Amlocard 10 mg

Description

Pharmacology
Amlodipine is a long-acting dihydropyridine calcium-channel blocker used in the treatment of hypertension and angina pectoris. It exerts its effects by influencing myocardial cells, the specialized conducting system of the heart, and vascular smooth muscle cells. Amlodipine primarily induces vasodilation, leading to reduced peripheral resistance, decreased blood pressure and afterload, increased coronary blood flow, and a reflexive rise in coronary heart rate. These effects contribute to improved myocardial oxygen supply and enhanced cardiac output.

Dosage & Administration
Hypertension: The standard starting dose is 5 mg once daily, with a maximum dosage of 10 mg once daily. Elderly patients and those with hepatic insufficiency may begin with a lower dose of 2.5 mg once daily, which can also be used when combining Amlodipine with other antihypertensive medications.

Angina (Chronic Stable or Vasospastic): The usual dosage ranges from 5 to 10 mg daily, with the lower dose recommended for elderly patients and those with hepatic impairment. Most patients require a 10 mg dose for optimal results.

Administration: Amlodipine can be taken with or without food.

Take medication as directed by a registered physician.

Drug Interactions

• Potentially Hazardous Interactions: Limited data exist for patients with severely impaired cardiac left ventricular function. However, as with other calcium channel blockers, the combination of Amlodipine with beta-blockers should be avoided in such cases.
• Other Interactions:
  • Digoxin: Clinical studies show no significant interaction between Amlodipine and Digoxin.
  • Cimetidine: No reported interaction in clinical trials.
  • Warfarin: Studies indicate that Amlodipine does not significantly impact Warfarin’s effect on prothrombin time.
  • Food: The absorption of Amlodipine is not affected by food intake.

Contraindications
Amlodipine is contraindicated in patients with hypersensitivity to dihydropyridine derivatives. It should not be used by pregnant women unless necessary.

Side Effects
Common side effects related to vasodilation include dizziness, flushing, headache, hypotension, and peripheral edema. Other potential adverse effects include gastrointestinal disturbances, increased urination frequency, lethargy, eye pain, and depression. In rare cases, some patients may experience paradoxical chest pain, excessive drops in blood pressure leading to cerebral or myocardial ischemia, transient blindness, skin rashes, fever, or liver function abnormalities due to hypersensitivity reactions.

Pregnancy & Lactation
Amlodipine falls under Pregnancy Category C, meaning there are no well-controlled studies in pregnant women. It should be used only if the benefits outweigh potential risks. It is unknown whether Amlodipine is excreted in breast milk, so discontinuing nursing while on this medication is advisable.

Precautions & Warnings
Caution is advised for patients with hepatic impairment and for pregnant or breastfeeding women.

Use in Special Populations

• Children (6-17 years): The initial dose is 2.5 mg once daily, which can be increased to 5 mg if the desired blood pressure reduction is not achieved after four weeks. Doses above 5 mg have not been studied in pediatric patients.
• Children under 6 years: The effects of Amlodipine on blood pressure in this age group are unknown.
• Elderly: The medication is well tolerated in both elderly and younger patients. Standard dosage recommendations apply, but dose increases should be done cautiously.
• Renal Impairment: Amlodipine plasma concentrations are not affected by renal impairment; thus, normal dosages are recommended. The drug is not dialyzable.
• Hepatic Impairment: Patients with mild to moderate hepatic impairment should start at the lowest dose, with gradual titration. Severe hepatic impairment requires cautious dosing, beginning at 2.5 mg daily.

Overdose Effects

• Symptoms: Severe overdose may lead to excessive vasodilation, reflex tachycardia, and profound hypotension, potentially resulting in shock or fatal outcomes.
• Management: Treatment involves close monitoring of cardiac and respiratory functions, fluid volume maintenance, and urine output assessment. A vasoconstrictor may be administered if not contraindicated. Intravenous calcium gluconate may help counteract calcium channel blockade effects. In some cases, gastric lavage and activated charcoal (if administered within two hours) may reduce drug absorption. Due to high protein binding, dialysis is not expected to be beneficial.

Therapeutic Class
Calcium-channel blockers

Storage Conditions
Keep out of reach of children. Store in a cool, dry place away from light.