Olmevas AM

Indication

Olmevas AM is indicated for the treatment of hypertension, alone or with other antihypertensive agents.

Olmevas AM may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Dosage & Administration

General considerations

Maximum antihypertensive effects are attained within 2 weeks. Olmevas AM may be taken with or without food. Olmevas AM may be administered with other antihypertensive agents. Dosage may be increased after 2 weeks. The maximum recommended dose of Olmevas AM is 2 tablets (10/40 mg) once daily.

Initial therapy

The usual starting dose of Olmevas AM is one tablet (5/20 mg) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 1-2 weeks to two tablets of Olmevas AM (10/40 mg) once daily.

Replacement therapy

Olmevas AM may be substituted for its individually titrated components. When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.

Add-on Therapy

Olmevas AM may be used to provide additional blood pressure lowering for patients not adequately controlled with Amlodipine (or another dihydropyridine calcium channel blocker) alone or with Olmesartan Medoxomil (or another Angiotensin receptor blocker) alone.

Elderly patients

No dosage adjustment is necessary in elderly patients > 65 years age.

Patients with hepatic impairment

Initial therapy with Olmevas AM is not recommended in patient's >75 years and in patients with hepatic impairment.

Children

The safety and effectiveness of OLMEVAS AM in pediatric patients have not been established.

Use in Pregnancy and Lactation

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetaland neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure and death. When pregnancy is detected, discontinue Olmevas AM as soon as possible.

Precautions

Caution should be exercised in patients with volume or salt depletion, severe aortic stenosis, severe obstructive coronary artery disease, congestive heart failure, impaired renal function and hepatic impairment. No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (Creatinine clearance <40 mL/min). Combination of Amlodipine and Olmesartan is not recommended below creatinine clearance <20 mL/min.