Furosemide 1%: Product Information (Page 2 of 2)

TOXICOLOGY


Acute Toxicity:

The following table illustrates low acute toxicity of furosemide in three different species. (Two values indicated two different studies).

LD50 of furosemide in mg/kg body weight
Species Oral Intravenous
Mouse 1050-1500 308
Rat 2650-4600* 680
Dog >1000 and >4640 >300 and >464

*Note: The lower oral LD50 value for the rat was obtained in a group of fasted animals; the higher figure is from a study performed on fed rats.

Toxic doses lead to convulsions, ataxia, paralysis and collapse. Animals surviving toxic doses may become dehydrated and depleted of electrolytes due to the massive diuresis and saluresis.

Chronic Toxicity:

Chronic toxicity studies with furosemide were done in a one-year study in rats and dogs. In a one-year study in rats, renal tubular degeneration occurred with all doses higher than 50 mg/kg. A six-month study in dogs revealed calcification and scarring of the renal parenchyma at all doses above 10 mg/kg.

Reproductive Studies

Reproductive studies were conducted in mice, rats and rabbits. Only in rabbits administered high doses (equivalent to 10 to 25 times the recommended average dose of 2 mg/kg for dogs, horses and cattle) of furosemide during the second trimester did unexplained maternal deaths and abortions occur. Furosemide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effects of alcohol administered to pregnant Beagles at 3 and at 3.6 g/kg/day throughout gestation suggests that alcohol may reduce the number of offspring per litter, the birth weight per pup and increase the incidence of stillbirths. There have been no studies conducted in pregnant dogs administered alcohol at levels found in Furosemide Syrup 1%.

REFERENCES

  1. Timmerman RJ, Springman FR, Thomas RK: Evaluation of furosemide, a new diuretic agent. Curr Ther Res 6:88-94, 1964.
  2. Muschaweck R, Hajdu P: The saluretic action of 4-Chloro-N-(2 furylmethyl)-5-sulfamyl-anthranilic acid. (Die salidiuretische Wirksamkeit der Chlor-N-(2- furylmethyl)-5-sulfamyl-anthranilsaure.) Arzneim Forsch 14:44-47, 1964.
  3. Suki W, Rector FC Jr, Seldin DW: The site of action of furosemide and other sulfonamide diuretics in the dog. J Clin Invest 44:1458-1469. 1965.
  4. Deetjen P: Micropuncture studies of the action of furosemide. (Mikropunktionsuntersuchungen zur Wirkung von Furosemid.) Pfuegers Arch 284: 184-190, 1965.
  5. Berman LB, Ebrahimi A: Experiences with furosemide in renal disease. Proc Soc Exp Biol Med 118:333-336, 1965.
  6. Schmidt HAE: Animal experiments with S35 tagged Lasix® in canine and ovine. Internal report, Radiochemical Pharmacological Laboratory, Frankfurt, West Germany, Farbwerke Hoechst, 1964.
  7. Haeussler A, Hajdu P: Methods of biological identification and results of studies on absorption, elimination, and metabolism. Internal report, Research Laboratories, Frankfurt, West Germany, Farbwerke Hoechst.
  8. Wilson AF, Simmons DH: Diuretic action in hypochloremic dogs. Clin Res 14:158, 1966.
  9. Hook JB, Williamson HE: Influence of probenecid and alterations and acid-base balance of the saluretic activity of furosemide. J Pharmacol Exp Ther 149:404-408, 1965.
  10. Antoniou LD, et al: Sodium and calcium transport in the kidney. Clin Res 15:476, 1967.
  11. Duarte CG: Effects of furosemide (F) and ethacrynic acid (ETA) on the renal clearance of phosphate (Cp), ultra-filterable calcium (CUf-Ca) and magnesium (CUfMg) Clin Res 15:357, 1967.
  12. Duarte CG: Effects of ethacrynic acid and furosemide on urinary calcium, phosphate and magnesium. Metabolism 17:867-876, 1968.
  13. Nielsen SP, Andersen O, Steven KE, Magnesium and calcium metabolism during prolonged furosemide (Lasix®) administration to normal rats. Acta Pharmacol Toxicol 27:469-479, 1969.
  14. Reimold EW: The effect of furosemide on hypercalcemia due to dihydrotachysterol. Metabolism 21 :593-598, 1972.

Store at 20°C to 25°C (68°F to 77°F)

Manufactured for:

Cronus Pharma LLC, East Brunswick, NJ 08816
Contact No: 1-844-227-6687 (1-844-2-CRONUS)
e-FAX No: 732-647-1272
Email: contact@cronuspharma.com
PIC01960-01
Revised: 05/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label:

Furosemide Syrup 1% 60 mL

furosemide-bottle
(click image for full-size original)

Master Carton Label:

Furosemide Syrup 1% 60 mL

furosemide-carton
(click image for full-size original)
FUROSEMIDE 1% furosemide syrup
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:69043-019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE (FUROSEMIDE) FUROSEMIDE 10 mg in 1 mL
Product Characteristics
Color ORANGE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69043-019-60 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 60 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (69043-019-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200382 01/07/2021
Labeler — Cronus Pharma LLC (079421067)

Revised: 01/2021 Cronus Pharma LLC

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