Valsartan and Amlodipine Tablets 80mg/5mg
Composition:
Each tablet contains:
- Valsartan 80mg
- Amlodipine (as Amlodipine Besylate) 5mg
Description:
This fixed-dose combination contains Valsartan, an angiotensin II receptor blocker (ARB), and Amlodipine, a calcium channel blocker (CCB). Together, they help lower high blood pressure (hypertension) by relaxing blood vessels and improving blood flow.
Indications:
Valsartan and Amlodipine Tablets are indicated for:
- Hypertension (high blood pressure) in patients who require combination therapy
- Reduction of cardiovascular risk in patients with high blood pressure and additional risk factors
Dosage & Administration:
Adults:
- Usual starting dose: 1 tablet (80mg/5mg) once daily
- Dose adjustment: Based on blood pressure response
- Maximum dose: 320mg/10mg per day
- Can be taken with or without food
Pediatric Use:
- Not recommended for children under 18 years due to insufficient safety data.
Renal Impairment:
- No dose adjustment required for mild-to-moderate impairment.
- Severe renal impairment (eGFR <30 mL/min/1.73m²): Use with caution.
Hepatic Impairment:
- Use with caution in patients with mild to moderate liver disease.
- Severe hepatic impairment: Not recommended.
Contraindications:
- Hypersensitivity to Valsartan, Amlodipine, or excipients
- Pregnancy and breastfeeding (Category D - risk to fetus)
- Severe liver disease
- Severe hypotension (low blood pressure)
- History of angioedema with ARBs
Precautions:
- Hypotension: Risk in volume-depleted patients; correct dehydration before starting.
- Kidney Function: Monitor renal function in patients with kidney disease.
- Hyperkalemia: Caution in patients taking potassium supplements or potassium-sparing diuretics.
- Heart Failure: Use with caution in patients with congestive heart failure.
Adverse Reactions:
- Common: Dizziness, headache, fatigue, peripheral edema, flushing
- Gastrointestinal: Nausea, abdominal pain
- Cardiovascular: Hypotension, palpitations
- Musculoskeletal: Muscle cramps, back pain
- Serious (rare): Angioedema, severe hypotension, kidney dysfunction
Drug Interactions:
- NSAIDs: May reduce antihypertensive effect and worsen kidney function.
- Potassium-sparing diuretics (e.g., spironolactone): Risk of hyperkalemia.
- Lithium: Risk of lithium toxicity.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase Amlodipine levels.
- Other antihypertensives: May enhance blood pressure-lowering effects.
Storage Conditions:
- Store below 25°C, in a dry place, away from light.
- Keep out of reach of children.
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