Active substanceStreptomycinStreptomycin
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  • Streptomycin
    powder w / m 
  • Streptomycin
    powder w / m 
    BIOCHEMIST, OJSC     Russia
  • Streptomycin
    powder w / m 
    SYNTHESIS, OJSC     Russia
  • Dosage form: & nbspPowder for solution for intramuscular injection
    Composition:
    Streptomycin sulfate
    in terms of streptomycin 0.5 g 1.0 g
    Solvent (if included): one polyethylene cartridge contains 2 ml or 5 ml of solvent - water for injection.

    Description:
    Preparation: white or almost white crystalline powder, hygroscopic. Solvent: water for injections (if included): colorless transparent liquid, odorless.

    Pharmacotherapeutic group:Antibiotic. Aminoglycoside
    ATX: & nbsp

    J.01.G.A   Streptomycins

    J.01.G.A.01   Streptomycin

    Pharmacodynamics:
    A broad-spectrum antibiotic from the aminoglycoside group. It is formed in the process of vital activity of radiant fungi of Streptomyces globisporus or other species of Streptomyces spp. At low concentrations, bacteriostatic action: penetrating into the microbial cell, binds to specific receptor proteins on the 30S subunit of the ribosome, disrupting the formation of the initiating complex - the matrix P1IK-30S subunit of the ribosome, which leads to the decay of the polyribosomes, and as a result - defects when reading information with DNA, defective proteins are synthesized, which leads to a halt in the growth and development of the microbial cell. AT
    higher concentrations have a bactericidal effect (damages the cytoplasmic membrane, causing death of the microbial cell).
    Has a wide range of action. It is active against Mycobacterium tuberculosis, the majority of gram-negative bacteria (Escherichia coli, Salmonella spp., Shigella spp., Yersinia spp. Klebsiella spp., Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Neisseria meningitidis, Brucella spp., Francisella tularensis., Yersinia pestis , Calymmatobacterium granulomatis (donovanosis, granuloma inguinale), Proteus spp.), some gramnolozhntelnyh microorganisms (Staphylococcus spp.), moderately active against Streptococcus spp., including Streptococcus pneumoniae, Enterococcus spp. Stable in slightly acidic environment, but easily destroyed in solutions of strong acids and alkalis with heating. Secondary resistance (stability) of bacteria develops rapidly.
    In combination with penicillin or vancomycin is effective in the treatment of endocarditis caused by Enterococcus faecalis or Streptococcus viridans.
    Streptomycin is not active against anaerobic bacteria, the family. Spirochaetactaceac, Rickettsia spp., Pseudomonas aeruginosa.

    Pharmacokinetics:
    With intramuscular injection (in / m) quickly and completely absorbed. The time to reach the maximum concentration in the blood is about 0.5-1.5 hours. The maximum concentration in the blood after the / m administration of 1 g is approximately 25-50 μg / ml. Communication with plasma proteins is less than 10%. Distributed in all tissues of the body (except brain tissue), incl. in extracellular fluid, fluid abscesses, pleural effusion, in ascitic, pericardial, synovial, lymphatic and peritoneal fluids.High concentrations are created in the kidneys, liver, lungs; low - in bone and adipose tissue. The volume of distribution in adults is about 0.26 l / kg, in children about 0.2-0.4 l / kt, in newborns less than 1 week old and weighing less than 1500 g - up to about 0.68 l / kg, in age less than 1 week and body weight over 1500 g - up to about 0.58 l / kg, in cystic fibrosis patients approximately 0.3-0.39 l / kg. It does not penetrate the intact blood-brain barrier. Penetrates through the placenta and into breast milk. Metabolism is not affected. The half-life in adults is about 2-4 hours, in newborns about 5-8 hours, in older children - about 2.5-4 hours. The final half-life is more than 100 hours (release from the intracellular depot). In patients with renal insufficiency, the half-life period varies depending on the degree of insufficiency up to 100 hours, in patients with cystic fibrosis about 1-2 hours, in patients with burns and hyperthermia may be shorter compared with the average values ​​due to elevated clearance. It is excreted by the kidneys (95%) unchanged.

    Indications:
    Tuberculosis of different localization, incl. tuberculous meningitis (as part of combination therapy); venereal granuloma; tularemia, brucellosis,plague; bacterial endocarditis (only in combination with benzylpenicillip or vancomycosis); acute bacterial intestinal infections, urinary tract infections (after the sensitivity of the pathogen).

    Contraindications:
    Hypersensitivity to streptomycin (including other aminoglycosides in the anamnesis), severe chronic renal failure with azotemia and uremia, organic lesions of the VIII pair of cranial nerves, pregnancy.

