Fosinopril Sodium

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Overview

What is Fosinopril Sodium?

Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme.

Fosinopril sodium, USP is designated chemically as:L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium,USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is:

Its empirical formula is CHNNaOP, and its molecular weight is 585.65.

Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone.

What does Fosinopril Sodium look like?

What are the available doses of Fosinopril Sodium?

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What should I talk to my health care provider before I take Fosinopril Sodium?

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How should I use Fosinopril Sodium?

Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see ).

In using fosinopril sodium, 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 sodium does not have a similar risk (see ).

In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see ).

Hypertension

Adults

The recommended initial dose of fosinopril sodium tablets is 10 mg once a day, both as monotherapy and when the drug is added to a diuretic. Dosage should then be adjusted according to blood pressure response at peak (2 to 6 hours) and trough (about 24 hours after dosing) blood levels. The usual dosage range needed to maintain a response at trough is 20 to 40 mg but some patients appear to have a further response to 80 mg. In some patients treated with once daily dosing, the antihypertensive effect may diminish toward the end of the dosing interval. If trough response is inadequate, dividing the daily dose should be considered. If blood pressure is not adequately controlled with fosinopril sodium alone, a diuretic may be added.

Concomitant administration of fosinopril sodium with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see ).

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of fosinopril sodium tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with fosinopril sodium tablets (see ). Then, if blood pressure is not controlled with fosinopril sodium tablets alone diuretic therapy should be resumed. If diuretic therapy cannot be discontinued, an initial dose of 10 mg of fosinopril sodium tablets should be used with careful medical supervision for several hours and until blood pressure has stabilized. (See and ).

Since concomitant administration of fosinopril sodium tablets with potassium supplements, or potassium containing salt substitutes or potassium-sparing diuretics may lead to increases in serum potassium, they should be used with caution (see ).

Pediatrics

In children, doses of fosinopril sodium tablets between 0.1 and 0.6 mg/kg have been studied and shown to reduce blood pressure to a similar extent (see ). Based on this, the recommended dose of fosinopril sodium tablets USP in children weighing more than 50 kg is 5 to 10 mg once per day as monotherapy. An appropriate dosage strength is not available for children weighing less than 50 kg.

Heart Failure

Digitalis is not required for fosinopril sodium tablets to manifest improvements in exercise tolerance and symptoms. Most placebo-controlled clinical trial experience has been with both digitalis and diuretics presents as background therapy.

The usual starting dose of fosinopril sodium tablets should be 10 mg once daily. Following the initial dose of fosinopril sodium tablets, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostasis and, if present, until blood pressure stabilizes. An initial dose of 5 mg is preferred in heart failure patients with moderate to severe renal failure or those who have been vigorously diuresed.

Dosage should be increased, over a several week period, to a dose that is maximal and tolerated but not exceeding 40 mg once daily. The usual effective dosage range is 20 mg to 40 mg once daily.

The appearance of hypotension, orthostasis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretic.

For Hypertensive or Heart Failure Patients with Renal Impairment:

What interacts with Fosinopril Sodium?

Fosinopril sodium tablets are contraindicated in patients who are hypersensitive to this product or to any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema with any other ACE inhibitor therapy).

Do not co-administer fosinopril sodium tablets with aliskiren in patients with diabetes.

What are the warnings of Fosinopril Sodium?

Anaphylactoid and Possibly Related Reactions

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including fosinopril sodium) may be subject to a variety of adverse reactions, some of them serious.

Array

Intestinal Angioedema:

Anaphylactoid reactions during desensitization:

Anaphylactoid reactions during membrane exposure:

Hypotension

Fosinopril sodium can cause symptomatic hypotension. Like other ACE inhibitors, fosinopril has been only rarely associated with hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who have been volume-and /or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume and/or salt depletion should be corrected before initiating therapy with fosinopril sodium.

In patients with heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia and, rarely, with acute renal failure and death. In such patients, fosinopril sodium therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of fosinopril or diuretic is increased. Consideration should be given to reducing the diuretic dose in patients with normal or low blood pressure who have been treated vigorously with diuretics or who are hyponatremic.

If hypotension occurs, the patient should be placed in a supine position, and, if necessary, treated with intravenous infusion of physiological saline. Fosinopril sodium treatment usually can be continued following restoration of blood pressure and volume.

