STREPTOMYCIN FOR INJECTION USP POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

STREPTOMYCIN (STREPTOMYCIN SULFATE)

זמין מ:

STERIMAX INC

קוד ATC:

J01GA01

INN (שם בינלאומי):

STREPTOMYCIN

כמות:

1G

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

STREPTOMYCIN (STREPTOMYCIN SULFATE) 1G

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

5 ML

סוג מרשם:

Prescription

איזור תרפויטי:

AMINOGLYCOSIDES

leaflet_short:

Active ingredient group (AIG) number: 0131356002; AHFS:

מצב אישור:

MARKETED

תאריך אישור:

2001-10-15

מאפייני מוצר

1
PRESCRIBING INFORMATION
PR
STREPTOMYCIN FOR INJECTION USP
Powder for Solution
Aminoglycoside Antibiotic
SteriMax Inc.
2770 Portland Drive,
Oakville, ON
L6H 6R4
Date of Revision:
July 17, 2018
Control No.: 214715
2
ACTIONS AND CLINICAL PHARMACOLOGY
Streptomycin is a water soluble aminoglycoside derived from
_Streptomyces _
_griseus. _It is marketed as the sulphate salt of streptomycin. The
chemical name
of streptomycin sulphate is
D-Streptamine,_0_-2-deoxy-2-(methylamino)-α-L-
glucopyranosyl-(1→2)-_0_-5-deoxy-3-_C-_formyl-α-L-lyxofuranosyl-(1→4)-_N,N_
_1_
-
bis(aminoiminomethyl)-,sulphate (2:3) (salt). The molecular formula
for
streptomycin sulphate is (C
21
H
39
N
7
O
12
)
2
•3H
2
SO
4
and the molecular weight is
1457.41. It has the following structural formula:
Streptomycin sulphate, equivalent to 1 g streptomycin/vial is supplied
as a sterile
nonpyrogenic lyophilized powder for intramuscular use after
reconstitution.
After reconstitution the pH range for Sterile Streptomycin for
Injection USP
should be between 4.5 and 7.0 in a solution containing 200 mg of
streptomycin
activity per mL.
Each vial contains Streptomycin Sulphate USP equivalent to 1 g of
streptomycin.
3
PHARMACOLOGY:
In recommended doses, Streptomycin is active against susceptible
strains of
many gram-negative and gram-positive organisms, and _M. tuberculosis.
_When
used alone, bacterial resistance has been shown to develop rapidly.
Therefore, in
the treatment of tuberculosis, it should be used in combination with
other
antitubercular drugs.
PHARMACOKINETICS:
Streptomycin is not absorbed from the gastro-intestinal tract when
given orally
and therefore should be administered parenterally for systemic action.
Following intramuscular injection of 1 g of the drug, a peak serum
level of 25 to
50 μg/mL is reached within 1 hour, diminishing slowly to about 50%
after 5 to 6
hours. Appreciable concentrations are found in all organ tissues
except the brain.
Significant amounts have been found in pleural fluid and tuberculous
cavities.
Streptomycin