FUROSEMIDE 40 MG 100 TAB
Generic: Furosemide
FUROSEMIDE 40 MG 100 TAB
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Identification
Furosemide
Furosemide
Leading Pharma, LLC
HUMAN PRESCRIPTION DRUG
Administration
TABLET
ORAL
ANDA077293
Active Ingredients
| Ingredient | Strength |
|---|---|
| FUROSEMIDE | 40 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Clinical Drug 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 tablets 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 tablets alone.
Warnings
WARNINGS In patients with hepatic cirrhosis and ascites, Furosemide tablets 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 tablets should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that Furosemide tablets ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside 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 tablets per minute has been used). (See PRECAUTIONS: Drug Interactions)
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 (eg, 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 cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use ). Pediatric patients The usual initial dose of oral Furosemide tablets 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 tablets 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 tablets are 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 tablets are added to the regimen. As the blood pressure falls under the potentiating effect of Furosemide tablets, 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 ).
Adverse Reactions
ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions hepatic encephalopathy in patients with hepato-cellular insufficiency pancreatitis jaundice (intrahepatic cholestatic jaundice) increased liver enzymes anorexia oral and gastric irritation cramping diarrhea constipation nausea vomiting Systemic Hypersensitivity Reactions Severe anaphylactic or anaphylactoid reactions (e.g. with shock) systemic vasculitis interstitial nephritis necrotizing angiitis Central Nervous System Reactions tinnitus and hearing loss paresthesias vertigo dizziness headache blurred vision xanthopsia Hematologic Reactions aplastic anemia thrombocytopenia agranulocytosis hemolytic anemia leukopenia anemia eosinophilia Dermatologic-Hypersensitivity Reactions toxic epidermal necrolysis Stevens-Johnson Syndrome erythema multiforme drug rash with eosinophilia and systemic symptoms acute generalized exanthematous pustulosis exfoliative dermatitis bullous pemphigoid purpura photosensitivity rash pruritis urticaria Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. Increase in cholesterol and triglyceride serum levels Other Reactions hyperglycemia glycosuria hyperuricemia muscle spasm weakness restlessness urinary bladder spasm thrombophlebitis fever Whenever adverse reactions are moderate or severe, Furosemide tablets dosage should be reduced or therapy withdrawn. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.
Information for Patients
Information For Patients Patients receiving Furosemide tablets should be advised that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia. Patients with diabetes mellitus should be told that furosemide may increase blood glucose levels and thereby affect urine glucose tests. The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide. Hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.