Active substanceAcyclovirAcyclovir
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  • Dosage form: & nbspointment eye
    Composition:

    Active substance: acyclovir (micronized) 3,0 g.

    Excipient: white petrolatum up to 100.0 g.

    Description:

    Soft, homogeneous, white or almost white, translucent, oily mass with a weak characteristic odor, which does not contain grains, lumps and foreign particles.

    Pharmacotherapeutic group:Antiviral for topical use
    ATX: & nbsp

    S.01.A.D   Antiviral drugs

    Pharmacodynamics:

    Acyclovir is an antiviral drug that is highly effective against herpes simplex virus (HSV) type 1 and type 2 and varicella zoster virus, and its toxicity to mammalian cells is very low.

    After entering the virus-infected cells acyclovir phosphorylated to the active substance of acyclovir triphosphate with viral thymidine kinase. Acyclovir triphosphate acts as a nonspecific inhibitor and substrate for viral DNA polymerase and prevents the synthesis of viral DNA without damaging the host cells.
    Pharmacokinetics:

    Acyclovir is rapidly absorbed by the epithelium of the cornea and by eye-like tissues, as a result of which the concentration of the drug necessary for suppressing the virus is created in the intraocular fluid. Currently, there are no methods for determining acyclovir in the blood with external application of ophthalmic ointment Zovirax. Acyclovir with external application is determined only in urine, and in a small amount. This concentration has no therapeutic significance.

    Indications:

    Treatment of keratitis caused by the herpes simplex virus (HSV).

    Contraindications:

    Hypersensitivity to acyclovir or valacyclovir.

    Pregnancy and lactation:

    Fertility

    Information about the effect of Zovirax, tablets or Zovirax preparation, lyophilizate for the preparation of a solution for infusions on female fertility is absent. In a study involving 20 male patients with a normal number of spermatozoa, it was demonstrated that ingestion acyclovir in doses up to 1 g per day up to 6 months does not have a clinically significant effect on the number of spermatozoa, their mobility or morphology.

    Pregnancy

    In the post-registration period with use of acyclovir in any dosage form by women during pregnancy there was no increase in the number of congenital malformations in children compared with the general population; while the identified congenital malformations were not characterized by uniformity or patterns indicating a common cause of their occurrence. In systemic use of acyclovir, embryotoxic or teratogenic effects in rabbits, rats, or mice have not been identified in internationally accepted standardized tests.

    In non-standard test on rats with subcutaneous administration of the drug in high doses, which exert a toxic effect on the female organism,observed malformations of the fetus. The clinical significance of these results is unknown.

    The use of the drug during pregnancy is possible if the potential benefit to the mother exceeds the probability of the unknown risk for the fetus.

    Breastfeeding period

    Limited clinical data show, that the drug is found in breast milk at the system application, however, the quantity the drug that the baby will receive when breastfeeding, will be negligible.

    Dosing and Administration:

    Adults and children

    A strip of ointment 10 mm long should be placed in the lower conjunctival sac 5 times a day at intervals of about 4 hours. Treatment should continue for 3 more days after healing.

    Side effects:

    The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1 000 and <1/100), rarely (> 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Categories of frequency were formed on the basis of clinical studies of Zovirax, ointment ointment.

    Due to the nature of the observed undesirable phenomena it is impossible to unequivocally determine which phenomena are caused by the use of the drug, and which ones are caused by the disease itself. The basis for determining the frequency of such phenomena in the post-marketing period is data from spontaneous messages.

    Table 1. Frequency of occurrence of undesirable reactions

    Immune system disorders

    Very rare reactions: immediate type hypersensitivity, including angioedema.

    Disturbances on the part of the organ of sight

    Very often: spot superficial keratopathy, which does not require cessation of treatment and disappears without consequences. Often: a transient, mild burning sensation immediately after application of the ointment; conjunctivitis. Rarely: blepharitis.

    Overdose:

    If you accidentally swallow the full contents of the tube with Zovirax, ophthalmic ointment in an amount of 135 g, no undesirable reactions are expected.

    Interaction:

    Clinically significant interactions were not detected.

    Special instructions:

    Patients should be informed about the possible appearance of an easy transient sensation of burning immediately after application of the drug.

    Do not wear contact lenses during the treatment.

    The drug Zovirax ophthalmic ointment should be used within 1 month after opening the tube.

    Effect on the ability to drive transp. cf. and fur:

    No data.

    Form release / dosage:Eye ointment 3%.
    Packaging:

    4.5 grams per tube of polyolefin / aluminum / polyolefin laminate with a polyethylene nozzle and a screw cap. One tube with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At temperatures below 25 ° C, out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015101 / 01
    Date of registration:29.12.2008
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO
    Information update date: & nbsp22.09.2014
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