Neutropenia/Agranulocytosis

Another angiotensinconverting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Available data from clinical trials of fosinopril are insufficient to show that fosinopril does not cause agranulocytosis at similar rates. Monitoring of white blood cell counts should be considered in patients with collagen-vascular disease, especially if the disease is associated with impaired renal function.

Fetal Toxicity

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue fosinopril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue fosinopril, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of exposure to fosinopril for hypotension, oliguria, and hyperkalemia.[see , ].

No teratogenic effects of fosinopril were seen in studies of pregnant rats and rabbits. On a mg/kg basis, the doses used were up to 180 times (in rats) and one time (in rabbits) the maximum recommended human dose.

When fosinopril was given to pregnant rats at doses about 80 to 250 times (on a mg/kg basis) the maximum recommended human dose, three similar orofacial malformations and one fetus with situs inversus were observed among the offspring.

Hepatic Failure

Rarely, ACE Inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

What are the precautions of Fosinopril Sodium?

General

Impaired Renal Function:

In hypertensive patients with renal artery stenosis in a solitary kidney or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. Experience with another angiotensin converting enzyme inhibitor suggests that these increases are usually reversible upon discontinuation of ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy. Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when fosinopril sodium has been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of fosinopril sodium and/or discontinuation of the diuretic may be required.

Evaluation of patients with hypertension or heart failure should always include assessment of renal function (see ).

Impaired renal function decreases total clearance of fosinoprilat and approximately doubles AUC. In general, no adjustment of dosing is needed. However, patients with heart failure and severely reduced renal function may be more sensitive to the hemodynamic effects (e.g., hypotension) of ACE inhibition (see ).

Array

Cough:

Impaired Liver Function:

Surgery/Anesthesia:

Hemodialysis

Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors as medication. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of medication. (See )

Information for Patients

Array

Symptomatic Hypotension:

All patients should be cautioned that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Hyperkalemia:

Neutropenia:

Pregnancy:

Drug Interactions

Array

With potassium supplements and potassium-sparing diuretics:

With lithium:

With antacids:

Gold:

Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors):

The antihypertensive effect of ACE inhibitors, including fosinopril may be attenuated by NSAIDs.

Agents that inhibit mTOR:

Dual Blockade of the Renin-Angiotensin System (RAS):

Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid use of aliskiren with fosinopril in patients with renal impairment (GFR <60 ml/min).

Other:

In a pharmacokinetic interaction study with warfarin, bioavailability parameters, the degree of protein binding, and the anticoagulant effect (measured by prothrombin time) of warfarin were not significantly changed.

Drug/Laboratory Test Interaction

Fosinopril may cause a false low measurement of serum digoxin levels with the Digi-Tab RIA Kit, for Digoxin. Other Kits, such as the Coat-A-Counts RIA Kit, may be used.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

No evidence of a carcinogenic effect was found when fosinopril was given in the diet to mice and rats for up to 24 months at doses up to 400 mg/kg/day. On a body weight basis, the highest dose in mice and rats is about 250 times the maximum human dose of 80 mg, assuming a 50 kg subject. On a body surface area basis, in mice, this dose is 20 times the maximum human dose; in rats, this dose is 40 times the maximum human dose. Male rats given the highest dose level had a slightly higher incidence of mesentery/omentum lipomas.

Neither fosinopril nor the active fosinoprilat was mutagenic in the Ames microbial mutagen test, the mouse lymphoma forward mutation assay, or a mitotic gene conversion assay. Fosinopril was also not genotoxic in a mouse micronucleus test and a mouse bone marrow cytogenetic assay .

In the Chinese hamster ovary cell cytogenetic assay, fosinopril increased the frequency of chromosomal aberrations when tested without metabolic activation at a concentration that was toxic to the cells. However, there was no increase in chromosomal aberrations at lower drug concentrations without metabolic activation or at any concentration with metabolic activation.

There were no adverse reproductive effects in male and female rats treated with 15 or 60 mg/kg daily. On a body weight basis, the high dose of 60 mg/kg is about 38 times the maximum recommended human dose. On a body surface area basis, this dose is 6 times the maximum recommended human dose. There was no effect on pairing time prior to mating in rats until a daily dose of 240 mg/kg, a toxic dose, was given; at this dose, a slight increase in pairing times was observed. On a body weight basis, this dose is 150 times the maximum recommended human dose. On a body surface area basis, this dose is 24 time the maximum recommended human dose.

