BUMETANIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

BUMETANIDE (UNII: 0Y2S3XUQ5H) (BUMETANIDE - UNII:0Y2S3XUQ5H)

Pieejams no:

NCS HealthCare of KY, LLC dba Vangard Labs

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity. Bumetanide is contraindicated in anuria. Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the cond

Produktu pārskats:

Bumetanide Tablets USP are available as green, round, flat-faced, beveled edge, plain on one side and debossed with " 700" on other side, containing 0.5 mg bumetanide, USP. Bumetanide Tablets USP are available as yellow, round, flat-faced, beveled edge, plain on one side and debossed with" 701" on other side, containing 1 mg bumetanide, USP packaged in blistercards of 30 tablets (NDC 0615-8361-39). Bumetanide Tablets USP are available as peach, round, flat-faced, beveled edge, plain on one side and debossed with " 702" on other side, containing 2 mg bumetanide, USP packaged in blistercards of 30 tablets (NDC 0615-8362-39). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Centaur Pharmaceuticals Pvt. Ltd. Hinjewadi, Pune-411057, India. Manufactured for: Heritage Pharma Labs Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Iss. 05/19

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

BUMETANIDE- BUMETANIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
RX ONLY
WARNING
Bumetanide 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 dosage schedule have to be
adjusted to the
individual patient's needs (see DOSAGE AND ADMINISTRATION).
DESCRIPTION
Bumetanide Tablets USP are a loop diuretic available as 0.5 mg
(green), 1 mg (yellow)
and 2 mg (peach) tablets for oral administration; each tablet also
contains: anhydrous
lactose, corn starch, magnesium stearate, microcrystalline cellulose
and talc, with the
following colorants: 0.5 mg (D&C Yellow No. 10 Aluminum Lake and FD&C
Blue No. 1
Aluminum Lake); 1 mg (D&C Yellow No. 10 Aluminum Lake); 2 mg (Ferric
oxide red).
Chemically, bumetanide, USP is
3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is
a practically white powder. It is slightly soluble in water and
soluble in alkaline solutions. It
has the following structural formula:
CLINICAL PHARMACOLOGY
Bumetanide is a loop diuretic with a rapid onset and short duration of
action.
Pharmacological and clinical studies have shown that 1 mg bumetanide
has a diuretic
potency equivalent to approximately 40 mg furosemide. The major site
of bumetanide
action is the ascending limb of the loop of Henle.
The mode of action has been determined through various clearance
studies in both
humans and experimental animals. Bumetanide inhibits sodium
reabsorption in the
ascending limb of the loop of Henle, as shown by marked reduction of
free-water
clearance (CH O) during hydration and tubular free-water reabsorption
(T H O) during
hydropenia. Reabsorption of chloride in the ascending limb is also
blocked by
bumetanide, and bumetanide is somewhat more chloruretic than
natriuretic.
2
C
2
Potassium excretion is also increased by bumetanide, in a dose-related
fashion.
Bumetanide may have an additional action in the proximal tubule. Since
phosphate
reabsorption takes