Universal reference book for medicines
Product name: PROVIRSAN В® (PROVIRSAN В® )

Active substance: aciclovir

Type: Antiviral drug

Manufacturer: PRO.MED.CS Praha (Czech Republic)
Composition, form of production and packaging
Tablets are
white, round, flat, with a notch on one side.

1 tab.

Acyclovir 200 mg

Excipients: lactose monohydrate, microcrystalline cellulose, carboxymethylamilopectin sodium, magnesium stearate, copovidone, polysorbate 80.

10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Antiviral drug, a synthetic analogue of 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.Acyclovirtriphosphate is inserted into the viral DNA chain and blocks its synthesis by competitive inhibition of the viral DNA polymerase. In vitro, acyclovir is effective against herpes simplex virus - Herpes simplex type 1 and 2I, against the virus Varicella zoster; higher concentrations are required to inhibit 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 penetrates well 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 spinal fluid is about 50% of its concentration in the plasma.Acyclovir penetrates the placental barrier and accumulates in breast milk. With MAX after administration inward 200 mg 5 times / day - 0.7 Ојg / ml, T max - 1.5-2 hours Metabolized in the liver to form a pharmacologically inactive compound 9-carboxymethoxymethylguanine. T 1/2 in adults with normal renal function is 2-3 hours.
In patients with severe renal insufficiency T 1/2 - 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 Herpes simplex type 1 and 2 viruses, both primary and secondary, including genital herpes;

- prevention of exacerbations of recurrent infections caused by Herpes simplex type 1 and 2 viruses in patients with normal immune status;

- prevention of primary and recurrent infections caused by Herpes simplex type 1 and 2 viruses in immunocompromised patients;

- in the complex therapy of patients with severe immunodeficiency: in HIV infection (stage 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 Varicella zoster virus (chicken pox, and herpes zoster, herpes zoster).

DOSING MODE

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 1 and 2, adults and children over 2 years of age, the drug is prescribed 200 mg 5 times a day for 5 days at intervals of 4 hours during the day and at intervals of 8 hours per night.
In more severe cases, the course of treatment can be extended to the doctor's prescription. As part of complex therapy for severe immunodeficiency, incl. with a developed clinical picture of HIV infection (including, early clinical manifestations of HIV infection and AIDS stage), after the bone marrow implantation , 400 mg 5 times a day are prescribed.
To prevent the recurrence of infections caused by Herpes simplex type 1 and 2 viruses , patients with normal immune status and recurrent disease are prescribed 200 mg 4 times / day every 6 hours.

To prevent infections caused by Herpes simplex type 1 and 2 viruses , adults and children older than 2 years with immunodeficiency, the drug should be prescribed 200 mg 4 times / day every 6 hours, the maximum dose to 400 mg of acyclovir 5 times a day in 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 at intervals of 4 hours during the day and an interval of 8 hours at night.
Duration of treatment 7-10 days. Children older than 2 years are prescribed 20 mg / kg 4 times / 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 / day every 6 hours for 5 days.

In patients with impaired renal function : in the treatment and prevention of infections 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 2 times / day at intervals of 12 hours.

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 / day at intervals of 12 hours ;
with the clearance of creatinine up to 25 ml / min is prescribed 800 mg 3 times / day at intervals of 8 hours.
The drug is taken during or immediately after a meal and is washed down with a sufficient amount of water.

SIDE EFFECT

The drug is usually well tolerated.

From the digestive system: in isolated cases - abdominal pain, nausea, vomiting, diarrhea, a transient slight increase in the activity of liver enzymes.

On the part of laboratory indicators: rarely - a small increase in levels of urea and creatinine, hyperbilirubinemia, leukopenia, erythropenia.

From the side of the central nervous system: rarely - headache, weakness;
in some cases - tremor, dizziness, fatigue, drowsiness, hallucinations.
Allergic reactions: skin rash.

Other: rarely - alopecia, fever.

CONTRAINDICATIONS

- lactation period;

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

With caution - dehydration, renal failure, neurological disorders, incl.
in the anamnesis.
PREGNANCY AND LACTATION

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

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function : in the treatment and prevention of infections 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 2 times / day at intervals of 12 hours.

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 / day at intervals of 12 hours ;
with the clearance of creatinine up to 25 ml / min is prescribed 800 mg 3 times / day at intervals of 8 hours.
APPLICATION FOR CHILDREN

To prevent infections caused by Herpes simplex type 1 and 2 viruses , children older than 2 years with immunodeficiency, the drug should be prescribed at 200 mg 4 times / day every 6 hours, the maximum dose - up to 400 mg of acyclovir 5 times / day, depending on severity of infection.

In the treatment of infections caused by Varicella zoster , children older than 2 years are prescribed 20 mg / kg 4 times / day for 5 days, children with a body weight of more than 40 kg, the drug is prescribed in the same dosage as adults.

SPECIAL INSTRUCTIONS

Use strictly according to the doctor's prescription in order to avoid complications in adults and children over 2 years old.

Caution is prescribed for patients with impaired renal function, elderly patients due to an increase in T 1/2 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).

OVERDOSE

There were no cases of overdose after oral administration of acyclovir.

DRUG INTERACTION

Simultaneous application with probenecid results in an increase in the mean T 1/2 and a decrease in the clearance of acyclovir.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Keep in dry the dark place out of the reach of children, at a temperature of 15 В° -25 В° C.
Shelf life - 3 years.
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