Generic

Olmesartan Medoxomil

Indications

Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.

Pharmacology

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the main active hormone of the renin-angiotensin system and an important component in the pathophysiology of hyperthyroidism. It also stimulates the secretion of aldosterone by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-reducing effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor found in many tissues (eg, vascular smooth muscle, adrenal gland). Binding studies indicate that olmesartan is a reversible and competitive inhibitor of the AT 1 receptor. Olmesartan does not inhibit ACE (kinase I, the enzyme that converts angiotensin I to angiotensin II and breaks down bradykinin ).

Dosage & Administration

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.

Interaction

Drugs: No significant drug interactions have been reported with co-administration of olmesartan.

With food and others: Food does not affect the bioavailability of olmesartan.

Contraindications

Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.

Side Effects

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, hypertriglyceridemia, influenza like symptoms, pharyngitis, rhinitis and sinusitis.

Pregnancy & Lactation

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.

Precautions & Warnings

• Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance.
• When pregnancy is detected, Olmesartan must be discontinued as soon as possible.
• Hypotension in volume or salt-depleted patients may occur.
• Impaired renal function

Therapeutic Class

Angiotensin-ll receptor blocker

Storage Conditions

Store at temperature not exceeding 25 ºC in a dry place. Protect from light.

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.