Gerpevir 2.5% 5 g ointment
Instructions for the use of the drug for specialists GERPEVIR Trade name Gerpevir International nonproprietary name Acyclovir Dosage form Ointment 2.5%, 5 g Composition 1 g of ointment contains the active substance - acyclovir in terms of dry matter 0.025 g, excipients: proxanol 268, propylene glycol, polyethylene oxide 400, emulsifier No. 1. Description Homogeneous ointment of white color, with a slight specific odor Pharmacotherapeutic group Other antimicrobial drugs for external use. Antiviral drugs. Acyclovir. ATC code D06BB03 Pharmacological properties Pharmacokinetics When used externally, it is practically not absorbed into the systemic circulation and does not have a systemic effect. When applying the ointment to the affected area of the skin, a therapeutic concentration of the drug is created in it, which is maintained at a constant level for at least 5 hours. Pharmacodynamics Gerpevir is an analogue of the purine nucleoside deoxyguanidine, a component of DNA (deoxyribonucleic acid). The drug is especially effective against herpes simplex and shingles viruses. The similarity of the structures of herpevir and deoxyguanidine allows it to interact with viral enzymes, which leads to an interruption of the virus reproduction cycle. After herpevir is introduced into a cell affected by herpes, under the influence of thymidine kinase secreted by the virus, it is converted into acyclovir monophosphate. Acyclovir monophosphate is converted by host cell enzymes into acyclovir diphosphate. After which, it is converted into the active form of acyclovir triphosphate, which selectively blocks the synthesis of viral DNA. Acyclovir triphosphate has virtually no effect on DNA replication of the host (human) cell. Herpevir for herpes 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. Indications for use: herpetic lesions of the skin and external mucous membranes (herpes of the lips, external genitalia) caused by Herpes simplex viruses types 1 and 2, Varicella zoster - primary and recurrent herpetic infections in patients with immunodeficiency. Directions for use and dosage: For external use only! It is recommended to use rubber gloves or finger caps to prevent the spread of infection. Treatment should be prescribed when the first symptoms of a herpes infection occur. The ointment is applied to the affected skin and external mucous membranes. Before applying the ointment, the affected surface must be washed with soap and water and dried thoroughly. The ointment is applied in a thin layer at the following rate (for adults): a 1.25 cm strip of ointment should be applied to 25 cm2 of the affected area 4-5 times a day and rubbed in with light movements for 1 minute. Children from 3 months. up to 12 years of age, the ointment is applied in a thin layer at the rate of acyclovir 250 mg/m2 of body surface. The ointment should also be applied to areas bordering the affected surface. The ointment must be applied regularly; in cases where you miss the next application, you should not double the dose the next time you use the drug. It is recommended to complete the full course of treatment - 10 days, even if the symptoms of the disease disappear before the specified period. If there is no effect when applied externally, it is recommended to prescribe the drug in tablet form for oral administration. Side effects - burning sensation, mild pain at the site of the lesion, itching - if it comes into contact with the internal mucous membranes, inflammation may develop Contraindications - hypersensitivity to Gerpevir - infectious diseases with similar symptoms, but caused by other pathogens - pregnancy and lactation - children under 3 months Drug interactions Probenecid slows down the elimination of the drug - the half-life is extended. The interaction of Gerpevir with other drugs that are also used topically has not been studied. Special instructions Gerpevir is used as soon as possible after the first symptoms of herpes appear. Protect affected areas from irritation. Avoid sexual intercourse if one of your sexual partners has symptoms of herpes. Do not allow the ointment to come into contact with the mucous membranes of the mouth, nose, eyes, or vagina. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. Not studied. Overdose Symptoms: erythema, peeling, burning sensation, burns are possible in areas where the ointment is applied for a long time. Treatment: drug withdrawal. Release form and packaging Ointment 2.5%, 5 g in a tube, 1 tube in a cardboard box. Storage conditions Store in a dry place at a temperature from +8 °C to +15 °C. Keep out of the reach of children! Shelf life 3 years Do not use after the expiration date indicated on the package Conditions for dispensing from pharmacies Without a prescription Manufacturer OJSC “Kievmedpreparat” Ukraine, 01032, Kiev, st. Saksaganskogo, 139 tel./fax; 216-14-74.
