Acyclovir-AKOS - description of the drug, instructions for use, reviews

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Manufacturers: Synthesis

Active ingredients

• Acyclovir

Disease class

• Immunodeficiency, unspecified
• Anogenital herpetic viral infection
• Other and unspecified infectious diseases
• Cytomegalovirus disease
• Disease caused by HIV with manifestations of other viral infections
• Herpes simplex virus infections
• Herpetic gingivostomatitis and pharyngotonsillitis
• Herpetic eye disease
• Chicken pox [varicella]
• Shingles

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antiviral

Pharmacological group

• Antiviral (except HIV) drugs

Oral tablets Acyclovir-AKOS (Aciclovir-AKOS)

Instructions for medical use of the drug

Description of pharmacological action

Penetrates into virus-infected cells, competitively interacts with viral thymidine kinase and is sequentially phosphorylated to form mono-, di- and triphosphate. Acyclovir triphosphate is integrated into the viral DNA chain, competitively inhibits the viral DNA polymerase and suppresses its replication.

Indications for use

For systemic use: - treatment of infections of the skin and mucous membranes caused by Herpes simplex viruses type I and II (primary and secondary, including genital herpes); - prevention of exacerbations of recurrent infections caused by Herpes simplex viruses type I and II in patients with normal immune status; - prevention of primary and recurrent infections caused by Herpes simplex viruses type I and II in patients with immunodeficiency; — as part of complex therapy for patients with severe immunodeficiency: with HIV infection (stage of AIDS, early clinical manifestations and detailed clinical picture) and in patients who have undergone bone marrow transplantation; - treatment of primary and recurrent infections caused by the Varicella zoster virus (chickenpox, herpes zoster). For external use: skin herpes simplex, genital herpes (simple and recurrent), labial herpes; herpes zoster and chicken pox.

Release form

tablets 200 mg; dark glass jar (jar) 20, cardboard pack 1; tablets 200 mg; contour packaging 10, cardboard pack 3; tablets 200 mg; contour packaging 10, cardboard pack 1; tablets 200 mg; contour packaging 10, cardboard pack 2;

Pharmacodynamics

It has high specificity for herpes simplex virus types I and II, the virus that causes chickenpox and herpes zoster (Varicella zoster), Epstein-Barr virus and cytomegalovirus.

Pharmacokinetics

When taken orally, bioavailability is 15–30%, Cmax is achieved after 1.5–2 hours. The concentration after oral administration of 200 mg 5 times a day is 0.7 mcg/ml. Plasma protein binding is 9–33% and is independent of the concentration of acyclovir in plasma. Penetrates well into all organs and tissues, including the brain and skin. The concentration in the cerebrospinal fluid is 50% of the concentration in plasma. Passes through the placental barrier and accumulates in breast milk. Metabolized in the liver to form a pharmacologically inactive derivative - 9-carboxymethoxymethylguanine. T1/2 in adults with normal renal function is 2-3 hours, in severe renal failure - 20 hours, in patients with hemodialysis - 5.7 hours (at the same time, the concentration of acyclovir in plasma decreases to 60% of the initial value). It is excreted by the kidneys (84% unchanged, 14% as a metabolite), less than 2% through the intestines. Renal clearance accounts for 75–80% of the total clearance.

Use during pregnancy

Possibly if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be stopped during treatment.

Contraindications for use

Hypersensitivity, incl. to acyclovir or components of the drug, breastfeeding; with caution - dehydration, renal failure, neurological disorders, incl. in the anamnesis.

Side effects

From the nervous system and sensory organs: rarely - headache, weakness; in some cases - tremor, dizziness, increased fatigue, drowsiness, hallucinations. From the gastrointestinal tract: in isolated cases - abdominal pain, nausea, vomiting, diarrhea. Allergic reactions: skin rash. Other: transient increase in liver enzyme activity; rarely - increased levels of urea and creatinine, hyperbilirubinemia, leukopenia, erythropenia, alopecia, fever.

