CYTOPAN 50MG/200MCG TAB
CYTOPAN 50MG/200MCG TABLET:
CYTOPAN 50 mg/200mcg tablet is a combination of diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and prostaglandin, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog.
CYTOPAN 50 mg/200mcg tablet is indicated for:
- Acute and chronic treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, enclosing spondylitis and acute musculoskeletal disorders.
- The Prostaglandin component of CYTOPAN 50 is indicated for the prevention of NSAID (non-steroidal anti-inflammatory drugs, including Aspirin)-induced gastric and duodenal ulcers.
The most common adverse reactions encountered with CYTOPAN 50 mg/200mcg tablet are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. The following adverse reactions occurred.
CYTOPAN 50 mg/200mcg tablet cannot be used to substitute for corticosteroids or to treat for corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
WHEN NOT TO USE:
CYTOPAN 50 mg/200mcg tablet is not used in:
- Patients with hypersensitivity to diclofenac sodium or to Prostaglandin or other prostaglandins.
- It is contraindicated in pregnant women, because its Prostaglandin component can cause abortion.
- It should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- It is not recommended for use in patients having advanced kidney disease.
- It is not recommended in combination with aspirin and magnesium containing antacids.
- It is not recommended for use in patients with active liver disease.
- It is contraindicated in lactating patients.
CYTOPAN 50 mg/200mcg tablet is contraindicated:
- Digoxin: Patients receiving digoxin with diclofenac sodium + Prostaglandin combination should be monitored for possible digoxin toxicity. Antihypertensive agents.
- NSAIDs can inhibit the activity of antihypertensive, including ACE inhibitors. Thus, caution should be taken when administering this with such agents.
- Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.
- Oral hypoglycemic: Marketing experiences reports, changes in effects of insulin or oral hypoglycemic agents in the presence of diclofenac sodium that necessitated changes in the doses of such agents.
- Methotrexate and Cyclosporine: Diclofenac sodium + Prostaglandin combination may increase serum concentrations of methotrexate and increase cyclosporine nephrotoxicity.
- Lithium: When NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
- Diuretics: Concomitant therapy of NSAIDs with potassium-sparing diuretics may be associated with increased serum potassium levels.
The recommended dosage for maximal GI mucosal protection for CYTOPAN 50 mg/200mcg tablet is three tablets in a day.
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- Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist.
- Please read the enclosed instruction leaflet.
- Keep out of reach of children.