Fosinopril Sodium
Fosinopril · Tablet · Oral
Uses
Fosinopril sodium tablets are indicated for the treatment of hypertension. They 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 DOSAGE AND ADMINISTRATION ) . In using fosinopril sodium tablets, 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 tablets do not have a similar risk (see WARNINGS ). In considering use of fosinopril sodium tablets, 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 WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema) .
Dosage and administration
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 mg 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 tablets alone, a diuretic may be added. Concomitant administration of fosinopril sodium tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS ). 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 WARNINGS ). 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 WARNINGS , PRECAUTIONS , Information for Patients and Drug Interactions ). 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 PRECAUTIONS ). Pediatric Patients In children, doses of fosinopril sodium tablets between 0.1 mg/kg and 0.6 mg/kg have been studied and shown to reduce blood pressure to a similar extent (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects ). Based on this, the recommended dose of fosinopril sodium tablets in children weighing more than 50 kg is 5 mg 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 present 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 easy 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 Rena/Impairment : In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than in patients with normal renal function. Since hepatobiliary elimination partially compensates for diminished renal elimination, the total body clearance of fosinoprilat does not differ appreciably with any degree of renal insufficiency (creatinine clearances <80 mL/min/1.73m 2 ), including end-stage renal failure (creatinine clearance <10 mL/min/1.73m 2 ). This relative constancy of body clearance of active fosinoprilat, resulting from the dual route of elimination, permits use of the usual dose in patients with any degree of renal impairment. (See WARNINGS, Anaphylactoid Reactions During Membrane Exposure and PRECAUTIONS , Hemodialysis ).
Contraindications
Fosinopril sodium is 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).
Warnings
Anaphylactoid and Possible 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. Head and Neck Angioedema: Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis, or larynx has been reported in patients treated with ACE inhibitors. If angioedema involves the tongue, glottis, or larynx, airway obstruction may occur and be fatal. If laryngeal stridor or angioedema of the face, lips, mucous membranes, tongue, glottis, or extremities occurs, treatment with fosinopril sodium should be discontinued and appropriate therapy instituted immediately. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) should be promptly administered ( see PRECAUTIONS , Information for Patients and ADVERSE REACTIONS) . Intestinal Angioedema : Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. Anaphylactoid Reactions During Desensitization : Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. Anaphylactoid Reactions During Membrane Exposure: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. 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 angiotensin-converting 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.
Precautions
General Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe congestive heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors, including fosinopril sodium tablets, may be associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. 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 DOSAGE AND ADMINISTRATION ). 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 CLINICAL PHARMACOLOGY ). Hyperkalemia : In clinical trials, hyperkalemia (serum potassium greater than 10% above the upper limit of normal) has occurred in approximately 2.6% of hypertensive patients receiving fosinopril sodium. In most cases, these were isolated values which resolved despite continued therapy. In clinical trials, 0.1% of patients (two patients) were discontinued from therapy due to an elevated serum potassium. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with fosinopril sodium tablets (see PRECAUTIONS , Drug Interactions ). Cough : Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough. Impaired Liver Function : Since fosinopril is primarily metabolized by hepatic and gut wall esterases to its active moiety, fosinoprilat, patients with impaired liver function could develop elevated plasma levels of unchanged fosinopril. In a study in patients with alcoholic or biliary cirrhosis. the extent of hydrolysis was unaffected, although the rate was slowed. In these patients, the apparent total body clearance of fosinoprilat was decreased and the plasma AUC approximately doubled. Surgery/Anesthesia : In patients undergoing surgery or during anesthesia with agents that produce hypotension, fosinopril will block the angiotensin II formation that could otherwise occur secondary to compensatory renin release. Hypotension that occurs as a result of this mechanism can be corrected by volume expansion. 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 WARNINGS, Anaphylactoid Reactions During Membrane Exposure ). Information for Patients Angioedema : Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Patients should be advised to immediately report to their physician any signs or symptoms suggesting angioedema (e.g., swelling of face, eyes, lips, tongue, larynx, mucous membranes, and extremities; difficulty in swallowing or breathing; hoarseness) and to discontinue therapy (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema ). Symptomatic Hypotension: Patients should be cautioned that lightheadedness can occur, especially during the first days of therapy, and it should be reported to a physician. Patients should be told that if syncope occurs, fosinopril sodium should be discontinued until the physician has been consulted. 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 : Patients should be told not to use potassium supplements or salt substitutes containing potassium without consulting the physician. Neutropenia : Patients should be told to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia. Pregnancy : Female patients of childbearing age should be told about the consequences of exposure to fosinopril during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
Side effects
