Description of the drug VIROLEX® for systemic use


Pharmacological properties of the drug Virolex Virolex tablets

Acyclovir is an antiviral drug active against herpes simplex virus types 1 and 2 and herpes zoster virus. Has a virostatic effect. Inhibits the synthesis of viral DNA without affecting the physiological processes in the cell. After oral administration, acyclovir is slowly and incompletely absorbed from the digestive tract. The maximum concentration in blood plasma is reached after 1.5–2 hours. The bioavailability of acyclovir is 13–21%. The half-life with unchanged renal function is 3.3 hours. Acyclovir easily penetrates into the tissues, organs and biological fluids of the body: the brain, kidneys, lungs, liver, muscles, spleen, uterus, vaginal mucosa, vaginal secretions, cerebrospinal fluid and contents herpetic blisters. 15.4% of acyclovir is bound to plasma proteins. In healthy individuals, acyclovir is excreted primarily in the urine. Pharmacokinetics in children over 1 year of age are similar to those in adults.

Indications for use of the drug Virolex Virolex tablets

Infections caused by the Herpes simplex virus: primary genital herpes, recurrent genital herpes, herpetic encephalitis and generalized infections, herpes of the skin and mucous membranes in patients with immunodeficiency, other infections (herpetic eczema, hepatitis, proctitis, esophagitis, pneumonia). Prevention of infections caused by the Herpes simplex virus: after bone marrow or kidney transplantation, with bone marrow aplasia after treatment with cytotoxic drugs; recurrent genital herpes (with a frequency of 6 times a year or more); frequent recurrent infections in patients with normal immune status; infections in patients with immunodeficiency. Infections caused by the Varicella zoster virus: chickenpox in patients with immunodeficiency; severe or prolonged forms of chickenpox in patients with normal immune status; complications of chickenpox caused by the direct action of the Varicella zoster ; herpes zoster in patients with immunodeficiency; complications of herpes zoster caused by the direct action of the Varicella zoster ; ocular and ear forms of herpes zoster; herpes zoster in people over 50 years of age.

Virolex tablets 200 mg No. 20

Virolex tablets 200mg No. 20
Virolex Buy Virolex in pharmacies
DOSAGE FORMS tablets 200mg

MANUFACTURERS Krka d.d. (Slovenia)

GROUP Antiherpetic drugs

COMPOSITION Active substance: Acyclovir.

INTERNATIONAL NON-PROPENTED NAME Acyclovir

SYNONYMS Acigerpin, Acyclovir, Acyclovir Belupo, Acyclovir Hexal, Acyclovir Sandoz, Acyclovir forte, Acyclovir-Akos, Acyclovir-Acri, Acyclostad, Vero-Acyclovir, Vivorax, Gervirax, Herperax, Zovirax, Medovir

PHARMACOLOGICAL ACTION Antiviral. It has a highly selective effect on herpes simplex viruses type 1 and 2, herpes zoster, Epstein-Barr and cytomegalovirus. Easily passes through the corneal epithelium (eye ointment) and creates a therapeutic concentration in the ocular fluid. When used topically in the form of a cream, it is not absorbed into the systemic circulation. Penetrates through the BBB and placental barrier, excreted in breast milk. In case of herpes, it prevents the formation of new rash elements, reduces the likelihood of skin dissemination and visceral complications, accelerates the formation of crusts, and reduces pain in the acute phase of herpes zoster. Has an immunostimulating effect.

INDICATIONS FOR USE Primary and recurrent herpetic lesions of the skin and mucous membranes (including genital herpes), herpetic lesions in patients with immunodeficiency (treatment and prevention), herpes zoster, chicken pox, simple herpetic keratitis.

CONTRAINDICATIONS Hypersensitivity, breastfeeding.

SIDE EFFECTS Headache, fatigue, neurological disorders, shortness of breath, nausea, vomiting, diarrhea, intestinal colic, increased body temperature, edema, lymphadenopathy, increased levels of bilirubin, urea, creatinine, transient increase in the activity of liver transaminases, allergic reactions in the form of skin rash, itching. With intravenous administration - agitation, impaired consciousness, lethargy, tremor, convulsions, hallucinations, psychosis, coma; reactions at the IV injection site - local inflammation, phlebitis. When used externally - erythema, peeling, burning sensation, burn.

INTERACTION Probenecid slows down excretion (blocks tubular secretion).

OVERDOSE Symptoms: headache, neurological disorders, shortness of breath, nausea, vomiting, diarrhea, renal failure, lethargy, convulsions, coma. Treatment: maintenance of vital functions, hemodialysis.

SPECIAL INSTRUCTIONS Restrictions on use: Pregnancy. To prevent crystallization in the tubular apparatus, it is recommended to take large amounts of liquid. Caution should be exercised in patients with psychoneurotic disorders, impaired renal and liver function, electrolyte disturbances, and severe hypoxia. It is recommended to apply the cream using rubber gloves to prevent infection of other areas of the skin. For more detailed information, see the instructions for use.

STORAGE CONDITIONS List B. In a dry place, at a temperature not exceeding 25 °C.

