Virollex (Virolex)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppills
Composition:1 tablet contains:
Active substance: Acyclovir 200 mg
Excipients: lactose monohydrate 213.60 mg, microcrystalline cellulose 53.40 mg, sodium starch glycolate 20.00 mg, povidone 10.00 mg, magnesium stearate 4.00 mg.
Description:

Round biconvex tablets of white color.

Pharmacotherapeutic group:Antiviral agent
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 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 I and II, 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 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 breast milk. The maximum concentration after the administration of 200 mg 5 times a day - 0.7 μg / ml, the time to reach the maximum concentration of 1,5-2 hours.

Metabolised in the liver to form a pharmacologically inactive compound 9-carboxymethoxymethylguanine. The half-life in adults with normal renal function 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. Renal Acyclovir clearance is 75-80% of the total plasma clearance. Less than 2% of acyclovir is excreted from the body through the intestine.

Indications:

1 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.

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

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

4 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.

5 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:

Pregnancy, elderly people and patients receiving large doses, especially against dehydration, renal dysfunction, neurological disorders, or neurological reactions to the use of cytotoxic drugs (including 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. The drug is taken during or immediately after a meal and is washed down with a sufficient amount of water.

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

The dosage regimen is set 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: the drug is prescribed at 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 of the disease, the course of treatment can be extended to the doctor's prescription up to 10 days. As part of complex therapy with expressed immunodeficiency, including with the expanded clinical picture of HIV infection (including, early clinical manifestations of HIV infection and stage of AIDS),after the implantation of the Bone marrow, 400 mg 5 times a day are prescribed.

For prevention of 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, the duration of the course is from 6 to 12 months.

For prevention of infections caused by viruses Herpes simplex type I and II, adults 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.

Children: for the treatment of infection caused by Herpes-simplex and prevention of this infection in patients with weakened immune defenses, children older than 3 years receive the same dose as adults.

In the treatment of infections caused by Varicella zoster:

Adults: 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: with chicken pox prescribe 20 mg / kg 4 times a day for 5 days (maximum single dose 800 mg), from 3 to 6 years: 400 mg 4 times a day, over 6 years: 800 mg 4 times a day for 5 days.

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.

Side effects:

From the gastrointestinal tract: in isolated cases - abdominal pain, nausea, vomiting, diarrhea.

Laboratory indicators: a transient slight increase in the activity of liver enzymes, rarely a slight increase in urea and creatinine levels, hyperbilirubinemia, leukopenia, erythropenia.

From the central nervous system: rarely - headache, weakness; at individual cases of tremors, dizziness, fatigue, exhaustion, drowsiness, insomnia, confusion, hallucinations, agitation, paresthesia, decreased concentration of attention.

Allergic reactions: skin rash, itching, Lyell's syndrome, hives, multiforme exudative erythema, incl. Stevens-Johnson syndrome, fever.

Other: myalgia, rarely - alopecia, peripheral edema, visual impairment, 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. Peritoneal dialysis is less effective.

Interaction:

Simultaneous use with drugs that block tubular secretion leads to an increase in the mean half-life and decrease in 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 emergence of strains of viruses,insensitive to its action. Use strictly according to the doctor's prescription to avoid complications.

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:Tablets 200 mg.
Packaging:

10 tablets in a blister pack. 2 blisters per pack of cardboard along with the instructions.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:P N014287 / 04
Date of registration:14.03.2008
Date of cancellation:2018-04-12
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
KRKA, d.d. Slovenia
Representation: & nbspKRKA KRKA Slovenia
Information update date: & nbsp12.04.2018
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