Nursing Mothers

Ingestion of 20 mg daily for three days resulted in detectable levels of fosinoprilat in breast milk.

Fosinopril sodium should not be administered to nursing mothers.

Geriatric Use

Clinical studies of fosinopril sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for and elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Pediatric Use

Neonates with a history of exposure to fosinopril sodium tablets:

If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Removal of fosinopril, which crosses the placenta, from the neonatal circulation is not significantly accelerated by these means

The antihypertensive effects of fosinopril have been evaluated in a double-blind study in pediatric patients 6 to 16 years of age (see ). The pharmacokinetics of fosinopril have been evaluated in pediatric patients 6 to 16 years of age (see ). Fosinopril was generally well tolerated and adverse effects were similar to those described in adults (see ).

What are the side effects of Fosinopril Sodium?

Fosinopril sodium has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.

Hypertension

In placebo-controlled clinical trials (688 fosinopril sodium -treated patients), the usual duration of therapy was two to three months. Discontinuation due to any clinical or laboratory adverse event were 4.1% and 1.1% in fosinopril sodium-treated and placebo-treated patients, respectively. The most frequent reasons (0.4 to 0.9%) were headache, elevated transaminases, fatigue, cough (see ), diarrhea, and nausea and vomiting

During clinical trials with any fosinopril sodium regimen, the incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with fosinopril sodium alone and at least as frequent on fosinopril sodium as on placebo in placebo-controlled clinical trials are shown in the table below.

The following events were also seen at >1% on fosinopril sodium but occurred in the placebo group at a greater rate: headache, diarrhea, fatigue, and sexual dysfunction. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.2 to 1.0% of patients (excepted as noted) treated with fosinopril sodium in controlled or uncontrolled clinical trials (N=1479) and less frequent, clinically significant events include (listed by body system):

General:

Cardiovascular:

Orthostatic

Dermatologic:

Endocrine/Metabolic:

Gastrointestinal:

Hematologic:

Array

Musculoskeletal:

Nervous/Psychiatric:

Respiratory:

Special Senses:

Urogenital:

Heart Failure

In placebo-controlled clinical trials (361 fosinopril sodium -treated patients), the usual duration of therapy was 3 to 6 months. Discontinuations due to any clinical or laboratory adverse events, except for heart failure, were 8.0% and 7.5% in fosinopril sodium-treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of fosinopril sodium was angina pectoris (1.1%). Significant hypotension after the first dose of fosinopril sodium occurred in 14/590 (2.4%) of patients; 5/590 (0.8%) patients discontinued due to first dose hypotension.

Clinical adverse events probably or possibly relate or of uncertain relationship to therapy, occurring in at least 1% of patients treated with fosinopril sodium and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.

The following events also occurred at a rate of 1% or more on fosinopril sodium, but occurred on placebo more often: fatigue, dyspnea, headache, rash, abdominal pain, muscle cramp, angina pectoris, edema, and insomnia.

The incidence of adverse events in the elderly (≥65 years old) was similar to that seen in younger patients.

Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.4 to 1.0% of patients (except as noted) treated with fosinopril sodium in controlled clinical trials (N=516) and less frequent, clinically significant events include (listed by body system):

General:

Cardiovascular:

Orthostatic

Dermatologic:

Endocrine/Metabolic:

Gastrointestinal:

Immunologic:

Musculoskeletal:

Nervous/Psychiatric:

Respiratory:

Special Senses:

Urogenital:

Potential Adverse Effects Reported with ACE Inhibitors

Array

Other medically important adverse effects reported with ACE inhibitors include: Cardiac arrest; eosinophilic pneumonitis; neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), thrombocytopenia; acute renal failure; hepatic failure, jaundice (hepatocellular or cholestatic); symptomatic hyponatremia; bullous pemphigus, exfoliative dermatitis; a syndrome which may include: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive ANA, leukocytosis, eosinophilia, or an elevated ESR.

Laboratory Test Abnormalities

Array

Array

Array

Liver Function Tests:

Pediatric Patients

The adverse experience profile for pediatric patients is similar to that seen in adult patients with hypertension. The long-term effects of fosinopril sodium on growth and development have not been studied.

What should I look out for while using Fosinopril Sodium?