Use of the drug Virolex tablets

Treatment with acyclovir should be started as early as possible, immediately after the first signs of the disease appear. Virolex is used every 4 days during the day; 6 or 12 hours, taking a break at night. Treatment of infections caused by the Herpes simplex virus Adults:

Type of infection
Dose, mg
Frequency of reception
Duration of treatment
Herpes of the skin and mucous membranes 200 5 5 days
Herpes of the skin and mucous membranes in patients with immunodeficiency 400 5 10 days
Genital herpes:
Primary 200 5 5–10 days
Secondary 200 5 5 days
Herpetic eczema 200 5 5 days
Prevention of recurrent genital herpes 200 or 400 2–4 6–12 months until the risk of infection disappears
Prevention of infections in patients with immunodeficiency 400

Children: in children over 2 years of age, use the same dose as in adults. Children under 2 years of age are prescribed at half the adult dose. Treatment of infections caused by the Varicella zoster virus

Type of infection
Dose, mg
Frequency of reception
Duration of treatment
Ocular form of herpes zoster 800 5 7–10 days
Shingles 800 5 7–10 days
Chickenpox: Children under 2 years of age Children between 2 and 6 years of age Children over 6 years of age 20 mg/kg* 200 400 800 4 4 4 4 5 days 5 days 5 days 5 days

*The maximum single dose is 800 mg.

For patients with renal failure and creatinine clearance less than 0.16 ml/s (10 ml/min), the dose should be reduced: for herpes simplex - to 200 mg every 12 hours, and for the treatment of herpes zoster - to 800 mg every 12 hours. Treatment of elderly people should be carried out with extreme caution under the control of creatinine clearance.

Virolex tablet 200 mg in blister pack. in pack №10x2

Name

Virolex tablet 200 mg in blister pack. in pack №10x2

Main active ingredient

Acyclovir

Release form

Pills

Dosage

200mg

pharmachologic effect

Pharmacological action - antiherpetic, antiviral.

Pharmacodynamics

Penetrating into the cell, it is phosphorylated and converted into the active form: acyclovir triphosphate. The latter, being an inhibitor and substrate of herpes DNA polymerase, prevents the synthesis of viral DNA. Suppresses the development of Herpes simplex viruses type 1 and 2 and Varicella zoster.

Indications for use

Infections caused by the herpes simplex virus (types 1 and 2), incl. genital herpes (primary and secondary), herpes eczema, herpes of the skin, eyes, mucous membranes and other lesions (esophagitis, hepatitis) in patients with a weakened immune system, chicken pox (in patients with a normal and weakened immune system); prevention of diseases caused by the Herpes simplex virus: after transplantation, secondary genital herpes (6 years or more), neonatal chickenpox.

Directions for use and doses

IV drip, internally, externally, conjunctivally. For infections caused by the herpes simplex virus, adults and children (over 2 years old) - 200-400 mg orally 5 times a day for 5-10 days; for prevention - 200–400 mg 4 times a day during the entire risk period. For infections caused by the varicella zoster virus, adults - 800 mg 5 times a day (7 days), children (under 2 years old) - 200 mg 4 times. For patients with renal failure (with creatinine Cl below 10 ml/min), the oral dose is reduced to 200 mg every 12 hours for herpes simplex and to 500 mg every 12 hours for diseases caused by Herpes zoster. In case of severe infection, treatment begins with intravenous drip administration (over 1 hour): adults and children over 12 years old - 5-10 mg/kg every 8 hours, children from 3 months to 12 years - 250-500 mg /m2 every 8 hours for 5–10 days, for prevention - 250 mg/m2 every 8 hours during the entire risk period. Newborns - IV 10 mg/kg every 8 hours

Use during pregnancy and lactation

Not recommended during pregnancy (except for treatment of life-threatening conditions). Nursing mothers - not recommended.

Precautionary measures

Use with caution (orally or intravenously) in elderly people and those suffering from renal failure. The infusion solution is stable for 12 hours at temperatures up to 25 °C. The solution should not be stored in the refrigerator.

Interaction with other drugs

Probenecid increases plasma concentrations and prolongs T1/2 of acyclovir.

Contraindications

Hypersensitivity.

Compound

1 tablet contains acyclovir 200 mg; 10 pcs in a strip pack, 2 packs in a box.

Overdose
Side effect

With intravenous administration - increased levels of urea and creatinine in plasma, increased levels of liver enzymes, acute renal failure; if it enters the perivascular tissue, it results in local inflammation. Confusion, hallucinations, anxiety, drowsiness, psychosis, coma (in complex forms of the disease); weakness, vomiting, skin rashes, decreased hematological index. At the site of application of the cream - erythema, dryness, peeling of the skin; at the site of application of the ointment - burning, point excoriation of the surface epithelium. When used orally - weakness, vomiting, diarrhea, headache, fatigue, skin inflammation.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of the reach of children.

