Arbitel^®

Arbitel is a preparation of Telmisartan which is a non-peptide angiotensin II receptor antagonist. Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme. Angiotensin II is the principal agent of the renin-angiotensin system. Telmisartan blocks the vasoconstrictor and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the ATI receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

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Arbitel is indicated for-
• Treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors.

Route of administration: Arbitel should be taken in oral route with or without food.

Treatment of hypertension: In case of hypertension usually 40 mg once daily for at least 4 weeks. Increase if necessary up to maximum 80 mg once daily. Blood pressure response is dose related over the range of 20 mg to 80 mg.
Cardiovascular risk reduction: 80 mg once daily.

Pregnancy: Telmisartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Lactation: There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan.

Use in children and adolescents
Safety and effectiveness in pediatric patients have not been established.

Caution should be taken in patients with biliary obstructive disorders or hepatic insufficiency. Use of drugs that act on the renin-angiotensin system during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Telmisartan may potentially cause extreme low blood pressure or a decrease in kidney
function. Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels.

The most common side effects are back pain, diarrhea, sinusitis, claudication and skin ulcer.

It is contraindicated in patients with known hypersensitivity of Telmisartan or any of the components of the product.

Drug interaction with medication: Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of telmisartan. Concomitant administration with non-steroidal
anti-inflammatory drugs (NSAIDs) may cause reduced diuretic, natriuretic, antihypertensive effects and increased risk of renal impairment. Do not co-administer aliskiren with telmisartan in patients with diabetes. When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Drug interaction with food and others: Not applicable.

In case of telmisartan overdose, hypotension, dizziness and tachycardia can occur. If overdose occurs, supportive treatment should be given.

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Store in a cool (below 25°C) and dry place. Protect from light.

Arbitel 20 tablet: Each coated tablet contains Telmisartan BP 20 mg.
Arbitel 40 tablet: Each coated tablet contains Telmisartan BP 40 mg.
Arbitel 80 tablet: Each coated tablet contains Telmisartan BP 80 mg.

Storage
Store below 25°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Arbitel 20 tablet: Carton of 56 tablets in blister pack.
Arbitel 40 tablet: Carton of 56 tablets in blister pack.
Arbitel 80 tablet: Carton of 42 tablets in blister pack.