FUROSEMIDE, INJECTION, USP, 10 mg/mL

/FUROSEMIDE, INJECTION, USP, 10 mg/mL
FUROSEMIDE, INJECTION, USP, 10 mg/mL2018-09-06T09:12:40+00:00

Prescription Drug Name:

FUROSEMIDE, INJECTION, USP, 10 mg/mL

ID:

b2442be8-4bea-4091-8ef2-28b2a8b2fb93

Code:

34391-3

WARNING


id: 6a8eb475-31ca-4431-89a0-6576d1271fde
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient’s needs. (See DOSAGE AND ADMINISTRATION.)

DESCRIPTION


id: 7798810b-e856-4705-a7c2-e2da37e66a16
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows: Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.

CLINICAL PHARMACOLOGY


id: 2ef22d25-0542-489a-9530-45c2c96e1a6e
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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 reabsorption 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 this 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 μg/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 intravenous administration is within 5 minutes and somewhat later after intramuscular administration. The peak effect occurs within the first half hour. The duration of diuretic effect is approximately 2 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 intravenous 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.

INDICATIONS AND USAGE


id: 52ca0966-3f7b-4a26-be3e-650119aa4aee
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.

CONTRAINDICATIONS


id: cd34fe40-a86b-4a28-8560-35b9a396a12b
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

WARNINGS


id: 86c4abff-1afd-4b66-8151-2b49da115c98
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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, 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 per minute has been used). (See PRECAUTIONS, Drug Interactions.)

ADVERSE REACTIONS


id: faf4f0c2-0784-4e90-be2c-e4cd243f0b57
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Adverse reactions are categorized below by organ system and listed by decreasing severity.


Gastrointestinal System Reactions
1. Hepatic encephalopathy in patients

       with hepatocellular insufficiency

6. Oral and gastric irritation

7. Cramping

2. Pancreatitis 8. Diarrhea
3. Jaundice (intrahepatic cholestatic jaundice) 9. Constipation
4. Increased liver enzymes 10. Nausea
5. Anorexia 11. Vomiting

Systemic Hypersensitivity Reactions
1. Severe anaphylactic or anaphylactoid

       reactions (e.g. with shock)

3. Interstitial nephritis

4. Necrotizing angiitis

2. Systemic vasculitis

Central Nervous System Reactions
1. Tinnitus and hearing loss 5. Headache
2. Paresthesias 6. Blurred vision
3. Vertigo 7. Xanthopsia
4. Dizziness

Hematologic Reactions
1. Aplastic anemia 5. Leukopenia
2. Thrombocytopenia 6. Anemia
3. Agranulocytosis 7. Eosinophilia
4. Hemolytic anemia

Dermatologic-Hypersensitivity Reactions
1. Exfoliative dermatitis 6. Urticaria
2. Bullous pemphigoid 7. Rash
3. Erythema multiforme 8. Pruritus
4. Purpura 9. Stevens-Johnson Syndrome
5. Photosensitivity 10. Toxic epidermal necrolysis

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 7. Urinary bladder spasm
2. Glycosuria 8. Thrombophlebitis
3. Hyperuricemia

4. Muscle spasms

9. Transient injection site pain following

intramuscular injection

5. Weakness 10. Fever
6. Restlessness
Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

OVERDOSAGE


id: b739595d-a5b7-4eaa-aee3-7ef97a1bd58e
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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 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 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.

HOW SUPPLIED


id: 33b2e4a3-a173-47de-8961-6385dee3d855
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Furosemide Injection, USP (10 mg/mL)

NDC 54868-2299-0 10 mL single dose amber colored vials Boxes of 25
Do not use if solution is discolored.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Protect from light.
IN5702
Rev. 6/11
MG #7822
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Additional barcode labeling by:

Physicians Total Care, Inc.
Tulsa, Oklahoma      74146