Fosinopril Sodium and Hydrochlorothiazide

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Manufacturer: CIPLA USA INC.

Score: 143.0

Quick Summary

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The combination of fosinopril, an angiotensin-converting enzyme (ACE) inhibitor, and hydrochlorothiazide, a thiazide diuretic, provides additive antihypertensive effects. However, the use of this combination is not recommended for initial therapy. Fosinopril sodium and hydrochlorothiazide tablets should be used with caution in patients with severe renal disease, and are contraindicated in patients who are anuric or hypersensitive to fosinopril, hydrochlorothiazide, or other ACE inhibitors or sulfonamide-derived drugs.

Key Clinical Findings and Indications

Treatment of hypertension
Additive antihypertensive effects when combined
Not recommended for initial therapy

Important Safety Information

Warning

Fetal toxicity: when pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible

Contraindications

Anuric patients
Hypersensitivity to fosinopril, hydrochlorothiazide, or other ACE inhibitors or sulfonamide-derived drugs

Adverse Reactions

Head and neck angioedema
Intestinal angioedema
Anaphylactoid reactions
Hypotension
Neutropenia/agranulocytosis
Fetal toxicity

Dosing Recommendations

General Guidance

Dose adjustments should be guided by clinical response, and patients with severe renal impairment may require reduced dosages

Hypertension

Adult Dose

10-80 mg of fosinopril and 12.5-50 mg of hydrochlorothiazide once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Discontinue fosinopril and hydrochlorothiazide as soon as possible when pregnancy is detected
Fetal toxicity may occur

Nursing Mothers

Both fosinopril and hydrochlorothiazide are excreted in human milk
Decision should be made to discontinue nursing or the drug

Pediatric Use

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

Geriatric Use

Dose selection should be cautious, starting at the low end of the dosing range
Greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy