Arbitel AM5 mg+40 mg

Approved Indications

Arbitel AM is a fixed-dose combination of a calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (telmisartan) that is indicated for the treatment of hypertension, either as:

• Initial therapy in patients whose blood pressure is likely to need multiple drugs to reach their blood pressure goal.
• Add-on/substitution therapy in patients who are not adequately controlled on amlodipine or telmisartan monotherapy alone.

Arbitel AM is not indicated as initial therapy for patients whose blood pressure may be controlled adequately with a single antihypertensive agent. Lowering blood pressure with Arbitel AM reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

Arbitel AM is not indicated for the initial management of hypertensive emergencies.

Amlodipine + Telmisartan tablets contain a fixed-dose combination of two active ingredients:

• Amlodipine (as amlodipine besylate) — a dihydropyridine calcium channel blocker.
• Telmisartan — an angiotensin II receptor blocker (ARB).

Amlodipine + Telmisartan is typically available in strength combinations such as 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg (telmisartan/amlodipine), along with standard pharmaceutical excipients.

Arbitel AM is an oral, once-daily, fixed-dose combination antihypertensive medicine that pairs a calcium channel blocker with an angiotensin II receptor blocker. Combining two agents with complementary mechanisms allows more patients to reach their blood pressure targets than either component alone, while generally causing less peripheral edema than amlodipine used by itself, because telmisartan's vasodilating effect on the venous side offsets amlodipine's arteriolar dilation.

Arbitel AM is intended for long-term, once-daily use in adults with hypertension, under the supervision of a physician.

Arbitel AM belongs to the therapeutic class of antihypertensive combinations, specifically a Calcium Channel Blocker (dihydropyridine) + Angiotensin II Receptor Blocker (ARB) combination.

Pharmacodynamics

Amlodipine + Telmisartan combines two complementary antihypertensive mechanisms:

• Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It relaxes vascular smooth muscle, producing arteriolar vasodilation and a reduction in peripheral vascular resistance and blood pressure.
• Telmisartan selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, blocking the vasoconstrictive and aldosterone-secreting effects of angiotensin II, which lowers blood pressure.

Pharmacokinetics

Amlodipine is slowly absorbed, with peak plasma concentrations reached in 6–12 hours and an elimination half-life of about 30–50 hours, allowing once-daily dosing. It is extensively metabolized in the liver. Telmisartan is rapidly absorbed, undergoes minimal hepatic metabolism, is eliminated almost entirely via biliary/faecal excretion, and has a long elimination half-life (over 20 hours). Co-administration in Amlodipine + Telmisartan does not significantly alter the individual pharmacokinetics of either component.

Arbitel AM tablets should be taken orally, once daily, at approximately the same time each day, with or without food. Tablets should be swallowed whole with a glass of water and should not be crushed or chewed unless directed by a physician. It is important not to miss doses; if a dose is missed, the next dose should be taken at the regular time without doubling up, unless a physician advises otherwise. Arbitel AM should be taken exactly as prescribed and not stopped abruptly without medical advice, as blood pressure may rebound.

Clinically Significant Drug Interactions

This list is not exhaustive. Patients should inform their physician or pharmacist about all prescription, over-the-counter, and herbal products being used before starting Arbitel AM.

Common Side Effects

• Peripheral (ankle/leg) edema
• Dizziness
• Headache
• Flushing
• Fatigue
• Back pain
• Upper respiratory tract infection symptoms

Less Common but Clinically Important Effects

• Symptomatic hypotension
• Hyperkalemia (elevated blood potassium)
• Palpitations

Rare but Serious Effects

• Angioedema (swelling of the face, lips, tongue, or throat) — rare but potentially life-threatening; requires immediate medical attention
• Rhabdomyolysis
• Significant liver enzyme abnormalities/hepatic dysfunction
• Worsening angina or myocardial infarction, particularly after starting or increasing the dose in patients with severe obstructive coronary artery disease

Patients should seek prompt medical attention for swelling of the face/throat, difficulty breathing, severe dizziness/fainting, chest pain, or irregular heartbeat while taking Arbitel AM.

Pregnancy

Arbitel AM is contraindicated in pregnancy. Drugs that act directly on the renin-angiotensin system, such as the telmisartan component of Arbitel AM, can cause injury and death to the developing fetus, including oligohydramnios, fetal renal impairment, skeletal deformations, and death, when used during the second and third trimesters (and possibly the first trimester). If pregnancy is detected while taking Arbitel AM, it should be discontinued as soon as possible and the patient should contact her physician immediately to discuss alternative antihypertensive therapy. Women of childbearing potential should be counselled about this risk before starting Arbitel AM.

