furosemide- Furosemide tablet furosemide- Furosemide solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

INN (Διεθνής Όνομα):

Furosemide

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Περίληψη προϊόντος:

Furosemide Tablets USP 20 mg white, unscored tablets (Identified 54 840). NDC 0054-8297-25: Unit dose amber blisters, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4297-25: Bottle of 100 tablets. NDC 0054-4297-31: Bottle of 1000 tablets. 40 mg white, scored tablets (Identified 54 583). NDC 0054-8299-25: Unit dose amber blisters, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4299-25: Bottle of 100 tablets. NDC 0054-4299-31: Bottle of 1000 tablets. 80 mg white, scored tablets (Identified 54 533). NDC 0054-8301-25: Unit dose amber blisters, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4301-25: Bottle of 100 tablets. NDC 0054-4301-29: Bottle of 500 tablets.   Store and Dispense: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Note: Dispense in a tight light-resistant container as defined in the USP/NF. Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed. Protect From Moisture. PROTECT FROM LIGHT. Furosemide Oral Solution USP 10 mg per mL Oral Solution (orange-flavored, orange-colored) NDC 0054-3294-46: Bottle of 60 mL with calibrated dropper [graduations of 0.5 mL (5 mg), 0.75 mL, 1 mL (10 mg), 1.25 mL, 1.5 mL (15 mg), 1.75 mL, and 2 mL (20 mg) on the dropper]. NDC 0054-3294-50: Bottle of 120 mL with calibrated spoon (graduations of 20 mg, 40 mg, 60 mg, and 80 mg on the spoon). PROTECT FROM LIGHT. Note: Discard opened bottle after 90 days. 40 mg per 5 mL Oral Solution (pineapple-peach flavored, orange-colored) NDC 0054-8298-16: Unit dose Patient CupTM filled to deliver 5 mL (40 mg Furosemide), ten 5 mL Patient CupsTM per shelf pack, four shelf packs per shipper. NDC 0054-3298-63: Bottle of 500 mL. Store and Dispense: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a tight light-resistant container as defined in the USP/NF. PROTECT FROM LIGHT. 4052000//04  Revised May 2006 © RLI, 2006

Αρχείο Π.Χ.Π.

FUROSEMIDE- FUROSEMIDE TABLET
FUROSEMIDE- FUROSEMIDE SOLUTION
----------
FUROSEMIDE TABLETS USP, 20 MG, 40 MG, 80 MG
FUROSEMIDE ORAL SOLUTION USP, 40 MG PER 5 ML AND 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 SCHEDULE MUST BE ADJUSTED TO THE INDIVIDUAL PATIENT’S
NEEDS. (SEE “DOSAGE AND
ADMINISTRATION”.)
DESCRIPTION
Each tablet for oral administration contains:
Each mL of Oral Solution for oral administration contains:
Furosemide is a diuretic which is an anthranilic acid derivative.
Chemically, it is 4-chloro-_N_-furfuryl-
5-sulfamoylanthranilic acid. Furosemide 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 CAS Registry Number is 54-31-9.
The structural formula is as follows:
C H CIN O S M.W. 330.74
Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of
furosemide. The tablets meet
USP Dissolution Test 1. Furosemide Oral Solution is available in two
strengths: 40 mg per 5 mL, and
10 mg per mL.
_Inactive Ingredients:_
The tablets contain colloidal silicon dioxide, NF, corn starch, NF,
lactose monohydrate, NF,
microcrystalline cellulose, NF, pregelatinized starch, NF, sodium
lauryl sulfate, NF, sodium starch
glycolate, NF and stearic acid, NF.
The oral solutions contain D and C Yellow No. 10, FD and C Yellow No.
6, flavors, potassium
carbonate 1 1/2 hydrate, propylene glycol, USP, sorbitol solution, USP
and water. The 10 mg/mL
solution is orange flavored and the 40 mg/5 mL solution is
pineapple-peach flavored. The 10 mg/mL
oral solution also contains saccharin sodium, USP.
Furosemide . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg
Furosemide . . . . . . . . . . . . . . . . 10 mg, or 8 mg (40 mg per 5
mL)
12
11
2
5
CLINICAL PHARMACOLOGY
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