Generic

Olmesartan Medoxomil

Indications

The drug Olmesartan Medoxomil is used to treat hypertension. It can be taken alone or with other antihypertensive medications.

Pharmacology

Angiotensin-II is a powerful vasoconstrictor, the principal vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It is generated from angiotensin-I in a mechanism catalyzed by angiotensin-converting enzyme (ACE). It also causes the adrenal cortex to secrete more aldosterone. Olmesartan inhibits angiotensin-vasoconstrictor II’s and aldosterone-secreting activities by preventing angiotensin-binding II’s to the AT 1 receptor, which is located in numerous tissues (e.g. vascular smooth muscle, adrenal gland). Olmesartan is a reversible and competitive inhibitor of the AT 1 receptor, according to in vitro binding experiments.

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 a 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

When Olmesartan was co-administered with other medications, no major drug interactions were reported.

Olmesartan’s bioavailability is unaffected by food or other factors.

Contraindications

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

Side Effects

Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.

Rare: Chest pain, peripheral edema, arthritis.

Pregnancy & Lactation

Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

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

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Precautions & Warnings

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.

Therapeutic Class

Angiotensin-ll receptor blocker

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children’s reach.

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.