Prescription Drug Information: Furosemide (Page 2 of 3)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Furosemide was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. A small but significantly increased incidence of mammary gland carcinomas occurred in female mice at a dose 17.5 times the maximum human dose of 600 mg. There were marginal increases in uncommon tumors in male rats at a dose of 15 mg/kg (slightly greater than the maximum human dose) but not at 30 mg/kg.

Furosemide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system, and questionably positive for gene mutation in mouse lymphoma cells in the presence of rat liver S9 at the highest dose tested. Furosemide did not induce sister chromatid exchange in human cells in vitro, but other studies on chromosomal aberrations in human cells in vitro gave conflicting results. In Chinese hamster cells it induced chromosomal damage but was questionably positive for sister chromatid exchange. Studies on the induction by furosemide of chromosomal aberrations in mice were inconclusive. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.

FUROSEMIDE TABLET (furosemide) produced no impairment of fertility in male or female rats, at 100 mg/kg/day (the maximum effective diuretic dose in the rat and 8 times the maximal human dose of 600 mg/day).

Pregnancy

PREGNANCY CATEGORY C — Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. There are no adequate and well-controlled studies in pregnant women. FUROSEMIDE TABLET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights.

The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits.

Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (2 times the maximal recommended human dose of 600 mg/day). In another study, a dose of 50 mg/kg (4 times the maximal recommended human dose of 600 mg/day) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived a dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths.

The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses derived from the treated dams as compared with the incidence in fetuses from the control group.

Nursing Mothers

Because it appears in breast milk, caution should be exercised when FUROSEMIDE TABLET is administered to a nursing mother.

FUROSEMIDE TABLET may inhibit lactation.

Pediatric Use

In premature infants FUROSEMIDE TABLET may precipitate nephrocalcinosis/nephrolithiasis. Nephrocalcinosis/ nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with FUROSEMIDE TABLET. Monitor renal function, and renal ultrasonograph should be considered, in pediatric patients receiving FUROSEMIDE TABLET.

If FUROSEMIDE TABLET is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.

Geriatric Use

Controlled clinical studies of FUROSEMIDE TABLET did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.(See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION.)

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.
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 TABLET 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

OVERDOSAGE

The principal signs and symptoms of overdose with FUROSEMIDE TABLET are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action.

The acute toxicity of FUROSEMIDE TABLET 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 TABLET 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.

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 TABLET 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 TABLET 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 TABLET 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 TABLET 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 TABLET 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 TABLET is added to the regimen. As the blood pressure falls under the potentiating effect of FUROSEMIDE TABLET, 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).

HOW SUPPLIED

FUROSEMIDE TABLETS 40 mg are supplied as white, round, scored tablets in Bottles of 30 (NDC 63187-790-30) 60 (NDC 63187-790-60) and 90 (63187-790-90). The 40 mg tablets are imprinted with “EP 117” on one side and “40” on the other.

Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Meets USP Dissolution Test 2

Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F). [See USP Controlled Room Temperature.]

Rev. 02 03/16

Mfd. by:

Leading Pharma, LLC

Fairfield, NJ 07004

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

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