streptomycin

WARNING
THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTS WITHIMPAIRED RENAL FUNCTION OR PRE-RENAL AZOTEMIA streptomycin. THESE INCLUDE DISTURBANCES OFVESTIBULAR AND COCHLEAR FUNCTION streptomycin. OPTIC NERVE DYSFUNCTION, PERIPHERAL NEURITIS,ARACHNOIDITIS, AND ENCEPHALOPATHY MAY ALSO OCCUR streptomycin. THE INCIDENCE OF CLINICALLYDETECTABLE, IRREVERSIBLE VESTIBULAR DAMAGE IS PARTICULARLY HIGH IN PATIENTSTREATED WITH STREPTOMYCIN streptomycin.

RENAL FUNCTION SHOULD BE MONITORED CAREFULLY; PATIENTS WITH RENAL IMPAIRMENTAND/OR NITROGEN RETENTION SHOULD RECEIVE REDUCED DOSAGES streptomycin. THE PEAK SERUM CONCENTRATIONIN INDIVIDUALS WITH KIDNEY DAMAGE SHOULD NOT EXCEED 20 TO 25 MCG/ML streptomycin.

THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGSWITH STREPTOMYCIN SULFATE, INCLUDING NEOMYCIN, KANAMYCIN, GENTAMICIN, CEPHALORIDINE,PAROMOMYCIN, VIOMYCIN, POLYMYXIN B, COLISTIN, TOBRAMYCIN AND CYCLOSPORINE SHOULDBE AVOIDED streptomycin.

THE NEUROTOXICITY OF STREPTOMYCIN CAN RESULT IN RESPIRATORY PARALYSIS FROMNEUROMUSCULAR BLOCKAGE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER THE USEOF ANESTHESIA OR OF MUSCLE RELAXANTS streptomycin.

THE ADMINISTRATION OF STREPTOMYCIN IN PARENTERAL FORM SHOULD BE RESERVED FORPATIENTS WHERE ADEQUATE LABORATORY AND AUDIOMETRIC TESTING FACILITIES ARE AVAILABLEDURING THERAPY streptomycin.

DESCRIPTION
Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus streptomycin. It is marketed as the sulfate salt of streptomycin streptomycin. The chemical name of streptomycinsulfate is D-Streptamine, O -2-deoxy-2-(methylamino)-(alpha)-L-glucopyranosyl-(1->2)-O -5-deoxy-3- C -formyl-(alpha)-L-lyxofuranosyl-
(1->4)- N,N '-bis(aminoiminomethyl)-, sulfate (2:3) (salt) streptomycin. The empiricalformula for Streptomycin Sulfate is (C 21 H 39 N 7 O 12 ) 2 .3H 2 SO 4 and themolecular weight is 1457.38 streptomycin. It has the following structure:

Streptomycin Sulfate Injection, 1 g/2.5 mL (400 mg/mL), is supplied as a sterile,nonpyrogenic solution for intramuscular use streptomycin.

Each mL contains: Streptomycin sulfate equivalent to 400 mg of streptomycin,sodium citrate dihydrate 12 mg, phenol 0.25% w/v as preservative, sodium metabisulfite2 mg in Water for Injection streptomycin. pH range 5.0 to 8.0 streptomycin.

CLINICAL PHARMACOLOGY
Following intramuscular injection of 1 g of streptomycin, as the sulfate, apeak serum level of 25 to 50 mcg/mL is reached within 1 hour, diminishing slowlyto about 50 percent after 5 to 6 hours streptomycin.

Appreciable concentrations are found in all organ tissues except the brain streptomycin. Significant amounts have been found in pleural fluid and tuberculous cavities streptomycin. Streptomycin passes through the placenta with serum levels in the cord bloodsimilar to maternal levels streptomycin. Small amounts are excreted in milk, saliva, andsweat streptomycin.

Streptomycin is excreted by glomerular filtration streptomycin. In patients with normalkidney function, between 29% and 89% of a single 600 mg dose is excreted inthe urine within 24 hours streptomycin. Any reduction of glomerular function results in decreasedexcretion of the drug and concurrent rise in serum and tissue levels streptomycin.

Microbiology

Streptomycin sulfate is a bactericidal antibiotic streptomycin. It acts by interfering withnormal protein synthesis streptomycin.

Streptomycin has been shown to be active against most strains of the followingorganisms both in vitro and in clinical infection streptomycin. (See INDICATIONS AND USAGE.):

Brucella (brucellosis),

Calymmatobacterium granulomatis (donovanosis, granuloma inguinale),

Escherichia coli, Proteus spp., Aerobacter aerogenes, Klebsiella pneumoniae,and Enterococcus faecalis in urinary tract infections,

Francisella tularensis,

Haemophilus ducreyi (chancroid),

Haemophilus influenzae (in respiratory, endocardial, and meningeal infections--concomitantlywith another antibacterial agent),

Klebsiella pneumoniae pneumonia (concomitantly with another antibacterial agent),

Mycobacterium tuberculosis,

Pasteurella pestis

Streptococcus viridans, Enterococcus faecalis (in endocardial infections--concomitantlywith penicillin) streptomycin.

SUSCEPTIBILITY TESTS: Diffusion Techniques
Quantitative methods that require measurement of zone diameters give the mostprecise estimate of the susceptibility of bacteria to antimicrobial agents streptomycin. One such standard procedure 1 which has been recommended for use with disksto test susceptibility of organisms to streptomycin uses the 10 mcg streptomycindisk streptomycin. Interpretation involves the correlation of the diameter obtained in thedisk test with the minimum inhibitory concentration (MIC) for streptomycin streptomycin.

Reports from the laboratory giving results of the standard single disk susceptibilitytest with a 10 mcg streptomycin disk should be interpreted according to thefollowing criteria:

Zone Diameter (mm) Interpretation
>/=15 (S) Susceptible
11-12 (I) Intermediate
</=10 (R) Resistant

A report of "Susceptible" indicates that the pathogen is likely torespond to monotherapy with streptomycin streptomycin. A report of "Intermediate"indicates that the result be considered equivocal, and, if the organism is notfully susceptible to alternative clinically feasible drugs, the test shouldbe repeated streptomycin. This category provides a buffer zone which prevents small uncontrolledtechnical factors from causing major discrepancies in interpretations streptomycin. A reportof "Resistant" indicates that achievable drug concentrations are unlikelyto be inhibitory and other therapy should be selected streptomycin.

Standardized procedures require the use of laboratory control organisms streptomycin. The10 mcg streptomycin disk should give the following zone diameter:

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