Orbas-20 mg Tab

Orbas-20

Description

ORBAS (Olmesartan Medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.

ORBAS (Olmesartan Medoxomil) is a selective AT1 subtype angiotensin II receptor antagonist. ORBAS (Olmesartan

Medoxomil) blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis.

Composition

ORBAS 20: Each film-coated tablet contains Olmesartan Medoxomil INN 20 mg.

ORBAS 40: Each film-coated tablet contains Olmesartan Medoxomil INN 40 mg.

Indication

ORBAS (Olmesartan Medoxomil) 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 ORBAS (Olmesartan Medoxomil) 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. ORBAS (Olmesartan Medoxomil) 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 ORBAS (Olmesartan

Medoxomil) alone, a diuretic may be added. ORBAS

(Olmesartan Medoxomil) may be administered with other antihypertensive agents. Pediatric Hypertension (6 to 16 years of age)

The usual recommended starting dose of ORBAS (Olmesartan

Medoxomil) 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 who weigh < 35 kg or 40 mg once daily for patients who weigh > 35 kg.

OR, AS DIRECTED BY PHYSICIAN.

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.

Contraindication

● Hypersensitivity to Olmesartan or any component of the product ● Contraindicated in case of biliary obstruction Precaution

● Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance

● 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 Interactions

No significant drug interactions were reported in studies in which Olmesartan medoxomil was co-administrated 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 dose in humans.

The most likely manifestation of over dose would be hypotension and tachycardia, bradycardia could occur from

parasympathetic (Vagal) stimulation. If symptomatic hypotension occurs, supportive treatment should be initiated.

Supply

ORBAS 20: Each box contains 3 x 10 tablets in blister pack.

ORBAS 40: Each box contains 3 x 1