Fosinopril-Hydrochlorothiazide (fosinopril sodium/hydrochlorothiazide)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Hydrochlorothiazide is a thiazide diuretic and antihypertensive agent.
Fosinopril is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor.
Fosinopril, a phosphinic acid derivative, is an angiotensin-converting enzyme (ACE, bradykininase, kininase II) inhibitor. Unlike captopril or lisinopril, but similar to benazepril, enalapril, moexipril, perindopril, quinapril, ramipril, and trandolapril, fosinopril, the propylester of fosinoprilat, is a prodrug that has little pharmacologic activity until hydrolyzed to fosinoprilat. Like benazepril, enalapril, lisinopril, moexipril, quinapril, and ramipril but unlike captopril, fosinopril does not contain a sulfhydryl group.
In addition, fosinopril differs from these other ACE inhibitors by the presence of a phosphinic acid group.
Fosinopril is absorbed slowly in the proximal small intestine after oral administration, with approximately 36% of an oral dose absorbed. While the rate of absorption may be slowed in the presence of food in the GI tract, the extent of absorption is not affected. Fosinoprilat is approximately 99.4% protein bound; fosinopril and fosinoprilat do not cross the blood-brain barrier.
After single and multiple oral doses of fosinopril, plasma levels, AUC, and peak concentrations increase in a dose-proportional manner; peak concentrations are achieved in approximately 3 hours. Following a single oral dose, antihypertensive effects are observed within 1 hour, with peak blood pressure reductions at 2-6 hours; these effects last for 24 hours. Following oral administration of radiolabeled fosinopril, 75% of radioactivity was present as active fosinoprilat, 20-30% as a glucuronide conjugate of fosinoprilat, and 1-5% as a p-hydroxy metabolite of fosinoprilat.
Renal and hepatobiliary excretion contribute to a similar extent in the elimination of fosinoprilat. After IV administration, fosinoprilat was eliminated approximately equally by the liver and kidney. After oral administration of a radiolabeled dose, approximately half of the dose is excreted in the urine and the remainder is excreted in the feces.
The terminal elimination half-life of fosinoprilat, after an IV administration of a radiolabeled dose, is approximately 12 hours; half-life of fosinopril is 11.5 hours in hypertensive patients with normal renal and hepatic function and 14 hours in patients with heart failure. The terminal elimination half-life of fosinoprilat ranges from 11-13 hours in pediatric patients, which is similar to that in adults.
USES: This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 2 medications, fosinopril and hydrochlorothiazide.
Fosinopril belongs to a class of drugs known as ACE inhibitors. It works by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is a "water pill" (diuretic) that increases the amount of urine you make.
This helps your body to get rid of extra water and salt.
Generic name: fosinopril sodium/hydrochlorothiazide
Pronunciation: (fos-IN-oh-pril/HYE-droe-KLOR-oh-THYE-a-zide)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Fosinopril-Hydrochlorothiazide
Indications
The following indications are listed for Fosinopril-Hydrochlorothiazide:
- Hypertension
Also known as: Elevated Blood Pressure, Essential Hypertension, Hyperpiesia, Hyperpiesis, Hypertensive Disorder, Systemic Arterial Hypertension.
Dosing
Dosage of hydrochlorothiazide should be individualized according to the patient's requirements and response. The lowest dosage necessary to produce the desired clinical effect should be used. If hydrochlorothiazide is added to the regimen of a patient stabilized on a potent hypotensive agent, dosage of the hypotensive agent should initially be reduced to avoid the possibility of severe hypotension.
Hydrochlorothiazide is administered orally.
Fosinopril sodium is administered orally as tablets. Fosinopril sodium is also commercially available as single-entity 10, 20, or 40 mg tablets and also as a fixed-combination tablet containing fosinopril sodium and hydrochlorothiazide; see the full prescribing information for administration of this combination product.
Store fosinopril tablets in a tightly closed bottle, protected from moisture at 20-25degreesC.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to fosinopril or any other angiotensin-converting enzyme (ACE) inhibitors.
*Concomitant use with aliskiren in patients with diabetes mellitus.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in >=1% of patients receiving fosinopril for hypertension include cough, dizziness, and nausea or vomiting.
Adverse effects reported in >=1% of patients receiving fosinopril for heart failure include dizziness, cough, hypotension, musculoskeletal pain, nausea or vomiting, diarrhea, non-cardiac chest pain, upper respiratory infection, orthostatic hypotension, subjective cardiac rhythm disturbances, and weakness.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of fosinopril have not been established in children younger than 6 years of age. The long-term effects of fosinopril on growth and development in children have not been studied. The safety profile of the drug in pediatric patients is similar to that in adults with hypertension.
Fosinopril can cause fetal harm when administered to pregnant females. Use of medications that impact the RAS, such as fosinopril, during the second and third trimesters of pregnancy decreases fetal renal function and increases fetal/neonatal morbidity and mortality. Oligohydramnios caused by medications that act on the RAS can result in fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), anuria, hypotension, renal failure, and death. Discontinue fosinopril as soon as possible when pregnancy is detected. In the rare case that there is no appropriate alternative to therapy with drugs affecting the RAS, apprise the mother of the potential hazard to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. Based on the week of pregnancy, fetal testing may be appropriate. However, patients and clinicians should be aware that oligohydramnios may not manifest until after the fetus has sustained irreversible injury. Closely observe neonates with a history of in utero exposure to fosinopril for hypotension, oliguria, and hyperkalemia. Monitor pregnant females with hypertension carefully and manage accordingly.
Fosinoprilat is distributed into breast milk in humans. Because of the potential for serious adverse reactions from fosinopril in nursing infants, the manufacturer states that the drug should not be used in nursing women.
The manufacturers makes no specific dosage recommendations for geriatric patients. Because of the greater frequency of decreased hepatic, renal, and cardiac function and of concomitant diseases or other drug therapies in geriatric patients, dosage of fosinopril sodium should be cautious, usually starting at the lower end of the dosing range.
Experience with fosinopril in patients 65 years of age or older is insufficient to determine whether they respond differently from younger adults. Dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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