg
  • Misoprostol 200 mcg

    Description / Properties

    Each tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg Misoprostol.

    Diclofenac component of Rotec 50™ provides better anti-inflammatory action than conventional NSAIDs and COX-2 Inhibitors.

    Misoprostol component of Rotec 50™ is the only agent approved by FDA for preventing NSAID induced ulcers.

    Due to established efficacy and safety of Diclofenac and Misoprostol, Rotec 50™ can be given safely to a wide variety of patients including high-risk patients.

    Due to built-in GI mucosal protection, the cost of concomitant acid suppressive therapies and cost of NSAID induced GI hospitalization is reduced significantly.

    Patient compliance is improved with just I tablet BID.

    Indications

    For acute and chronic treatment of the signs and symptoms of:

  • Osteoarthritis
  • Rheumatoid arthritis

    Contraindication

    Pregnancy, hypersensitivity, lactation, patients with active gastrointestinal bleeding

    Drug Interactions

    Concomitant treatment with aspirin, anti-coagulants, potassium sparing diuretics, lithium, digoxin, methotrexate, magnesium containing antacids.

    Side Effects

    Abdominal pain, diarrhea, nausea/vomiting, headache and dermatological reactions. Diarrhea is usually mild to moderate and transient and can be minimized by taking Rotec 50™ with food and by avoiding magnesium containing antacid.

    Warning and Precautions

    In patients receiving long term NSAID should be monitored as a precautionary measure (e.g. renal, hepatic function and blood counts). The safety and efficacy of Rotec 50™ in children under the age of 18 years have not been established.

    Dosage

    One tablet to be taken with food two or three times daily . Tablets should be swallowed whole not to chewed, crushed or dissolved.

    Presentations Available

    Blister pack of 20 Tablets

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