Arbitel^® Plus

Arbitel Plus is a combination of Telmisartan and Hydrochlorothiazide. Telmisartan is a non-peptide angiotensin II receptor antagonist and Hydrochlorothiazide is a thiazide diuretics. Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme. 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. Hydrochlorothiazide affects the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.

No Data

Arbitel Plus is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It is not indicated for initial therapy.

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

Treatment of hypertension: Initiate a patient with Arbitel Plus 80 mg/12.5 mg once daily whose blood pressure is not adequately controlled with Telmisartan monotherapy 80 mg. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Initiate a patient with Arbitel Plus 80 mg/12.5 mg once daily whose blood pressure is not adequately controlled by 25 mg once daily of Hydrochlorothiazide, or is controlled but who experiences hypokalemia. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Hepatic Insufficiency: Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg. Arbitel Plus is not indicated for severe hepatic impairment patients.

Pregnancy: This combination can cause fetal harm when administered to a pregnant woman. When pregnancy is detected or expected, discontinue this combination as soon as possible.

Lactation: There is no information regarding the presence of this combination or telmisartan in human milk, the effects on the breastfed infant or the effects on milk production. Limited published studies report that hydrochlorothiazide is present in human milk. 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 this combination.

Use in children and adolescents
Safety and effectiveness of this combination 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 trimesters 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. Hydrochlorothiazide can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

The most common side effects are upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms and nausea.

It is contraindicated in patients with known hypersensitivity to telmisartan or hydrochlorothiazide or any other components of this product. It is also contraindicated in patients with anuria and for co-administration with aliskiren in patients with diabetes.

Drug interaction with medication: Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia. Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Concomitant administration with non-steroidal anti-inflammatory drugs (NSAIDs) may cause reduced diuretic, natriuretic, antihypertensive effects and increased risk of renal impairment. Dual blockade of the renin-angiotensin-aldosterone system (RAS) with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia and renal impairment. When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Dosage adjustment of antidiabetic drugs may be required when co-administered with hydrochlorothiazide. Co-administration with cholestyramine and colestipol may reduce absorption of hydrochlorothiazides.

Drug interaction with food and others: Not applicable.

Telmisartan: Limited data are available with regard to overdose in humans. The most likely manifestation of overdose with Telmisartan would be hypotension, dizziness and tachycardia. If overdose occur, supportive treatment should be given.

Hydrochlorothiazide: The most common signs and symptoms observed in patients with a Hydrochlorothiazide overdose are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. Hydrochlorothiazide is removed by hemodialysis has not been established.

No Data

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

Arbitel Plus 40 tablet: Each coated tablet contains Telmisartan BP 40 mg & Hydrochlorothiazide BP 12.5 mg.
Arbitel Plus 80 tablet: Each coated tablet contains Telmisartan BP 80 mg & Hydrochlorothiazide BP 12.5 mg.

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

Packing
Arbitel Plus 40 tablet: Carton of 30 tablets in blister pack.
Arbitel Plus 80 tablet: Carton of 30 tablets in blister pack.