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Fosinopril Sodium And Hydrochlorothiazide Medication Summary

No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.

This patient-friendly summary is based on FDA/DailyMed prescribing information. It is not a substitute for medical advice. Not every medication has a separate FDA Medication Guide.
This label includes a boxed warning. Review the full prescribing information and talk to a healthcare professional.

What is this medication?

Fosinopril Sodium and Hydrochlorothiazide is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.

What is this medication used for?

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION .) In using fosinopril sodium and hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than.

What should I know before taking it?

Fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to fosinopril, to any other ACE inhibitor, to hydrochlorothiazide, or other sulfonamide-derived drugs, or any other ingredient or component in the formulation. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

What important warnings are listed?

When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity

How is this medication usually taken?

Fosinopril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg per day. In clinical trials of fosinopril/hydrochlorothiazide combination therapy using fosinopril doses of 2.5 to 40 mg and hydrochlorothiazide doses at 5 to 37.5 mg, the antihypertensive effects increased with increasing dose of either component. The hazards (see WARNINGS ) of fosinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter.

What side effects are listed?

Fosinopril sodium and hydrochlorothiazide tablets have been evaluated for safety in over 660 patients with hypertension; approximately 137 of these patients were treated for more than one year. The observed adverse events were generally mild, transient, and similar to those seen with fosinopril and hydrochlorothiazide taken separately. There was no relationship between the incidence of side effects and age. In placebo-controlled clinical trials of fosinopril sodium and hydrochlorothiazide, the usual duration of therapy was two months. Adverse clinical or laboratory events led to discontinuation of therapy by 4.3% of 368 placebo-treated patients and by 3.5% of 660 fosinopril sodium and.

What interactions are listed?

Potassium supplements and potassium-sparing diuretics As noted above (“Derangements of Serum Electrolytes”), the net effect of fosinopril sodium and hydrochlorothiazide may be to elevate a patient’s serum potassium, to reduce it, or to leave it unchanged. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be given with caution, and the patient’s serum potassium should be monitored frequently. Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with.

Where can I find the official prescribing information?

Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=35019655-9a30-4305-a262-936ad0e73071

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Source: DailyMed prescribing information ↗

⚠️ Disclaimer

This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.

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