Virolex - description of the drug, instructions for use, reviews

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Manufacturers: Krka (Slovenia)

Active ingredients

• Acyclovir

Disease class

• Anogenital herpetic viral infection
• Herpes simplex virus infections
• Herpetic eye disease
• Chicken pox [varicella]
• Shingles

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antiviral
• Antiherpetic

Pharmacological group

• Antiviral (except HIV) drugs

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.

Lyophilisate for the preparation of solution for infusion Virolex (Virolex)

Instructions for medical use of the drug

Description of pharmacological action

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.

Release form

lyophilisate for the preparation of solution for infusion 250 mg; bottle (bottle) 15 ml, box (box) 5;

Pharmacokinetics

After intravenous drip administration to adults, the average Cmax values ​​1 hour after infusion at a dose of 2.5; 5 and 10 mg/kg were 5.1; 9.8 and 20.7 μg/ml, respectively. Cmin 7 hours after infusion were respectively equal to 0.5; 0.7 and 2.3 μg/ml. In children over 1 year of age, the values ​​of Cmax and Cmin when administered at doses of 250 and 500 mg/m2 were similar to those in adults at doses of 5 and 10 mg/kg, respectively. In newborns and infants under 3 months of age, to whom acyclovir was administered at a dose of 10 mg/kg intravenously over 1 hour every 8 hours, Cmax was 13.8 μg/ml) and Cmin was 2.3 μg/ml. Protein binding is low (9–33%). Passes through the blood-brain barrier, the placental barrier, and is found in breast milk (at a dose of 1 g/day, 0.3 mg/kg enters the child’s body with mother’s milk). Penetrates well into organs, tissues and body fluids, including the brain, kidneys, liver, lungs, aqueous humor, tear fluid, intestines, muscles, spleen, uterus, mucous membrane and vaginal secretions, sperm, cerebrospinal fluid, contents of herpetic vesicles . The highest concentrations are found in the kidneys, liver and intestines. The concentration in the cerebrospinal fluid is 50% of that in the blood plasma. Metabolized in the liver, under the action of alcohol and aldehyde dehydrogenase and, to a lesser extent, aldehyde oxidase into inactive metabolites. The metabolism of acyclovir is not associated with cytochrome P450 enzymes. The main route of elimination is through the kidneys by glomerular filtration and tubular secretion. When taken orally, approximately 14% is excreted unchanged, and when administered intravenously - 45–79%. The main metabolite found in urine is 9-carboxymethoxymethylguanine. The main metabolite accounts for up to 14% (with normal renal function). Less than 2% is excreted in feces, trace amounts are determined in exhaled air.

Use during pregnancy

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

Contraindications for use

Hypersensitivity.

Side effects

With intravenous administration - increased levels of urea and creatinine in plasma, increased levels of liver enzymes, acute renal failure; With systemic use: From the gastrointestinal tract: with intravenous administration - anorexia, nausea and/or vomiting; when taken orally - nausea and/or vomiting, diarrhea, abdominal pain. From the nervous system: with intravenous administration - dizziness, signs of encephalopathy (confusion, hallucinations, convulsions, tremor, coma), delirium, depression or psychosis (neurological disorders are usually observed in patients with predisposing conditions); when taken orally - malaise, headache, dizziness, agitation, drowsiness. From the cardiovascular system and blood: with intravenous administration - anemia, neutropenia/neutrophilia, thrombocytopenia/thrombocytosis, leukocytosis, hematuria, disseminated intravascular coagulation syndrome, hemolysis, decreased blood pressure. From the genitourinary system: with intravenous administration - a transient increase in the level of urea nitrogen in the blood and the level of creatinine in the blood serum (associated with the Cmax value in plasma and the state of the patient’s water balance), acute renal failure (more often with rapid intravenous injection) . Other: anaphylactic reactions, allergic skin reactions (itching, rash, Lyell's syndrome, urticaria, erythema multiforme, etc.), blurred vision, fever, leukopenia, lymphadenopathy, peripheral edema, transient increase in the activity of liver transaminases and bilirubin levels; with i.v. administration - reactions at the i.v. injection site: phlebitis or local inflammation (pain, swelling or redness), necrosis (if the drug gets under the skin); when taken orally - myalgia, paresthesia, alopecia.

Directions for use and doses

The dosage regimen is set individually, depending on the indications and severity of the process. The dose for children is calculated depending on the indication, age, surface area/body weight. Treatment should begin as early as possible, when the first signs and symptoms of the disease appear. IV drip (administered at a constant rate for at least 1 hour): for herpetic infection, severe herpetic lesions of the genital organs and herpes zoster in adults - 5 mg/kg 3 times a day (every 8 hours) for 5 days; for patients with immune system disorders, for herpetic encephalitis - 10 mg/kg every 8 hours for 10 days. The maximum dose for adults with intravenous administration is 30 mg/kg or 1.5 g/m2/day.

Overdose

Symptoms: headache, neurological disorders, shortness of breath, nausea, vomiting, diarrhea, renal failure, lethargy, convulsions, coma. Treatment: symptomatic therapy, maintenance of vital functions, adequate hydration, hemodialysis (especially in acute renal failure and anuria). There is no evidence of overdose with topical use.

Interactions with other drugs

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

Precautions for use

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.

Storage conditions

List B.: At a temperature of 8–25 °C.

Best before date

36 months

ATX classification:

D Dermatotropic drugs

D06 Antimicrobials for the treatment of skin diseases

D06B Other antimicrobials for external use

D06BB Antiviral drugs

D06BB03 Aciclovir

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.

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:

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

*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.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Virolex, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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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.