Ampre Plus

Approved Indications:

• Essential Hypertension (Primary Hypertension): For the treatment of mild to moderate hypertension in patients where monotherapy is insufficient.
• Stable Angina Pectoris (Chronic Stable Angina): Indicated for patients with exertional angina to reduce anginal episodes and improve exercise tolerance.
• Co-existing Hypertension and Coronary Artery Disease (CAD): Used to control blood pressure and prevent ischemic episodes in patients with both conditions.
• Post-Myocardial Infarction (in select cases): As maintenance therapy to manage blood pressure and reduce cardiac workload when both a beta-blocker and calcium channel blocker are clinically indicated.

Clinically Accepted Off-label Uses:

• Hypertension with Tachycardia: Due to atenolol's beta-blocking effect and amlodipine's vasodilatory effect.
• Hypertension in Diabetic Patients (with caution): Sometimes used in diabetic patients, though atenolol may mask hypoglycemia; requires monitoring.
• Hypertensive Cardiomyopathy (early-stage): To reduce afterload and heart rate in patients with concentric hypertrophy.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults:

For Hypertension (High Blood Pressure):

• Initial dose: Amlodipine 5 mg + Atenolol 50 mg once daily.
• If blood pressure is not adequately controlled, the dose may be increased to Amlodipine 10 mg + Atenolol 50–100 mg once daily, depending on clinical response and tolerance.

For Chronic Stable Angina:

• Initial dose: Amlodipine 5 mg + Atenolol 50 mg once daily.
• If angina symptoms persist, the dose may be increased to Amlodipine 10 mg + Atenolol 50–100 mg once daily.

Elderly:

• Start at lower dose (e.g., Amlodipine 2.5 mg + Atenolol 25 mg) due to increased sensitivity. Monitor for hypotension and bradycardia.

Pediatrics:

• Not recommended; safety and efficacy not established.

Special Considerations

• Tablets should be taken once daily, preferably at the same time each day.
• Can be taken with or without food.
• Dose adjustments may be required in elderly patients, or those with renal or hepatic impairment.
• Regular monitoring of blood pressure and heart rate is recommended.
• Do not discontinue therapy abruptly, especially in patients with angina, without consulting a physician.

Maximum Recommended Dose

• Amlodipine 10 mg + Atenolol 100 mg once daily.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

This combination exerts complementary cardiovascular effects. Amlodipine, a dihydropyridine calcium channel blocker, inhibits calcium influx into vascular smooth muscle and myocardial cells, causing peripheral arterial vasodilation and decreased systemic vascular resistance. Atenolol, a cardioselective beta-1 adrenergic blocker, reduces heart rate, myocardial contractility, and cardiac output, and suppresses renin release. Together, they lower blood pressure, reduce cardiac workload, and improve oxygen supply to the myocardium, making the combination effective for hypertension and angina.

Amlodipine:

• Absorption: ~64–90%; peak plasma level in 6–12 hours.
• Distribution: Extensive (Volume of distribution ~21 L/kg); highly protein-bound (~93%).
• Metabolism: Hepatic via CYP3A4.
• Elimination: Primarily via urine (~60% as metabolites).
• Half-life: 30–50 hours.
• Bioavailability: ~64%.

Atenolol:

• Absorption: ~50%; unaffected by food.
• Distribution: Low protein binding (~6–16%); does not cross blood-brain barrier significantly.
• Metabolism: Minimal hepatic metabolism.
• Elimination: Primarily renal (~85% unchanged).
• Half-life: 6–9 hours (prolonged in renal impairment).
• Bioavailability: ~40–50%.

• Pregnancy: Category C. Atenolol has been associated with fetal growth restriction when used in the second or third trimester. Use only if potential benefits justify risk to fetus. Avoid in late pregnancy.
• Lactation: Both drugs are excreted in breast milk. Atenolol especially may accumulate in infants and cause bradycardia or hypotension. Avoid or use alternative drugs during breastfeeding.
• Caution: Consider alternate antihypertensive agents during pregnancy/lactation unless no alternatives exist.

• Primary Class: Antihypertensive Agents
• Subclasses:
• Amlodipine: Dihydropyridine Calcium Channel Blocker (CCB)
• Atenolol: Cardioselective Beta-1 Adrenergic Blocker

• Hypersensitivity to amlodipine, atenolol, or excipients
• Sinus bradycardia or second/third-degree AV block (without pacemaker)
• Overt cardiac failure or cardiogenic shock
• Severe hypotension (systolic BP <90 mmHg)
• Sick sinus syndrome (without pacemaker)
• Severe peripheral arterial circulatory disorders
• Untreated pheochromocytoma
• Pregnancy (third trimester) and lactation (relative contraindication)

• Bradycardia and Hypotension: Monitor closely, especially in elderly or patients with conduction abnormalities.
• Heart Failure: Atenolol may worsen symptoms in uncontrolled CHF.
• Hepatic Impairment: Amlodipine metabolism may be delayed; adjust dose if needed.
• Renal Impairment: Atenolol clearance reduced; monitor renal function.
• Discontinuation: Do not stop abruptly, especially atenolol; may cause rebound angina or MI.
• Peripheral Edema: Amlodipine may cause dose-dependent pedal edema.
• Diabetes Mellitus: Atenolol may mask hypoglycemia symptoms; monitor glucose levels.
• Asthma/COPD: Use atenolol cautiously, even though it is cardioselective.

Common:

• Cardiovascular: Bradycardia, hypotension, palpitations, edema (especially pedal)
• CNS: Dizziness, fatigue, headache
• Gastrointestinal: Nausea, abdominal discomfort
• General: Cold extremities (atenolol-related)

Less Common:

• Depression, sleep disturbances, decreased libido, dry mouth

Serious/Rare:

• AV block, heart failure exacerbation, hepatotoxicity (rare with amlodipine), bronchospasm (especially in asthmatics)

Most side effects are dose-related and reversible upon discontinuation.

• With Other Antihypertensives (e.g., ACEIs, ARBs, diuretics): Additive hypotensive effects
• Calcium Channel Blockers (Non-dihydropyridine, e.g., verapamil, diltiazem): Increased risk of bradycardia or AV block
• Digitalis Glycosides: Enhanced bradycardic effect
• NSAIDs: May reduce antihypertensive efficacy
• CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin): Increase amlodipine plasma levels
• CYP3A4 Inducers (e.g., rifampin, carbamazepine): Reduce amlodipine efficacy
• Alcohol: May enhance hypotensive effect
• Beta-blockers + Clonidine: Abrupt withdrawal of clonidine may cause rebound hypertension if beta-blockers are continued

• European Society of Cardiology (ESC) Guidelines (2023): Reaffirmed the efficacy of combination therapy (CCB + Beta-blocker) in hypertensive patients with stable angina and those with multiple comorbidities.
• No recent FDA label changes or black box warnings for this fixed-dose combination.
• Amlodipine-Atenolol remains widely recommended for dual-agent therapy when monotherapy fails.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C–30°C
• Humidity: Store in a dry place; avoid exposure to moisture
• Light: Protect from direct sunlight
• Handling: Keep in original blister/strip until use
• Refrigeration: Not required
• Other: Keep out of reach of children