TOBRAMYCIN- tobramycin sulfate injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Tobramycin Sulfate (UNII: HJT0RXD7JK) (Tobramycin - UNII:VZ8RRZ51VK)

Disponibil de la:

Akorn

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concur

Rezumat produs:

Tobramycin Injection, USP, in multi-dose vials, is supplied as follows: Each vial of Tobramycin Injection, USP contains tobramycin sulfate equivalent to 80 mg/2 mL or 1200 mg/30 mL of tobramycin and each mL contains tobramycin sulfate equivalent to 40 mg tobramycin; phenol 5 mg; sodium metabisulfite 3.2 mg; edetate disodium 0.1 mg and water for injection, q.s. Sulfuric acid and/or sodium hydroxide may have been added to adjust the pH (3.0 to 6.5). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 TOB00N        Rev. 05/18

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TOBRAMYCIN - TOBRAMYCIN SULFATE INJECTION, SOLUTION
AKORN
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TOBRAMYCIN INJECTION, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
tobramycin and other antibacterial drugs, tobramycin should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
WARNINGS
PATIENTS TREATED WITH TOBRAMYCIN INJECTION, USP AND OTHER
AMINOGLYCOSIDES SHOULD BE UNDER CLOSE CLINICAL OBSERVATION, BECAUSE
THESE DRUGS HAVE AN INHERENT POTENTIAL FOR CAUSING OTOTOXICITY AND
NEPHROTOXICITY.
NEUROTOXICITY, MANIFESTED AS BOTH AUDITORY AND VESTIBULAR OTOTOXICITY,
CAN OCCUR. THE AUDITORY CHANGES ARE IRREVERSIBLE, ARE USUALLY
BILATERAL,
AND MAY BE PARTIAL OR TOTAL. EIGHTH-NERVE IMPAIRMENT AND
NEPHROTOXICITY
MAY DEVELOP, PRIMARILY IN PATIENTS HAVING PRE-EXISTING RENAL DAMAGE
AND
IN THOSE WITH NORMAL RENAL FUNCTION TO WHOM AMINOGLYCOSIDES ARE
ADMINISTERED FOR LONGER PERIODS OR IN HIGHER DOSES THAN THOSE
RECOMMENDED. OTHER MANIFESTATIONS OF NEUROTOXICITY MAY INCLUDE
NUMBNESS, SKIN TINGLING, MUSCLE TWITCHING, AND CONVULSIONS. THE RISK
OF
AMINOGLYCOSIDE-INDUCED HEARING LOSS INCREASES WITH THE DEGREE OF
EXPOSURE TO EITHER HIGH PEAK OR HIGH TROUGH SERUM CONCENTRATIONS.
PATIENTS WHO DEVELOP COCHLEAR DAMAGE MAY NOT HAVE SYMPTOMS DURING
THERAPY TO WARN THEM OF EIGHTH-NERVE TOXICITY, AND PARTIAL OR TOTAL
IRREVERSIBLE BILATERAL DEAFNESS MAY CONTINUE TO DEVELOP AFTER THE DRUG
HAS BEEN DISCONTINUED. RARELY, NEPHROTOXICITY MAY NOT BECOME APPARENT
UNTIL THE FIRST FEW DAYS AFTER CESSATION OF THERAPY. AMINOGLYCOSIDE-
INDUCED NEPHROTOXICITY USUALLY IS REVERSIBLE.
RENAL AND EIGHTH-NERVE FUNCTION SHOULD BE CLOSELY MONITORED IN
PATIENTS
WITH KNOWN OR SUSPECTED RENAL IMPAIRMENT AND ALSO IN THOSE WHOSE
RENAL FUNCTION IS INITIALLY NORMAL BUT WHO DEVELOP SIGNS OF RENAL
DYSFUNCTION DURING THERAPY. PEAK AND TROUGH SERUM CONCENTRATIONS OF
AMINOGLYCOSIDES SHOULD BE MONITORED PERIODICALLY DURING THERAPY TO
ASSURE ADEQUATE LEVELS AND TO AVOID POTENTIALLY TOXIC LEVELS.
PR