Amlovas VS 5 mg+160 mg

Description

Indications

Amlodipine and Valsartan combination is prescribed for the treatment of hypertension. This fixed-dose combination is not recommended as the initial therapy for hypertension.
Take this medication as per the advice of a registered physician.

Pharmacology

Amlodipine is a dihydropyridine calcium channel blocker that prevents the influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan, an angiotensin II receptor blocker (ARB), inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II by selectively blocking its binding to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. Since this action does not depend on angiotensin II synthesis pathways, it provides an independent mechanism of action. Amlodipine and Valsartan effectively lower blood pressure through complementary mechanisms—Amlodipine by blocking calcium entry and Valsartan by reducing angiotensin II-induced vasoconstriction.

Dosage & Administration

For Hypertension Treatment:

• Amlodipine is effective at doses ranging from 2.5 mg to 10 mg once daily, while Valsartan is effective between 80 mg and 320 mg once daily.
• Clinical studies using Amlodipine doses of 5 mg–10 mg and Valsartan doses of 160 mg–320 mg have demonstrated improved antihypertensive effects with increasing doses.
• Most of the blood pressure-lowering effect is achieved within two weeks of initiating therapy or adjusting the dosage. If necessary, the dose may be increased after 1–2 weeks to a maximum of 10 mg/320 mg once daily for optimal blood pressure control.
• This combination can be taken with or without food and may be used alongside other antihypertensive medications.
• Patients whose blood pressure is not adequately controlled with Amlodipine or Valsartan alone may switch to this combination therapy.

Special Populations:

• Elderly Patients: Due to reduced clearance of Amlodipine, treatment should generally start at 2.5 mg.
• Renal Impairment: No initial dose adjustment is required for patients with mild to moderate renal impairment. However, careful dose titration is recommended for those with severe renal impairment.
• Hepatic Impairment: Patients with mild to moderate liver dysfunction do not require an initial dose adjustment, but dose adjustments should be made gradually in those with hepatic impairment.
  Take this medication as per the advice of a registered physician.

Drug Interactions

No specific interaction studies have been conducted for the Amlodipine and Valsartan combination; however, interaction studies have been performed for each component individually.

Contraindications

This medication is contraindicated in individuals with known hypersensitivity to any of its components.

Side Effects

Most side effects are mild and temporary. Common adverse effects may include:

• Peripheral edema
• Nasal congestion
• Sore throat and difficulty swallowing
• Upper respiratory tract infections
• Dizziness

Pregnancy & Lactation

• Pregnancy Category D: This medication should not be used during pregnancy as it may cause harm to the fetus.
• It is unclear whether Amlodipine or Valsartan is excreted in human breast milk. Due to potential risks to the infant, a decision should be made to either discontinue the drug or stop breastfeeding, considering the importance of the medication to the mother.

Precautions & Warnings

• Avoid exposure to the fetus or newborn.
• Monitor for potential hypotension.
• Patients with severe obstructive coronary artery disease should be informed about the risk of myocardial infarction or worsening angina.
• Gradual dose titration is necessary for patients with severe hepatic or renal impairment.

Use in Special Populations

The safety and effectiveness of this medication in pediatric patients have not been established.

Therapeutic Class

Combination antihypertensive medications.

Storage Conditions

• Store below 30°C.
• Protect from light and moisture.
• Keep out of reach of children.