Directions for use and doses

Orally, during or immediately after a meal, with plenty of water. In the treatment of infections of the skin and mucous membranes caused by Herpes simplex I or II, adults and children over 2 years of age - 200 mg 5 times a day for 5 days at 4 hour intervals during the day and at 8 hour intervals at night (if necessary the course can be extended). As part of complex therapy for severe immunodeficiency (including with a full-blown clinical picture of HIV infection, including early clinical manifestations of HIV infection and AIDS), after bone marrow transplantation - 400 mg 5 times a day. To prevent relapses of infections caused by Herpes simplex I or II, in patients with normal immune status and in case of relapse of the disease - 200 mg 4 times a day every 6 hours (maximum dose - up to 400 mg 5 times a day, depending on the severity of the infection). When treating infections caused by Varicella zoster, adults and children weighing more than 40 kg - 800 mg 5 times a day every 4 hours during the day and at 8-hour intervals at night. Duration of treatment is 7–10 days. Children over 2 years old - 20 mg/kg 4 times a day for 5 days. When treating infections caused by Herpes zoster, adults - 800 mg 4 times a day every 6 hours during the day for 5 days. If renal function is impaired during the treatment and prevention of infections caused by Herpes simplex, in patients with creatinine Cl less than 10 ml/min, the dose of the drug is reduced to 200 mg 2 times a day with a 12-hour interval. In the treatment and prevention of infections caused by Varicella zoster, in patients with creatinine Cl less than 10 ml/min, the dose of the drug is reduced to 800 mg 2 times a day with 12 hour intervals, with creatinine Cl up to 25 ml/min - 800 mg 3 times a day. day with 8 hour intervals.

Interactions with other drugs

When taken orally: probenecid increases the average T1/2 and reduces the clearance of acyclovir; nephrotoxic drugs increase the risk of renal dysfunction.

Precautions for use

Prescribe with caution to patients with impaired renal function and elderly patients (due to an increase in T1/2). When using the drug, it is recommended to take a sufficient amount of fluid. During treatment, it is necessary to monitor kidney function (urea and creatinine levels in the blood). The ointment is not recommended to be applied to the mucous membranes of the mouth, eyes, and genitals (local inflammation may develop).

Special instructions for use

Use internally strictly as prescribed by a doctor in adults and children over 2 years of age (to avoid complications). It is recommended to start treatment when the first signs of the disease appear (the effectiveness will be higher). In patients with immunodeficiency, with multiple repeated courses, viral resistance to acyclovir may develop.

Storage conditions

In a dry place, protected from light, at a temperature of 8–15 °C.

Best before date

36 months

ATX classification:

J Antimicrobials for systemic use

J05 Antiviral drugs for systemic use

J05A Direct acting antivirals

J05AB Nucleosides and nucleotides

J05AB01 Aciclovir

Acyclovir-AKOS 200 mg No. 20 tab.

