Olmetec 10Mg Tablet

Description

OLMETEC 10MG TABLET

Description :

Olmetec 10 mg Tablet: Each tablet contains 10 mg of olmesartan medoxomil.

Olmetec 20 mg Tablet: Each tablet contains 20 mg of olmesartan medoxomil.

Olmetec 40 mg Tablet: Each tablet contains 40 mg of olmesartan medoxomil.

OLMETEC (olmesartan medoxomil), a prodrug, which is hydrolysed to the active metabolite olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.

Olmesartan medoxomil is described chemically as (5-methyl-2-oxo-1,3-dioxolen-4-yl) methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2′-(1H-tetrazol-5-yl)-1,1′-biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylate. Alternatively, it can be described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.

Its empirical formula is C29H30N6O6.

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol.

Indications / Uses :

Olmesartan medoxomil is indicated for the treatment of hypertension.

Administration :

May be taken with or without food.

Contraindications :

Olmesartan medoxomil is contraindicated in patients who are hypersensitive to any component of the tablet, such as microcrystalline cellulose, low substituted hydroxypropylcellulose, lactose, hydroxypropylcellulose and magnesium stearate, talc, titanium dioxide and hypromellose.

Patients who become pregnant should discontinue the use of olmesartan medoxomil as soon as possible unless no alternative to a drug acting on the renin-angiotensin system can be found. See Use in Pregnancy & Lactation.

Do not co-administer aliskiren with olmesartan medoxomil in patients with diabetes (see Interactions).

Special Precautions :

Volume- or Salt-Depleted Patients and Patients with Activated Renin-Angiotensin System: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g. those being treated with high doses of diuretics), symptomatic hypotension may occur following the initiation of treatment with olmesartan medoxomil.

Impaired Renal Function: In patients whose renal function may depend predominantly on the activity of the renin-angiotensin system, treatment with drugs that affect this system has been associated with azotemia, oliguria or, rarely, acute renal failure.

There is an increased risk of renal insufficiency when patients with bilateral renal artery stenosis (or stenosis of the artery to a single functioning kidney) are treated with medicinal products that affect the renin-angiotensin system.

Sprue-Like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan medoxomil, exclude other etiologies. Consider discontinuation of olmesartan medoxomil in cases where no other etiology is identified.