Fosinopril sodium 40 mg/1
Fosinopril sodium · TABLET · Exelan Pharmaceuticals, Inc.
Fosinopril sodium is a tablet containing fosinopril sodium at 40 mg/1, taken oral. Manufactured by Exelan Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Fosinopril sodium
- Generic Name
- Fosinopril sodium
- NDC Code (Product)
76282-202- Manufacturer
- Exelan Pharmaceuticals, Inc.
- Strength
- 40 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077222
- Marketing Start
- 06/21/2005
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: FOSINOPRIL SODIUM, Tablet, 10 mg may have potentially been mislabeled as the following drug: MERCapsuleTOPURINE, Tablet, 50 mg, NDC 00054458111, Pedigree: AD54549_1, EXP: 5/20/2014.
Sandoz Inc
Subpotent; Hydrochlorothiazide at the 9 month time point.
Aidapak Services, LLC
Labeling:Label Mixup; FOSINOPRIL SODIUM Tablet, 10 mg may be potentially mislabeled as CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD46414_10, EXP: 5/16/2014.
Aidapak Services, LLC
Labeling:Label Mixup; FOSINOPRIL SODIUM, Tablet, 20 mg may be potentially mislabeled as TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: AD65478_1, EXP: 5/29/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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, 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 WARNINGS ). 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 WARNINGS , Head and Neck Angioedema and Intestinal Angioedema ).
Dosage & Administration
DOSAGE AND ADMINISTRATION Hypertension Adults The recommended initial dose of fosinopril sodium tablets USP 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 tablets USP alone, a diuretic may be added. Concomitant administration of fosinopril sodium tablets USP 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 USP. To reduce the likelihoo…
Warnings
WARNINGS 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. 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 ). Patients taking concomitant mTOR inhibitor (e.g. temsirolimus) therapy may be at in…
Contraindications
CONTRAINDICATIONS 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.
Drug Interactions
Drug Interactions Diuretics Patients on diuretics, especially those with intravascular volume depletion, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with fosinopril sodium tablets. The possibility of hypotensive effects with fosinopril sodium can be minimized by either discontinuing the diuretic or increasing salt intake prior to initiation of treatment with fosinopril sodium. If this is not possible, the starting dose should be reduced and the patient should be observed closely for several hours following an initial dose and until blood pressure has stabilized (see DOSAGE AND ADMINISTRATION ). Agents increasing serum potassium Coadministration of fosinopril with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recomme…
Adverse Reactions
ADVERSE REACTIONS Fosinopril sodium tablets have 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 2 to 3 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 fosinopr…
Frequently Asked Questions
What is Fosinopril sodium used for?
Fosinopril sodium contains Fosinopril sodium. It is a tablet taken oral. Consult your doctor for specific uses.
Is Fosinopril sodium a controlled substance?
Fosinopril sodium is not classified as a controlled substance by the DEA.
What is the generic name for Fosinopril sodium?
The generic name for Fosinopril sodium is Fosinopril sodium. There are 7 other brand versions of Fosinopril sodium.
What is the NDC code for Fosinopril sodium 40 mg/1?
The NDC (National Drug Code) for Fosinopril sodium 40 mg/1 is 76282-202, listed by Exelan Pharmaceuticals, Inc..
Other Fosinopril Brands
See all →- Fosinopril Sodium and Hydrochlorothiazide20 mg/169097-973
- Fosinopril Sodium40 mg/162135-043
- Fosinopril Sodium and Hydrochlorothiazide20 mg/165862-309
- Fosinopril Sodium20 mg/162135-042
- Fosinopril Sodium and Hydrochlorothiazide10 mg/165862-308
- Fosinopril Sodium10 mg/165862-471
- Fosinopril Sodium20 mg/165862-472
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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