Acyclovir, eye ointment 3%, 5 g

Acyclovir J

Treatment of infections caused by herpes simplex virus (HSV)

Acyclovir J should be administered as a slow intravenous infusion over 1 hour.

The course of treatment with Acyclovir J, lyophilisate for solution for infusion, is usually 5 days, but may vary depending on the patient's condition and response to therapy. The duration of treatment for herpetic encephalitis is usually 10 days.

The duration of treatment for herpes in newborns is usually 14 days in the case of infection of the skin and mucous membranes (eyes, mouth) and 21 days in the case of disseminated lesions or damage to the central nervous system.

Adults

For obese patients, calculating the dose of intravenous acyclovir based on actual body weight may result in higher plasma acyclovir concentrations. Therefore, the need to reduce the dose should be considered in obese patients, especially in elderly patients or with impaired renal function.

Patients with infection caused by HSV (except herpetic encephalitis) are prescribed Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 5 mg/kg body weight every 8 hours, provided there is no impairment of renal function.

Patients with herpetic encephalitis are prescribed the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 10 mg/kg body weight every 8 hours, provided there is no impairment of renal function.

Children from 12 to 18 years old

In children aged 12 to 18 years, the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, should be used in the dosage regimen indicated for adults.

Children from 3 months to 12 years

The dose calculation of Acyclovir J, lyophilisate for preparing a solution for infusion, in children aged 3 months to 12 years is carried out depending on the body surface area.

Children from 3 months to 12 years with an infection caused by HSV (except herpetic encephalitis) are prescribed the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 250 mg/m2 of body surface every 8 hours, provided there is no impairment of renal function.

Children from 3 months to 12 years with herpetic encephalitis are prescribed the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 500 mg/m2 of body surface every 8 hours, provided there is no impairment of renal function.

In children with reduced renal function, dose adjustment is required according to the degree of renal impairment.

Children from 29 days of life to 3 months

In children aged 29 days to 3 months, the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, should be used in the dosage regimen indicated for newborns.

Newborns (children up to 28 days of life inclusive)

In newborns, doses are determined depending on body weight.

The recommended dose of the drug Acyclovir J, lyophilisate for the preparation of a solution for infusion, for newborns with herpes or suspected herpes is 20 mg/kg body weight every 8 hours for 21 days in the case of disseminated lesions and damage to the central nervous system or for 14 days in the case of disease , limited to damage to the skin and mucous membranes. For patients with reduced renal function, the prescribed dose should be adjusted according to the degree of renal impairment.

Elderly patients

The possibility of renal impairment in elderly patients must be taken into account, and doses should be adjusted according to the degree of renal impairment.

Adequate levels of body hydration should be maintained.

Patients with impaired renal function

Acyclovir J, a lyophilisate for solution for infusion, should be administered with caution to patients with reduced renal function.

Adequate levels of body hydration should be maintained.

Dose adjustment for patients with impaired renal function is based on creatinine clearance, which for adults and children over 12 years of age is presented in units of ml/min, for newborns, children from 29 days of life to 3 months, children from 3 months to 12 years - ml /min/1.73 m2.

Dose adjustment schemes:

Table 1. Dose adjustment scheme for the treatment of infections caused by HSV for children over 12 years of age and adults with impaired renal function

Table 2. Dose adjustment scheme for the treatment of infections caused by HSV in newborns, children from the 29th day of life to 3 months, children from 3 months to 12 years with impaired renal function

Prevention of herpes simplex virus (HSV) infections in immunocompromised patients

Acyclovir J should be administered as a slow intravenous infusion over 1 hour.

The duration of prophylactic use of the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, is determined by the duration of the period of risk of infection.

Adults

For obese patients, calculating the dose of intravenous acyclovir based on actual body weight may result in higher plasma acyclovir concentrations. Therefore, the need to reduce the dose should be considered in obese patients, especially in elderly patients or with impaired renal function. Treatment regimens are the same as for the treatment of infections caused by HSV.

Children from 12 to 18 years old

In children aged 12 to 18 years, the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, should be used in the dosage regimen indicated for adults.

Children from 3 months to 12 years

The dose calculation of Acyclovir J, lyophilisate for preparing a solution for infusion, in children aged 3 months to 12 years is carried out depending on the body surface area.

Treatment regimens are the same as for the treatment of infections caused by HSV.

In children from 3 months to 12 years with reduced renal function, dose adjustment is required according to the degree of renal impairment.

Elderly patients

It is necessary to take into account the likelihood of renal impairment in elderly patients, the dose of the drug should be adjusted in accordance with the degree of renal impairment.

Adequate levels of body hydration should be maintained.

Patients with impaired renal function

Acyclovir J, a lyophilisate for solution for infusion, should be administered with caution to patients with impaired renal function.

Adequate levels of body hydration should be maintained.

The dose for patients with impaired renal function should be adjusted according to Table 1 or 2.

Treatment of infections caused by the varicella zoster virus (VZV, Varicella zoster virus),

including chickenpox and herpes zoster

Acyclovir J should be administered as a slow intravenous infusion over 1 hour.

