Each film-coated tablet contains: Olmesartan Medoxomil 20 mg.
Pharmacology: Pharmacodynamics: Olmesartan Medoxomil is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin II (AT1) receptors results in increases in plasma renin levels and angiotensin I and II concentrations, and some decrease in plasma aldosterone concentrations.
Pharmacokinetics: Olmesartan medoxomil is an ester prodrug that is hydrolysed during absorption from the gastrointestinal tract to the active form olmesartan. The absolute bioavailability is about 26%. Peak plasma concentrations of olmesartan occur about 1 to 2 hours after oral doses. Olmesartan is at least 99% bound to plasma proteins. It is excreted in the urine and the bile as olmesartan; about 35 to 50% of the absorbed doses is excreted in the urine and the remainder in the bile. The terminal elimination half-life is between 10 and 15 hours.
Olmesartan is an angiotensin II receptor antagonist with actions similar to those of losartan. It is used in the management of hypertension.
Olmesartan is given orally as the ester prodrug Olmesartan medoxomil. After a dose the hypotensive effect lasts for 24 hours. Most of the hypotensive effect is apparent within 2 weeks.
The usual recommended starting dose of Olmesartan medoxomil is 10 mg tablet once a day. If blood pressure is not controlled, it may be increased to 20 mg once daily as an optimal dose. The dose may be increased to 40 mg once daily if required.
Route of Administration: Oral.
The most likely effect of overdosage is hypotension. In the event of overdosage, the patient should be carefully monitored and treatment should be symptomatic and supportive.
Olmesartan medoxomil is contraindicated in pregnancy.
Olmesartan medoxomil should be used with caution in patients with renal artery stenosis. It is excreted in urine and in bile and reduced doses may therefore be required in patients with renal impairment and should be considered in patients with hepatic impairment. Patients with volume depletion may experience hypotension; volume depletion should be corrected before starting therapy, or a low initial dose should be used. Since hyperkalemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment, and potassium-sparing diuretics should generally be avoided.
The use of angiotensin II antagonists is not recommended during the first trimester of pregnancy. The use of angiotensin II antagonists is contra-indicated during the 2nd and 3rd trimester of pregnancy.
It is not known whether Olmesartan is excreted in human milk. Because no information is available regarding the use of Olmesartan Medoxomil during breast-feeding, Olmesartan Medoxomil is not recommended.
Adverse effects have been reported to be usually mild and transient, and include dizziness, headache, and dose-related orthostatic hypotension. Hypotension may occur particularly in patients with volume depletion. Impaired renal function and, rarely, rash, urticaria, pruritus, angioedema, and raised liver enzyme values may occur. Hyperkalemia, myalgia, and arthralgia have been reported. Other adverse effects reported with angiotensin II receptor antagonist include respiratory-tract disorders, back pain, gastrointestinal disturbances, fatigue and neutropenia. Rhabdomyolysis has been reported lately.
The antihypertensive effect of Olmesaratn medoxomil may be potentiated by drugs or other agents that lower blood pressure. An additive hyperkalaemic effect is possible with potassium supplements, potassium-sparing diuretics, or other drugs that can cause hyperkalemia; olmesartan medoxomil and potassium-sparing diuretics should not generally be given together. NSAIDs should be used with caution in patients taking olmesartan as the risk of renal impairment may be increased, particularly in those who are inadequately hydrated; use of NSAIDs may also attenuate the hypotensive effect of olmesartan medoxomil.
Store at temperatures not exceeding 30°C. Protect from light.
C09CA08 - olmesartan medoxomil ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Olmepas FC tab 20 mg
30's
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