Rofenta
Rofecoxib 12.5, 25 mg tablet

Presentation
Rofenta 12.5 : Each tablet contains Rofecoxib INN 12.5 mg.
Rofenta 25 : Each tablet contains Rofecoxib INN 25 mg.

Description
Rofecoxib is a nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic and antipyretic activities. The mechanism of action is believed to be due to the inhibition of prostaglandin synthesis by cyclooxygenase-2 (COX-2). At therapeutic concentrations in humans, Rofecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

Indications and Uses
Rofenta 12.5 & 25 is indicated
1) For relief of the signs and symptoms of osteoarthritis
2) For the management of acute pain in adults
3) For the treatment of primary dysmenorrhea

Dosage and Administration
For osteoarthritis, the starting dose of Rofenta should be 12.5 mg, maximum 25 mg for each patient daily. These doses can be given without regard to timing of meals.
For acute pain and dysmenorrhea, 50 mg daily. Use of Rofecoxib for more than 5 days in management of pain has not been needed.

Contraindications
Rofecoxib is contraindicated in patients with known hypersensitivity to Rofecoxib, or who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Precautions
Rofecoxib cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. Rofecoxib should be prescribed with extreme caution in patients with a prior history of GI ulcer disease or GI bleeding, hepatic and renal insufficiency, heart failure, those taking diuretics or ACE inhibitors, preexisting asthma and elderly patients.

Side-effects
Gastrointestinal side effects include abdominal pain, dyspepsia, gastroenteritis, nausea, vomiting. Cardiovascular side effects include aggravated hypertension, angina pectoris, coronary artery disorder. Other side effects include aggravated allergy, allergic reaction, headache, asthenia, influenza-like symptoms. These clinical adverse experiences occurring within 2% of patients treated with Rofecoxib.

Use in Pregnancy and Lactation
Rofecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Rofecoxib should be avoided because it may cause premature closure of ductus arteriosus.
It is not known whether Rofecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Rofecoxib, a decision should be made whether to nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Use in Children
The safety and efficacy of Rofecoxib have not been established for children and neonates and for age group below 18 years.

Drug Interactions
Clinical studies with Rofecoxib have identified potentially significant interactions with rifampicin, methotrexate and warfarin. Experience with nonsteroidal anti-inflammatory drugs (NSAIDs) suggests the potential for interactions with furosemide and ACE inhibitors. The effects of Rofecoxib on the pharmacokinetics and/or pharmacodynamics of ketoconazole, digoxin, oral contraceptive and prednisolone have been studied in vivo and clinically important interactions have not been found. Concomitant administration of low dose aspirin with Rofecoxib may result in an increased rate of GI ulceration or other complications.

Overdosage
No overdosage of Rofecoxib were reported during clinical trials. Administration of single doses of Rofecoxib 1000 mg to 6 healthy volunteers and multiple doses of 250 mg/day for 14 days to 75 healthy volunteers did not result in serious toxicity.
In the event of overdose, it is reasonable to employ the usual supportive measures.
Rofecoxib is not removed by hemodialysis, it is not known whether Rofecoxib is removed by peritoneal dialysis.

Commercial Pack
Rofenta 12.5 : Box containing 5 blister strips of 10 tablets.
Rofenta 25 : Box containing 5 blister strips of 10 tablets.