Virolex
Virolex: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Virolex
ATX code: D06BB03
Active ingredient: acyclovir (Aciclovir)
Manufacturer: KRKA d.d. (KRKA, dd) (Slovenia)
Description and photo update: 2019-26-08
Prices in pharmacies: from 257 rubles.
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Virolex is an antiviral agent.
Release form and composition
Dosage forms of Virolex:
- Lyophilisate for preparation of solution for infusion: porous mass of almost white or white color (in 15 ml vials, 5 vials in a cardboard box);
- Tablets: round biconvex white (in blisters of 10 pcs., In a cardboard box 2 blisters);
- Eye ointment 3%: homogeneous consistency, oily, light transparent, almost white or white (in aluminum tubes of 4.5 g, in a cardboard box 1 tube);
- Cream for external use 5%: homogeneous, almost white or white, with a characteristic odor (in aluminum tubes of 5 g, in a cardboard box 1 tube).
1 vial with lyophilisate contains the active ingredient: acyclovir (in the form of sodium salt) - 250 mg.
Composition of 1 tablet:
- Active ingredient: acyclovir - 200 mg;
- Auxiliary components: sodium starch glycolate, lactose monohydrate, magnesium stearate, povidone, microcrystalline cellulose.
Composition of 1 g of eye ointment:
- Active ingredient: acyclovir - 30 mg;
- Auxiliary component: white petroleum jelly.
Composition of 1 g cream for external use:
- Active ingredient: acyclovir - 50 mg;
- Auxiliary components: sodium lauryl sulfate, propylene glycol, cetostearyl alcohol, poloxamer 407, petroleum jelly, liquid paraffin, purified water.
Pharmacological properties
Pharmacodynamics
The active substance of Virolex, acyclovir, is a synthetic analogue of a purine nucleoside, has activity against herpes viruses, including Herpes simplex type I and II, Epstein Barr virus, Varicella zoster, Cytomegalovirus.
Acyclovir is characterized by high selectivity of action. Thymidine kinase of cells infected with a virus sequentially converts the substance into acyclovir mono-, di- and triphosphate. The latter inhibits viral DNA polymerase and competitively replaces deoxyguanosine triphosphate in the DNA of viruses. Thus, defective viral DNA is formed, as a result of which the replication of new viruses is inhibited.
Acyclovir is highly active against Herpes simplex types I and II, Varicella zoster (the causative agent of shingles and chickenpox) and Epstein Barr virus - the types of viruses are listed in ascending order of the minimum inhibitory concentration of acyclovir.
The drug is moderately effective against Cytomegalovirus.
With herpes, Virolex reduces pain in the acute phase, accelerates the formation of crusts, prevents the formation of new elements of the rash, and reduces the likelihood of developing cutaneous dissemination and visceral complications. It has an immunostimulating effect.
Pharmacokinetics
With intravenous (iv) drip infusion of the drug for 1 hour at doses of 2.5 mg / kg, 5 mg / kg and 10 mg / kg, the maximum concentration of the substance (C max) is 5.1, respectively; 9.8 and 20.7 μg / ml. When Virolex is administered to children aged 1 year and older at a dose of 250 and 500 mg / m 2, the maximum and minimum (C min) concentrations are similar to those in adults receiving Virolex at a dose of 5 and 10 mg / kg. With the introduction of acyclovir to newborns and children under 3 months of age at a dose of 10 mg / kg IV drip for 1 hour three times a day C max is 13.8 μg / ml, C min - 2.3 μg / ml.
When taking Virolex inside, the bioavailability of acyclovir is 15-30%. When taking the drug at a dose of 200 mg 5 times a day, C max - 0.7 μg / ml, is achieved within 1.5–2 hours.
The connection with plasma proteins does not depend on the concentration of the substance in the plasma and is 9–33%. Acyclovir penetrates well into all organs and tissues, including the brain, lungs, kidneys, liver, spleen, intestines, skin, muscles, lacrimal fluid, semen, vaginal secretions, uterus, amniotic fluid and the contents of herpetic vesicles. In the cerebrospinal fluid, the drug level is about 50% of the plasma concentration. Acyclovir passes through the blood-brain and placental barrier, accumulates in breast milk.
The substance is metabolized in the liver with the formation of a pharmacologically inactive metabolite - 9-carboxymethoxymethylguanine (8.5-14% acyclovir). It is excreted mainly by the kidneys by tubular secretion and glomerular filtration - approximately 80% unchanged and 14% in the form of a metabolite, as well as in a small amount through the intestines - less than 2%. Renal clearance is 75–80% of the total plasma clearance.
The half-life (T 1/2) in adults with normal renal function is 2–3 hours, in children 1–18 years old - 2.6 hours, in children under 3 months - 3.8 hours (with intravenous drip administration of 10 mg / kg for 1 hour three times a day). In patients with severe chronic renal failure, T 1/2 is 20 hours, in patients on hemodialysis - 5.7 hours (the plasma concentration of acyclovir is reduced to 60% of the initial level).
