Active substanceAcyclovirAcyclovir
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    One film-coated tablet contains:

    Active substance: Acyclovir 400 mg.

    Excipients:

    core tablet: povidone, sodium carboxymethyl starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

    tablet shell: Opadry Pink OY-24926 (composition: hypromelose, titanium dioxide, vacrogol, iron oxide red oxide, iron oxide yellow dye).

    Description:

    Elliptical tablets covered with a film sheath, pale pink with a risk on one side.

    Pharmacotherapeutic group:Antiviral agent
    ATX: & nbsp

    S.01.A.D   Antiviral drugs

    Pharmacodynamics:

    Acyclovir is an antiviral drug, a synthetic analogue of the acyclic purine nucleoside, which has a highly selective effect on herpes viruses. Inside virus-infected cells under the influence of viral thymidine kinase, a number of consecutive reactions of the transformation of acyclovir into mono-, di- and triphosphate of acyclovir occur. Acyclovir triphosphate is inserted into the chain with viral DNA and blocks its synthesis through competitive inhibition atand a DNA polymerase.

    In vitro Acyclovir is effective against herpes simplex virus - Herpes simplex type I and II, against the virus Varicella zoster; The higher concentrations are required for inhibition of the Epstein-Barr virus. In vivo Acyclovir is therapeutically and prophylactically effective, especially in viral infections caused by Herpes simplex.

    Pharmacokinetics:

    When administered orally, the bioavailability is 15-30%. Acyclovir well penetrates into all organs and tissues of the body, including the brain and skin. Binding to plasma proteins is 9-33% and does not depend on its concentration in the plasma. The concentration in the cerebrospinal fluid is about 50% of its concentration in the plasma. Acyclovir penetrates the placental barrier and accumulates in the breast milk. The maximum concentration after the administration of 200 mg 5 times a day - 0.7 mcg/ ml, the time to reach the maximum concentration is 1.5-2 hours.

    Metabolised in the liver to form a pharmacologically inactive compound 9-carboxymethoxymethylguanine. The half-life in adults with normal renal puncture is 2-3 hours. In patients with severe renal failure, the half-life is 20 hours, with hemodialysis - 5.7 hours (with the concentration of acyclovir in the plasma decreases to 60% of the initial value). About 84% is excreted by the kidneys unchanged and 14% - in the form of a metabolite. Aciclovir renal clearance is 75-80% of the total plasma clearance. Less than 2% of acyclovir is excreted from the body through the intestine.

    Indications:

    - Treatment of infections of the skin and mucous membranes caused by viruses Herpes simplex type I and II, both primary and secondary, including genital herpes.

    - Prevention of exacerbations of recurrent infections caused by viruses Herpes simplex type I and II, the patients with normal immune status.

    - Prevention of primary and recurrent infections caused by viruses Herpes simplex type I and II the of patients with immunodeficiency.

    - In the complex therapy of patients with severe immunodeficiency: in HIV infection (stage of AIDS, early clinical manifestations and a developed clinical picture) and in patients who underwent bone marrow transplantation.

    - Treatment of primary and recurrent infections caused by the virus Varicella zoster (chicken pox, as well as shingles - Herpes zoster).

    Contraindications:

    Hypersensitivity to acyclovir, ganciclovir, famciclovir, valaciclovir or any auxiliary substance of the drug.

    The drug is contraindicated during lactation.

    Children under 3 years (for this dosage form).

    Carefully:

    Dehydration, renal failure, neurological disorders, incl. in the anamnesis.

    Pregnancy and lactation:

    Use during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus. Acyclovir penetrates the placental barrier and accumulates in breast milk. If you need to take acyclovir during lactation, interruption of breastfeeding is required.

    Dosing and Administration:

    Inside.

    Treatment should be started as soon as possible, immediately after the appearance of the first symptoms of the disease.

    It is established individually depending on the severity of the disease.

    In the treatment of infections of the skin and mucous membranes caused by Herpes simplex type I and II adults and children over 3 years of age the drug is prescribed 200 mg 5 times a day for 5 days with 4 hour intervals during the day and with an 8-hour interval at night. In more severe cases, the course of treatment can be extended to the doctor's prescription. As part of complex therapy with severe immunodeficiency, including when the clinical picture of HIV infection (including, early clinical manifestations of HIV infection and stage of AIDS), after the implantation of the bone marrow is prescribed 400 mg 5 times a day.

