Acyclovir

Acyclovir 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 herpes simplex virus

For the treatment of infections caused by the herpes simplex virus, the recommended dose of Acyclovir 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 Acyclovir can be increased to 400 mg. As an alternative, the possibility of using acyclovir in a lyophilisate dosage form for the preparation of a solution for infusion may be considered.

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.

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

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

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

Sometimes lower doses of Acyclovir are effective: 200 mg 3 times a day (every 8 hours) or 200 mg 2 times a day (every 12 hours).

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

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

Prevention of infections caused by herpes simplex virus in patients with immunodeficiency

For the prevention of infections caused by the herpes simplex virus in patients with immunodeficiency, the recommended dose of Acyclovir 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 Acyclovir can be increased to 400 mg 4 times a day. As an alternative, the possibility of using acyclovir 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 Acyclovir 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 acyclovir in a lyophilisate dosage form for the preparation of a solution for infusion.

Treatment for herpes zoster should begin as soon as possible after the rash appears, as in this case the treatment will be 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 herpes simplex virus infections: prevention of herpes simplex virus infections in immunocompromised patients

- 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 accurately, 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 the herpes simplex virus in patients with normal immune status; Treatment of herpes zoster There are no data on the 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 Acyclovir to patients with impaired renal function. It is necessary to ensure that adequate water balance is maintained. In patients with renal failure, taking acyclovir orally at recommended doses for the treatment and prevention of infections caused by the herpes simplex virus does not lead to the accumulation of the drug to concentrations exceeding established safe levels. However, in patients with creatinine clearance less than 10 ml/min, the dose of Acyclovir is recommended to be reduced to 200 mg 2 times a day (every 12 hours).

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

- with creatinine clearance 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).

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Description:

Round flat-cylindrical tablets of white or almost white color with a chamfer and a score.

Pharmacological group:

antiviral agent.

ATX code:

J05AB01

pharmachologic effect

Pharmacological properties

Pharmacodynamics

Mechanism of action

Acyclovir

is a synthetic analogue of a purine nucleoside that has the ability to inhibit in vitro and in vivo human herpes viruses, including herpes simplex virus (HSV) types 1 and 2, varicella zoster virus and herpes zoster virus (Varicella zoster virus (Varicella zoster virus). VZV), Epstein-Barr virus (EBV) and cytomegalovirus (CMV). In cell culture, acyclovir has the most pronounced antiviral activity against HSV-1, followed in descending order of activity by HSV-2, VZV, EBV and CMV.

The inhibitory effect of acyclovir on herpes viruses (HSV-1, HSV-2, VZV, EBV and CMV) is highly selective. Acyclovir is not a substrate for the thymidine kinase enzyme in uninfected cells, therefore acyclovir is of low toxicity to mammalian cells. However, thymidine kinase of cells infected with HSV, VZV, EBV and CMV viruses converts acyclovir into acyclovir monophosphate, a nucleoside analogue, which is then sequentially converted into diphosphate and triphosphate under the action of cellular enzymes. The incorporation of acyclovir triphosphate into the viral DNA chain and subsequent chain termination blocks further replication of the viral DNA.

In patients with severe immunodeficiency, long-term or repeated courses of acyclovir therapy may lead to the emergence of resistant strains, so further treatment with acyclovir may be ineffective. Most isolated strains with reduced sensitivity to acyclovir had a relatively low content of thymidine kinase, as well as a disorder in the structure of the viral thymidine kinase or DNA polymerase. In vitro exposure of herpes simplex virus (HSV) strains to acyclovir may also result in the formation of strains that are less sensitive to it. A correlation has not been established between the sensitivity of herpes simplex virus (HSV) strains to acyclovir in vitro and the clinical effectiveness of the drug.

Pharmacokinetics

Suction

Acyclovir is only partially absorbed from the intestine. After taking 200 mg of acyclovir every 4 hours, the mean maximum steady-state plasma concentration (Cssmax) was 3.1 μM (0.7 μg/ml), and the mean steady-state minimum plasma concentration (Cssmin) was 1.8 μM (0 .4 µg/ml). When administered orally 400 mg and 800 mg of acyclovir every 4 hours, Cssmax was 5.3 µM (1.2 µg/ml) and 8 µM (1.8 µg/ml), respectively, and Cssmin was 2.7 µM (0.6 µg /ml) and 4 µM (0.9 µg/ml), respectively.

Distribution

The concentration of acyclovir in the cerebrospinal fluid is approximately 50% of its concentration in blood plasma.

Acyclovir binds to blood plasma proteins to an insignificant extent (9-33%), so drug interactions due to displacement from binding sites with blood plasma proteins are unlikely.

Removal

In adults, after taking acyclovir orally, the half-life from blood plasma is about 3 hours. Most of the drug is excreted unchanged by the kidneys. The renal clearance of acyclovir significantly exceeds the clearance of creatinine, which indicates that acyclovir is eliminated through not only glomerular filtration, but also tubular secretion. 9-carboxymethoxy-methylguanine is the main metabolite of acyclovir and accounts for about 10-15% of the dose excreted in the urine. When acyclovir was administered 1 hour after taking 1 g of probenecid, the half-life of acyclovir and AUC (area under the concentration-time pharmacokinetic curve) increased by 18 and 40%, respectively.

Indications for use

— Treatment of infections of the skin and mucous membranes caused by the herpes simplex virus, including primary and recurrent genital herpes;

- prevention of relapses of infections caused by the herpes simplex virus in patients with normal immune status;

- prevention of infections caused by the herpes simplex virus in patients with immunodeficiency;

- treatment of chickenpox and herpes zoster (early treatment of herpes zoster with acyclovir has an analgesic effect and can reduce the incidence of postherpetic neuralgia).

Use during pregnancy and lactation.

Fertility

There is no data on the effect of acyclovir on female fertility.

A study of 20 male patients with normal sperm counts found that oral acyclovir up to 1 g per day for 6 months had no clinically significant effect on sperm count, motility or morphology.

Pregnancy

The post-registration registry of pregnancies during treatment with acyclovir collected data on pregnancy outcomes in women taking acyclovir in different dosage forms. In an analysis of registry data, there was no increase in the number of birth defects in infants whose mothers took acyclovir during pregnancy compared with the general population. The identified birth defects were not uniform or consistent, suggesting a common cause.

However, caution should be exercised when prescribing Acyclovir to women during pregnancy and assess the expected benefit to the mother and the possible risk to the fetus.

Breastfeeding period

After taking the drug Acyclovir orally at a dose of 200 mg 5 times a day, acyclovir was determined in breast milk at a concentration ranging from 60 to 410% of the plasma concentration. At such concentrations in breast milk, breastfed infants can receive acyclovir in doses up to 0.3 mg/kg/day. Given this, caution should be exercised when prescribing Acyclovir to nursing women.

Overdose

Acyclovir is only partially absorbed from the gastrointestinal tract. As a rule, no toxic effects have been reported with a random single dose of acyclovir up to 20 g. With repeated oral doses over several days of doses exceeding the recommended ones, disturbances from the gastrointestinal tract (nausea, vomiting) and nervous system (headache and confusion) were observed. Sometimes neurological effects such as seizures and coma may occur.

Patients require careful medical monitoring to identify possible symptoms of intoxication. Acyclovir is eliminated from the body by hemodialysis, so hemodialysis can be used to treat overdose.