Fosinopril sodium has been evaluated for safety in more than 2,100 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. Discontinuations 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 PRECAUTIONS, General, Cough ), 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. Clinical Adverse events In Placebo-Controlled Trials (Hypertension) Fosinopril Sodium (N=688) Incidence (Discontinuation) Placebo (N=184) Incidence (Discontinuation) Cough 2.2 (0.4) 0.0 (0.0) Dizziness 1.6 (0.0) 0.0 (0.0) Nausea/Vomiting 1.2 (0.4) 0.5 (0.0) The following events were also seen at >1% on fosinopril sodium tablets 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 (except as noted) treated with fosinopril sodium in controlled or uncontrolled clinical trials (N; 1 ,479) and less frequent, clinically significant events include (listed by body system): General : Chest pain, edema, weakness, excessive sweating. Cardiovascular : Angina/myocardial infarction, cerebrovascular accident, hypertensive crisis, rhythm disturbances, palpitations, hypotension, syncope, flushing, claudication. Orthostatic : hypotension occurred in 1.4% of patients treated with fosinopril monotherapy. Hypotension or orthostatic hypotension was a cause for discontinuation of therapy in 0.1% of patients. Dermatologic : Urticaria, rash, photosensitivity, pruritus. Endocrine/Metabolic: Gout, decreased libido. Gastrointestinal: Pancreatitis, hepatitis, dysphagia, abdominal distention, abdominal pain, flatulence, constipation, heartburn, appetite/weight change, dry mouth. Hematologic: Lymphadenopathy. Immunologic: Angioedema. (See WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema) . Musculoskeletal : Arthralgia, musculoskeletal pain, myalgia/muscle cramp. Nervous/Psychiatric: Memory disturbance, tremor, confusion, mood change, paresthesia, sleep disturbance, drowsiness, vertigo. Respiratory: Bronchospasm, pharyngitis, sinusitis/rhinitis, laryngitis/hoarseness, epistaxis. A symptom-complex of cough, bronchospasm, and eosinophilia has been observed in two patients treated with fosinopril. Special Senses: Tinnitus, vision disturbance, taste disturbance, eye irritation. Urogenita l: Renal insufficiency, urinary frequency. 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 event, 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 related 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. Clinical Adverse events In Placebo-Controlled Trials (Heart Failure) Fosinopril Sodium (N=361) Incidence (Discontinuation) Placebo (N=373) Incidence (Discontinuation) Dizziness 11.9 (0.6) 5.4 (0.3) Cough 9.7 (0.8) 5.1 (0.0) Hypertension 4.4 (0.8) 0.8 (0.0) Musculoskeletal Pain 3.3 (0.0) 2.7 (0.0) Nausea/Vomiting 2.2 (0.6) 1.6 (0.3) Diarrhea 2.2 (0.0) 1.3 (0.0) Chest Pain (non-cardiac) 2.2 (0.0) 1.6 (0.0) Upper Respiratory Infection 2.2 (0.0) 1.3 (0.0) Orthostatic Hypotension 1.9 (0.0) 0.8 (0.0) Subjective Cardiac Rhythym Disturbance 1.4 (0.6) 0.8 (0.3) Weakness 1.4 (0.3) 0.5 (0.0) 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 : Fever, influenza, weight gain, hyperhidrosis, sensation of cold, fall, pain. Cardiovascular : Sudden death, cardiorespiratory arrest, shock (0.2%), atrial rhythm disturbance, cardiac rhythm disturbances, non anginal chest pain, edema lower extremity, hypertension, syncope, conduction disorder, bradycardia, tachycardia. Dermatologic: pruritus. Endocrine/Metabolic: Gout, sexual dysfunction.
Overdosage
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 overdosage is likely to be hypotension. Laboratory determinations 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 sodium. 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.
Description
Fosinopril sodium tablets, USP are the sodium salt of fosinopril, 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 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: Empirical formula: C 30 H 45 NNa0 7 P Molecular weight: 585.65 Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate. "Image Description"
How supplied
Fosinopril Sodium Tablets, USP for oral administration are available as: 10 mg: White to off white, round tablets de-bossed with “CE” above “97” on one side and scored on the other side, packaged with a desiccant and supplied as: NDC 62135-041-90 - bottles of 90 20 mg: White to off white, round tablets de-bossed with “CE” above “98” on one side and plain the other side, packaged with a desiccant and supplied as: NDC 62135-042-90 - bottles of 90 40 mg: White to off white, round tablets de-bossed with “CE” above “99” on one side and plain the other side, packaged with a desiccant and supplied as: NDC 62135-043-90 - bottles of 90 STORAGE Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP with a child-resistant closure, as required. Protect from moisture. To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71513 Revised: 10/2025
Label text from the FDA structured product label by Chartwell RX, LLC (revised Oct 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fosinopril Sodium in 21 products
Fosinopril Sodium NDC products (21)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-2977 | Fosinopril Sodium 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4743 | Fosinopril Sodium 40 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 65862-473 | Fosinopril Sodium 40 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-472 | Fosinopril Sodium 20 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 65862-471 | Fosinopril Sodium 10 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 71335-9703 | Fosinopril Sodium 40 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0726 | Fosinopril Sodium 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0381 | Fosinopril Sodium 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0187 | Fosinopril Sodium 20 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 62135-043 | Fosinopril Sodium 40 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-042 | Fosinopril Sodium 20 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-041 | Fosinopril Sodium 10 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 69097-856 | Fosinopril Sodium 10 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 69097-857 | Fosinopril Sodium 20 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 69097-858 | Fosinopril Sodium 40 mg/1 Tablet | Cipla USA Inc. | ANDA |
| 76282-200 | Fosinopril Sodium 10 mg/1 Tablet | Exelan Pharmaceuticals, Inc. | ANDA |
| 76282-201 | Fosinopril Sodium 20 mg/1 Tablet | Exelan Pharmaceuticals, Inc. | ANDA |
| 76282-202 | Fosinopril Sodium 40 mg/1 Tablet | Exelan Pharmaceuticals, Inc. | ANDA |
| 43547-388 | Fosinopril Sodium 40 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 43547-387 | Fosinopril Sodium 20 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 43547-386 | Fosinopril Sodium 10 mg/1 Tablet | Solco Healthcare LLC | ANDA |
Frequently asked questions
What is Fosinopril Sodium used for?
Fosinopril sodium tablets are indicated for the treatment of hypertension. They 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 DOSAGE AND ADMINISTRATION ) . In using fosinopril sodium tablets,…
What are the side effects of Fosinopril Sodium?
Fosinopril sodium has been evaluated for safety in more than 2,100 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… See the full label for the complete list.
Who makes Fosinopril Sodium?
Fosinopril Sodium is listed by 7 labelers in the FDA NDC directory, including A-S Medication Solutions, Aurobindo Pharma Limited, Bryant Ranch Prepack, Chartwell RX, LLC.