    To prevent recurrence of infections caused by viruses Herpes simplex type I and II, patients with normal immune status and relapse of the disease are prescribed 200 mg 4 times a day every 6 hours.

    To prevent infections caused by viruses Herpes simplex type I and II, adults and children older than 3 years with immunodeficiency, the drug is recommended to appoint 200 mg 4 times a day every 6 hours, the maximum dose - up to 400 mg of acyclovir 5 times a day, depending on the severity of the infection.

    In the treatment of infections caused by Varicella zoster, adults are prescribed 800 mg 5 times a day every 4 hours in the afternoon and with an 8-hour interval at night. Duration of treatment 7-10 days. Children older than 3 years are prescribed 20 mg / kg 4 times a day for 5 days, children with a body weight of more than 40 kg, the drug is prescribed in the same dosage as adults.

    In the treatment of infections caused by Herpes zoster, adults are prescribed 800 mg 4 times a day every 6 hours for 5 days.

    In patients with impaired renal function:

    In the treatment and prevention of infections caused by Herpes simplex, in patients with creatinine clearance less than 10 ml / min, the dosage of the drug should be reduced to 200 mg twice a day with 12-hour intervals.

    In the treatment of infections caused by Varicella zoster, in patients with creatinine clearance less than 10 ml / min, it is recommended to reduce the dosage of the drug to 800 mg 2 times a day with 12-hour intervals; with a creatinine clearance of up to 25 ml / min, 800 mg 3 times a day with 8 hour intervals is prescribed.

    The drug is taken during or immediately after a meal and is washed down with a sufficient amount of water.

    Side effects:

    The drug is usually well tolerated.

    From the gastrointestinal tract: in isolated cases - abdominal pain, nausea, vomiting, diarrhea. Laboratory indicators: a slight increase in the activity of liver enzymes, rarely a slight increase in levels of urea and creatinine, 1| iperbilirubinemia, leukopenia, erythropenia.

    From the side of the central nervous system: rarely - headache, weakness; in some cases, tremors, dizziness, fatigue, drowsiness, confusion, hallucinations, paresthesia, agitation.

    Allergic reactions: anaphylactic reactions, skin allergic reactions (itching, Lyell's syndrome, urticaria, multiforme exudative erythema, including Stevens-Johnson syndrome), peripheral edema.


    Other:
    rarely - alopecia, fever, myalgia, impaired vision, lymphadenopathy.
    Overdose:

    Oral administration of 20 g of acyclovir did not lead to the development of specific symptoms. There may be side effects from the central nervous system - cramps, tremors, lethargy.

    In case of an overdose after ingestion, it is necessary to induce vomiting (best within 30 minutes after taking the drug) and take absorbents.

    In the case of acute renal failure and anuria: maintenance of vital functions, hemodialysis.

    Interaction:

    Simultaneous application with probenecid results in an increase in the mean half-life and a decrease in the clearance of acyclovir.

    With simultaneous admission with nephrotoxic drugs, the risk of renal dysfunction increases.

    An increase in the effect is noted with the simultaneous appointment of immunostimulants.

    Special instructions:

    Long-term or repeated treatment with acyclovir patients with reduced immunity can lead to the appearance of strains of viruses that are insensitive to its action. Use strictly according to the doctor's prescription in order to avoid complications in adults and children older than 3 years.

    Caution is prescribed for patients with impaired renal function, elderly patients due to an increase in the half-life of acyclovir.

    When using the drug, it is necessary to ensure the supply of a sufficient amount of liquid.

    When taking the drug should monitor the function of the kidneys (the level of blood urea and blood plasma creatinine).

    Acyclovir does not prevent sexual transmission of herpes, therefore during treatment it is necessary to abstain from sexual intercourse, even in the absence of clinical manifestations.

    Form release / dosage:Film coated tablets 400 mg.
    Packaging:For 7 tablets coated with a film sheath in PVC / Al blister. One, two, three or five blisters together with the instructions for use are placed in a cardboard box.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003653/07
    Date of registration:07.11.2007 / 21.06.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp22.09.2017
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