The course of treatment with Acyclovir J, lyophilisate for solution for infusion, is usually 5 days, but may vary depending on the patient's condition and response to therapy.

Adults

For obese patients, calculating the dose of intravenous acyclovir based on actual body weight may result in higher plasma acyclovir concentrations. Therefore, the need to reduce the dose should be considered in obese patients, especially in elderly patients or with impaired renal function.

Patients with VZV infections are prescribed Acyclovir J, a lyophilisate for solution for infusion, at a dose of 5 mg/kg body weight every 8 hours, provided there is no impairment of renal function.

Patients with immunodeficiency and infections caused by VZV are prescribed the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 10 mg/kg body weight every 8 hours, provided there is no impairment of renal function.

Children from 12 to 18 years old

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children aged 12 to 18 years, the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, should be used in the dosage regimen indicated for adults.

Children from 3 months to 12 years

The dose calculation of Acyclovir J, lyophilisate for preparing a solution for infusion, in children aged 3 months to 12 years is carried out depending on the body surface area.

Children from 3 months to 12 years with infection caused by VZV are prescribed the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 250 mg/m2 of body surface every 8 hours, provided there is no impairment of renal function.

Children from 3 months to 12 years with immunodeficiency and infections caused by VZV are prescribed the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, at a dose of 500 mg/m2 of body surface every 8 hours, provided there is no impairment of renal function.

Children from 3 months to 12 years with impaired renal function require dose adjustment in accordance with the degree of impaired renal function (see Table 2).

Elderly patients

The possibility of renal impairment in elderly patients must be taken into account, and the dose should be adjusted according to the degree of renal impairment.

Adequate levels of body hydration should be maintained.

Patients with impaired renal function

Acyclovir J, a lyophilisate for solution for infusion, should be administered with caution to patients with impaired renal function.

Adequate levels of body hydration should be maintained.

Doses in patients with impaired renal function should be adjusted according to Table 1 or 2.

Prevention of cytomegalovirus (CMV) infection in bone marrow transplant recipients

Acyclovir J should be administered as a slow intravenous infusion over 1 hour.

The duration of prophylactic use of the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, is determined by the duration of the period of risk of infection.

Adults

For obese patients, calculating the dose of intravenous acyclovir based on actual body weight may result in higher plasma acyclovir concentrations. Therefore, the need to reduce the dose should be considered in obese patients, especially in elderly patients or with impaired renal function. For the prevention of CMV in bone marrow transplant recipients, the drug Acyclovir J, a lyophilisate for the preparation of a solution for infusion, is prescribed at a dose of 500 mg/m2 of body surface intravenously 3 times a day with an interval of 8 hours, provided there is no impairment of renal function. The duration of treatment is from 5 days before transplantation to 30 days after transplantation.

Children from 12 to 18 years old

In children aged 12 to 18 years, the drug Acyclovir J, lyophilisate for the preparation of solution for infusion, should be used in the dosage regimen indicated for adults.

Children from 3 months to 12 years

The dose calculation of Acyclovir J, lyophilisate for preparing a solution for infusion, in children aged 3 months to 12 years is carried out depending on the body surface area.

Limited data suggest that in children over 2 years of age who have undergone bone marrow transplantation, the dose indicated for adults can be used to prevent CMV infection.

In children from 3 months to 12 years with impaired renal function, dose adjustment is required in accordance with the degree of impaired renal function.

Elderly patients

The possibility of renal impairment in elderly patients must be taken into account, and the dose should be adjusted according to the degree of renal impairment.

Adequate levels of body hydration should be maintained.

Patients with impaired renal function

Acyclovir J, a lyophilisate for solution for infusion, should be administered with caution to patients with impaired renal function.

Adequate levels of body hydration should be maintained.

Doses in patients with impaired renal function should be calculated according to Table 3 for children from 12 years of age and adults and Table 4 for children from 3 months to 12 years.

Table 3. Dose adjustment scheme for the prevention of CMV infection for children over 12 years of age and adults with impaired renal function

Table 4. Dose adjustment scheme for the prevention of CMV infection for children from 3 months to 12 years with impaired renal function

Preparation of solution and method of administration

The recommended dose of Acyclovir J should be administered as a slow intravenous infusion over 1 hour.

To prepare a solution for infusion, the contents of the bottle with Acyclovir J are restored by adding water for injection or sodium chloride solution for injection (0.9%) to obtain a solution containing 25 mg of acyclovir in 1 ml.

The volume of infusion solution indicated in the table must be added to the bottle with the appropriate amount of lyophilisate of the drug Acyclovir J and shaken carefully until the contents of the bottle are completely dissolved.

After dilution, the solution of the drug Acyclovir J can be administered as an intravenous infusion using a special infusion pump that regulates the rate of administration.

As an alternative method of preparation, the reconstituted solution of Acyclovir J is further diluted to obtain an acyclovir concentration not exceeding 5 mg/ml (0.5%).

To do this, you need to add the reconstituted solution of the drug to the selected infusion solution (options for recommended infusion solutions are given below) and shake well until completely mixed.

