Furosemide


Graviti Pharmaceuticals Private Limited
Human Prescription Drug
NDC 69844-052
Furosemide is a human prescription drug labeled by 'Graviti Pharmaceuticals Private Limited'. National Drug Code (NDC) number for Furosemide is 69844-052. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Furosemide drug includes Furosemide - 40 mg/1 . The currest status of Furosemide drug is Active.

Drug Information:

Drug NDC: 69844-052
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Furosemide
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Furosemide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Graviti Pharmaceuticals Private Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:FUROSEMIDE - 40 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 17 Oct, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 30 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA216629
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Graviti Pharmaceuticals Private Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:197732
310429
313988
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000175366
N0000175590
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:7LXU5N7ZO5
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Loop Diuretic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Diuresis at Loop of Henle [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:Increased Diuresis at Loop of Henle [PE]
Loop Diuretic [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
69844-052-0150 TABLET in 1 BOTTLE (69844-052-01)17 Oct, 2022N/ANo
69844-052-02100 TABLET in 1 BOTTLE (69844-052-02)17 Oct, 2022N/ANo
69844-052-031000 TABLET in 1 BOTTLE (69844-052-03)17 Oct, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Furosemide furosemide furosemide furosemide lactose monohydrate starch, corn talc silicon dioxide magnesium stearate biconvex tablet 16;0 furosemide furosemide furosemide furosemide lactose monohydrate starch, corn talc silicon dioxide magnesium stearate flat face, beveled edge scored tablet 17;0 furosemide furosemide furosemide furosemide lactose monohydrate starch, corn talc silicon dioxide magnesium stearate flat face, facetted-edge scored tablet 19;0

Indications and Usage:

Indications and usage edema furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide tablets are particularly useful when an agent with greater diuretic potential is desired. hypertension oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.

Warnings:

Warnings in patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. in hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. if increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminogl
ycoside antibiotics, ethacrynic acid, or other ototoxic drugs. if the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4mg furosemide per minute has been used) (see precautions: drug interactions ).

Warnings and Cautions:

Warning furosemide tablets are a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs (see dosage and administration ).

Dosage and Administration:

Dosage and administration edema therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. adults --the usual initial dose of furosemide is 20 mg to 80 mg given as a single dose. ordinarily a prompt diuresis ensues. if needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. the dose may be raised by 20 mg or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. the individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). the dose of furosemide may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states. edema may be most efficiently and safely mobilized by giving furosemide on 2 to 4 consecutive days each week. when doses exceeding 80 mg/day are given for prolonged periods, careful clinical observa
tion and laboratory monitoring are particularly advisable (see precautions: laboratory test ). geriatric patients --in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see precautions: geriatric use ). pediatric patients --the usual initial dose of oral furosemide in pediatric patients is 2 mg/kg body weight, given as a single dose. if the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. doses greater than 6 mg/kg body weight are not recommended. for maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level. hypertension therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response. adults --the usual initial dose of furosemide for hypertension is 80mg, usually divided into 40mg twice a day. dosage should then be adjusted according to response. if response is not satisfactory, add other antihypertensive agents. changes in blood pressure must be carefully monitored when furosemide is used with other antihypertensive drugs, especially during initial therapy. to prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when furosemide is added to the regimen. as the blood pressure falls under the potentiating effect of furosemide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary. geriatric patients --in general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see precautions: geriatric use ).

Contraindications:

Contraindications furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Adverse Reactions:

Adverse reactions adverse reactions are categorized below by organ system and listed by decreasing severity. gastrointestinal system reactions 1.hepatic encephalopathy in patients with hepatocellular insufficiency 6.oral and gastric irritation 2.pancreatitis 7.cramping 3.jaundice (intrahepatic cholestatic jaundice) 8.diarrhea 4.increased liver enzymes 9.constipation 5.anorexia 10.nausea 11.vomiting systemic hypersensitivity reactions 1.severe anaphylactic or anaphylactoid reactions (eg., with shock) 3.interstitial nephritis 2.systemic vasculitis 4.necrotizing angiitis central nervous system reactions 1.tinnitus and hearing loss 5.headache 2.paresthesias 6.blurred vision 3.vertigo 7.xanthopsia 4.dizziness hematologic reactions 1.aplastic anemia 5.leukopenia 2.thrombocytopenia 6.anemia 3.agranulocytosis 7.eosinophilia 4.hemolytic anemia dermatologic-hypersensitivity reactions 1.toxic epidermal necrolysis 2.stevens-johnson syndrome 3.erythema multiforme 4.drug rash with eosinophilia and s
ystemic symptoms 5.acute generalized exanthematous pustulosis 6.exfoliative dermatitis 7.bullous pemphigoid 8.purpura 9.photosensitivity 10.rash 11.pruritis 12.urticaria cardiovascular reaction 1. orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics. 2. increase in cholesterol and triglyceride serum levels other reactions 1.hyperglycemia 6. restlessness 2.glycosuria 7.urinary bladder spasm 3.hyperuricemia 8.thrombophlebitis 4.muscle spasm 5.weakness 9. fever whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. to report suspected adverse reactions, contact graviti pharmaceuticals, inc., 1-855-298-4506 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Adverse Reactions Table:

1.hepatic encephalopathy in patients with hepatocellular insufficiency 6.oral and gastric irritation
2.pancreatitis 7.cramping
3.jaundice (intrahepatic cholestatic jaundice) 8.diarrhea
4.increased liver enzymes 9.constipation
5.anorexia 10.nausea
11.vomiting