Instructions for medical use of the drug ACICLOVIR-AKOS Trade name ACICLOVIR-AKOS International nonproprietary name Acyclovir Dosage form Tablets, 0.2 g Composition One tablet contains the active substance - acyclovir (in terms of anhydrous substance) 0.2 g, excipients: starch potato, magnesium stearate, talc Description White flat-cylindrical tablets with a chamfer and a score Pharmacotherapeutic group Antiviral drugs for systemic use. Nucleosides and nucleotides. ATC code J05АВ01 Pharmacological properties Pharmacokinetics After oral administration, it is partially absorbed into the intestine; due to low lipophilicity, absorption after oral administration of 200 mg is 20% (15 - 30%), however, dose-dependent concentrations are created that are sufficient for the effective treatment of viral diseases. Food does not have a significant effect on the absorption of acyclovir. With increasing dose, bioavailability decreases. The maximum concentration (Cmax) after oral administration of 200 mg 5 times a day is 0.7 mcg/ml, the minimum concentration (Cmin) is 0.4 mcg/ml, the time to reach the maximum concentration is 1.5-2 hours. Communication with blood plasma proteins – 9 – 33%. Penetrates the blood-brain barrier. Penetrates well into organs and tissues (including the brain, kidneys, lungs, liver, aqueous humor, tear fluid, intestines, muscles, spleen, breast milk, uterus, mucous membrane and vaginal secretions, sperm, amniotic fluid, contents herpetic vesicles); concentration in the cerebrospinal fluid is 50% of that in the blood. Acyclovir crosses the placenta and is excreted in breast milk in small concentrations. After oral administration at a dose of 200 mg 5 times a day, acyclovir is detected in breast milk in concentrations of 0.6 - 4.1% of plasma concentrations (at such concentrations in breast milk, breastfed children can receive acyclovir with mother's milk in a dose of up to 0.3 mg/kg/day). Metabolized in the liver to form a metabolite - 9-carboxy-methoxymethylguanine. It is excreted by the kidneys through glomerular filtration and tubular secretion: when taken orally, most of it is unchanged (62 - 91% of the dose) and in the form of a metabolite (on average 14%). Less than 2% is excreted through the gastrointestinal tract; trace amounts are determined in exhaled air. With a single session of hemodialysis for 6 hours, the concentration of acyclovir in plasma decreases by approximately 60%; During peritoneal dialysis, the clearance of acyclovir does not change significantly. The half-life (T1/2) when taken orally in adults is 3.3 hours, in children and adolescents from 1 year to 18 years – 2.6 hours. The rate of elimination slows down with age, but T1/2 of the active drug increases slightly. In patients with severe chronic renal failure T1/2 - up to 20 hours. T1/2 with renal failure (in adults, depending on the values ​​of creatinine clearance (CC)): with CC 80 ml/min - 2.5 hours, 50-80 ml/ min – 3 hours, 15-50 ml/min – 3.5 hours; with anuria - 19.5 hours, during hemodialysis - 5.7 hours, with continuous ambulatory peritoneal dialysis - 14-18 hours. With the simultaneous administration of acyclovir and zidovudine to HIV-infected patients, the pharmacokinetic characteristics of both drugs practically do not change. Pharmacodynamics Antiviral (antiherpetic) agent is a synthetic analogue of purine nucleoside, which has the ability to inhibit in vitro and in vivo replication of Herpes simplex viruses type 1 and 2, Varicella zoster virus, Epstein-Barr virus and cytomegalovirus. Highly active against Herpes simplex viruses type 1 and 2; the virus that causes chickenpox and herpes zoster (Varicella zoster); Epstein-Barr virus (types of viruses are listed in increasing order of the minimum inhibitory concentration of acyclovir). Moderately active against cytomegalovirus. In infected cells containing viral thymidine kinase, phosphorylation and conversion of acyclovir to acyclovir monophosphate occurs. Under the influence of acyclovir guanylate cyclase, monophosphate is converted into diphosphate and, under the action of several cellular enzymes, into triphosphate. The high selectivity of action specifically on viruses and low toxicity to humans are due to the fact that acyclovir is not a substrate for the thymidine kinase enzyme of uninfected cells, therefore it is of low toxicity to mammalian cells. Acyclovir triphosphate inhibits the synthesis (replication) of viral DNA by three mechanisms: 1) competitively replaces deoxyguanosine triphosphate in DNA synthesis; 2) “integrates” into the DNA chain being synthesized and stops its elongation; 3) inhibits the enzyme DNA polymerase of the virus. As a result, the multiplication of the virus in the body is blocked. The specificity and very high selectivity of the action of acyclovir are also due to its predominant accumulation in cells affected by viruses. Has an immunostimulating effect. Indications for use - herpes simplex of the skin and mucous membranes (primary and recurrent) - genital herpes (primary and recurrent) - herpes zoster (herpes zoster) - chicken pox (in the first 24 hours after the appearance of a typical rash) - in patients with severe immunodeficiency ( including after transplantation, when taking immunosuppressive drugs, in HIV-infected patients, during chemotherapy) Method of administration and dosage: Take orally, regardless of food intake, with a full glass of water. Adults for the treatment of herpes simplex of the skin and mucous membranes - 200 mg 5 times a day (every 4 hours while awake, excluding night sleep) for 5 days, if necessary, the duration of treatment can be extended. When treating patients with immunodeficiency, the single dose of the drug should be increased to 400 mg, the course duration should be 10 days or more. Adults for the treatment of genital herpes - 200 mg 5 times a day (every 4 hours while awake, excluding night sleep) for 10 days, if necessary, the duration of treatment can be extended. When treating patients with