Fosinopril sodium tablets are contraindicated in patients who are hypersensitive to this product or to any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema with any other ACE inhibitor therapy).

Do not co-administer fosinopril sodium tablets with aliskiren in patients with diabetes.

What might happen if I take too much Fosinopril Sodium?

Oral doses of fosinopril at 2600 mg/kg in rats were associated with significant lethality. Human overdoses of fosinopril have not been reported, but the most common manifestation of human fosinopril over dosage is likely to be hypotension.

Laboratory determination of serum levels of fosinoprilat and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of fosinopril overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of fosinopril and its metabolites. Fosinoprilat is poorly removed from the body by both hemodialysis and peritoneal dialysis.

Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of fosinopril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of fosinopril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat fosinopril overdose by infusion of normal saline solution.

No adverse clinical events were reported in 23 pediatric patients, age 6 months to 6 years, given a single 0.3 mg/kg oral dose of fosinopril.

There is a published report of a 20 month-old female, weighing 12 kg, who ingested approximately 200 mg fosinopril sodium. After receiving gastric lavage and activated charcoal within one hour of the ingestion, she made an uneventful recovery.

How should I store and handle Fosinopril Sodium?

Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017Fosinopril Sodium Tablets, USP10 mg tablets:20 mg tablets:40 mg tablets:STORAGEStore at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closedDispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured for:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130Sunrise, FL 33323 Manufactured by:InvaGen Pharmaceuticals, Inc.(a subsidiary of Cipla Ltd.)Hauppauge, NY 11788Revised: 05/2017

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Clinical Information

Chemical Structure

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Clinical Pharmacology

In animals and humans, fosinopril sodium is hydrolyzed by esterases to the pharmacologically active form, fosinoprilat, a specific competitive inhibitor of angiotensin-converting enzyme (ACE).

ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium.

In 647 hypertensive patients treated with fosinopril alone for an average of 29 weeks, mean increases in serum potassium of 0.1 mEq/L were observed. Similar increases were observed among all patients treated with fosinopril, including those receiving concomitant diuretic therapy. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.

ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of fosinopril sodium remains to be elucidated.

While the mechanism through which fosinopril sodium lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, fosinopril sodium has an antihypertensive effect even in patients with low-renin hypertension. Although fosinopril sodium was antihypertensive in all races studied, black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to ACE inhibitor monotherapy than non-black patients.

In patients with heart failure, the beneficial effects of fosinopril sodium are thought to result primarily from suppression of the renin-angiotensin-aldosterone system; inhibition of the angiotensin-converting enzyme produces decreases in both preload and afterload.

Non-Clinical Toxicology

Fosinopril sodium tablets are contraindicated in patients who are hypersensitive to this product or to any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema with any other ACE inhibitor therapy).

Do not co-administer fosinopril sodium tablets with aliskiren in patients with diabetes.

With potassium supplements and potassium-sparing diuretics:

With lithium:

With antacids:

Gold:

Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors):

The antihypertensive effect of ACE inhibitors, including fosinopril may be attenuated by NSAIDs.

Agents that inhibit mTOR:

Dual Blockade of the Renin-Angiotensin System (RAS):

Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid use of aliskiren with fosinopril in patients with renal impairment (GFR <60 ml/min).

Other:

In a pharmacokinetic interaction study with warfarin, bioavailability parameters, the degree of protein binding, and the anticoagulant effect (measured by prothrombin time) of warfarin were not significantly changed.

Impaired Renal Function:

In hypertensive patients with renal artery stenosis in a solitary kidney or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. Experience with another angiotensin converting enzyme inhibitor suggests that these increases are usually reversible upon discontinuation of ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy. Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when fosinopril sodium has been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of fosinopril sodium and/or discontinuation of the diuretic may be required.

Evaluation of patients with hypertension or heart failure should always include assessment of renal function (see ).

Impaired renal function decreases total clearance of fosinoprilat and approximately doubles AUC. In general, no adjustment of dosing is needed. However, patients with heart failure and severely reduced renal function may be more sensitive to the hemodynamic effects (e.g., hypotension) of ACE inhibition (see ).

Hyperkalemia:

Cough:

Impaired Liver Function:

Surgery/Anesthesia:

Hemodialysis

Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors as medication. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of medication. (See )

Fosinopril sodium has been evaluated for safety in more than 2100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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