Afdol Tab 10 Mg 4×14’s-Potential Overview:

Brand Name: Afdol
Generic Name: Amlodipine Besylate
Active Ingredient(s): Amlodipine 10 mg

For the General Public:

Uses:
Afdol is prescribed to:

• Manage high blood pressure (hypertension).
• Relieve chest pain (angina) due to reduced blood flow to the heart.
• Lower the risk of heart attack, stroke, or other cardiovascular complications.

Dosage:

• Adults: The typical dose is 10 mg once daily.
• Take at the same time each day with or without food. Do not exceed the prescribed dose.

Possible Side Effects:

• Common Side Effects: Swelling (especially in the ankles or feet), headache, dizziness, fatigue, nausea, or flushing.
• Serious (Less Common) Side Effects:
  • Severe hypotension (low blood pressure).
  • Rapid or irregular heartbeat.
  • Allergic reactions (rash, swelling of the face or throat).

Important Information:

• Dosage Instruction: Take the tablet exactly as prescribed by your doctor.
• Usage Instruction: Swallow the tablet with water; avoid breaking or crushing it.
• General Information:
  • Do not use if allergic to amlodipine or similar medications.
  • Inform your healthcare provider if you are pregnant, breastfeeding, or have liver issues.
  • Avoid abruptly stopping the medication without consulting your doctor.

Drug Interactions:

• Interactions with Other Medications: Beta-blockers, CYP3A4 inhibitors (e.g., ketoconazole), and statins (e.g., simvastatin).
• Interactions with Food: Avoid grapefruit juice, which can increase the medication’s effect.

Regulatory Approval & Manufacturer:
Approved by [regulatory body], manufactured by [manufacturer name].

Antidotes (If Overdose or Misuse by Patients):
Provide supportive measures such as intravenous fluids and monitoring of vital signs. Administer calcium gluconate in severe cases.

For Pharmacists:

Medicine Name: Afdol
Brand: Afdol
Active Ingredient(s): Amlodipine 10 mg

Indications:
Indicated for:

• Management of essential hypertension.
• Chronic stable angina and vasospastic angina (Prinzmetal’s angina).
• Prevention of cardiovascular events in high-risk patients.

Pharmacodynamics:

• Mechanism of Action:
  Amlodipine is a dihydropyridine calcium channel blocker. It inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to vasodilation and reduced blood pressure.
• Pharmacological Effects:
  • Reduces systemic vascular resistance and arterial pressure.
  • Improves oxygen delivery to the myocardium by dilating coronary arteries.
• Receptor Binding:
  Binds to L-type calcium channels, stabilizing the inactive state and reducing calcium influx, which relaxes vascular smooth muscle and cardiac cells.

Pharmacokinetics:

• Absorption: High oral bioavailability (64-90%).
• Distribution: Extensively distributed in body tissues; plasma protein binding ~93%.
• Metabolism: Metabolized by the liver via CYP3A4.
• Elimination: Excreted mainly in urine (~60%) and feces (~10%).
• Half-Life: Long half-life of 30-50 hours, allowing for once-daily dosing.
• Effect of Food: Food does not significantly impact absorption or efficacy.

Dosage and Administration:

• Adults: 10 mg once daily.
• Pediatric: Not typically used at this strength in children. Consult a physician for dose adjustment if required.
• Special Populations:
  • Elderly: Start with lower doses if required.
  • Liver Impairment: Use with caution; dosage adjustment may be needed.

Contraindications:

• Known hypersensitivity to amlodipine or other calcium channel blockers.
• Severe hypotension (systolic BP <90 mmHg).
• Cardiogenic shock or unstable heart failure post-myocardial infarction.

Warnings and Precautions:

• Use cautiously in patients with severe aortic stenosis or hepatic impairment.
• Monitor for potential exacerbation of angina or myocardial infarction upon initiation.

Drug-Drug Interactions:

• CYP3A4 inhibitors (e.g., itraconazole) increase plasma concentration of amlodipine.
• Concomitant use with simvastatin may increase the risk of statin-related side effects.

Drug-Food Interactions:

• Grapefruit juice may enhance the bioavailability of amlodipine, leading to increased drug effects.

Adverse Reactions:

• Common: Peripheral edema, headache, dizziness, fatigue.
• Serious: Severe hypotension, bradycardia, syncope, or allergic reactions.

Therapeutic Effects:

• Effectively lowers blood pressure and relieves chest pain by reducing vascular resistance and improving blood flow to the heart.

Storage:
Store at room temperature (15-30°C) in a cool, dry place, away from direct sunlight and moisture.

Packaging:
Available in tablet form, packaged in blister packs of 56 tablets (4×14’s).

Clinical Considerations:

• Pregnancy Category: C (use only if benefits outweigh risks).
• Lactation Category: Use with caution; consult a healthcare provider.
• Pediatric Category: Safety and efficacy not established for this dose in children under 6 years.
• Geriatric Category: Increased sensitivity; start at lower doses.

Conclusion:

Afdol Tab 10 mg is a potent and effective option for managing hypertension and angina. With its long half-life, it offers convenient once-daily dosing. Patients must adhere to their prescribed dosage and avoid grapefruit juice to prevent interactions. Pharmacists should counsel patients on side effects, monitor for drug interactions, and ensure proper usage for optimal therapeutic outcome.