immunodeficiency, the single dose of the drug should be increased to 400 mg. Treatment should begin as soon as possible after infection occurs; 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. To prevent relapses of infections caused by the herpes simplex virus (including in patients with immunodeficiency), the drug is prescribed 200 mg 4 times a day (every 6 hours). For patients with normal immune status, for the prevention of herpes simplex of the skin and mucous membranes, it is possible to prescribe 400 mg 2 times a day (every 12 hours). In case of severe immunodeficiency (after bone marrow transplantation or in case of impaired absorption from the intestine) - 400 mg 5 times a day. Recurrent genital herpes (less than 6 episodes per year): intermittent therapy - 200 mg 5 times a day for 5 days. Recurrent genital herpes (more than 6 episodes per year): long-term suppressive therapy - 400 mg 2 times a day or 200 mg 3-5 times a day (course duration up to 12 months). The duration of the preventive course of therapy is determined by the length of the period when there is a risk of infection. When treating herpes zoster (herpes zoster): 800 mg 5 times a day (every 4 hours while awake, excluding night sleep) for 7-10 days. The maximum single dose per reception is 800 mg. Patients taking high doses orally should receive sufficient fluids. For children over 3 years of age, the drug is prescribed in the same dose as for adults. Treatment of chickenpox: adults and children over 6 years old - 800 mg 4 times a day; children 3-6 years old - 400 mg 4 times a day. More accurately, the dose can be determined at the rate of 20 mg/kg, but not more than 800 mg 4 times a day. The course of treatment is 5 days. In patients with impaired renal function, dose adjustment and dosage regimen are necessary depending on the magnitude of creatinine clearance and the type of infection. For the treatment of infection caused by Herpes simplex, with creatinine clearance less than 10 ml/min, the daily dose of the drug should be reduced to 400 mg, divided into 2 doses (with intervals between them of at least 12 hours, i.e. 200 mg 2 times a day ). In the treatment of infections caused by Varicella zoster, and in the maintenance therapy of patients with severe immunodeficiency - patients with a creatinine clearance of 10-25 ml/min, the drug is prescribed at a dose of 2.4 g / day in 3 doses with an interval of 8 hours (800 mg 3 times a day ). In patients with creatinine clearance less than 10 ml/min, the daily dose is reduced to 1.6 g, dose frequency 2 times a day with an interval of 12 hours (800 mg 2 times a day). Side effects Very rare - nausea, vomiting, diarrhea, abdominal pain, reversible increase in bilirubin levels and liver enzyme activity - anemia, leukopenia, thrombocytopenia - acute renal failure - dizziness, confusion, hallucinations, drowsiness, paresthesia, convulsions, coma (usually these side effects were observed in patients with renal failure who took the drug in doses higher than recommended) Rarely - increased levels of urea and creatinine in the blood - headache - allergic reactions: sometimes - rash, photosensitivity, urticaria, itching, rarely - shortness of breath, angioedema edema, anaphylaxis, fever, lymphadenopathy, peripheral edema, blurred vision, agitation, myalgia - other: sometimes - fatigue, rarely - alopecia Contraindications - hypersensitivity to acyclovir - prophylactic use of the drug in patients with impaired renal function or anuria - lactation period - children age up to 3 years Drug interactions An enhanced effect is observed with the simultaneous administration of immunostimulants. Other nephrotoxic drugs – increased risk of nephrotoxicity. Special instructions Use as prescribed by a doctor. With caution: pregnancy, lactation, dehydration and renal failure. Adequate and strictly controlled clinical studies of the safety of the drug during pregnancy have not been conducted. Long-term or repeated treatment with acyclovir in patients with reduced immunity can lead to the emergence of strains of viruses that are insensitive to its action. Most isolated strains of viruses that are insensitive to acyclovir show a relative lack of viral thymidine kinase; Strains with altered thymidine kinase or with altered DNA polymerase were isolated. In vitro, the effect of acyclovir on isolated strains of the Herpes simplex virus may cause the emergence of less sensitive strains. During therapy with high oral doses of the drug, sufficient fluid intake should be ensured in the patient's body. Acyclovir does not prevent the sexual transmission of herpes, so during the treatment period it is necessary to abstain from sexual intercourse, even in the absence of clinical manifestations. Pregnancy and lactation Use during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to take acyclovir during lactation, interruption of breastfeeding is required. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms When using the drug acyclovir, the following may occur: dizziness, confusion, hallucinations, drowsiness, therefore, during treatment you should refrain from driving a vehicle or potentially dangerous mechanisms. Overdose Oral administration of 20 g of acyclovir did not lead to the development of specific symptoms. Release form and packaging Tablets, 0.2 g. 10 tablets per blister pack. 2 blister packs together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions Store in a dry place, protected from light at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription. Russian Federation, 640008, Kurgan, Constitution Avenue, 7. tel./fax Name and country of the owner of the registration certificate Sintez OJSC, Russian Federation Address of the organization that accepts claims from consumers on the quality of products of STOFARM LLP on the territory of the Republic of Kazakhstan 000100, Republic of Kazakhstan, Kostanay region, Kostanay, st. Uralskaya, 14 tel.

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