Usual Adult Dose for Hypertension

Initial doses (as determined by titration of the individual components):

• Hydrochlorothiazide 15 mg-Methyldopa 250 mg orally 2 or 3 times a day, OR
• Hydrochlorothiazide 25 mg-Methyldopa 250 mg orally twice a day, OR
• Hydrochlorothiazide 30 to 50 mg-Methyldopa 500 mg orally once a day

• This drug is not indicated for initial therapy. Dosage must be individualized, as determined by titration of the individual components.
• Initiate dose increases in the evening to minimize sedation.
• Tolerance to methyldopa may occur, usually between the second and third month of therapy. Additional separate doses of methyldopa or replacement of this drug with the individual components may be required.
• If this drug is given with antihypertensives other than thiazides, the initial dose of methyldopa should be limited to 500 mg a day in divided doses.

Renal Dose Adjustments

Mild to moderate renal dysfunction: Data not available
Severe renal dysfunction: Use with caution

If progressive renal impairment becomes evident: Consider withholding or discontinuing this drug

Liver Dose Adjustments

Contraindicated in patients with active hepatic disease

Precautions

US BOXED WARNING:

• INITIAL THERAPY: This fixed combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static, but must be re-evaluated as conditions in each patient warrant.

Dialysis

Data not available

Other Comments

Storage requirements: Protect from light.

Monitoring:

• Metabolic: Serum electrolytes prior to starting treatment and periodically thereafter.