White, round, flat uncoated tablets with beveled edge and embossed with 'F/40' on one side of the tablets separated by bisecting line. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Furosemide tablets are indicated for: The treatment of fluid retention associated with heart failure, including left ventricular failure, cirrhosis of the liver and renal disease including nephrotic syndrome. The treatment of mild to moderate hypertension when brisk diuretic response is required. Alone or in combination with other antihypertensive agents in the treatment of more severe cases. - Hypersensitivity to furosemide, or to any of the excipients listed in section 6.1 - Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives - Hypovolaemia and dehydration (with or without accompanying hypotension) (see section 4.4) - Severe hypokalaemia: severe hyponatraemia (see section 4.4). Furosemide 40 mg tablets are contraindicated in children and adolescents under 18 years of age (safety in this age group has not yet been established). - Comatose or pre-comatose states associated with hepatic cirrhosis (see section 4.4). - Anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure associated with hepatic coma - Impaired renal function with a creatinine clearance below 30ml/min per 1.73 m body surface area (see section 4.4). - Children and adolescents under 18 years of age (safety in this age group has not yet been established) - Digitalis intoxication (see section 4.5). - Concomitant potassium supplements or potassium sparing diuretics (see section 4.5). Published online: September 30, 2009 Number of Print Pages: 9 Number of Figures: 0 Number of Tables: 0 ISSN: 1661-7800 (Print) e ISSN: 1661-7819 (Online) For additional information: https:// Inhaled furosemide has been shown to attenuate bronchospasm in asthmatics and to increase lung compliance in infants with bronchopulmonary dysplasia (BPD). The reports involving BPD used a dose of 1 mg/kg and some have failed to show an effect with that dose. We determined the pharmacokinetics of furosemide administered directly to the airway in 7 young adult male guinea pigs who received intravenous and intratracheal doses of furosemide. Surfactant delayed the absorption of furosemide but did not alter the fraction absorbed. The mean fraction of the intratracheal dose absorbed was 0.50–0.60 for all doses.
Pharmacokinetic (absorption, distribution, metabolism, and excretion – ADME) parameters are today considered to have a crucial role in the selection process of oral candidate drugs for product development. Fundamental BCS parameters, such as permeability, solubility, and fraction dose absorbed, are among those ADME parameters and therefore it has been suggested that these fundamental BCS parameters should be useful in both the discovery and early development process. For instance, it is clear that new compounds with a very low permeability and/or solubility/dissolution will certainly result in low and highly variable bioavailability, which may limit the possibilities that a clinically useful product can be developed. It is obvious that a selection of candidates that fulfil the BCS requirement of high permeability/high solubility (class I) almost guarantees the absence of failures due to incomplete and highly variable GI absorption. However, these BCS limits are generally too conservative to use as acceptance criteria in drug screening since many useful drugs can be found in classes II–III and even class IV. First of all, a class I drug is expected to provide complete absorption whereas a certain reduction in bioavailability due to permeability or solubility, as well as due to other reasons (e.g., first-pass metabolism), is generally acceptable. A summary of the different factors that have to be taken into account when defining more relevant acceptance criteria follows: Such procedures have also been introduced in the industry, including solubility screens using turbidimetric measurements and automatic permeability screens in cell-based systems (such as Caco-2 cell model). Edema associated with congestive heart failure (CHF), liver cirrhosis, and renal disease, including nephrotic syndrome 20-80 mg PO once daily; may be increased by 20-40 mg q6-8hr; not to exceed 600 mg/day Alternative: 20-40 mg IV/IM once; may be increased by 20 mg q2hr; individual dose not to exceed 200 mg/dose Refractory CHF may necessitate larger doses Excessive diuresis may cause dehydration and electrolyte loss in elderly; lower initial dosages and more gradual adjustments are recommended (eg, 10 mg/day PO)Increase in blood urea nitrogen (BUN) and loss of sodium may cause confusion in elderly; monitor renal function and electrolytes Anaphylaxis Anemia Anorexia Diarrhea Dizziness Glucose intolerance Glycosuria Headache Hearing impairment Hyperuricemia Hypocalcemia Hypokalemia Hypomagnesemia Hypotension Increased patent ductus arteriosus during neonatal period Muscle cramps Nausea Photosensitivity Rash Restlessness Tinnitus Urinary frequency Urticaria Vertigo Weakness Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, drug rash with eosinophila and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, bullous pemphigoid purpura, pruritus Agent is potent diuretic that, if given in excessive amounts, may lead to profound diuresis with water and electrolyte depletion Careful medical supervision is required; dosing