Use of the drug Gerpevir
Systemic use: for children with primary infections caused by the Herpes simplex types 1 and 2, under the age of 2 years are prescribed a dose of 0.5 g / day, over 2 years - 1 g / day in 5 divided doses. For children with infections caused by Varicella zoster , under the age of 2 years, the daily dose is 0.8 g, from 2 to 6 years - 1.6 g, over 6 years - 3.2 g. The frequency of administration is 4 times. The course of treatment is at least 5 days. Adults with primary infections caused by the Herpes simplex types 1 and 2 are prescribed 0.2 g (1 tablet) 5 times a day with a break at night (daily dose - 1 g). The course of treatment is 5 days. Patients with immunodeficiency (including after organ or bone marrow transplantation, with impaired absorption in the intestine) are prescribed 0.4 g 5 times a day; the course of treatment is at least 5 days, if necessary - up to 10 days. For the prevention of infections caused by the Herpes simplex types 1 and 2, in adults with normal immune status, the daily dose is 0.8 g (0.2 g 4 times a day with an interval of 6 hours or 0.4 g 2 times with an interval of 12 hours). In some cases, the daily dose can be reduced to 0.6 g (in 2-3 doses). Patients with severe immunodeficiency are prescribed 0.4 g 4 times a day. The duration of the course of preventive treatment is determined individually. For adults with normal immune status for infections caused by Varicella zoster , the daily dose is 4 g (0.8 g 5 times a day). The course of treatment is at least 7 days. In case of impaired renal excretory function and when prescribed to elderly people, the dose of the drug should be reduced taking into account creatinine clearance: when treating infections caused by Herpes simplex , with creatinine clearance ≤10 ml/min, the daily dose is reduced to 0.4 g in 2 doses with an interval between them for at least 12 hours; in the treatment of infections caused by Varicella zoster , and during maintenance therapy in patients with a pronounced decrease in immunity and with a creatinine clearance of 10–25 ml/min, the drug is prescribed at 2.4 g/day in 3 doses with an interval of 8 hours; in patients with creatinine clearance ≤10 ml/min, the daily dose is reduced to 1.6 g in 2 divided doses with an interval of 12 hours. The drug is administered intravenously slowly. Before use, the contents of 1 bottle should be dissolved in 10 ml of water for injection or isotonic sodium chloride solution; administered using an infusion pump. To prepare an infusion solution, the contents of 2 bottles ex tempore in 100 ml of isotonic sodium chloride solution or Ringer's lactate solution; if it is necessary to administer a dose exceeding 500 mg, add an adequate amount of solvent. The preparation of an infusion solution for children who require doses ≤10 mg is performed in 2 stages: first, the contents of the bottle are dissolved in 10 ml of water for injection or isotonic sodium chloride solution, and then the appropriate dose is added to the infusion solution in the ratio 1:5 (for example 4 ml in 20 ml).
Infection | Dosage for adults and children over 12 years of age | Dosing for children aged 3 months to 12 years | Duration of treatment |
| Herpes simplex | 5 mg/kg every 8 hours | 250 mg/kg every 8 hours | 5 days |
| Herpetic encephalitis | 10 mg/kg every 8 hours | 500 mg/kg every 8 hours | 10 days |
| Chickenpox in patients with normal immune status | 5 mg/kg every 8 hours | 250 mg/kg every 8 hours | 7 days |
| Chickenpox in immunocompromised patients | 10 mg/kg every 8 hours | 500 mg/kg every 8 hours | From 7 to 10 days |
| Prevention of infections | 250 mg/kg every 8 hours | ||
In case of impaired renal function and in the elderly, the dose is reduced taking into account the level of creatinine excretion from the body.