In renal failure, T 1/2 depends on creatinine clearance (CC): CC 80 ml / min - 2.5 h, CC 50-80 ml / min - 3 h, CC 15-50 ml / min - 3.5 h. With anuria, the half-life of the drug reaches 19.5 hours, with hemodialysis - 5.7 hours, with constant outpatient peritoneal dialysis - 14-18 hours.
Data on the pharmacokinetic characteristics of Virolex in the form of an ophthalmic ointment and cream for external use are limited. The ointment easily penetrates the corneal epithelium and creates a therapeutic concentration in the ocular fluid. With prolonged use of the cream, systemic absorption is minimal.
Indications for use
Lyophilisate for preparation of solution for infusion and tablets
- Diseases caused by the viruses Varicella zoster and Herpes simplex types 1 and 2;
- Severe immunodeficiency in patients after bone marrow transplantation and in the clinical picture of HIV infection (as part of complex therapy);
- Prevention of viral infections Herpes simplex and Varicella zoster, including patients with reduced immunity;
- Prevention of cytomegalovirus infection after bone marrow transplantation.
Eye ointment 3%
Treatment of keratitis and other eye diseases caused by the Herpes simplex virus.
Cream for external use
Skin infections caused by the viruses Varicella zoster and Herpes simplex.
Contraindications
All Virolex dosage forms are contraindicated if the patient has hypersensitivity to any component of the drug, valacyclovir or famciclovir.
Lyophilisate and tablets, in addition, are prohibited for use during lactation.
Virolex tablets are not recommended for children under 3 years of age because of the solid dosage form.
The drug should be used with caution:
- Intravenous: in case of renal failure (due to the risk of nephrotic action), dehydration, pregnancy, in old age, in the case of the development of neurological disorders or reactions to taking cytotoxic drugs (including in the history);
- Inside: pregnant women, the elderly, with impaired renal function, in case of development of neurological disorders or reactions to taking cytotoxic drugs (including in the history), as well as if it is necessary to use high doses of Virolex, especially against the background of dehydration.
Instructions for the use of Virolex: method and dosage
The dose and duration of application of Virolex is prescribed by the attending physician based on clinical indications.
Lyophilisate for preparation of solution for infusion
The finished solution is administered intravenously (IV) by drop.
Recommended dosage:
- Patients over 12 years of age: Virolex is prescribed taking into account the patient's weight at the rate of 5-10 mg per 1 kg of body weight. The daily dose for adults should not exceed 30 mg per 1 kg of body weight;
- Children from 3 months to 12 years old: the dose is determined depending on the surface area of the child's body - 250-500 mg per 1 m 2;
- Newborns - 10 mg per 1 kg of body weight.
The interval between infusions is 8 hours.
In case of renal failure, the dose must be adjusted, taking into account the severity of the liver dysfunction.
Pills
Virolex tablets are taken orally.
Dosing regimen for adults and children over 2 years of age: 200-400 mg 3-5 times a day, in severe forms of the disease, the dose can be prescribed at the rate of 20 mg per 1 kg of patient weight (up to 800 mg per dose) 4 times a day …
Children under 2 years appoint 1 / 2 doses for adults.
The duration of treatment is 5-10 days.
Patients with renal insufficiency need correction of the Virolex dosage regimen.
Eye ointment 3%
Ophthalmic ointment Viroleks is applied topically by placing in the lower conjunctival sac 5 times a day.
Cream for external use 5%
Virolex cream is applied in sufficient quantity to the affected area 5 times a day.
Side effects
- IV injection: nausea, vomiting, acute renal failure, crystalluria, inflammation or phlebitis at the injection site, encephalopathy in the form of drowsiness, confusion, agitation, hallucinations, seizures, tremors, psychosis, coma;
- Ingestion: abdominal pain, nausea, diarrhea, vomiting, skin rash, dizziness, headache, decreased concentration, increased fatigue, hallucinations, insomnia or drowsiness, fever; rarely - hair loss, leukopenia, erythropenia, lymphocytopenia, a transient increase in the level of urea, bilirubin, creatinine in the blood, the activity of liver enzymes;
- Application of ophthalmic ointment: burning sensation upon application, conjunctivitis, punctate superficial keratitis, blepharitis;
- External application of the cream: itching, rash, dry skin, possibly a burning sensation at the site of application, peeling, erythema; on contact with mucous membranes - inflammation.
Overdose
Lyophilisate for preparation of solution for infusion
Overdose symptoms: impaired renal function, hypercreatininemia, increased urea nitrogen, convulsions, lethargy, coma.
Treatment: symptomatic, aimed at maintaining the vital functions of the body. If necessary, hemodialysis is performed (peritoneal dialysis is less effective).
Pills
When taking acyclovir orally at a dose of 20 g, no specific symptoms were noted. The development of undesirable phenomena from the central nervous system, such as tremors, convulsions, lethargy, is possible.
