Amlocard 5 mg

Description

Indications

• Essential Hypertension: Amlocard is effective as a stand-alone treatment for high blood pressure. It may also be combined with other antihypertensive medications.
• Angina Pectoris: It is indicated for chronic stable angina, working effectively as monotherapy or alongside other antianginal treatments.
• Vasospastic Angina: Amlocard is suitable for the treatment of confirmed or suspected vasospastic angina, either as a single agent or in combination with additional antianginal drugs.
  Use this medication only as directed by a registered physician.

Pharmacology
Amlodipine, a long-acting dihydropyridine calcium channel blocker, is employed in the management of hypertension and angina. It exerts its effects on myocardial cells, the heart’s conduction system, and vascular smooth muscle cells. The primary action is vasodilation, which lowers peripheral resistance, blood pressure, and afterload, while simultaneously increasing coronary blood flow and inducing a reflex rise in heart rate. This mechanism ultimately enhances myocardial oxygen supply and boosts cardiac output.

Dosage & Administration

• Hypertension:
  • Usual Dose: 5 mg once daily.
  • Maximum Dose: 10 mg once daily.
  • Special Considerations: In elderly patients or those with hepatic insufficiency, treatment may start at 2.5 mg once daily. This lower dose is also advisable when Amlocard is added to other antihypertensive therapies.
• Angina (Chronic Stable or Vasospastic):
  • Dose Range: 5 to 10 mg daily, with most patients typically requiring 10 mg.
  • Special Considerations: Use a lower dose for elderly patients or those with hepatic insufficiency.
• Administration: Can be taken with or without food.
  Use this medication only as directed by a registered physician.

Interactions

• Drug Interactions:
  • Potential Hazards: There is limited data in patients with markedly impaired left ventricular function. Therefore, as with other calcium antagonists, combining Amlocard with beta-blockers should be avoided in such patients.
• Other Significant Interactions:
  • Digoxin: Controlled studies in healthy volunteers have demonstrated no significant interaction.
  • Cimetidine: Unpublished data indicate no interaction between Amlocard and Cimetidine in healthy subjects.
  • Warfarin: Studies suggest that Amlocard does not significantly affect Warfarin’s impact on prothrombin time.
  • Food: The rate and extent of Amlocard absorption are not affected by food.

Contraindications
Amlocard should not be used in patients with known hypersensitivity to dihydropyridine derivatives or by pregnant women.

Side Effects
Common side effects primarily result from its vasodilatory properties and may include:

• Dizziness, flushing, headache, hypotension, and peripheral edema.
  Additional adverse effects include gastrointestinal disturbances, increased frequency of urination, lethargy, eye pain, and depression.
• An initial paradoxical increase in ischemic chest pain may occur when starting treatment.
• In some cases, an excessive drop in blood pressure has led to cerebral or myocardial ischemia or transient blindness.
• Hypersensitivity reactions may also present as rashes, fever, or liver function abnormalities.

Pregnancy & Lactation

• Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Amlocard should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
• Lactation: It is not known if Amlodipine is excreted in human milk. Therefore, discontinuation of breastfeeding is recommended during treatment.

Precautions & Warnings

• Exercise caution in patients with hepatic impairment.
• Additional care should be taken during pregnancy and breastfeeding.

Use in Special Populations

• Children (6–17 Years):
  • Starting Dose: 2.5 mg once daily, titrated to 5 mg once daily if blood pressure goals are not achieved after 4 weeks.
  • Note: Doses above 5 mg daily have not been studied in pediatric patients.
• Children Under 6 Years:
  • The effects on blood pressure have not been established.
• Elderly:
  • Amlocard is generally well-tolerated at standard doses, but any dosage increases should be approached with caution.
• Renal Impairment:
  • No dosage adjustment is required since plasma concentrations do not correlate with the degree of renal impairment. Amlocard is not removed by dialysis.
• Hepatic Impairment:
  • In mild to moderate cases, initiate treatment at the lower end of the dosing range and titrate carefully.
  • In severe hepatic impairment, start at 2.5 mg once daily and increase gradually.

Overdose Effects

• Symptoms:
  • An overdose may cause excessive peripheral vasodilation and reflex tachycardia, potentially leading to marked and prolonged hypotension, shock, and even fatal outcomes.
• Management:
  • Active cardiovascular support is required, including monitoring cardiac and respiratory function, elevating extremities, and ensuring proper fluid balance.
  • A vasoconstrictor may be administered if not contraindicated, and intravenous calcium gluconate can help reverse the calcium channel blockade.
  • Gastric lavage and the use of activated charcoal (within 2 hours of ingestion) may reduce drug absorption.
  • Due to high protein binding, dialysis is unlikely to be beneficial.

Therapeutic Class
Calcium Channel Blockers

Storage Conditions

• Keep this medication out of the reach of children.
• Store in a cool, dry place, protected from light.