OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Manufacturer: Accord Healthcare Inc.

Score: 148.0

Quick Summary

Olmesartan medoxomil and hydrochlorothiazide is a combination medication used to treat high blood pressure. It combines an angiotensin II receptor antagonist (olmesartan) with a thiazide diuretic (hydrochlorothiazide). The medication works by relaxing blood vessels and increasing urine production, which helps lower blood pressure. It is not recommended for initial therapy of hypertension but can be used in patients whose blood pressure is not adequately controlled with olmesartan or hydrochlorothiazide monotherapy. The starting dose is typically 40/12.5 mg once daily for patients not adequately controlled with olmesartan monotherapy, and 20/12.5 mg once daily for those not adequately controlled with hydrochlorothiazide monotherapy. Important safety information includes warnings about fetal toxicity, and contraindications such as hypersensitivity to any component of the medication, anuria, and coadministration with aliskiren in patients with diabetes. Adverse reactions may include dizziness, nausea, and hyperuricemia. Special population considerations include use during pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Treatment of hypertension to lower blood pressure
Combination of olmesartan medoxomil and hydrochlorothiazide
Not indicated for initial therapy of hypertension
May be used in combination with other antihypertensive drugs

Important Safety Information

Warning

Fetal toxicity: When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible.

Contraindications

Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets
Anuria
Coadministration with aliskiren in patients with diabetes

Adverse Reactions

Dizziness
Nausea
Hyperuricemia
Upper respiratory infection

Dosing Recommendations

General Guidance

Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide

Hypertension not adequately controlled with olmesartan monotherapy

Adult Dose

40/12.5 mg once daily

Pediatric Dose

Not established

Hypertension not adequately controlled with hydrochlorothiazide monotherapy

Adult Dose

20/12.5 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible when pregnancy is detected
Fetal toxicity risks

Nursing Mothers

It is not known whether olmesartan is excreted in human milk
Thiazides appear in human milk
Decision should be made whether to discontinue nursing or discontinue olmesartan medoxomil and hydrochlorothiazide tablets

Pediatric Use

Safety and effectiveness not established in pediatric patients
Neonates with a history of in utero exposure to olmesartan medoxomil and hydrochlorothiazide tablets may require support of blood pressure and renal perfusion

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
Dose selection should be cautious, usually starting at the low end of the dosing range

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