must be adjusted to patient's needs Use caution in systemic lupus erythematosus, liver disease, renal impairment Concomitant ethacrynic acid therapy (increases risk of ototoxicity) Risks of fluid or electrolyte imbalance (including causing hyperglycemia, hyperuricemia, gout), hypotension, metabolic alkalosis, severe hyponatremia, severe hypokalemia, hepatic coma and precoma, hypovolemia (with or without hypotension) Do not commence therapy in hepatic coma and in electrolyte depletion until improvement is noted IV route twice as potent as PO Food delays absorption but not diuretic response May exacerbate lupus Possibility of skin sensitivity to sunlight Prolonged use in premature neonates may cause nephrocalcinosis Efficacy is diminished and risk of ototoxicity increased in patients with hypoproteinemia (associated with nephrotic syndrome); ototoxicity is associated with rapid injection, severe renal impairment, use of higher than recommended doses, concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs To prevent oliguria, reversible increases in BUN and creatinine, and azotemia, monitor fluid status and renal function; discontinue therapy if azotemia and oliguria occur during treatment of severe progressive renal disease FDA-approved product labeling for many medications have included a broad contraindication in patients with a prior allregic reaction to sulfonamides; however, recent studies have suggested that crossreactivity between antibiotic sulfonamides and nonantibiotic sulfonamides is unlikely to occur In cirrhosis, electrolyte and acid/base imbalances may lead to hepatic encephalopathy; prior to initiation of therapy, correct electrolyte and acid/base imbalances, when hepatic coma is present High doses ( 80 mg) of furosemide may inhibit binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by overall decrease in total thyroid hormone levels In patients at high risk for radiocontrast nephropathy furosemide can lead to higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast Observe patients regularly for possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions Cases of tinnitus and reversible or irreversible hearing impairment and deafness reported Hearing loss in neonates has been associated with use of furosemide injection; in premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients Increases in blood glucose and alterations in glucose tolerance tests (with abnormalities of fasting and 2 hour postprandial sugar) have been observed, and rarely, precipitation of diabetes mellitus reported Patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine; these patients require careful monitoring, especially during initial stages of treatment Hypokalemia may develop with furosemide, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives Pregnancy category: C; treatment during pregnancy necessitates monitoring of fetal growth because of risk for higher fetal birth weights Lactation: Drug excreted into breast milk; use with caution; may inhibit lactation Loop diuretic; inhibits reabsorption of sodium and chloride ions at proximal and distal renal tubules and loop of Henle; by interfering with chloride-binding cotransport system, causes increases in water, calcium, magnesium, sodium, and chloride Solution: Fructose10W, invert sugar 10% in multiple electrolyte #2 Additive: Amiodarone (at high concentrations of both drugs), buprenorphine, chlorpromazine, diazepam, dobutamine, eptifibatide, erythromycin lactobionate, gentamicin(? ), isoproterenol, meperidine, metoclopramide, netilmicin, papaveretum, prochlorperazine, promethazine Syringe: Caffeine, doxapram, doxorubicin, eptifibatide, metoclopramide, milrinone, droperidol, vinblastine, vincristine Y-site: Alatrofloxacin, amiodarone (incompatible at furosemide 10 mg/m L; possibly compatible at 1 mg/m L), chlorpromazine, ciprofloxacin, cisatracurium (incompatible at cisatracurium 2 mg/m L; possibly compatible at 0.1 mg/m L), clarithromycin, diltiazem, diphenhydramine, dobutamine, dopamine, doxorubicin (incompatible at furosemide 10 mg/m L and doxorubicin 2 mg/m L; possibly compatible at furosemide 3 mg/m L and doxorubicin 0.2 mg/m L), droperidol, eptifibatide, esmolol, famotidine(? ), fenoldopam, gatifloxacin, gemcitabine, gentamicin(? ), hydralazine, idarubicin, labetalol, levofloxacin, meperidine, metoclopramide, midazolam, milrinone, morphine, netilmicin, nicardipine, ondansetron, quinidine, thiopental, vecuronium, vinblastine, vincristine, vinorelbine Not specified: Tetracycline Additive: Cimetidine, epinephrine, heparin, nitroglycerin, potassium chloride, verapamil Syringe: Heparin Y-site: Epinephrine, fentanyl, heparin, norepinephrine, nitroglycerin, potassium chloride, verapamil(? ), vitamins B and C Injection: Inject directly or into tubing of actively running IV over 1-2 minutes Administer undiluted IV injections at rate of 20-40 mg/min; not to exceed 4 mg/min for short-term intermittent infusion; in children, give 0.5 mg/kg/min, titrated to effect Use infusion solution within 24 hours The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
The pharmacokinetics of furosemide were studied in 12 patients with advanced renal failure. The elimination half-life of furosemide averaged 9.7 hours. Describes the medication furosemide Lasix, a drug used to treat excessive fluid accumulation and swelling edema of the body caused by heart failure.