1.severe anaphylactic or anaphylactoid reactions (eg., with shock) 3.interstitial nephritis
2.systemic vasculitis 4.necrotizing angiitis

1.tinnitus and hearing loss 5.headache
2.paresthesias 6.blurred vision
3.vertigo 7.xanthopsia
4.dizziness

1.aplastic anemia 5.leukopenia
2.thrombocytopenia 6.anemia
3.agranulocytosis 7.eosinophilia
4.hemolytic anemia

1.toxic epidermal necrolysis 2.stevens-johnson syndrome 3.erythema multiforme 4.drug rash with eosinophilia and systemic symptoms 5.acute generalized exanthematous pustulosis 6.exfoliative dermatitis 7.bullous pemphigoid 8.purpura 9.photosensitivity 10.rash 11.pruritis 12.urticaria

1.hyperglycemia 6. restlessness
2.glycosuria 7.urinary bladder spasm
3.hyperuricemia 8.thrombophlebitis
4.muscle spasm 5.weakness 9. fever

Overdosage:

Overdosage the principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. the acute toxicity of furosemide has been determined in mice, rats and dogs. in all three, the oral ld 50 exceeded 1,000 mg/kg body weight, while the intravenous ld 50 ranged from 300 to 680 mg/kg. the acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. the concentration of furosemide in biological fluids associated with toxicity or death is not known. treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). hemodialysis does not accelerate furosemide elimination.

Description:

Description furosemide tablets, usp are a diuretic which is an anthranilic acid derivative. furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose monohydrate, corn starch, pregelatinized starch, talc, colloidal silicon dioxide, magnesium stearate. chemically, it is 4-chloro-n-furfuryl-5-sulfamoylanthranilic acid. furosemide tablets are available as white tablets for oral administration in dosage strengths of 20 mg, 40 mg and 80 mg. furosemide is a white to off-white odorless crystalline powder. it is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. the cas registry number is 54-31-9. the structural formula is as follows: meets usp dissolution test 1. image

Clinical Pharmacology:

Clinical pharmacology investigations into the mode of action of furosemide have utilized micro puncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. it has been demonstrated that furosemide inhibits primarily the absorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of henle. the high degree of efficacy is largely due to the unique site of action. the action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone. recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. furosemide is extensively bound to plasma proteins, mainly to albumin. plasma concentrations ranging from 1 μg/ml to 400 μg/ml are 91% to 99% bound in healthy individuals. the unbound fraction averages 2.3% to 4.1% at therapeutic concentrations. the onset of diuresis following or
al administration is within 1 hour. the peak effect occurs within the first or second hour. the duration of diuretic effect is 6 to 8 hours. in fasted normal men, the mean bioavailability of furosemide from furosemide tablets and furosemide oral solution is 64% and 60%, respectively, of that from an intravenous injection of the drug. although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. the terminal half-life of furosemide is approximately 2 hours. significantly more furosemide is excreted in urine following the iv injection than after the tablet or oral solution. there are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine. geriatric population furosemide binding to albumin may be reduced in elderly patients. furosemide is predominantly excreted unchanged in the urine. the renal clearance of furosemide after intravenous administration in older healthy male subjects (60 to 70 years of age) is statistically significantly smaller than in younger healthy male subjects (20 to 35 years of age). the initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects (see precautions: geriatric use ).

How Supplied:

How supplied furosemide tablets, usp 20 mg are supplied as white, oval, biconvex tablets debossed with "16" on one side and plain on other side. ndc 69844-051-01 bottles of 50 tablets ndc 69844-051-02 bottles of 100 tablets ndc 69844-051-03 bottles of 1,000 tablets furosemide tablets, usp 40 mg are supplied as white, round, flat face, beveled edge scored tablets debossed with "17" on one side and plain on other side. ndc 69844-052-01 bottles of 50 tablets ndc 69844-052-02 bottles of 100 tablets ndc 69844-052-03 bottles of 1,000 tablets furosemide tablets, usp 80 mg are supplied as white, round, flat face, facetted-edge scored tablets debossed with "19" on one side and plain on other side. ndc 69844-053-01 bottles of 50 tablets ndc 69844-053-02 bottles of 100 tablets ndc 69844-053-03 bottles of 1,000 tablets note: dispense in well-closed, light-resistant containers. exposure to light might cause a slight discoloration. discolored tablets should not be dispensed. store at 68° to 77Â
f (20° to 25°c); excursions permitted to 59° to 86°f (15° to 30°c) [see usp controlled room temperature]. manufactured for: graviti pharmaceuticals inc., wilmington, delaware – 19801, usa. manufactured by: graviti pharmaceuticals pvt. ltd. telangana-502307, india. made in india revised: july 2022

Package Label Principal Display Panel:

Package label.principal display panel principal display panel - 20 mg tablets: container label ndc 69844-051-01 furosemide tablets 20 mg rx only 50 tablets manufactured for graviti pharmaceuticals inc. made in india. image

Package label.principal display panel principal display panel - 40 mg tablets: container label ndc 69844-052-01 furosemide tablets 40 mg rx only 50 tablets manufactured for graviti pharmaceuticals inc. made in india image

Package label.principal display panel principal display panel - 80 mg tablets: container label ndc 69844-053-01 furosemide tablets 80 mg rx only 50 tablets manufactured for graviti pharmaceuticals inc. made in india image


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