Acyclovir Hexal: acyclovir hexal cream instructions for use. Special instructions for use. Description of pharmacological action

In this article you can read the instructions for use of the drug Acyclovir. Feedback from site visitors - consumers - is presented of this medicine, as well as the opinions of specialist doctors on the use of Acyclovir in their practice. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications were observed and side effects, perhaps not stated by the manufacturer in the annotation. Acyclovir analogues, if available structural analogues. Use for the treatment of oral and genital herpes in adults, children, as well as during pregnancy and lactation. Trade marks various options acyclovir: Acri, HEXAL, AKOS.

Acyclovir- antiviral drug, synthetic analogue thymidine nucleoside, which has a highly selective effect on herpes viruses. Inside infected with the virus cells under the influence of viral thymidine kinase undergoes a series of sequential reactions of transformation of acyclovir into mono-, di- and triphosphate of acyclovir. Acyclovir triphosphate is incorporated into the viral DNA chain and blocks its synthesis through competitive inhibition of viral DNA polymerase.

The specificity and very high selectivity of action are also due to its predominant accumulation in cells affected by the herpes virus. Highly active against Herpes simplex virus types 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 case of herpes, it 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.

Pharmacokinetics

After oral administration, bioavailability is 15-30%, which creates dose-dependent concentrations sufficient for effective treatment viral diseases. Food does not have a significant effect on the absorption of acyclovir. Acyclovir penetrates well into many organs, tissues and body fluids. Acyclovir penetrates the blood-brain and placental barriers and accumulates in breast milk. About 84% is excreted unchanged by the kidneys, 14% in the form of a metabolite. Less than 2% of acyclovir is excreted from the body through the intestines.

Indications

treatment of infections of the skin and mucous membranes caused by Herpes simplex viruses types 1 and 2 (genital and oral herpes), both primary and secondary, including genital herpes;
prevention of exacerbations of recurrent infections caused by Herpes simplex types 1 and 2 in patients with normal immune status;
prevention of primary and recurrent infections caused by Herpes simplex viruses types 1 and 2 in patients with immunodeficiency;
as part of complex therapy patients with severe immunodeficiency: with HIV infection (stage AIDS, early clinical manifestations and a detailed clinical picture) and in patients who have undergone transplantation bone marrow;
treatment of primary and recurrent infections caused by the Varicella zoster virus (chickenpox, as well as herpes zoster).

Release forms

Tablets 200 mg.

Ointment for external use 5%.

Cream for external use 5%.

Eye ointment 3%.

Lyophilisate for preparing a solution for infusion (in injections).

Instructions for use and dosage

Acyclovir is taken during or immediately after a meal and washed down with plenty of water. The dosage regimen is set individually depending on the severity of the disease.

Treatment of skin and mucous membrane infections caused by Herpes simplex types 1 and 2

Adults

Acyclovir is prescribed 200 mg 5 times a day for 5 days at 4-hour intervals during the day and at 8-hour intervals at night. In more severe cases disease, the course of treatment can be extended as prescribed by a doctor up to 10 days. As part of complex therapy for severe immunodeficiency, incl. when deployed clinical picture HIV infections, including early clinical manifestations of HIV infection and the stage of AIDS; after bone marrow transplantation or if absorption from the intestine is impaired, 400 mg is prescribed 5 times a day.

Treatment should begin as soon as possible after infection occurs; for relapses, acyclovir is prescribed in the prodromal period or when the first elements of the rash appear.

Prevention of recurrence of infections caused by Herpes simplex types 1 and 2 in patients with normal immune status

The recommended dose is 200 mg 4 times a day (every 6 hours) or 400 mg 2 times a day (every 12 hours). In some cases, more effective low doses- 200 mg 3 times a day (every 8 hours) or 2 times a day (every 12 hours).

Prevention of infections caused by Herpes simplex types 1 and 2 in patients with immunodeficiency.

The recommended dose 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 dose is increased to 400 mg 5 times a day. The duration of the preventive course of therapy is determined by the duration of the period of existence of the risk of infection.

Treatment of infections caused by the Varicella zoster virus (chickenpox)

Adults

Prescribe 800 mg 5 times a day every 4 hours during the day and at 8-hour intervals at night. The duration of treatment is 7-10 days.

Children

Prescribed 20 mg/kg 4 times a day for 5 days (maximum single dose 800 mg), children from 3 to 6 years old: 400 mg 4 times a day, over 6 years old: 800 mg 4 times a day within 5 days.

