Arbitel^® AM

Arbitel AM is a preparation of Amlodipine and Telmisartan. Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Telmisartan is a non-peptide angiotensin II receptor antagonist. 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.

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Arbitel AM is indicated-
• For the treatment of hypertension alone or with other antihypertensive agents.
• As initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Route of administration: Arbitel AM should be taken in oral route with or without food.
Initiate with Arbitel AM 5/40 mg once daily. Patients requiring larger blood pressure reductions may be started on Arbitel AM 5/80 mg once daily. Initial therapy with Arbitel AM is not recommended in patients 2 ≥ 75 years old or with hepatic impairment. Dosage may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of Arbitel AM tablets is 10/80 mg once daily.

Replacement therapy
Patients receiving amlodipine and telmisartan from separate tablets may instead receive Arbitel AM tablets containing the same component doses once daily. When substituting for individual components, increase the dose of Arbitel AM if blood pressure control has not been satisfactory.

Add-on therapy for patients with hypertension not adequately controlled on antihypertensive monotherapy
Arbitel AM tablets may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to Arbitel AM 5/40 mg tablets once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.

Renal impairment
No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic impairment
Monitor carefully and titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency. Since patients with hepatic impairment have decrease clearance of amlodipine, start amlodipine or add amlodipine 2.5 mg to telmisartan. But here the lowest dose is 5/40 mg; therefore, initial therapy with Arbitel AM tablets is not recommended in hepatically impaired 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 amlodipine 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.

Avoid fetal or neonatal exposure. Correct any volume or salt depletion before initiating therapy. Observe for signs or symptoms of hypotension. Titrate slowly in patients with hepatic or severe renal impairment. Monitor for worsening in Heart Failure patients. Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker. Uncommonly, initiating a CCB in patients severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina.

The most common side effect are peripheral edema, dizziness, hypotension and back pain.

This combination is contraindicated in patients with a known hypersensitivity to amlodipine or telmisartan or any of the components of the products.

Drug interaction with medication: Do not co-administer aliskiren with this combination in patients with diabetes. Avoid use of aliskiren with this combination in patients with renal impairment (GFR<60 ml/min). When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A4 inhibitors. Patients should be monitored for adequate clinical effect when amlodipine is co-administered with CYP3A4 inducers
Drug interaction with food and others: Not applicable.

Amlodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential.
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.

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

Arbitel AM 5/40 tablet: Each coated tablet contains Amlodipine Besilate BP 6.935 mg equivalent to 5 mg Amlodipine and Telmisartan BP 40 mg.
Arbitel AM 5/80 tablet: Each coated tablet contains Amlodipine Besilate BP 6.935 mg equivalent to 5 mg Amlodipine and Telmisartan BP 80 mg.

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

Packing
Arbitel AM 5/40 tablet: Carton of 30 tablets in blister pack.
Arbitel AM 5/80 tablet: Carton of 30 tablets in blister pack.