Fosinopril/Hydrochlorothiazide

Fosinopril/Hydrochlorothiazide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2], Amr Marawan, M.D. [3]

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Black Box Warning

FETAL TOXICITY See full prescribing information for complete Boxed Warning. 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

Overview

Fosinopril/Hydrochlorothiazide is an Angiotensin converting enzyme inhibitor, Thiazide diuretic that is FDA approved for the {{{indicationType}}} of hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cough (5.6%), fatigue (3.9% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

• Dosing Information

• Initial dose (not receiving a diuretic): 10-20 mg Fosinopril / 12.5-25 mg hydrochlorothiazide PO qd should be used.

• Maintenance dose: depends on individual titration and clinical response. Once dialy fixed combination is usual, but for optimal response divied doses can be given. The dosage range is Fosinopril 10-80 mg and hydrochlorothiazide is 12.5 to 50 mg.

Off-Label Use and Dosage (Adult)

Non–Guideline-Supported Use

Diabetic nephropathy

• Class of Recommendation: (Class IIb)

• Strength of Evidence: (Category B)

• Adult, Evidence favors efficacy

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

FDA Package Insert for Fosinopril and Hydrochlorothiazide tablet contains no information regarding safety and efficacy in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Fosinopril/Hydrochlorothiazide Contraindications in the drug label.

Warnings

FETAL TOXICITY See full prescribing information for complete Boxed Warning. 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

There is limited information regarding Fosinopril/Hydrochlorothiazide Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Fosinopril/Hydrochlorothiazide Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Fosinopril/Hydrochlorothiazide Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Fosinopril/Hydrochlorothiazide Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Fosinopril/Hydrochlorothiazide in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fosinopril/Hydrochlorothiazide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fosinopril/Hydrochlorothiazide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide in geriatric settings.

Gender

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fosinopril/Hydrochlorothiazide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fosinopril/Hydrochlorothiazide in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Fosinopril/Hydrochlorothiazide Administration in the drug label.

Monitoring

There is limited information regarding Fosinopril/Hydrochlorothiazide Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fosinopril/Hydrochlorothiazide and IV administrations.

Overdosage

There is limited information regarding Fosinopril/Hydrochlorothiazide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Fosinopril/Hydrochlorothiazide Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Fosinopril/Hydrochlorothiazide Mechanism of Action in the drug label.

Structure

There is limited information regarding Fosinopril/Hydrochlorothiazide Structure in the drug label.

Pharmacodynamics

There is limited information regarding Fosinopril/Hydrochlorothiazide Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Fosinopril/Hydrochlorothiazide Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Fosinopril/Hydrochlorothiazide Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Fosinopril/Hydrochlorothiazide Clinical Studies in the drug label.

How Supplied

There is limited information regarding Fosinopril/Hydrochlorothiazide How Supplied in the drug label.

Storage

There is limited information regarding Fosinopril/Hydrochlorothiazide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Fosinopril/Hydrochlorothiazide Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Fosinopril/Hydrochlorothiazide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fosinopril/Hydrochlorothiazide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Fosinopril/Hydrochlorothiazide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.