Treatment should begin at the earliest signs or symptoms appear chickenpox.

Treatment of infections caused by the Herpes zoster virus (shingles)

Adults

Prescribe 800 mg 4 times a day every 6 hours for 5 days. For children over 3 years of age, the drug is prescribed in the same dose as for adults.

Treatment and prevention of infections caused by Herpessimplex types 1 and 2 in patients childhood with immunodeficiency and normal immune status.

Children from 3 years to 6 years - 400 mg; over 6 years old - 800 mg 4 times a day. A more precise dose is determined at the rate of 20 mg/kg body weight, but not more than 800 mg. The course of treatment is 5 days. Data on the prevention of recurrence of infections caused by the herpes simplex virus and the treatment of herpes zoster in children with normal indicators no immunity.

For treatment children over 3 years of age, 800 mg of acyclovir is prescribed 4 times a day every 6 hours (as for the treatment of adults with immunodeficiency).

In old age, there is a decrease in the clearance of acyclovir in the body in parallel with a decrease in creatinine clearance. Those taking large doses of the drug orally should receive sufficient fluids. At renal failure it is necessary to decide on reducing the dose of the drug.

Side effect

nausea, vomiting, diarrhea;
abdominal pain;
a slight increase in the concentration of urea and creatinine;
leukopenia, erythropenia, anemia, thrombocytopenia;
headache;
dizziness;
agitation, confusion, drowsiness;
tremor;
hallucinations;
convulsions;
dyspnea;
anaphylactic reactions;
skin rash, itching, urticaria;
fatigue;
fever;
myalgia.

Contraindications

lactation period;
children under 3 years of age (for this dosage form).

Use during pregnancy and breastfeeding

Acyclovir crosses the placental barrier and accumulates in breast milk. The use of the drug 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 is required. breastfeeding.

special instructions

Acyclovir is used strictly as prescribed by a doctor to avoid complications in adults and children over 3 years of age.

Duration or re-treatment acyclovir in patients with reduced immunity can lead to the emergence of strains of viruses that are insensitive to its action. Most identified 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.

The drug is prescribed with caution to patients with impaired renal function and elderly patients due to an increase in the half-life of acyclovir.

When using the drug, it is necessary to ensure the supply of a sufficient amount of fluid.

When taking the drug, kidney function should be monitored (blood urea and plasma creatinine concentrations). 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. It is necessary to inform patients about the possibility of transmission of the genital herpes virus during the period of rash, as well as about cases of asymptomatic virus carriage.

Impact on the ability to drive vehicles and operate machinery

No data. However, it should be borne in mind that dizziness may develop during treatment with acyclovir, so care must be taken when driving vehicles and doing potentially dangerous activities. dangerous species activities requiring increased concentration attention and speed of psychomotor reactions.

Drug interactions

An increase in the effect of acyclovir is observed with the simultaneous administration of immunostimulants.

At simultaneous administration with nephrotoxic drugs, the risk of developing renal dysfunction increases.

Analogues of the drug Acyclovir

Structural analogues of the active substance:

Acigerpin;
Acyclovir Belupo;
Acyclovir HEXAL;
Acyclovir Sandoz;
Acyclovir forte;
Acyclovir-AKOS;
Acyclovir-Acri;
Acyclovir-Ferein;
Acyclostad;
Vero-Acyclovir;
Vivorax;
Virolex;
Gervirax;
Gerpevir;
Herperax;
Herpesin;
Zovirax;
Lisavir;
Medovir;
Provirsan;
Supraviran;
Cyclovax;
Cyclovir;
Citivir.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

(aciclovir | acyclovir)

Registration number

Trade name: ACYCLOVIR HEXAL

International generic name acyclovir

Dosage form– cream for external use

Compound
1 g of cream contains:
Active substance: acyclovir - 50 mg
Excipients: macrogol and fatty acids ether (Arlaton 983S), dimethicone 350, cetyl alcohol, white petrolatum, liquid paraffin, propylene glycol, purified water.

Description
A homogeneous cream of white or almost white color.
Pharmacotherapeutic group. Antiviral agent.

ATX code. D06ВВ03.

Pharmachologic effect. Acyclovir is active against Herpes simplex types 1 and 2, Varicella zoster virus, Epstein Barr virus and cytomegaloviruses. Thymidine kinase of virus-infected cells, through a series of sequential reactions, actively converts acyclovir into mono-, di- and triphosphate of acyclovir. The latter interacts with viral DNA polymerase and is integrated into the DNA that is synthesized for new viruses. Thus, “defective” viral DNA is formed, which leads to the suppression of the replication of new generations of viruses.

