Furosemide
Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9863Furosemide is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Furosemide is 0404-9863. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Furosemide drug includes Furosemide - 10 mg/mL . The currest status of Furosemide drug is Active.
Drug Information:
| Drug NDC: | 0404-9863 |
| 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: | Henry Schein, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| 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 - 10 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| 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: | 10 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA202747 |
| 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: | Henry Schein, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1719291
|
| 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. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0404-9863-04 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9863-04) / 4 mL in 1 VIAL, SINGLE-DOSE | 10 Jan, 2022 | N/A | No |
| 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 water sodium chloride sodium hydroxide hydrochloric acid
Boxed Warning:
Warning furosemide is 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.) rx only
Indications and Usage:
Indications and usage parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. edema: furosemide is 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 is particularly useful when an agent with greater diuretic potential is desired. furosemide is indicated as adjunctive therapy in acute pulmonary edema. the intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. if gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. parenteral use should be replaced with oral furosemide as soon as practical.
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 aminog
Read more...lycoside 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 4 mg furosemide per minute has been used) (see precautions, drug interactions.) pediatric use: in premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (pda), possibly through a prostaglandin-e-mediated process. literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. hearing loss in neonates has been associated with the use of furosemide injection (see warnings, above).
Contraindications:
Contraindications furosemide is 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 2. pancreatitis 3. jaundice (intrahepatic cholestatic jaundice) 4. increased liver enzymes 5. anorexia 6. oral and gastric irritation 7. cramping 8. diarrhea 9. constipation 10. nausea 11. vomiting systemic hypersensitivity reactions 1. severe anaphylactic or anaphylactoid reactions (e.g. with shock) 2. systemic vasculitis 3. interstitial nephritis 4. necrotizing angiitis central nervous system reactions 1. tinnitus and hearing loss 2. paresthesias 3. vertigo 4. dizziness 5. headache 6. blurred vision 7. xanthopsia hematologic reactions 1. aplastic anemia 2. thrombocytopenia 3. agranulocytosis 4. hemolytic anemia 5. leukopenia 6. anemia 7. eosinophilia dermatologic-hypersensitivity reactions 1. exfoliative dermatitis 2. bullous pemphigoid 3. erythema multiforme 4. purpura 5.
Read more... photosensitivity 6. urticaria 7. rash 8. pruritus 9. stevens-johnson syndrome 10. toxic epidermal necrolysis 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 2. glycosuria 3. hyperuricemia 4. muscle spasm 5. weakness 6. restlessness 7. urinary bladder spasm 8. thrombophlebitis 9. transient injection site pain following intramuscular injection 10. fever whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
Geriatric Use:
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 (60-70 years of age) is statistically significantly smaller than in younger healthy male subjects (20-35 years of age). the initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects. (see precautions: geriatric use.)
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 ld50 exceeded 1000 mg/kg body weight, while the intravenous ld50 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 is a diuretic which is an anthranilic acid derivative. chemically, it is 4-chloro-n-furfuryl-5-sulfamoylanthranilic acid. furosemide injection 10 mg/ml is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. 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 structural formula is as follows: each ml contains: furosemide 10 mg, water for injection q.s., sodium chloride for isotonicity, sodium hydroxide and, if necessary, hydrochloric acid to adjust ph between 8.0 and 9.3. formula1.jpg
Clinical Pharmacology:
Clinical pharmacology investigations into the mode of action of furosemide have utilized micropuncture studies is 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 reabsorption 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 this 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 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 intravenous
Read more... administration is within 5 minutes and somewhat later after intramuscular administration. the peak effect occurs within the first half hour. the duration of diuretic effect is approximately 2 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 intravenous 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.
How Supplied:
How supplied furosemide injection, usp (10 mg/ml) protect from light. baxter manufactured for: baxter healthcare corporation deerfield, il 60015 usa manufactured by: baxter pharmaceuticals india private ltd ahmedabad 382213, india issue date: 2018-10-27 1400007271 product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 36000-284-25 10 ml single dose amber colored vials boxes of 25 ndc 0404-9862-10 1 10 ml single dose vial in a bag (vial bears ndc 36000-284-25) 10 mg/ml ndc 36000-283-25 4 ml single dose amber colored vials boxes of 25 ndc 0404-9863-04 1 4 ml single dose vial in a bag (vial bears ndc 36000-283-25) 10 mg/ml image1.jpg
Package Label Principal Display Panel:
Sample package label label1.jpg