for medical use
of ACYCLOVIR medicine
the Trade name
the International unlicensed
name Acyclovir Dosage Form 5% Ointment Structure on one tuba, in grams
active agent: acyclovir of 0.250 g,
excipients: chicken oil (a component lipidic bird’s fat, LIPOKOMP-S), emulsifier No. 1 – 0.004 g, a macrogoal 400 (polyethylene oxide-400, polyethyleneglycol-400), propylene glycol of 0.500 g, methylparahydroxybenzoate (nipagin, methylparaben) – 0.004 g, propilparagidroksibenzoat (nipazol, propylparaben) – 0.001 g, the water purified up to 5.000 g.
Ointment of color, white or white with yellowish shade.
Antibacterial drugs and antimicrobial drugs for treatment of diseases of skin. Antimicrobial drugs for topical administration.
Antiviral drugs. Acyclovir
the Code of automatic telephone exchange D06BB03
Pharmacokinetics At properties use of ointment on intact skin: the minimum absorption, is not defined in blood and urine. The affected skin: moderate absorption, at patients with normal function of kidneys the concentration in blood serum makes up to 0.28 mkg/ml, at patients with chronic kidney disease – up to 0.78 mkg/ml. It is removed by kidneys (up to 9.4% of a daily dose).
Antiviral (anti-herpetic) means for external use – a synthetic analog of a nucleoside of the thymidine which is the DNA natural component. In the infected cells containing a virus thymidinekinase there is a phosphorylation and transformation in acyclovir monophosphate. Under the influence of acyclovir guanylate cyclase, monophosphate will be transformed to diphosphate and under the influence of several cellular enzymes – to triphosphate. The sharp selectivity of action and hypotoxicity for the person are caused by lack of necessary enzyme for formation of acyclovir of triphosphate in intact cells of a macroorganism.
Acyclovir triphosphate inhibits synthesis (replication) of DNA of a virus three mechanisms:
1) competitively substitutes deoksiguanozin triphosphate in DNA synthesis,
2) it is built in a synthesizable chain of DNA and stops its lengthening,
3) enzyme a DNA polymerase of viruses oppresses.
Reproduction of a virus in an organism is as a result broken.
The specificity and very high selectivity of action are also caused by its primary accumulation in the cells affected with a herpes virus. It is highly active concerning the Herpes simplex 1 and 2 viruses of type, the virus causing chicken pox and shingles (Varicella zoster), Epstein-Barre’s virus (types of viruses are specified in ascending order of the size of the minimum overwhelming concentration of acyclovir). It is moderately active concerning a cytomegalovirus. In herpes prevents formation of new elements of rash, reduces the probability of skin dissimination and visceral complications, accelerates formation of crusts, reduces pain in a sharp phase of the surrounding herpes. Has immunopromoting effect.
– a skin herpes simplex
– genital herpes (primary and recurrent)
– the localized shingles (auxiliary treatment)
– chicken pox
the Route of administration and doses
Ointment is applied on affected areas of 5-6 times a day (as soon as possible after the beginning of an infection) at regular intervals.
It is important to begin treatment of a recurrent infection during a prodromal phase or at the very beginning of manifestation of an infection.
Therapy should be continued till that time while on bubbles the crust is not formed or until they completely begin to live.
Duration of treatment is not less than 5 days, at most 10 days.
– burning in the site of application
– a vulvitis
allergic reactions: sometimes – an itching, seldom skin rash
of the Contraindication
– hypersensitivity to acyclovir or a valatsiklovir or any other component of drug.
Use together with immunostimulators enhances effect of acyclovir.
With care: Ointment of acyclovir is effective for prevention of a recurrence of herpes of lips. The efficiency of treatment by that will be higher, than earlier it is begun (at the first symptoms of an infection).
To avoid drawing on mucous membranes (especially a mouth and a nose) and also hits in eyes. For use in ophthalmology there is other dosage form of acyclovir.
Not to wash and not to bathe right after putting drug.
For implementation of medical effect of acyclovir the condition
of the immune system of an organism matters. Patients with reduced immunity (in HIV/AIDS or after bone marrow transplantation) against the background of topical administration of ointment of acyclovir should appoint system administration of drug, just as in case of a heavy and recurrent course of a herpes infection. The strip of ointment of 1.25 cm should be applied on 25 sq. cm of the affected skin.
For prevention of autoinoculation on other sites of skin it is necessary to use fingerstalls or rubber gloves.
Acyclovir does not prevent transfer of herpes sexually therefore during treatment it is necessary to abstain from sexual contacts, even in the absence of clinical manifestations.
Pregnancy and a lactation
Use of drug at pregnancy is possible only when the expected advantage for mother exceeds potential risk for a fruit. At receipt in a system blood stream of mother acyclovir gets into breast milk, but amount of drug which the child at ointment use can receive, extremely slightly.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Are not described.
To apply on doctor’s orders.
Now about drug Acyclovir overdose cases ointment for external use it was not reported.
Form of release and packing
Ointment of 5%. On 5 g in tubas aluminum. Each tuba with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions at a temperature from 8 With up to 15 C.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
JSC Sintez producer 640008, Russian Federation, Kurgan, Konstitutsii Avenue, 7