If no more than 30 minutes have passed since taking Virolex, you should induce vomiting and take an absorbent. With anuria and acute renal failure, hemodialysis is performed. Treatment of an overdose is symptomatic, aimed at maintaining the vital functions of the body.
Eye ointment and cream for external use
There are no data on overdose of acyclovir when applied topically. Virolex is absorbed in minimal amounts, but the likelihood of developing systemic effects is not excluded: headache, convulsions, neurological disorders, diarrhea, nausea, vomiting, renal dysfunction, shortness of breath, lethargy, coma.
Treatment of an overdose is symptomatic, aimed at maintaining the vital functions of the body. If necessary, hemodialysis is prescribed.
special instructions
During the period of application of Virolex in the form of a lyophilisate and tablets, one should take into account the possibility of the development of acute renal failure against the background of the formation of a crystalline precipitate of acyclovir, especially with rapid intravenous administration, insufficient water load, simultaneous therapy with nephrotoxic agents, in patients with functional kidney disorder.
The use of acyclovir must be accompanied by monitoring of renal function with regular determination of the level of creatinine in the blood plasma and nitrogen of urea in the blood.
Elderly patients require close medical supervision and abundant drinking during the treatment period, since in this category of patients the half-life of acyclovir increases.
People with genital herpes need to abstain from sexual intercourse or use reliable barrier methods of contraception to keep their partner from getting the virus.
Cream for external use Virolex should not be applied to the mucous membranes of the eyes, mouth, vagina.
Influence on the ability to drive vehicles and complex mechanisms
With oral and parenteral use of Virolex, there is a risk of developing side effects from the central nervous system (for example, drowsiness or dizziness), therefore, it is recommended to be careful when performing potentially hazardous types of work.
With local application of Virolex, the effect on the speed of reactions and the ability to concentrate is unlikely.
Application during pregnancy and lactation
The efficacy and safety of acyclovir when used during pregnancy have not been established, therefore Virolex is prescribed only in cases where the benefits are definitely higher than the potential risks.
Acyclovir is excreted in breast milk, therefore, the use of Virolex during lactation is not recommended.
Pediatric use
Virolex is used to treat children according to the recommended dosage regimen. Because of the solid dosage form, tablets are not recommended for children under 3 years of age.
With impaired renal function
In the form of lyophilisate and tablets, Virolex should be used with caution in case of impaired renal function.
Use in the elderly
The drug should be used with caution in old age. It may be necessary to reduce the dose of Virolex in case of prescribing a lyophilisate or tablets.
Drug interactions
The simultaneous use of Virolex with probenecid leads to a decrease in the tubular secretion of acyclovir, causing an increase in its half-life and the level of concentration in the blood plasma.
When combined with nephrotoxic agents, the risk of developing nephrotoxic effects increases, especially in patients with impaired renal function.
With concomitant therapy with immunostimulants, the effect of acyclovir is enhanced.
When mixing solutions for intravenous administration, it must be borne in mind that the alkaline reaction of acyclovir pH 11.
Analogs
Analogs of Virolex are: Acyclovir, Acyclovir Forte, Acyclovir-Akrikhin, Acyclovir-Teva, Acyclovir Belupo, Acyclovir Sandoz, Acyclovir-Ferein, Zovirax, Agerp, Atsik, Atsivir, Herpetad, Herperaks, Provirsan.
Terms and conditions of storage
Keep out of reach of children at temperatures up to 25 ° C.
The shelf life is 5 years.
The ready-made infusion solution can be used within 12 hours (store at a temperature not exceeding 25 ° C, do not refrigerate).
Terms of dispensing from pharmacies
Available without a prescription.
Terms of dispensing from pharmacies
Lyophilisate for preparation of solution for infusion and tablets are dispensed by prescription, eye ointment and cream for external use - without a prescription.
Reviews about Virolex
According to reviews, Virolex, like other similar drugs containing acyclovir, is an effective treatment for the herpes virus.
Virolex tablets and injections are prescribed for the systemic treatment of herpes infections. Patients note fast and productive treatment provided that all the doctor's recommendations are followed. An external dosage form allows you to quickly get rid of skin manifestations of the disease and a rash on the lips.
Doctors note that it is almost impossible to completely get rid of the latent herpes virus. Sooner or later, the disease will reappear, therefore, complex therapy may be required with the simultaneous use of systemic and external dosage forms of Virolex.
Price for Virolex in pharmacies
The cream for external use and eye ointment Viroleks are currently not registered in Russia. The cost of a lyophilisate for preparing a solution for infusion is approximately 1232 rubles. per pack of 5 bottles of 250 mg. The price of Virolex in the form of 200 mg tablets is 207-225 rubles. per pack of 20
Virolex: prices in online pharmacies
Drug name Price Pharmacy |
Virolex 200 mg tablets 20 pcs. 257 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!