    Carefully:Myasthenia gravis, parkinsonism, botulism (aminoglycosides can cause a violation of the neuromuscular transmission, which leads to further weakening of the skeletal muscles), obliterating endarterin, heart failure II-III, chronic renal failure (creatinine clearance from 40 to 60 ml / min), dehydration, cerebral circulation disorder, tendency to bleeding, hearing disorders, elderly and children's age, lactation period (breastfeeding).
    Pregnancy and lactation:
    In pregnancy streptomycin contraindicated, because it penetrates through
    placental barrier and can exert nephrotoxic and ototoxic effects on the human fetus.
    In the period of lactation (thoracic feeding) apply with caution
    (streptomycin penetrates into breast milk in low concentrations, is poorly absorbed from the gastrointestinal tract, but since infants may have severe adverse reactions, breastfeeding should be stopped if streptomycin is needed during lactation).

    Dosing and Administration:
    Intramuscularly.
    The contents of the vial are dissolved in sterile water for injections in 2 ml or 4 ml
    solvent per 0.5 g or 1 g streptomycin respectively. The solution is prepared
    immediately before the introduction.
    Adults: single dose for intramuscular injection - 0.5-1 g, daily - 1-2 g. The maximum daily dose of streptomycin for an adult is 2 g. With poor tolerability, patients with a body weight of less than 50 kg, as well as those over 60 years of age, a daily dose 750 mg.
    Children: in the age up to 3 months - in a dose of 10 mg / kg / day, at the age of 3 to 6 months - 15 mg / kg / day, from 6 months to 2 beds - 20 mg / kg / day. for children under 13 years and adolescents - 15-20 mg / kg / day, but not more than 500 mg / day - for children under 13 years and 1 g / day for adolescents. Maximum doses of streptomycin for children of different ages:
    3-4 years - single 150 mg, daily - 300 mg;
    5-6 years - single - 175 mg, daily - 350 mg;
    7-9 years - single - 200 mg, daily - 400 mg;
    9-14 le g - single dose - 250 mg, daily - 500 mg;
    over 14 years - single 500 mg, daily - 1 g.
    Tuberculosis of the lungs and other organs - a daily dose of 15 mg / kt (but not more than 1 g) is administered once a day, with poor tolerance - in 2 divided doses; duration of treatment 3 months or more (in parallel with the administration of other antituberculous drugs).
    Bacterial endocarditis:
    Streptococcal ethnology (caused by Streptococcus spp., sensitive to penicillin) - streptomycin is administered in combination with benzylpeicillin for 2 weeks: in the first week - 1 g 2 times a day; during the second week - 500 mg 2 times a day; patients older than 60 years - 500 mg twice a day for 2 weeks; etiroscoccal etiology - streptomycin is administered in combination with benzylpeicillin for 6 weeks: in the first 2 weeks - 1 g 2 times a day; for the next four weeks - 500 mg twice a day (the duration of treatment can be reduced in cases of ototoxicity).
    Tularemia - 0.5-1 g 2 times a day for 7-14 days until the 5th-7th day of absence of febrile temperature.
    Plague, brucellosis - 1 g 2 times a day for at least 7-10 days.
    With a venereal granuloma, acute bacterial intestinal infections and urinary tract infections - the daily dose is divided into 2-4 injections, the duration of the course - at least 10 days (should not exceed 14 days).
    With renal failure, the daily dose of streptomycin should be reduced. When creatinine is cleared from 50 to 60 ml / min, the dose of ns should exceed 500 mg / day; when creatinine clearance is from 40 to 50 ml / min - no more than 400 mg / day.
    For patients with arterial hypertension and ischemic heart disease, the initial dose is 250 mg / day, with good tolerability, the dose is increased.

    Side effects:
    The risks of toxicity increase in direct proportion to the increase in the duration of therapy with streptom and chin.
    On the part of the digestive system: nausea, vomiting, diarrhea, impaired liver function (increased activity of hepatic enzymes - alanine aminotransferase (ALT), aspartate aminotransferase (ACT), hyperbirubirubinemia).
    From the side of the nervous system: headache, drowsiness, weakness, peripheral neuritis, facial nerve neuritis (burning sensation in the face or mouth, numbness, tingling), rarely - neuromuscular blockade with simultaneous administration with muscle relaxants (difficulty breathing, nocturnal apnea, stopping respiration), neurotoxic action (twitching of muscles, paresthesia,epileptic seizures, arachnoiditis, encephalopathy).
    From the senses: ototoxicity (hearing loss, ringing, buzzing or feeling "stuffed" in the ears, hearing loss down to irreversible deafness), vestibular and labyrinthine disorders (discoordination, dizziness, nausea, vomiting, imbalance), amblyopia.
    From the urinary system: iefrotoxicity (significant increase or decrease in frequency of urination, oliguria, polyuria, thirst, anorexia, nausea, vomiting).
    On the part of the hematopoiesis system: leukopenia, thrombocytopenia, nantzitopepeia, hemolytic anemia.
    Allergic reactions: itching. hyperemia of the skin, rash, fever, angioedema, anaphylactic shock.
    Local reactions: hyperemia and pain at the injection site.
    From the skin and soft tissues: exfoliative dermatitis.
    On the part of laboratory indicators: azotemia, eosinophilia.
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:
    Symptoms: toxic reactions (hearing loss, ataxia, dizziness, urination disorders, thirst,anorexia, nausea, vomiting, ringing or feeling in the ears, disturbed breathing until it stops).
    Treatment: to remove the blockade of the neuromuscular transmission and its consequences - hemodialysis or peritoneal dialysis, anti-cholinesterase drugs, calcium salts, artificial ventilation, other symptomatic and supportive therapy.
    Interaction:
    It is inadmissible to mix in one syringe with antibiotics of the penicillin series and cephaloenorins.
    When used simultaneously with other non-fluoro- and ototoxic drugs (including other aminoglycosides, polymyxia, capreomycin), the risk of oto and nephrotoxic action increases.
    Reduces the effectiveness of antimiasthenic drugs.
    Intravenous administration of indomethacin reduces the renal clearance of streptomycin, increasing the concentration in the blood and increasing the half-lead period.
    It exhibits synergism (increased action) with concomitant administration with beta-lactam antibiotics (penicillins and cephaloenorins).
    Methoxyflurane increases the risk of side effects of streptomycin. Preparations for inhalation anesthesia (halogenated hydrocarbons), opioid analgesics,transfusion of large amounts of blood with nitrate preservatives as anticoagulants, other drugs that block neuromuscular transmission when used with streptomycin, enhance neuromuscular blockade.