Buy Virolex tablet 200 mg in blister pack. in pack No. 10x2 in the pharmacy

Price for Virolex tablet 200 mg in blister pack. in pack №10x2

Instructions for use for Virolex tablet 200 mg in a blister pack. in pack №10x2

Special instructions for the use of Virolex tablets

The drug should be used with caution in cases of impaired renal function, in the elderly, and when prescribed in high doses, especially in patients with dehydration. The dose should be adjusted taking into account creatinine clearance. Prescribing the drug during pregnancy is possible only for life-threatening infections, when the expected benefit to the expectant mother outweighs the potential risk to the fetus. Acyclovir passes into breast milk, so breastfeeding must be stopped during treatment with the drug.

Virolex®

The drug Virolex tablets can be taken with meals, since food intake does not significantly interfere with its absorption. The tablets should be taken with a full glass of water.

Adults

Treatment of infections caused by HSV

For the treatment of infections caused by HSV, the recommended dose of Virolex is 200 mg 5 times a day (every 4 hours, except during night sleep). Usually the course of treatment is 5 days, but can be extended for severe primary infections.

In case of severe immunodeficiency (for example, after bone marrow transplantation) or in case of impaired absorption from the intestine, the oral dose of Virolex can be increased to 400 mg. As an alternative, the possibility of using Virolex in a lyophilisate dosage form for the preparation of a solution for infusion may be considered.

Treatment should begin as soon as possible after the appearance of the rash; in case of relapses, it is recommended to prescribe the drug already in the prodromal period or when the first elements of the rash appear.

Prevention of recurrent infections caused by the herpes simplex virus in patients with normal immune status

To prevent relapses of infections caused by HSV in patients with normal immune status, the recommended dose of Virolex is 200 mg 4 times a day (every 6 hours).

For many patients, a more convenient therapy regimen of 400 mg 2 times a day (every 12 hours) is suitable.

In some cases, lower doses of Virolex 200 mg 3 times a day (every 8 hours) or 200 mg 2 times a day (every 12 hours) are effective.

Some patients may experience exacerbation of infection when taking a total daily dose of 800 mg.

Treatment with Virolex should be periodically interrupted for 6-12 months to identify possible changes in the course of the disease.

Prevention of HSV infections in immunocompromised patients

For the prevention of infections caused by HSV in patients with immunodeficiency, the recommended dose of Virolex is 200 mg 4 times a day (every 6 hours).

In case of severe immunodeficiency (for example, after bone marrow transplantation) or in case of impaired absorption from the intestine, the oral dose of Virolex can be increased to 400 mg 4 times a day. As an alternative, the possibility of using Virolex in a lyophilisate dosage form for the preparation of a solution for infusion may be considered. The duration of the preventive course of therapy is determined by the length of the period when there is a risk of infection.

Treatment of chickenpox and herpes zoster

For the treatment of chickenpox and herpes zoster, the recommended dose of Virolex is 800 mg 5 times a day (every 4 hours, except during night sleep). The course of treatment is 7 days.

In patients with severe immunodeficiency (for example, after bone marrow transplantation) or in cases of impaired absorption from the intestine, it is necessary to consider the possibility of prescribing Virolex in the dosage form of a lyophilisate for the preparation of a solution for infusion.

The drug Virolex should be prescribed as soon as possible after the appearance of the rash, since in this case the treatment is more effective.

Treatment of chickenpox in patients with normal immune status should begin within 24 hours of the onset of the rash.

Special patient groups

Children aged 3 years and older

Treatment of infections caused by HSV, prevention of infections caused by HSV in patients with immunodeficiency

- aged 3 years and older - the same doses as for adults.

Treatment of chickenpox

- at the age of 6 years and older - 800 mg 4 times a day;

- aged 3 to 6 years - 400 mg 4 times a day.

More precisely, the dose can be determined at the rate of 20 mg/kg body weight (but not more than 800 mg) 4 times a day. The course of treatment is 5 days.

Prevention of recurrence of infections caused by HSV, treatment of herpes zoster

There are no data on dosage regimen.

Elderly patients

The likelihood of renal failure in elderly patients must be taken into account, and doses should be adjusted according to the degree of renal failure (see subsection "Patients with renal failure").

It is necessary to ensure that adequate water balance is maintained.

Patients with impaired renal function

Caution must be exercised when prescribing Virolex to patients with impaired renal function.

It is necessary to ensure that adequate water balance is maintained.

In patients with renal failure, oral administration of acyclovir at recommended doses for the treatment and prevention of infections caused by HSV does not lead to accumulation of the drug to concentrations exceeding established safe levels. However, in patients with creatinine clearance less than 10 ml/min, the dose of Virolex is recommended to be reduced to 200 mg twice a day (every 12 hours).

For the treatment of chickenpox and herpes zoster, the recommended doses of Virolex tablets are:

- if creatinine clearance is less than 10 ml/min - 800 mg 2 times a day (every 12 hours);

- with creatinine clearance 10-25 ml/min - 800 mg 3 times a day (every 8 hours).

Rating
( 1 rating, average 4 out of 5 )
Did you like the article? Share with friends:
For any suggestions regarding the site: [email protected]
Для любых предложений по сайту: [email protected]