Olmesafe-20 & 40

ANTIHYPERTENSIVES: Olmesartan Medoxomil BP

Indication

Olmesartan Medoxomil is indicated for the treatment of essential hypertension.

Contraindication

Hypersensitivity to the active substances, to any of the excipients. Severe renal impairment (creatinine clearance <20 mL/min). Severe hepatic impairment, 2nd and 3rd trimester of pregnancy and biliary obstructive disorders.

Dosage & Administration

Adults: The recommended starting dose of Olmesartan Medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of Olmesartan Medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, Olmesartan Medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added. Olmesartan Medoxomil tablets can be taken with or without food.

Elderly (age 65 years or older): No adjustment of dosage is generally required in elderly patients. If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored.

Renal impairment: The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 20 mg Olmesartan Medoxomil once daily.

Hepatic impairment: No adjustment of dosage recommendations is required for patients with mild hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg Olmesartan Medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily.

Side Effect

The most commonly reported adverse reactions during treatment with Olmesartan are headache, influenza-like symptoms and dizziness, hypertriglyceridemia and raised creatine phosphokinase.

Precaution

Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Olmesartan Medoxomil.

Drug Interaction

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and, rarely, with angiotensin-II antagonists. Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels may lead to increases in serum potassium. Such concomitant use is therefore not recommended. NSAIDs and angiotensin-II receptor antagonists may act synergistically by decreasing glomerular filtration. The risk of the concomitant use of NSAIDs and angiotensin-II antagonists is the occurrence of acute renal failure.

Use Children

Olmesartan is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

Use Pregnancy Lactation

When pregnancy is diagnosed, treatment with angiotensin-II antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started. It is not known whether Olmesartan is excreted in human milk. Because no information is available regarding the use of Olmesartan during breast-feeding, Olmesartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Storage

Store in a cool and dry place, at below 25 ºC. temperature and protected from light. Keep all medicines out of the reach of children.