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STREPTOMYCIN SULFATE REIG JOFRΙ 1 gr.
Streptomycin (OSD)
FOR INTRAMUSCULAR USE
COMPOSITION
Per vial:
Streptomycin (OSD) (sulfate)
1 gr.
Per ampoule of solvent:
Water for Injection
.. 3 ml.
PROPERTIES
Bactericidal antibiotic that is well absorbed after intramuscular administration and with appreciable concentrations in all organ fluids and tissues except the brain. Streptomycin is detectable in significant amounts in pleural fluid and tuberculous cavities. It is excreted rapidly in the urine by glomerular filtration and decreases in cases of renal insufficiency causing a concurrent rise in serum and tissue levels.
INDICATIONS
Streptomycin is indicated for all forms of tuberculosis (in conjunction with other tuberculostatics).
Other infections caused by susceptible strains of microorganisms: Brucellosis, plague, Streptococcus viridans, Enterococcus faecalis in endocardial infections (in combination with penicillin), urinary tract infections, gonorrhoea. It is an effective treatment via the oral route in the treatment of diarrhoea and enteritis, as well as for the reduction of the intestinal flora prior to surgery.
POSOLOGY
Usually:
ADULTS: The recommended dose is 1 gr. daily, which can be administered in 2 divided doses every 12 hours.
CHILDREN: The recommended dose is 0,5 gr. daily, which can be administered in 2 divided doses every 12 hours.
In children the dosage can be adjusted at the rate of 20 to 40 mg. / kg. of body weight daily in 2 to 4 divided doses every 6 - 12 hours.
INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE MEDICATION
STREPTOMYCIN SULFATE is usually administered via intramuscular route.
Administration via intrathecal route may be indicated in the treatment of meningitis caused by sensitive bacteria. The daily dose is usually 25 mg. or 50 mg. on alternate days, not exceeding 1 mg. per kg. of body weight. The injected dose should be dissolved in 10 ml. of water for injection or the cerebrospinal fluid of the patient. In any case, the volume of spinal fluid withdrawn should be slightly higher that that of the injection and it should be done slowly.
Administered via the oral route, the contents of the bottle can be dissolved in natural water and administered in 2 to 3 divided doses.
CONTRAINDICATIONS
STREPTOMYCIN SULFATE is contraindicated in patients with a prior history of hypersensitivity or serious toxic reaction to streptomycin.
PRECAUTIONS
It is convenient that cochlear and vestibular function be supervised in patients on prolonged treatment.
It is recomemend that those who use this product take the necessary precautions so as to avoid possible cutaneous hypersensitivity reactions to streptomycin.
WARNINGS
Streptomycin is neurotoxic and may affect VIII cranial nerve (especially vestibular related) causing nausea, vomiting, vertigo and deafness. The incidence of these side effects, which is greater in elderly patients or patients with renal insufficiency, is proportional to the duration of the treatment and the total dosage administered.
In cases of renal insufficiency the dose should be reduced proportionally.
The neurotoxicity of streptomycin can result in respiratory paralysis from neuromuscular blockade, especially when the medication is administered concomitantly or immediately after the use of anesthesia or concomitantly with muscle relaxants.
PREGNANCY AND LACTATION
Since streptomycin readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. It is also excreted in small amounts in human breast milk.
INCOMPATIBILITIES
None known.
INTERACTIONS
The concurrent or sequential use of other neurotoxic or nephrotoxic medications with streptomycin, including neomycin, kanamycin, gentamicin, tobramycin, amikacin, netilmicin, cephalodrine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, etc. should be avoided. Streptomycin should not be administered concomitantly or immediately after the use of anesthesia or curare or muscle relaxants.
SIDE EFFECTS
Ototoxicity, paraesthesia of face, skin rash and other rare allergic manifestations which are generally benign.
OVERDOSE AND ITS TREATMENT
If otologic symptoms are manifested the treatment should be discontinued. Should allergic reactions occur the treatment should be discontinued and appropriate treatment should be instituted with antihistamines, corticosteroids or adrenaline, depending on its severity.
In the case of an overdose or accidental ingestion, contact your local poison control centre.
PRESENTATION
Pack containing 1 vial and 1 ampoule with water for injection.
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