Creatinine clearance | Dosage regimen |
| 25–50 ml/min (0.41–0.83 ml/s) | Usual dose every 12 hours |
| 10–25 ml/min (0.16–0.41 ml/s) | Usual dose every 24 hours |
| 0–10 ml/min (0–0.16 ml/s) | 1/2 the usual dose every 24 hours and immediately after the dialysis procedure |
Research results and discussion
Gerpevir provided a good clinical effect in both the first and second groups (Fig. 1). When surveying patients, the majority of them—10 patients of group 1 (52.6%) and 11 patients of group 2 (57.9%)—noted improvement on days 2–3 after the start of treatment (decrease in the amount of discharge , itching, burning in the vagina and vulva). By the 3rd–4th day, in 14 (73.7%) and 15 (78.9%) patients of the 1st and 2nd groups, the appearance of new rashes, respectively, stopped, complete re-epithelialization of erosions occurred, swelling of the affected areas subsided, i.e. e. There was a steady regression of symptoms. Complete resolution of the clinical manifestations of the disease was observed starting from days 5–6 in 16 patients (84.2%) of the 1st group and in 17 (89.5%) of the 2nd group.
Based on anamnestic data and data from our study, the severity of disease relapses before and after treatment in patients of group 2 was assessed: there was a decrease in the duration of relapse and acceleration of reepithelialization from 5.5 to 3.5 days compared to previous relapses. In 18 (94.7%) patients, a weakening of the clinical course of the relapse was revealed. Against the background of Gerpevir monotherapy, the duration of relapse and the period of reepithelialization decreased from 5.4 to 3.3 days. The severity of the clinical picture of relapses decreased in 15 (78.9%) patients. With further observation of patients in group 2 during the year, only a slight decrease in the frequency of relapses was noted from 5 to 4.5 per year, which makes it necessary to prescribe pathogenetic therapy in combination with Gerpevir to patients with chronic recurrent HH (Table 1).
All patients of groups 1 and 2 who received Gerpevir noted its good tolerability. There were no observed side effects that could be associated with its use. There were also no toxic effects of the drug. Monitoring of the patients' hemogram, biochemical studies of the patients' main blood parameters, as well as urine analysis data did not reveal any deviations from generally accepted norms.
Side effects of the drug Gerpevir
When taken orally, the following adverse reactions are possible:
- from the gastrointestinal tract: nausea, vomiting, diarrhea, intestinal colic;
- allergic reactions : skin rash, itching; swelling, fever;
- from the central nervous system : headache, fatigue, dizziness;
- changes in laboratory parameters : increased levels of bilirubin, urea, creatinine, liver transaminases; deterioration of hematological parameters;
- other : rarely - anorexia; very rarely - alopecia.
With very rapid intravenous administration of acyclovir and dehydration, a transient increase in serum urea and creatinine levels may occur, so the infusion should be administered slowly and ensure adequate hydration. When the solution gets into the subcutaneous fatty tissue, a local tissue irritation reaction occurs.
Special instructions for the use of the drug Gerpevir
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. During treatment, renal function should be monitored (determining the level of urea nitrogen in the blood and creatinine in the blood plasma). If the condition of a woman with genital herpes does not improve within 1 week, it is necessary to conduct a gynecological examination (patients with genital herpes have an increased risk of developing cervical cancer, so a Pap test should be performed once a year to detect initial changes in the cervix). When treating genital herpes, sexual contact should be avoided. For chickenpox, therapy is more effective if it is started within 24 hours after the typical rash appears. Gerpevir can be taken with food. 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.
conclusions
Thus, this study demonstrated the main properties and advantages of the drug Gerpevir in the treatment of a primary episode and chronic recurrent genital herpes:
— the clinical effectiveness of Gerpevir in monotherapy, expressed in reducing the duration of relapse, the timing of re-epithelialization, reducing the severity of relapse (pain, itching, discomfort);
— safety, lack of toxicity, allergy and side effects, ease of oral administration;
— accessibility to a wide range of consumers, which makes it possible to provide high-quality etiotropic treatment to almost all social strata of the population suffering from HS.
The results obtained confirm the high effectiveness of Gerpevir as monotherapy, as well as in combination with other agents in the treatment of chronic recurrent herpes infection.
