Cyclomycin® Plus (Cyclomicin® plyus)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCycloserine + PyridoxineCycloserine + Pyridoxine
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    • Dosage form: & nbsp

    tablets, film-coated.

    Composition:1 tablet contains: active substances: Cycloserine (in terms of 100% substance) - mg, Pyridoxine hydrochloride (in terms of 100% substance) - 25.0 mg; Excipients: calcium hydrophosphate dihydrate 19.0 mg, pregelatinized starch 45.8 mg, copovidone 32.6 mg, silicon dioxide colloid (aerosil) 3.8 mg, calcium stearate 3.8 mg; composition of the shell: Copovidone 1.2 mg, giprolose (hydroxypropyl cellulose) 2.7 mg, Opadrai II 85F18422 - 16.1 mg: polyvinyl alcohol partially hydrolysed - 40.0%, macrogol-3350 - 20.2%, talc - 14.8%, titanium dioxide E 171 - 25.0%.
    Description:The tablets covered with a film membrane of white or almost white color, round, biconcave form.
    Pharmacotherapeutic group:Antibiotic.
    ATX: & nbsp

    J.04.A.B.01   Cycloserine

    A.11.H.A.02   Pyridoxine (vitamin B6)

    Pharmacodynamics:

    Combined drug.

    Cycloserin is a broad-spectrum bactericidal antibiotic that disrupts the synthesis of the cell wall, acting as a competitive antagonist of D-alanine, inhibits enzymes,responsible for the synthesis of the cell wall, Active against gram-negative microorganisms, in a concentration of 10-100 mg / l - Rickettsia spp., Treponema spp. The minimum inhibitory concentration (MPC) in relation to Mycobacterium tuberculosis is 3-25 mg / L on liquid and 10-20 mg / L and more - on a dense nutrient medium. Drug resistance appears slowly (after 6 months of treatment it develops in 20-60% of cases).

    Pyridoxine, which is part of the drug Cyclomycin Plus, reduces the severity of adverse reactions of cycloserine from the side of the central nervous system.

    Pharmacokinetics:

    Cycloserin is rapidly absorbed from the gastrointestinal tract (GIT) after ingestion, creating detectable levels in the blood plasma for one hour. Cycloserine freely distributed to the fluids and tissues of the body,

    Cycloserine penetrates the blood-brain barrier (BBB), levels in the cerebrospinal fluid are about the same as in plasma. In patients with tuberculosis cycloserine was found in sputum, as well as in pleural and ascitic fluids, bile, amniotic fluid and fetal blood, in breast milk, and tissues of the lungs of lymphoid tissue.

    Cycloserine is excreted in the urine, in which it is detected in half an hour after taking the dose. About 66% of the dose is found unchanged in the urine within 24 hours. 10% is displayed within the next 48 hours. Minor amounts are produced with feces. About 35% is metabolized, but metabolites have not been identified to date. The half-life of cycloserine fluctuates within 8-12 hours.

    Indications:

    In the combination therapy:

    • Tuberculosis: active pulmonary tuberculosis, extrapulmonary tuberculosis (including kidney damage) in case of sensitivity of microorganisms to the drug and after unsuccessful adequate treatment with essential drugs, chronic forms of tuberculosis.
    • Combination of tuberculosis with acute infections of the urinary tract caused by sensitive strains of gram-positive and gram-negative bacteria, especially Klebsiella spp., Enterobacter spp., Escherichia coli with ineffective essential drugs.
    • Atypical mycobacterial infections (including those caused by Mycobacterium avium), urinary tract infections.

    Contraindications:

    Hypersensitivity to the components that make up the drug, epilepsy,depression, marked state of arousal, psychosis, severe chronic renal failure (creatinine clearance less than 250 ml / min), acute and chronic heart failure, alcoholism, drug addiction, pregnancy, lactation.

    Carefully:

    During the treatment period, the level of cycloserine in the blood should be monitored (at concentrations above 30 mg / ml, toxicity is likely), hematologic parameters, kidney and liver function. To prevent symptoms of neurotoxicity (including tremors, seizures, conditions of excitement), it is possible to prescribe anticonvulsants or sedatives. Elderly patients are prescribed smaller doses on the background of impaired renal function. During the treatment should not drink alcohol.

    Childhood.

    Dosing and Administration:

    Inside, immediately before meals (with irritation of the gastrointestinal mucosa after eating), adults - 0.25 g every 12 hours for the first 12 hours, then if necessary taking into account the tolerability dose carefully increased to 0.25 g every 6 -8 hours under the control of the concentration of the drug in the blood serum. The maximum daily dose is 1 g.Patients older than 60 years, and also with a body weight of less than 50 kg - to 0.25 g 2 times a day.

    Children: the initial dose is from 0.01 g / kg 1-2 times a day. The daily dose is not more than 0.75 g / day.

    Side effects:

    Convulsions, drowsiness, headache, tremor, dysarthria, dizziness, confusion and disorientation accompanied by loss of memory; psychoses (including suicidal attempts); irritability, aggressiveness, peripheral paresis, hyperreflexia, paresthesia, large and small seizures of clonic convulsions, coma, allergic reactions (skin rash, itching), megaloblastic anemia, increased activity of "hepatic" aminotransferases, nausea, heartburn, diarrhea, especially in elderly patients with previous liver diseases; exacerbation of chronic heart failure (CHF) when applied at a dose of 1-1.5 g / day.

    Overdose:

    Overdose is observed at a plasma cycloserine concentration of 25-30 mg / ml - high doses, impaired renal clearance; Acute poisoning can occur if ingested more than 1 g / day.

    Symptoms of chronic intoxication with long-term admission in a dose of more than 0.5 g / day: headache, dizziness, confusion, increased irritability, paresthesia, psychosis, dysarthria, paresis, convulsions, coma.

    Treatment: symptomatic, Activated carbon, antiepileptic drugs. For the prevention of neurotoxic effects are introduced pyridoxine in a dose of 200-300 mg / day, preparations of benzodiazepine series (diazepam), nootropic drugs (piracetam, glutamic acid).

    Interaction:

    Reduces resistance to isoniazid, streptomycin and paraaminosalicylic acid (PASK).

    Enhances the neurotoxic effect of ethionamide. Ethanol increases the risk of seizures. Isoniazid increases the toxic effect of the drug on the central nervous system.

    Special instructions:

    Before the beginning of treatment it is necessary to determine the sensitivity of strains of microorganisms to cycloserine and other anti-tuberculosis drugs.

    During the treatment period, the level of cycloserine in the blood should be monitored (at concentrations above 30 mg / ml, toxicity is likely), hematologic parameters, kidney and liver function. In the treatment of patients with reduced renal function, taking a daily dose of more than 0.5 g, a weekly urine test should be monitored.

    In the case of development against the background of treatment of allergic dermatitis or symptoms of the central nervous system (convulsions, psychosis, drowsiness,confusion, hyperreflexia, headache, dizziness, tremor, peripheral paresis, dysarthria) drug treatment should be discontinued. Anticonvulsants or sedatives can be effective in preventing symptoms of central nervous system damage (including seizures, agitation, tremors).

    In some cases, the use of Cyclomycin Plus may lead to the development of insufficiency of cyanocobalamin and folic acid.

    Form release / dosage:

    Film-coated tablets.

    Packaging:

    10 tablets per contour cell packaging made of polyvinylchloride or polyvinyl chloride / polyvinylidene chloride film and aluminum foil printed lacquer;

    For 10 contour packagings together with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    AT protected from light at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001130/07
    Date of registration:09.06.2007
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.10.2015
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