FUROSEMIDE- furosemide injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

Available from:

Wockhardt USA LLC.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. 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 arentera syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of arenter is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical. Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

Furosemide injection, USP (10 mg/mL) Do not use if solution is discolored. Store at controlled room temperature 20° - 25°C (68° - 77° F) (See USP). Protect from light. Manufactured by: Wockhardt Limited At: Plot no. 42 to 52, Sy. No. 166, 171, 172, 177 Phase - III, TSIIC, Pashamylaram (V), Patancheru (M), Sangareddy Dist. - 502307, Telangana, INDIA. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.260821

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE - FUROSEMIDE INJECTION
WOCKHARDT USA LLC.
----------
FUROSEMIDE INJECTION USP, 10 MG PER ML
RX ONLY
WARNING
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
Furosemide is a diuretic which is an anthranilic acid derivative.
Chemically, it is 4-chloro- _N_-furfuryl-5-sulfamoylanthranilic acid.
Furosemide injection USP, 10 mg/mL is a sterile, non-pyrogenic
solution in vials for
intravenous and intramuscular injection.
Furosemide, USP is a white to slightly yellow 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:
Molecular Formula: C
H
ClN
O
S
Molecular Weight: 330.74
Each mL contains: 10 mg Furosemide, Water for Injection q.s., Sodium
Chloride for
isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to
adjust pH between
12
11
2
5
8.0 and 9.3.
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 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