Amlosartan (Amlodipine & Valsartan) Therapeutic Group: Cardiovascular » Anti Hypertensive » Combined Antihypertensive Preparations

 Presentation
Amlosartan 5/80: Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg & Valsartan USP 80 mg.

Amlosartan 5/160: Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg & Valsartan USP 160 mg.

Amlosartan 10/160: Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 10 mg & Valsartan USP 160 mg.

 Descriptions
Amlosartan is indicated for the treatment of hypertension. This combination drug is not indicated for the initial therapy of hypertension.

Indications
Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg to 10 mg while Valsartan is effective in doses of 80 mg to 320 mg. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure.
Amlosartan may be administered with or without food. Amlosartan may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to their combination therapy.
Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.
Renal impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Dosage & Administration
Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg to 10 mg while Valsartan is effective in doses of 80 mg to 320 mg. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure.
Amlosartan may be administered with or without food. Amlosartan may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to their combination therapy.
Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.
Renal impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.
Hepatic impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Side Effects
The most common side effects include peripheral edema, vertigo, nasopharyngitis, upper respiratory tract infection and dizziness.

 Precautions
Amlosartan should be used with caution because there is a risk for-
fetal or neonatal morbidity
hypotension
myocardial infarction or increased angina
Dose should be titrated slowly in patients with impaired hepatic or severely impaired renal function. In general, calcium channel blockers should be used with caution in patients with heart failure.

Contraindications
Amlodipine and Valsartan combination is contraindicated in patients who are hypersensitive to any compounds of this product.

Use in Pregnancy & Lactation
Pregnancy: Amlodipine and Valsartan combination should not be used in 2nd and 3rd trimester because it can cause fetal death .
Nursing Mothers: It is not known whether Valsartan and Amlodipine are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

 Overdose
Limited data of human overdosage have been reported.

Commercial Packaging
Amlosartan 5/80: Each box contains 3 alu-alu blister strips of 10 tablets.
Amlosartan 5/160: Each box contains 3 alu-alu blister strips of 10 tablets.
Amlosartan 10/160: Each box contains 3 alu-alu blister strips of 10 tablets.





Others
Pediatric use: The safety and effectiveness has not been established in pediatric patients.

Geriatric use: No differences in overall incidence of adverse events were observed in elderly.

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