FUROSEMIDE injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Lifestar Pharma LLC

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Furosemide Injection, USP (10 mg/mL) is a clear colorless solution filled in amber colored vials and is supplied as: Do not use if solution is discolored. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: September 2022, V-05

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FUROSEMIDE - FUROSEMIDE INJECTION, SOLUTION
LIFESTAR PHARMA LLC
----------
FUROSEMIDE INJECTION, USP
10 MG/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, USP 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 yellowish, odorless crystalline
powder. It is freely
soluble in acetone, in dimethylformamide, and in solutions of alkali
hydroxides, soluble in
methanol, sparingly soluble in alcohol, slightly soluble in ether,
very slightly soluble in
chloroform, practically insoluble in water.
The structural formula is as follows:
MOLECULAR FORMULA: C
H
ClN O S
MOLECULAR WEIGHT: 330.74
Each mL contains: Furosemide, USP 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.
12
11
2
5
between 8.0 and 9.3.
CLINICAL PHARMACOLOGY
Investigations into the mode of action of furosemide have utilized
micropuncture studies
is 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