Product Elements:
Furosemide furosemide furosemide furosemide silicon dioxide lactose monohydrate cellulose, microcrystalline starch, corn sodium lauryl sulfate sodium starch glycolate type a potato stearic acid 54;840 furosemide furosemide furosemide furosemide silicon dioxide lactose monohydrate cellulose, microcrystalline starch, corn sodium lauryl sulfate sodium starch glycolate type a potato stearic acid 54;583
Indications and Usage:
Indications and usage 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. 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, hyopproteinemia or concomitant therapy with aminogl
Read more...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 4 mg furosemide per minute has been used) (see precautions: drug interactions ).
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 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 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 observation and
Read more... laboratory monitoring are particularly advisable (see precautions : laboratory tests ). 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 patientâs 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 80 mg, usually divided into 40 mg 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 percent 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 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 reations (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. d
Read more...rug 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. 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 2. glycosuria 3. hyperuricemia 4. muscle spasm 5. weakness 6. restlessness 7. urinary bladder spasm 8. thrombophlebitis 9. fever whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
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 1000 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 each tablet for oral administration contains: furosemide usp . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg each ml of oral solution for oral administration contains: furosemide usp . . . . . . . . . . . . . . . . 10 mg per ml or 8 mg (40 mg per 5 ml) furosemide is a diuretic which is an anthranilic acid derivative. chemically, it is 4-chloro- n -furfuryl-5-sulfamoylanthranilic acid. furosemide is a white to slightly yellow, 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: c 12 h 11 cln 2 o 5 s m.w. 330.74 furosemide tablets usp are available for oral administration containing 20 mg, 40 mg or 80 mg of furosemide usp. the tablets meet dissolution test 1. each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and stearic acid. furosemide oral solution usp is also available for oral administration containing either 10 mg per ml or 40 mg per 5 ml. the oral solution contains the following inactive ingredients: d and c yellow no. 10, fd and c yellow no. 6, flavors, potassium carbonate 1½ hydrate, propylene glycol, sorbitol solution and water. the 10 mg/ml solution is orange flavored and contains prosweet liquid and also saccharin sodium. the 40 mg/5 ml solution is pineapple-peach flavored and contains sweet tone. chem.jpg
Clinical Pharmacology:
Clinical pharmacology investigations into the mode of action of furosemide have utilized micropuncture 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 to 400 mcg/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 oral administrat
Read more...ion 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 tablets are supplied as white, flat tablets with beveled edges, product identification â54 840â debossed on one side. ndc 0054-8297-25: unit dose amber blisters, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper ndc 0054-4297-25: bottle of 100 tablets ndc 0054-4297-31: bottle of 1000 tablets 40 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification â54 583â debossed on one side. ndc 0054-8299-25: unit dose amber blisters, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper ndc 0054-4299-25: bottle of 100 tablets ndc 0054-4299-31: bottle of 1000 tablets 80 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification â54 533â debossed on one side. ndc 0054-8301-25: unit dose amber blisters, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipp
Read more...er ndc 0054-4301-25: bottle of 100 tablets ndc 0054-4301-29: bottle of 500 tablets store and dispense store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] note: dispense in a tight, light-resistant, child-resistant container as defined in the usp/nf. exposure to light may cause slight discoloration. discolored tablets should not be dispensed. protect from moisture. protect from light. furosemide oral solution usp 10 mg per ml oral solution is supplied as a (orange-flavored) clear, orange-colored solution. ndc 0054-3294-46: bottle of 60 ml dispense only in this bottle and only with the calibrated dropper provided. ndc 0054-3294-50: bottle of 120 ml dispense only in this bottle. protect from light. note: discard opened bottle after 90 days. 40 mg per 5 ml oral solution is supplied as a (pineapple-peach flavored) clear, orange-colored solution. ndc 0054-3298-63: bottle of 500 ml dispense in a tight, light-resistant, child-resistant container as defined in the usp/nf. protect from light. store and dispense store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] distr. by: west-ward pharmaceuticals corp. eatontown, nj 07724 4052002//11 revised january 2016
Package Label Principal Display Panel:
Package/label principal display panel furosemide 20mg - 30 tablets
Package/label principal display panel furosemide 40mg - 30 tablets