Presentation

Xyotil 20: Each tablet contains Olmesartan Medoxomil INN 20 mg.

Xyotil 40: Each tablet contains Olmesartan Medoxomil INN 40 mg.

Description

Angiotensin II (formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme-ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT1 receptor. Olmesartan does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).

Indications

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

Dosage & Administration

Adult Hypertension:

The usual starting dose of Olmesartan is 20 mg once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be increased after 2 weeks to 40 mg. Olmesartan may be administered with or without food.

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.

If blood pressure is not controlled by Olmesartan alone, a diuretic may be added. Olmesartan may be administered with other antihypertensive agents.

Pediatric Hypertension (6 to 16 years of age):

The usual recommended starting dose of Olmesartan is 10 mg once daily for patients who weigh 20 to <35 kg, or 20 mg once daily for patients who weigh > 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 weigh <35 kg or 40 mg once daily for patients who weigh > 35 kg.

Side Effects

Treatment with Olmesartan is well tolerated. The common side-effects are dizziness, diarrhoea, headache, back pain etc. Other adverse effects are chest pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, vertigo etc.

Precautions

– 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

Use in Pregnancy & Lactation

Safety and effectiveness in both pregnant women & nursing mother have not been established. So, Olmesartan should be discontinued during both of these conditions.

Drug Interaction

No significant drug interactions were reported in studies in which olmesartan medoxomil was co-administered with digoxin or warfarin in healthy volunteers. 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. The bioavailability of olmesartan is not significantly altered by the co-administration of antacids.

Over Dose

Limited data are available in regard to over dosage in humans. The most likely manifestation of over dosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension occurs, supportive treatment should be initiated.

Commercial Pack

Xyotil 20: Each box contains 3 blister strips of 10 tablets.

Xyotil 40: Each box contains 3 blister strips of 10 tablets.

Others

Pediatric use:

Olmesartan is generally well tolerated in pediatric patients.

Geriatric use:

There is no significant differences in effectiveness or safety between elderly patients and younger patients with Olmesartan.