    Special instructions:
    Streptomycin can mask the manifestations of syphilis, and therefore, with the possibility of a mixed infection, you need a monthly serological analysis for 4 months.
    Dysfunction of the sensory organs:
    During the treatment period, it is necessary to control the function of the auditory nerve and vestibular apparatus at least once a week. When unsatisfactory audiometric tests, the dose of the drug is reduced or discontinued.
    Violation of the functions of the nights:
    The likelihood of developing nephrotoxicity is higher in patients with impaired renal function, as well as in the administration of high doses or for a long time (in this category of patients, daily monitoring of the function of the nights may be required).
    During the treatment period, it is necessary to monitor kidney function at least once a week. Violation of the functions of the intestinal tract:
    Streptomycin changes the normal flora of the intestine with an increase in the growth of Clostridium difficile,In this connection, long-term diarrhea, abdominal pain, fever, intoxication (weakness, weakness, nausea, vomiting), leukocytosis (an increase in the number of leukocytes in the blood) may appear in different degrees of severity. The described symptoms can develop in patients receiving streptomycin, but can develop
    after 1-2 weeks after discontinuation of the drug. Do not use drugs that inhibit the intestinal motility.
    Children:
    Children up to 1 year old streptomycin appoint only for "vital" indications. Resistance:
    In the absence of positive clinical dynamics, therapy should be stopped. It should be remembered about the possibility of the development of resistant microorganisms. In such cases, treatment should be discontinued and appropriate therapy initiated.

    Effect on the ability to drive transp. cf. and fur:
    Influence on ability to drive vehicles, mechanisms:
    During treatment, care should be taken when managing vehicles, mechanisms and other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Powder for solution for intramuscular injection 0.5 g and 1.0 g. Bottles / complete with a solvent - water for injection (polyethylene ampoules) 2 ml, 5 ml.
    Primary packaging.
    For 0.5 g or 1.0 g of the drug in glass bottles with a capacity of 10 ml, hermetically sealed with rubber stoppers, crimped aluminum caps with safety plastic caps.
    The label is labeled with label paper, or written paper, or from polymer materials, self-adhesive.
    1 bottle with the drug and 1 ampoule with solvent water for injection is placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.
    Secondary packaging.
    On 1 contour acheikova packing together with the instruction but to application place in a pack from a cardboard. The packets are placed in a group package.
    1 bottle with the drug, together with the instruction for use, is placed in a pack of cardboard. The eggs are placed in a group package.
    By 5. 10, 25, 50 or 100 vials with the drug and with an equal number of instructions in a box of cardboard (for hospitals). Packs of cardboard are placed in a group package.

    Packaging:

    Primary packaging.
    For 0.5 g or 1.0 g of the drug in glass bottles with a capacity of 10 ml, hermetically sealed with rubber stoppers, crimped aluminum caps with safety plastic caps.
    The label is labeled with label paper, or written paper, or from polymer materials, self-adhesive.
    1 bottle with the drug and 1 ampoule with solvent water for injection is placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.
    Secondary packaging.
    On 1 contour acheikova packing together with the instruction but to application place in a pack from a cardboard. The packets are placed in a group package.
    1 bottle with the drug, together with the instruction for use, is placed in a pack of cardboard. The eggs are placed in a group package.
    By 5. 10, 25, 50 or 100 vials with the drug and with an equal number of instructions in a box of cardboard (for hospitals). Packs of cardboard are placed in a group package.

    Storage conditions:
    In the original packaging of the manufacturer, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:
    3 years. Use Hs after the expiration date printed on the package. Solvent (if included): 4 years.Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003032
    Date of registration:15.06.2015
    The owner of the registration certificate:FARMASINTEZ, JSC (Irkutsk) FARMASINTEZ, JSC (Irkutsk) Russia
    Manufacturer: & nbsp
    Representation: & nbspFARMSINTEZ, PAO FARMSINTEZ, PAO Russia
    Information update date: & nbsp20.08.2015
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