Amdocal5 mg

Description

Indications

Essential Hypertension: Amdocal is effective as a monotherapy for managing hypertension. It can also be used in combination with other antihypertensive medications.

Chronic Stable Angina: Amdocal is prescribed for chronic stable angina and works effectively as a standalone treatment. It may also be combined with other antianginal drugs.

Vasospastic Angina: This medication is indicated for confirmed or suspected cases of vasospastic angina. It can be used alone or in combination with other antianginal agents.

(Use as directed by a registered physician.)

Pharmacology

Amdocal contains Amlodipine, a dihydropyridine calcium-channel blocker with a prolonged duration of action. It is primarily used for treating hypertension and angina. Amlodipine works by relaxing blood vessels, reducing peripheral resistance, and lowering blood pressure. It also improves coronary blood flow and enhances myocardial oxygen supply, which helps in increasing cardiac output.

Dosage & Administration

For Hypertension:

• The usual starting dose is 5 mg once daily.
• The maximum recommended dose is 10 mg once daily.
• Elderly patients or those with liver impairment may start with 2.5 mg once daily. This lower dose is also suitable when adding Amlodipine to an existing antihypertensive regimen.

For Angina (Chronic Stable or Vasospastic):

• Recommended dosage ranges from 5 mg to 10 mg daily.
• A lower dose is advised for elderly patients and those with liver impairment.
• Most patients require 10 mg daily for effective treatment.

Administration: This medication can be taken with or without food.

(Use as directed by a registered physician.)

Drug Interactions

Potentially Risky Combinations:

• There is limited data on the use of Amdocal in patients with severe left ventricular dysfunction. Like other calcium-channel blockers, it should not be combined with beta-blockers in these cases.

Other Notable Interactions:

• Digoxin: No significant interaction has been observed.
• Cimetidine: No interactions reported in clinical studies.
• Warfarin: Amdocal does not significantly alter Warfarin’s effect on blood clotting.
• Food: Does not affect the absorption or efficacy of Amdocal.

Contraindications

Amdocal should not be used in patients with a known allergy to dihydropyridine derivatives. It is also not recommended for use during pregnancy.

Side Effects

The most common side effects are related to vasodilation and may include:

• Dizziness, flushing, headache, hypotension, and peripheral edema.
  Other possible side effects include:
• Gastrointestinal disturbances, increased urination, fatigue, eye discomfort, and mood changes.
• A rare paradoxical effect: Some patients may experience worsening ischemic chest pain at the start of treatment.
• Severe reactions: In rare cases, excessive blood pressure drop can lead to cerebral or myocardial ischemia or temporary vision impairment.
• Allergic reactions: Skin rash, fever, and liver function abnormalities may occur.

Use During Pregnancy & Lactation

• Pregnancy Category C: There is no sufficient clinical data on Amlodipine use during pregnancy. It should only be used if the potential benefits outweigh the risks.
• It is uncertain whether Amlodipine is excreted in breast milk. Therefore, breastfeeding should be discontinued if treatment is necessary.

Precautions & Warnings

• Patients with liver disease should use Amdocal cautiously.
• Pregnant and breastfeeding women should only use it under medical supervision.

Use in Special Populations

• Children (6-17 years): Starting dose is 2.5 mg once daily, which may be increased to 5 mg daily if needed after 4 weeks. Higher doses have not been studied in children.
• Children under 6 years: The safety and effectiveness of Amlodipine in this age group are unknown.
• Elderly Patients: Well tolerated at normal doses, but dosage adjustments should be made cautiously.
• Renal Impairment: No dosage adjustments are required, as Amdocal is not affected by kidney function. It is not removed through dialysis.
• Liver Impairment: Patients with severe hepatic impairment should start with the lowest dose (2.5 mg once daily) and increase slowly if necessary.

Overdose Management

Symptoms of Overdose:

• Severe hypotension (low blood pressure), excessive vasodilation, and possible reflex tachycardia.
• In extreme cases, shock with fatal outcomes has been reported.

Treatment Measures:

• Immediate cardiovascular support is crucial.
• Monitor heart and respiratory function frequently.
• Raise the patient’s legs to improve blood flow.
• Fluid replacement and urine output monitoring should be performed.
• Vasoconstrictors may be administered if appropriate.
• Intravenous calcium gluconate may help counteract calcium-channel blockade.
• Gastric lavage and activated charcoal can be used if administered within 2 hours of overdose.
• Dialysis is ineffective, as Amlodipine binds strongly to proteins.

Therapeutic Class

Amdocal belongs to the Calcium-Channel Blocker class of medications.

Storage Instructions

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