Pharmacokinetics. When used topically, it is practically not absorbed through intact skin and is not detected in the blood or urine. When applied to affected skin, absorption is moderate; in patients with normal function kidney concentration in the blood serum is up to 0.28 mcg/ml, in patients with chronic renal failure – up to 0.78 mcg/ml. Excreted by the kidneys (up to 9.4% of the daily dose).

Indications for use
Skin infections caused by Herpes simplex virus types 1 and 2, including genital and labial herpes, herpes zoster, chickenpox.

Contraindications
Hypersensitivity to acyclovir and other components of the drug.
With caution - pregnancy, lactation, dehydration, renal failure.

Pregnancy and lactation
Adequate and controlled clinical trials The safety of the drug during pregnancy has not been studied. Use is indicated only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
During the treatment period, it is necessary to decide whether to stop breastfeeding.

Directions for use and doses
Externally. The drug is applied 5 times a day (every 4 hours) in a thin layer to the affected and adjacent areas of the skin. The cream is applied either with a cotton swab or with clean hands to avoid additional infection of the affected areas. Therapy should be continued until a crust forms on the blisters or until they are completely healed. The duration of therapy is on average 5 days and should not exceed 10 days.

Side effects
Hyperemia, dryness, peeling of the skin; burning, inflammation upon contact with mucous membranes. Allergic dermatitis may develop.

Interaction with other drugs
When used externally, no interaction with other medicines. An enhanced effect is observed with the simultaneous administration of immunostimulants.

special instructions
To achieve maximum therapeutic effect it is necessary to start using the drug as soon as possible after the onset of infection (at the first signs of the disease: burning, itching, tingling, feeling of tension and redness).
The cream is not recommended to be applied to the mucous membranes of the mouth and eyes, as severe local inflammation. When treating genital herpes, you should avoid sexual intercourse or use condoms, since the use of acyclovir does not prevent transmission of the virus to partners.

Release forms
Cream for external use 5%.
2 g or 5 g in an aluminum tube, the neck of the tube is sealed with a protective aluminum membrane and closed with a screw-on plastic cap with a recessed pin.
1 tube (with 2 g of the drug) in a cardboard box along with instructions for use.
1.4 tubes (with 5 g of the drug) in a cardboard box along with instructions for use

Storage conditions
At a temperature not higher than 25 °C.
Keep out of the reach of children.

Best before date
4 years.
Do not use the drug after the expiration date indicated on the package!

Release from pharmacies
Without a doctor's prescription.

Manufacturer
HEXAL AG, manufactured by Salutas Pharma GmbH, 83607 Holzkirchen, Industrialstrasse 25, Germany. HEXAL AG, manufactured by Salutas Pharma GmbH, Germany, 83607 Holzkirchen, Industriestrasse 25.

Consumer complaints should be sent to:
121170 Moscow, st. Kulneva, 3

Acyclovir Hexal release form, composition and packaging

Cream for external use 5% white or almost white, homogeneous.

1 g acyclovir 50 mg.

Excipients: macrogol and fatty acid ester (Arlaton 983S), dimethicone 350, cetyl alcohol, white petrolatum, liquid paraffin, propylene glycol, purified water.

Clinical and pharmacological group: Antiviral drug for external use.

The drug Acyclovir Hexal pharmacological action

The antiviral drug is a synthetic analogue of thymidine nucleoside. In infected cells containing viral thymidine kinase, phosphorylation occurs and is converted to acyclovir monophosphate. Under the influence of acyclovir guanylate cyclase, monophosphate is converted into diphosphate and, under the action of several cellular enzymes, into triphosphate. High selectivity of action and low toxicity to humans are due to the absence of the necessary enzyme for the formation of acyclovir triphosphate in intact cells of the macroorganism. Acyclovir triphosphate, “incorporating” into the DNA synthesized by the virus, blocks the reproduction of the virus. The specificity and very high selectivity of the action are also due to its predominant accumulation in cells affected by the herpes virus. Highly active against Herpes simplex virus types 1 and 2; the virus that causes chickenpox and herpes zoster (Varicella zoster); Epstein-Barr virus (types of viruses are indicated in increasing order of the MIC value of acyclovir). Moderately active against CMV. In case of herpes, it 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. Has an immunostimulating effect.

