Olmesartan Medoxomil is a selective angiotensin-II receptor antagonist (AT1 subtype). Olmesartan Medoxomil - a prodrug, is hydrolyzed to Olmesartan during absorption from the gastrointestinal tract.
Each film coated tablet contains 20 mg of Olmesartan Medoxomil USP.
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance < 40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Treatment with Olmesartan was well tolerated, with an incidence of adverse events similar to placebo. The following adverse events occurred in placebo -controlled clinical trials at an incidence of more than 1% of patients treated with Olmesartan, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hyper-triglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
When pregnancy is detected, discontinue Sevitan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. Pregnancy Categories: C (first trimester) and D (second and third trimesters).
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
No significant drug interactions were reported in studies. The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.
The most likely manifestations of over dosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan is unknown.
Store in a cool and dry place, protect from light and moisture.
Keep out of the reach of children.
Each box contains 3 Alu-Alu blister packs of 14 film coated tablets