FUROSEMIDE 10 mg/mL
FUROSEMIDE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
FUROSEMIDE is a injection, solution containing furosemide at 10 mg/mL, taken intramuscular. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- FUROSEMIDE
- Generic Name
- FUROSEMIDE
- NDC Code (Product)
51662-1226- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- NDA018667
- Drug Class
- Loop Diuretic [EPC]
- Marketing Start
- 09/14/2018
Recall History
Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Western Drug
Lack of Assurance of Sterility
Hospira, Inc.
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Leading Pharma, LLC
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
SCA Pharmaceuticals, Inc.
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Boehringer Ingelheim Roxane Inc
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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.
Dosage & 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 tablets is 20 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 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 tablets 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 tablets on 2 to 4 consecutive days each week. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests ). Geriatric Patients: In general, dose selection for the elderly patient should be cautio…
Warnings
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 ).
Contraindications
CONTRAINDICATIONS Furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Drug Interactions
Drug Interactions Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination. Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites. There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment. Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. Lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity. Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II rece…
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. 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. pruritus 12…
Frequently Asked Questions
What is FUROSEMIDE used for?
FUROSEMIDE contains FUROSEMIDE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is FUROSEMIDE a controlled substance?
FUROSEMIDE is not classified as a controlled substance by the DEA.
What is the generic name for FUROSEMIDE?
The generic name for FUROSEMIDE is FUROSEMIDE. There are 8 other brand versions of FUROSEMIDE.
What is the NDC code for FUROSEMIDE 10 mg/mL?
The NDC (National Drug Code) for FUROSEMIDE 10 mg/mL is 51662-1226, listed by HF Acquisition Co LLC, DBA HealthFirst.