Fosinopril Sodium (Fosinopril Sodium)

Trade Name : Fosinopril Sodium

Eon Labs, Inc.

TABLET

Strength 10 mg/1

FOSINOPRIL SODIUM Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fosinopril Sodium (Fosinopril Sodium) which is also known as Fosinopril Sodium and Manufactured by Eon Labs, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Fosinopril Sodium (Fosinopril Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

WARNING: FETAL TOXICITY

Fosinopril sodium tablets 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, .
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:
Molecular formula: CHNNaOP Molecular weight: 585.65
Fosinopril Sodium is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: lactose, microcrystalline cellulose, carnauba wax, crospovidone, and zinc stearate.

No data

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 ).
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 ).
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 and ).

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).

No data

No data

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.

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.

No data

Fosinopril Sodium Tablets, for oral administration, are available as
Arrayn- 10 mg
White to off-white, biconvex oval tablets, debossed u201c41u201d on one side and bisected on the other side, packaged with a desiccant and supplied as:
NDC 0185-0041-09 bottles of 90
NDC 0185-0041-10 bottles of 1000
Arrayn- 20 mg
White to off-white, capsule-shaped tablets, debossed u201c42u201d on one side and plain on the other side, packaged with a desiccant and supplied as:
NDC 0185-0042-09 bottles of 90
NDC 0185-0042-10 bottles of 1000
Arrayn- 40 mg
White to off-white, biconvex round tablets, debossed u201cu201d over u201c47u201d on one side and plain on the other side, packaged with a desiccant and supplied as:
NDC 0185-0047-09 bottles of 90
NDC 0185-0047-10 bottles of 1000
STORAGE
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
Dispense contents in a tight container as defined in the USP with a child-resistant closure, as required.
Protect from moisture.
KEEP TIGHTLY CLOSED.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Distributed by
Sandoz Inc.
Princeton, NJ 08540
OS7960
Rev. February 2016
MF0041REV02/16

NDC
Fosinopril Sodium Tablets
10 mg
Rx only
1000 Tablets
Sandoz

NDC
Fosinopril Sodium Tablets
20 mg
Rx only
1000 Tablets
Sandoz

NDC
Fosinopril Sodium Tablets
40 mg
Rx only
1000 Tablets
Sandoz

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Fosinopril Sodium (Fosinopril Sodium)

Trade Name : Fosinopril Sodium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Fosinopril Sodium (Fosinopril Sodium)

Trade Name : Fosinopril Sodium

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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