Kirin (Kirin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSpectinomycinSpectinomycin
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  • Kirin
    powder w / m 
    Medocemi Co., Ltd.     Cyprus
    • Dosage form: & nbspPowder for suspension for intramuscular administration
    Composition:Each vial contains: active substance - Spectinomycin 2 g in the form of spectinomycin dihydrochloride pentahydrate.
    Description:Powder from white to almost white.
    Pharmacotherapeutic group:Antibiotic - tricyclic
    ATX: & nbsp

    J.01.X.X   Other antibacterial drugs

    J.01.X.X.04   Spectinomycin

    Pharmacodynamics:

    Kirin (spectinomycin) is an antibiotic of a tricyclic structure from the group of aminocyclotols. Has a bacteriostatic effect. The mechanism of action is the inhibition of the synthesis of cellular proteins in bacteria by binding to the 30S subunit of bacterial ribosomes, resulting in impaired osmotic stability and lysis of microbial cells.

    Kirin is active against most strains of the gonococcus (the minimum suppressive MIC concentration is 7.5-20 μg / ml), including penicillinase-producing, as well as some other gram-negative microorganisms. Treponema and chlamydia do not work. Cross-resistance to penicillin is absent. Sometimes it is possible endemic resistance gonococci to the drug. It is effective in the treatment of gonorrhea in 95% of cases.

    Pharmacokinetics:

    Kirin is rapidly absorbed by intramuscular injection. In a single dose of 2 g peak of serum concentration (about 100 μg / ml) is achieved within an hour. The serum concentration inhibiting the majority of gonorrhea strains persists for 8 hours and is about 15 μg / ml. Spectinomycin practically does not bind to proteins. Biotransformation is not exposed. 70-100% of the dose is excreted in biologically active form with urine within 24-48 hours. The half-elution period is 1.7-2 hours, it increases with renal impairment, which is not clinically important for a single use.

    Irradiation of microorganisms is estimated by the absence of growth of cultures after 96 hours.

    Indications:
    Kirin is indicated for the treatment of urogenital gonorrhea in men and women.

    Contraindications:
    Hypersensitivity to spectinomycin; children's age up to 3 years.
    Pregnancy and lactation:

    There were no controlled studies in pregnant women. At the standard dosage for adults spectinomycin has been successfully used to treat gonorrhea in pregnant women, especially with allergies to penicillins or the resistance of the pathogen.Kirin should be used during pregnancy in those cases when the potential benefit for a woman exceeds the possible harm to the fetus.

    There is insufficient data on the use of the drug in nursing mothers. For the duration of Kirin's treatment, breast-feeding should be stopped.

    Dosing and Administration:

    To prepare the suspension, add 3.2 ml of water for injection with benzyl alcohol 0.9% to the contents of the vial. Mix immediately. Each vial yields 5 ml of a suspension containing 400 mg / ml of spectinomycin. The suspension should be used immediately after preparation, the unspent suspension is not subject to storage. A needle with a diameter of 0.8 mm and a length of 40 mm is used to introduce the suspension.

    Adults: One dose of 2 g (5 ml) for deep intramuscular injection. The injection should be done deep in the upper outer quadrant of the gluteus muscle. The dose can be divided into two injections. In severe cases, the dose can be increased to 4 g (10 ml).

    Elderly patients. In a usual dose for adults. There are no facts that suggest a worse tolerability of the drug in elderly patients.

    Children: children older than 3 years with a body weight of up to 45 kg, the drug is administered at a dose of 40 mg / kg body weight and children with a body weight of more than 45 kg - 2.0 g IM once.

    Side effects:

    Usually Kirin is well tolerated.

    Possible:

    Allergic reactions: occasionally itchy erythematous spotted rash, hives, fever, chills, very rarely - anaphylactic shock.

    From the central nervous system: rarely dizziness, insomnia.

    From the digestive system: nausea.

    From the side of the liver: very rarely hepatotoxicity, cholestatic jaundice.

    From the side of the kidneys: in some cases - a decrease in diuresis, hematuria.

    Irritant effect on the tissue: compaction and tenderness at the injection site (less than 1% of patients).

    Other: occasionally there is a decrease in the clearance of creatinine, hematocrit, hemoglobin, increased activity of alkaline phosphatase, urea and gamma-glutamyl transferase in the blood serum.

    Interaction:
    Spectinomycin reduces the excretion of lithium, which requires a reduction in the dose of lithium preparations.
    Special instructions:

    In patients with depressed renal function, the excretion time is significantly increased. With a one-time treatment regimen, this is not considered a contraindication, but use should be limited to cases where other treatments are ineffective.

    Kirin should not be prescribed 24 hours before the dialysis session,since the effectiveness of the drug can be reduced by reducing the concentration of the drug in the serum. Dialysis results in a 50% reduction in the level of spectinomycin in plasma.

    Treatment of gonorrhea with antibiotics in high doses can mask the incubation period of syphilis. Therefore, patients undergoing anti-gonorrhea therapy should be observed for 4-6 weeks. If there is a suspicion of syphilis, serological testing should be conducted for at least 4 months.

    Newborns and children under 3 years old. Do not administer the preparation, prepared on the basis of the applied solvent - water for injections with gasoline alcohol, in view of the fact that benzyl alcohol can cause neurological and other complications.

    Form release / dosage:

    Powder for suspension for intramuscular injection.

    Packaging:

    By 2.0 g of spectinomycin in a glass bottle (type II), sealed with a rubber stopper, rolled up with an aluminum cap.

    3.2 ml of solvent - water for injection with benzene alcohol 0.9% in a sealed glass ampoule (I type) of dark color with a fault strip on the neck of the ampoule.

    1 bottle with the drug and 1 ampoule with the solvent in a closed loop cell pack of IIBX and transparent polyethylene film.

    1 circuit cell pack together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    List B.

    Store at a temperature of 15 ° C - 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012833 / 01
    Date of registration:17.10.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:Medocemi Co., Ltd.Medocemi Co., Ltd. Cyprus
    Manufacturer: & nbsp
    Representation: & nbspMEDOKEMI LTD. MEDOKEMI LTD. Cyprus
    Information update date: & nbsp08.01.2018
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