Acyclovir Hexal cream indications

Cream and ointment for external use

herpes simplex of the skin and mucous membranes,

genital herpes (primary and recurrent),

localized herpes zoster (auxiliary treatment).

Eye ointment

herpetic keratitis

Medicine Acyclovir Hexal dosage regimen

Cream or ointment is applied to the affected areas 4-6 times a day (as early as possible after the onset of infection).

It is important to begin treatment for a recurrent infection during the prodromal phase or at the very beginning of the infection.

The duration of treatment is at least 5 days, maximum 10 days.

The eye ointment is squeezed out with a 1 cm long tape and placed in the lower conjunctival sac 5 times a day (every 4 hours).

Treatment is continued for at least 3 days after healing.

Acyclovir Hexal side effects

When used externally - pain, burning, itching, skin rash, vulvitis. When using eye ointment - burning at the application site, blepharitis, conjunctivitis, superficial keratopathy.

Ointment, cream Acyclovir Hexal contraindications

hypersensitivity.

With caution. Pregnancy, lactation period.

Acyclovir Hexal during pregnancy and lactation

The drug is used with caution.

Acyclovir Hexal special instructions

Acyclovir cream for cutaneous application should not be applied to the mucous membranes of the mouth, nose, eyes and vagina.

Acyclovir ointment is effective for preventing relapses of herpes lips.

The earlier it is started (at the first signs of infection), the higher the effectiveness of treatment.

For implementation therapeutic effect acyclovir status matters immune system body.

Patients with reduced immunity (HIV/AIDS or after bone marrow transplantation) due to local application acyclovir ointment should be prescribed systemic administration of the drug, as in the case of severe and recurrent course herpetic infection. A 1.25 cm strip of ointment should be applied to 25 cm2 of affected skin.

To prevent autoinoculation on other areas of the skin, it is necessary to use finger caps or rubber gloves.

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.

Drug Acyclovir Hexal overdose

Symptoms: headache, neurological disorders, shortness of breath, nausea, vomiting, diarrhea, renal dysfunction, lethargy, convulsions, coma.

Treatment: life support important functions, hemodialysis.

Acyclovir Hexal drug interactions

When mixing solutions, it is necessary to take into account the alkaline reaction of acyclovir for intravenous administration (pH 11). An enhanced effect is observed with the simultaneous administration of immunostimulants. Tubular secretion blockers slow down the excretion of acyclovir administered intravenously (increase in T1/2 by 18%).

Acyclovir Hexal conditions and shelf life

Store at 8–25 °C.

Shelf life: 3 years.

Hexal Pharma GmbH (Germany)

pharmachologic effect

Antiviral.

It has a highly selective effect on herpes simplex viruses type 1 and 2, herpes zoster, Epstein-Barr and cytomegalovirus.

Easily passes through the corneal epithelium ( eye ointment) and creates a therapeutic concentration in the ocular fluid.

When used topically in the form of a cream, it is not absorbed into the systemic circulation.

Penetrates through the BBB and placental barrier, excreted in breast milk.

Has an immunostimulating effect.

Side effect

Headache, fatigue, neurological disorders, shortness of breath, nausea, vomiting, diarrhea, intestinal colic, increased body temperature, edema, lymphadenopathy, increased levels of bilirubin, urea, creatinine, transient increase in the activity of liver transaminases, allergic reactions as skin rash, itching.

With intravenous administration - agitation, impaired consciousness, lethargy, tremor, convulsions, hallucinations, psychosis, coma; reactions at the IV injection site - local inflammation, phlebitis.

When used externally - erythema, peeling, burning sensation, burn.

Indications for use

Primary and recurrent herpetic lesions skin and mucous membranes (including genital herpes), herpetic lesions in patients with immunodeficiency (treatment and prevention), herpes zoster, chicken pox, simple herpetic keratitis.

Contraindications

Hypersensitivity, breastfeeding.

Directions for use and dosage

In case of infection of the skin and mucous membranes caused by the herpes simplex virus, cream or ointment (5%) is applied to the affected surface 5 times a day for 5-10 days.

Overdose

Symptoms:

headache,
neurological disorders,
shortness of breath,
nausea, nausea
vomiting
diarrhea,
renal failure,
lethargy,
seizures,
coma.

Treatment:

maintaining vital functions,
hemodialysis.

