Hypen-Max SR
Generic Name
Amlodipine + Valsartan (sustained release)
Manufacturer
MediTop Pharma Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Hypen-Max SR is a combination medicine used to treat high blood pressure (hypertension). It contains Amlodipine, a calcium channel blocker, and Valsartan, an angiotensin II receptor blocker. This combination helps to relax blood vessels, making it easier for your heart to pump blood, thereby lowering blood pressure. The 'SR' indicates a sustained-release formulation, providing prolonged action.
Uses & Indications
Dosage
Adults
The usual starting dose is one Hypen-Max SR tablet (e.g., 5 mg Amlodipine / 80 mg Valsartan) once daily. The dose can be increased after 1-2 weeks if blood pressure control is inadequate, up to a maximum of 10 mg Amlodipine / 320 mg Valsartan once daily.
Elderly
No dosage adjustment is generally required for elderly patients, but caution is advised due to potential for increased sensitivity.
Renal_impairment
No initial dosage adjustment is required for patients with mild to moderate renal impairment. For severe renal impairment or dialysis patients, caution is advised and dose adjustment may be necessary. Not recommended for patients with severe renal impairment (CrCl < 10 mL/min).
How to Take
Take Hypen-Max SR tablet orally, once daily, with or without food. Swallow the tablet whole with a glass of water; do not crush, chew, or break it, as this would interfere with the sustained-release mechanism.
Mechanism of Action
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This causes vasodilation, reducing peripheral vascular resistance and blood pressure. Valsartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues. This inhibition prevents the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased blood volume, and reduced blood pressure.
Pharmacokinetics
Onset
Onset of antihypertensive action for Amlodipine is gradual over several hours; for Valsartan, within approximately 2 hours. Full effect of combination is usually seen within 2 weeks.
Excretion
Amlodipine is excreted primarily through the urine (approximately 60% as inactive metabolites). Valsartan is excreted primarily in the feces (approximately 83%) and urine (approximately 13%) as unchanged drug and metabolites.
Half life
Amlodipine has a prolonged elimination half-life of 30-50 hours. Valsartan has an elimination half-life of approximately 6 hours.
Absorption
Amlodipine is well absorbed after oral administration, with peak plasma concentrations reached in 6-12 hours. Valsartan is variably absorbed, with peak plasma concentrations reached in 2-4 hours. The bioavailability of Valsartan is approximately 25%.
Metabolism
Amlodipine is extensively metabolized in the liver to inactive metabolites. Valsartan is minimally metabolized (approximately 20%) by the liver, primarily to a hydroxyl metabolite.
Side Effects
Contraindications
- Hypersensitivity to Amlodipine, Valsartan, or any excipients
- Severe hepatic impairment, biliary cirrhosis, or cholestasis
- Pregnancy and lactation
- Concomitant use with aliskiren in patients with diabetes or renal impairment (CrCl < 60 mL/min)
Drug Interactions
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of Valsartan and increase the risk of renal impairment.
CYP3A4 Inducers (e.g., Rifampicin, St. John's Wort)
May decrease Amlodipine exposure, leading to reduced efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin)
May increase Amlodipine exposure, leading to increased risk of hypotension.
Potassium-sparing Diuretics, Potassium Supplements, Salt substitutes containing potassium
May increase serum potassium levels due to Valsartan's effect.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include marked hypotension with possible reflex tachycardia or profound peripheral vasodilation leading to shock. Management involves symptomatic and supportive measures. If recent ingestion, gastric lavage may be considered. Intravenous calcium gluconate may be beneficial for reversing the effects of calcium channel blockade (Amlodipine). Hypotension secondary to Valsartan may respond to intravenous fluids. Hemodialysis is not effective for removing Amlodipine or Valsartan.
Pregnancy & Lactation
Hypen-Max SR is contraindicated during pregnancy, especially during the second and third trimesters, due to the risk of fetal injury or death from Valsartan. If pregnancy is detected, discontinue immediately. It is not recommended during lactation as it is unknown if Amlodipine or Valsartan are excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to Amlodipine, Valsartan, or any excipients
- Severe hepatic impairment, biliary cirrhosis, or cholestasis
- Pregnancy and lactation
- Concomitant use with aliskiren in patients with diabetes or renal impairment (CrCl < 60 mL/min)
Drug Interactions
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of Valsartan and increase the risk of renal impairment.
CYP3A4 Inducers (e.g., Rifampicin, St. John's Wort)
May decrease Amlodipine exposure, leading to reduced efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin)
May increase Amlodipine exposure, leading to increased risk of hypotension.
Potassium-sparing Diuretics, Potassium Supplements, Salt substitutes containing potassium
May increase serum potassium levels due to Valsartan's effect.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include marked hypotension with possible reflex tachycardia or profound peripheral vasodilation leading to shock. Management involves symptomatic and supportive measures. If recent ingestion, gastric lavage may be considered. Intravenous calcium gluconate may be beneficial for reversing the effects of calcium channel blockade (Amlodipine). Hypotension secondary to Valsartan may respond to intravenous fluids. Hemodialysis is not effective for removing Amlodipine or Valsartan.
Pregnancy & Lactation
Hypen-Max SR is contraindicated during pregnancy, especially during the second and third trimesters, due to the risk of fetal injury or death from Valsartan. If pregnancy is detected, discontinue immediately. It is not recommended during lactation as it is unknown if Amlodipine or Valsartan are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory authorities (e.g., FDA, EMA, DGDA)
Patent Status
Generic available
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of Amlodipine/Valsartan combination in treating hypertension, showing superior blood pressure reduction compared to monotherapy. Studies also support its long-term cardiovascular benefits.
Lab Monitoring
- Serum potassium levels (especially in patients with renal impairment or those on potassium-sparing diuretics)
- Renal function (BUN/creatinine) periodically
- Liver function tests (LFTs) if clinical symptoms suggest hepatic impairment
Doctor Notes
- Emphasize adherence for optimal blood pressure control.
- Monitor for signs of angioedema, especially during initial therapy or dose escalation.
- Advise patients on lifestyle modifications to complement pharmacotherapy.
- Caution with concomitant use of NSAIDs due to potential for reduced efficacy and increased renal risk.
Patient Guidelines
- Take the medicine at the same time each day.
- Do not stop taking the medicine without consulting your doctor, even if you feel well.
- Regularly monitor your blood pressure as advised by your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Hypen-Max SR may cause dizziness, fatigue, or visual disturbances, especially at the start of treatment or when changing doses. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Adopt a heart-healthy diet low in sodium and saturated fats.
- Engage in regular physical activity (e.g., 30 minutes of moderate exercise most days of the week).
- Maintain a healthy weight.
- Limit alcohol consumption.
- Quit smoking.
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