Lactation

It is not known whether the components of Arbitel AM pass into human breast milk. Because of the potential for serious adverse effects (including hypotension, hyperkalemia, and renal impairment) in a nursing infant, breastfeeding is generally not recommended while taking Arbitel AM; a physician should be consulted to weigh the benefits of breastfeeding against the potential risk, and to discuss alternative therapy if needed.

Fetal Toxicity Warning

Arbitel AM can cause fetal harm when administered during pregnancy. See Pregnancy and Lactation for full details; discontinue Arbitel AM as soon as pregnancy is detected.

Hypotension

Symptomatic hypotension may occur, particularly in patients who are volume- or salt-depleted (e.g., from diuretic therapy, dietary salt restriction, vomiting, or diarrhea). Correct volume depletion before starting Arbitel AM, or begin treatment under close medical supervision.

Hyperkalemia

The telmisartan component can cause hyperkalemia, especially in patients with renal impairment, diabetes, or heart failure, or in those taking potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium. Periodic monitoring of serum potassium is advised in at-risk patients.

Renal and Hepatic Impairment

Use with caution and titrate slowly in patients with renal or hepatic impairment; dose adjustment may be required (see Dosage and Administration and Use in Special Populations).

Dual Blockade of the Renin-Angiotensin System

Avoid combining Arbitel AM with an ACE inhibitor or another ARB, as this increases the risk of hypotension, hyperkalemia, and renal dysfunction without added cardiovascular benefit.

Ischemic Heart Disease

As with other calcium channel blockers, worsening angina or acute myocardial infarction can rarely occur after starting Arbitel AM or increasing its dose, particularly in patients with severe obstructive coronary artery disease.

Heart Failure

Use Arbitel AM with caution in patients with heart failure; the amlodipine component has been associated with increased reports of pulmonary edema in some patients with severe heart failure.

Arbitel AM should be used only under medical supervision, with regular blood pressure and, where indicated, renal function/electrolyte monitoring.

Overdose of Arbitel AM may cause marked hypotension, dizziness, tachycardia (from amlodipine), or bradycardia, with the possibility of shock and death. If overdose of Arbitel AM is suspected, seek immediate medical attention or contact emergency services/poison control right away. Do not attempt to manage a suspected overdose at home. Treatment is generally supportive, with monitoring of cardiac and respiratory function, blood pressure, and fluid/electrolyte status in a medical facility; because the components are highly protein-bound, hemodialysis is unlikely to be of significant benefit. Keep Arbitel AM out of reach of children to prevent accidental ingestion.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly (≥65 years, especially ≥75 years)

Arbitel AM is not recommended as initial therapy in patients ≥75 years of age; treatment is typically started with amlodipine alone at a low dose (2.5 mg) due to reduced clearance and increased drug exposure in this age group, with slow titration to combination therapy as needed.

Renal Impairment

No initial dose adjustment is generally needed in mild-to-moderate renal impairment; slower titration and monitoring of renal function and potassium are advised in severe renal impairment.

Hepatic Impairment

Arbitel AM is not recommended as initial therapy in patients with hepatic impairment; treatment is typically started with a low dose of amlodipine alone, with careful titration.

Pediatric Use

The safety and effectiveness of Arbitel AM in pediatric patients have not been established (see Pediatric Uses).

Arbitel AM is generally intended for long-term, ongoing use as maintenance therapy for hypertension, since high blood pressure is a chronic condition requiring continuous control. Duration of treatment should be determined by the prescribing physician based on blood pressure response, tolerability, and overall cardiovascular risk; Arbitel AM should not be stopped abruptly without medical advice.

Calcium Channel Blocker (dihydropyridine) + Angiotensin II Receptor Blocker (ARB) — fixed-dose antihypertensive combination

Amlodipine + Telmisartan lowers blood pressure through two complementary mechanisms acting on different points of vascular tone regulation:

• Amlodipine blocks L-type calcium channels in vascular smooth muscle, reducing calcium influx, which relaxes arteriolar smooth muscle and decreases peripheral vascular resistance.
• Telmisartan selectively and competitively blocks the AT1 receptor for angiotensin II, preventing angiotensin II–mediated vasoconstriction and aldosterone release, which lowers blood pressure and reduces sodium/water retention.

Because amlodipine primarily dilates arterioles while telmisartan reduces angiotensin II activity on both arterial and venous tone, the combination in Amlodipine + Telmisartan produces a more balanced blood pressure reduction and tends to reduce the peripheral edema commonly seen with amlodipine monotherapy.

X

The safety and effectiveness of Arbitel AM in patients under 18 years of age have not been established. Arbitel AM is therefore not recommended for use in children or adolescents. If antihypertensive therapy is required in a pediatric patient, this should be managed by a specialist physician using agents and doses with an established pediatric safety profile.