AGEN ZENTIVA 5mg Capsules (Hard Gelatin)

What is AGEN ZENTIVA 5mg

AGEN ZENTIVA 5mg is a prescription medication that contains Amlodipine (as besilate), a long-acting calcium channel blocker (CCB). It is primarily used for the management of cardiovascular conditions such as:

• Hypertension (High Blood Pressure): Helps lower elevated blood pressure, reducing the risk of strokes and heart attacks.
• Chronic Stable Angina: Relieves chest pain due to reduced blood flow to the heart.
• Vasospastic Angina (Prinzmetal’s Angina): Prevents coronary artery spasms causing sudden chest pain.

Each capsule contains 5mg of Amlodipine in the form of amlodipine besilate. The formulation is available in hard gelatin capsules and is typically supplied in packs of 30 capsules (10s blister x 3).

By relaxing the blood vessels, AGEN ZENTIVA reduces vascular resistance, allowing blood to flow more easily and easing the workload on the heart.

How to use AGEN ZENTIVA 5mg

To ensure optimal benefits and minimize risks, AGEN ZENTIVA 5mg should be used exactly as prescribed by a healthcare professional.

• Route of Administration: Oral, to be swallowed whole with water. Do not chew or crush the capsule.
• Timing: Can be taken with or without food, ideally at the same time each day.
• Standard Dosage: Usually starts at 5mg once daily. Dosage may be increased to 10mg based on therapeutic response and tolerance.
• Missed Dose: If a dose is missed, take it as soon as remembered unless it is near the time of the next dose. Never double the dose.
• Duration of Use: Amlodipine is used for long-term management of cardiovascular conditions. Do not stop therapy abruptly without medical advice.

Important: Regular monitoring of blood pressure and periodic cardiovascular assessments may be necessary to evaluate treatment effectiveness.

Mode of Action AGEN ZENTIVA 5mg

AGEN ZENTIVA 5mg exerts its effects through the action of Amlodipine, a dihydropyridine-type calcium channel blocker:

• Calcium Channel Inhibition: Amlodipine selectively inhibits L-type calcium channels in vascular smooth muscle and myocardium.
• Vasodilation: Inhibition of calcium entry leads to relaxation of arterial smooth muscles, causing peripheral vasodilation and reduced vascular resistance.
• Lowered Blood Pressure: By reducing systemic vascular resistance, it lowers both systolic and diastolic blood pressure without significantly affecting heart rate.
• Improved Myocardial Oxygen Supply: In angina patients, Amlodipine reduces oxygen demand and increases oxygen delivery by dilating coronary arteries and preventing vasospasm.

The onset of action is gradual, making it suitable for long-term treatment without causing abrupt drops in blood pressure.

AGEN ZENTIVA 5mg Interactions AGEN ZENTIVA 5mg

Drug interactions may affect the efficacy and safety of AGEN ZENTIVA 5mg. Common and clinically relevant interactions include:

• Other Antihypertensives: May have additive effects leading to hypotension when combined with beta-blockers, ACE inhibitors, or diuretics.
• Simvastatin: Amlodipine increases plasma concentrations of simvastatin. The simvastatin dose should not exceed 20 mg/day when used together.
• CYP3A4 Inhibitors: Drugs like ketoconazole, erythromycin, or diltiazem may increase amlodipine plasma levels, enhancing its effects and side effects.
• CYP3A4 Inducers: Rifampin or carbamazepine may reduce the therapeutic levels of amlodipine, making it less effective.
• Grapefruit Juice: May slightly increase amlodipine levels, although not typically clinically significant.
• NSAIDs: Long-term use may reduce the antihypertensive effect.

Note: Always inform your healthcare provider about all medications, supplements, or herbal products you are using to avoid harmful interactions.

Dosage of AGEN ZENTIVA 5mg

Dosage should be tailored to individual patient needs and clinical response:

• Adults (Hypertension/Angina):
  • Initial dose: 5mg once daily
  • Maximum dose: 10mg once daily
• Elderly or Hepatic Impairment: Start with 2.5mg daily if available or monitor closely when using 5mg; increased sensitivity may be observed.
• Renal Impairment: No dose adjustment typically required, but close monitoring is advised.
• Children (6–17 years): 2.5mg to 5mg once daily. Not recommended in children under 6 years.

Note: Dose titration should occur gradually over 7–14 days to assess the full blood pressure response and avoid adverse effects.

Possible side effects of AGEN ZENTIVA 5mg

While generally well-tolerated, AGEN ZENTIVA 5mg may cause side effects in some individuals. These can be categorized as common, less common, and rare:

• Common (≥1%):
  • Swelling of ankles or feet (peripheral edema)
  • Headache
  • Flushing
  • Dizziness
  • Fatigue
  • Palpitations
• Less Common:
  • Abdominal pain, nausea
  • Sleep disturbances
  • Muscle cramps
  • Vision disturbances
• Rare but Serious:
  • Allergic reactions (rash, itching, angioedema)
  • Hypotension or fainting
  • Hepatic enzyme elevations
  • Chest pain or worsening of angina (especially on initiation)

Recommendation: Seek medical help if you experience persistent swelling, fainting, or allergic symptoms.

AGEN ZENTIVA 5mg Contraindications AGEN ZENTIVA 5mg

The use of AGEN ZENTIVA 5mg is contraindicated in the following scenarios:

• Hypersensitivity: Known allergy to amlodipine, other dihydropyridine derivatives, or any excipients in the capsule.
• Severe Hypotension: Including shock states or hemodynamic instability.
• Cardiogenic Shock: Where reduced cardiac output can worsen with vasodilators.
• Aortic Stenosis (Severe): Fixed obstruction may limit benefit and increase risk of collapse.
• Heart Failure (Post-MI): In cases with unstable symptoms or reduced left ventricular function.

Precautions: Use cautiously in patients with liver dysfunction, as amlodipine is extensively metabolized in the liver.

Storage of AGEN ZENTIVA 5mg

Proper storage is essential to maintain the medication's stability and efficacy:

• Temperature: Store below 30°C (86°F). Do not freeze.
• Humidity: Keep in a dry place, away from excessive moisture and direct sunlight.
• Packaging: Store in the original blister pack until use to protect from light and humidity.
• Keep Out of Reach of Children: To prevent accidental ingestion.
• Disposal: Do not flush unused medication. Follow local guidelines for safe disposal.

Check the expiration date before use. Do not use AGEN ZENTIVA if the packaging is damaged or shows signs of tampering.