For children and newborns who need to administer minimal volumes of infusions, it is recommended to add 4 ml of a reconstituted solution of Acyclovir J (100 mg of acyclovir) to 20 ml of infusion solution when diluting.

For adults, it is recommended to use infusion solutions in 100 ml packages, even if the concentration of acyclovir is significantly lower than 0.5%. Thus, one package of 100 ml infusion solution can be used for any dose of acyclovir from 250 mg to 500 mg (10 and 20 ml of reconstituted solution). For doses from 500 mg to 1000 mg of acyclovir, two packages of infusion solution of this volume (100 ml) must be used.

With the specified dilution method, Acyclovir J, lyophilisate for solution for infusion, is compatible with the following infusion solutions and remains stable for up to 12 hours at room temperature (15 to 25 °C):

- sodium chloride for intravenous infusion (0.45% and 0.9%);

- sodium chloride (0.18%) and dextrose (4%) for intravenous infusion;

- sodium chloride (0.45%) and dextrose (2.5%) for intravenous infusion;

- Hartmann's solution.

When preparing Acyclovir J solution for infusion according to the scheme indicated above, the concentration of acyclovir is no more than 0.5%.

When reconstituted as recommended, the pH of Acyclovir J solution for infusion is approximately 11.

Reconstitution and dilution must be carried out under completely aseptic conditions immediately before administration of the drug, since the drug does not contain antimicrobial preservatives. Unused solution is discarded.

Reconstituted and diluted solutions should not be frozen.

If the solution becomes cloudy or crystals appear before or during infusion, the solution should be discarded.

Acyclovir, eye ointment 3%, 5 g

Manufacturer

Sintez OJSC, Russia

Compound

1 g of eye ointment contains:
active ingredient:

acyclovir 30 mg;

excipient:

petrolatum.

pharmachologic effect

An antiviral (antiherpetic) drug is a synthetic analogue of thymidine nucleoside. In virus-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. 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, integrating into the deoxyribonucleic acid (DNA) synthesized by the virus, blocks the reproduction of the virus. The specificity and very high selectivity of the action of acyclovir 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 (MIC) of acyclovir). Moderately active against cytomegalovirus (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. Pharmacokinetics
Acyclovir easily penetrates the corneal epithelium and creates a therapeutic concentration in the intraocular fluid. Currently, there are no methods for determining acyclovir in the blood when used as an eye ointment. When used externally, acyclovir is detected only in urine, and in small quantities. This concentration has no therapeutic value.

Indications

Herpetic keratitis caused by Herpes simplex virus types 1 or 2.

Use during pregnancy and breastfeeding

The use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Acyclovir crosses the placental barrier and accumulates in breast milk. If it is necessary to take acyclovir during lactation, interruption of breastfeeding is required.

For children, eye ointment in the form of a strip 1 cm long is placed in the lower conjunctival sac 5 times a day (every 4 hours) until healing.

Treatment is continued for another 3 days after healing.

Contraindications

• Breastfeeding period;
• hypersensitivity to acyclovir or valacyclovir.

Side effects

Side effects are given in accordance with the frequency of occurrence during clinical trials: very often (>10%); often (>1% and <10%); uncommon (>0.1% and <1%); rare (>0.01% and <0.1%); very rare (<0.01%).

Allergic reactions: very rarely - immediate hypersensitivity reactions (including angioedema).

On the part of the organ of vision: infrequently - punctate superficial keratopathy (does not require cessation of treatment and disappears without consequences); often – a slight burning sensation (passing over time); uncommon – conjunctivitis; rarely – blepharitis.

Interaction

Use together with immunostimulants enhances the effect of acyclovir.

How to take, course of administration and dosage

For adults and children, eye ointment in the form of a strip 1 cm long is placed in the lower conjunctival sac 5 times a day (every 4 hours) until healing.

Treatment is continued for another 3 days after healing.

Overdose

Overdose is possible if accidentally swallowed.

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

Treatment: maintenance of vital functions, hemodialysis.

Special instructions

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

Wearing contact lenses is not recommended during treatment with acyclovir ophthalmic ointment.

To realize the therapeutic effect of acyclovir, the state of the body's immune system is important. Patients with reduced immunity against the background of topical use of acyclovir ointment should be prescribed systemic administration of the drug, as well as in the case of severe and recurrent herpetic infection.

Impact on the ability to drive vehicles and operate machinery

After using the drug, a temporary decrease in the clarity of visual perception is possible, and until it is restored, it is not recommended to drive a car or engage in activities that require increased attention and reaction.

Release form

Acyclovir eye ointment. Ointment for topical use

Storage conditions

Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 15°C.

Best before date

3 years. After opening the tube, the eye ointment should be used within 1 month.

Active substance

Acyclovir

Conditions for dispensing from pharmacies

On prescription

Dosage form

ointment

Purpose

Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Herpes, Inflammatory eye diseases, Colds

Information in the State Register of Medicines

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Barcode and weight

Barcode: 4602565018818, 4602565031039 Weight: 0.010 kg