Olmevas 20 Tablet: Each film coated tablet contains 20 mg Olmesartan Medoxomil BP.
Olmevas 40 Tablet: Each film coated tablet contains 40 mg Olmesartan Medoxomil BP.
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, Kininase II). Angiotensin II is the principal pressor agent of the renin angiotensin system with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. An AT2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than a 12,500-fold greater affinity for the AT1 receptor than for the AT2 receptor. Olmesartan Medoxomil does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II levels do not overcome the effect of Olmesartan on blood pressure.
Olmesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents to lower blood pressure.
Adult Hypertension:
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), initiate Olmesartan under close medical supervision and give consideration to use of a lower starting dose. Olmesartan may be administered with or without food.
Pediatric Hypertension (6 to 16 years of age):
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 10 mg once daily for patients who has weight 20 to <35 kg or 20 mg once daily for patients who has weight ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to a maximum of 20 mg once daily for patients who has weight <35 kg or 20 mg once daily for patients who has weight ≥ 35 kg.
*Prescription only*
No significant drug interactions were reported in studies in which Olmesartan was co-administered with Digoxin or Warfarin in healthy volunteers. The bioavailability of Olmesartan was not significantly altered by the co-administration of antacids.
Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce, or are metabolized by those enzymes are not expected. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Olmesartan Medoxomil, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Olmesartan Medoxomil and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.
Pregnancy and lactation: Pregnancy Category-D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). Not recommended in lactation.
Caution in renal impairment: Symptomatic hypotension may occur in patients who are volume and/or salt-depleted. May be associated with oliguria, progressive azotaemia and acute renal failure (rare). Patients with bilateral or unilateral renal artery stenosis may have increased risk of severe hypotension and renal insufficiency.
Monitor serum creatinine and potassium levels periodically. Avoid use in severe renal impairment (CrCl< 20 ml/min) and severe hepatic impairment. Caution in patients with aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Patients with primary aldosteronism may not respond to angiotensin receptor antagonist.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.