Interaction

Probenecid slows down excretion (blocks tubular secretion).

special instructions

Restrictions on use:

Pregnancy.

To prevent crystallization in the tubular apparatus, it is recommended to take large quantity liquids.

Caution should be exercised in patients with psychoneurotic disorders, impaired renal and hepatic function, electrolyte disturbances, severe hypoxia.

More detailed information see instructions for use.

Acyclovir Hexal is an antiviral medicinal product for outdoor use. It has wide range actions against various pathogens of herpes infection and other infectious agents.

Indications for use

The instructions for use of the drug Acyclovir state that it can be used for the following conditions:

Infectious lesions skin that were caused by herpes simplex virus types 1 and 2, including the genital form and herpetic rashes on the face
Skin rashes caused by chickenpox
Herpes zoster type.

Composition of the drug

The main active ingredient is acyclovir, with a concentration of 50 mg/1g.

In addition, the composition includes polydimethylsiloxane 350, Arlaton 983S, ethyl, propylene glycol, liquid paraffin, white petroleum jelly, chemically purified water to compact the mass and long-term storage.

Medicinal properties

Acyclovir Hexal is a remedy for topical use with antiviral effect. The main ingredient is active against herpes simplex viruses type 1 and 2, cytomegalovirus, Epstein-Barr viruses and chickenpox. Thymidine kinase of cellular structures that are affected by a viral agent, after a series of specific transformations, is capable of converting acyclovir into its mono-, di- and triphosphate forms.

Acyclovir triphosphate binds with the DNA polymerase of the virus and is integrated into the DNA structure, which will be reproduced for new virus molecules. That is, viral DNA has been formed, but with a defect, and as a result, the replication process of new viral cells is inhibited.

When applied to healthy skin, absorption does not occur, and subsequent studies do not detect the drug in blood serum or urine. When applied to damaged areas of the skin, absorption is moderate and is excreted from the body through the kidneys.

Release forms

The release forms are as follows:

Mode of application

The drug should be used externally. The ointment or cream is applied in a thin layer to the affected area of the body, and can also be treated nearby tissues, up to 5 times a day. The product should be applied using cotton swab, if this is not at hand, then application is done with thoroughly washed hands in order to prevent the spread of infection to other parts of the body.

The course of treatment must be carried out until the bladder with serous contents has completely dried and a crust has formed, or until it has completely healed. Duration therapeutic treatment on average it lasts from 5 to 10 days; only a doctor can extend the course.

During pregnancy and pregnancy

During gestation and lactation, the drug is prescribed with extreme caution and only under the strict supervision of a physician: clinical trials No studies have been conducted regarding the effects of the active ingredient on the mother and fetus. During breastfeeding, if there is an urgent need to use the product, it is best to stop feeding the baby.

Contraindications

The main contraindication to the use of external forms of acyclovir is individual intolerance to the components of the drug, as well as possible allergic reactions.

WITH special attention and under the supervision of a doctor, the drug should be taken by expectant mothers and lactating mothers, with renal failure and dehydration.

Cross-drug interactions

External dosage forms acyclovir does not interact with other medications, but there is a slight increase in its effectiveness when used together with drugs from the group of immunostimulants.

Side effects

All adverse reactions, which are possible when using acyclovir, are observed on the skin. The most popular include:

Allergic type dermatitis
Redness of the skin
The skin becomes dry and begins to peel
Development of the inflammatory process.

Overdose

Cases of overdose with external forms of acyclovir have not been observed.

Conditions and shelf life

Analogs

Glaxo Smith Klein, UK

Price from 177 rub. up to 192 rub.

Cream for external use 5%. Available in the form of a cream, with a concentration active substance acyclovir 5%. The structure of the cream is homogeneous and has White color, packaged in aluminum tubes of 2 g.

Pros:

Another form of release is eye ointment.
Indications for use include possible use for genital herpes.

Minuses:

The volume of the tube is too small, which is not suitable for treating large areas of skin.

PJSC "Kievmedpreparat", Kiev, Ukraine

Price from 83 rub. up to 125 rubles, but for this moment the drug is not commercially available.

Ointment for external use 2.5%. Available in the form of an ointment, with a concentration of the active ingredient acyclovir of 2.5%. The ointment has a uniform structure and white color, packaged in aluminum tubes of 5 g and 15 g.

Pros:

Production of large tubes
Lower cost of the drug.

Minuses:

Low active ingredient content, only 2.5%
Cannot be used by children under 12 years of age.