BIOTSIKLOVIR-Biofarma

General characteristics. Structure:

Active ingredient: 1 bottle contains 250 mg or 500 mg of an acyclovir of sodium in a look (9-[marked (2-gidroksietoks)] a guanine of sodium salt).

Main physical and chemical properties: the lyophilized powder of white or almost white color.

Pharmacological properties:

Pharmacodynamics. Biotsiklovir – antiviral drug, active concerning a virus of a herpes simplex of types 1 and 2, a shingles virus. Has virostatichesky effect. After penetration into a cell which is infected with a virus the acyclovir under the influence of a thymidinekinase is transformed to an active acyclovir triphosphate. The last interacts with a virus DNA polymerase and is built in DNA which is synthesized for novy viruses. Thus defective virus DNA forms that leads to suppression of replication of novy generation of viruses.

Pharmacokinetics. The elimination half-life at persons with normal function of kidneys makes 2,9 h after intravenous administration. The most part of active agent is removed in not changed view with urine. Linkng with proteins of a blood plasma makes 9-33%. The only metabolite of an acyclovir is 9-karboksimetoksimetilguanin. At patients with a chronic renal failure the elimination half-life of an acyclovir increases. Concentration of active agent in cerebrospinal fluid makes about 50% of concentration in a blood plasma. Biotsiklovir well gets into fabrics, bodies and biological liquids of an organism: in a brain, kidneys, lungs, a liver, muscles, a spleen, a uterus, a mucous membrane of a vagina, a vaginal secret, medullispinal liquid and contents of herpetic bubbles. The pharmacokinetics at children is aged more senior than 1 year that is similar at adults.

Indications to use:

The infections caused by the Herpes simplex virus – primary herpes of generative organs recuring herpes of generative organs, herpetic encephalitis and generalized infections, herpes of skin and mucous membranes at patients with an immunodeficiency, herpes of newborns, other infections (herpetic eczema, hepatitis, a proctitis, an esophagitis, pneumonia);

prevention of the infections caused by the Herpes simplex virus – after a transplatation of marrow or a kidney, at a marrow aplasia after treatment by cytostatic drugs; recurrent herpes of generative organs (with a frequency of 6 times a year and more); frequent recurrent infections at patients with the normal immune status; infections at patients with an immunodeficiency;

the infections caused by the Varicella zoster virus – chicken pox at patients with an immunodeficiency; severe or long forms of chicken pox at patients with the normal immune status; the complications at chicken pox caused by direct action of the Varicella zoster virus, shingles in patients with an immunodeficiency; the complications at shingles caused by direct action of the Varicella zoster virus; eye and ear forms of shingles; shingles at persons is more senior than 50 years.

Route of administration and doses:

To administer the drug intravenously. Introduction duration not less than 1 hour.

Doses for newborns: 10 mg/kg every 8th hour.

 Before use drug should be dissolved in 10 ml of water for injections or isotonic solution of sodium of chloride; to enter by means of the infusional pump. For preparation of infusion solution the drug ex tempore is dissolved in 100 ml of isotonic solution of sodium of chloride or lactat solution of Ringer; in need of introduction of the dose exceeding 500 mg add adequate amount of solvent.

Preparation of infusion solution for children for whom doses on 10 mg and are necessary below is carried out in two stages; at first contents of a bottle are dissolved in 10 ml of water for injections or isotonic solution of sodium of chloride, and then the necessary amount of the received solution (corresponding to a dose) is added to infusion solution in the ratio 1:5 (for example, 4 ml to 20 ml).

Drug does not contain preservatives. Ready solution is steady during 12 h at ^{a temperature from 15 ° C to 25 ° C}. It is impossible to use solution in which opacification appeared or crystals were formed.

 Water for injections should not contain preservatives (benzyl alcohol or parabens).

Features of use:

At too bystry intravenous administration of a biotsiklovir and dehydration of an organism temporary increase in level of urea and creatine in blood serum therefore injection should be carried out slowly can be observed and to provide sufficient hydration of an organism.

Treatment biotsikloviry should be begun as soon as possible, at an opportunity during the premonitory period of a disease. Drug should be used with care. At a renal failure, to elderly people, and also at purpose of high doses, especially to patients with dehydration. The dose should be korregirovat taking into account clearance of creatinine. Use of a biotsiklovir during pregnancy is possible only according to vital indications. Active agent gets into breast milk therefore for the period of treatment the patient has to stop feeding by a breast.

Side effects:

The acute renal failure at use of drug is observed very seldom. At development of damage of kidneys during treatment biotsikloviry it is necessary to appoint adequate hydration, to lower a dose of drug or to stop treatment.

Neurologic symptoms (were seldom observed only at treatment of the complicated disease forms) which had reversible character: spasms, confusion of consciousness, hallucination, tremor, drowsiness, psychoses, coma. Nausea, vomiting, rash, increase in activity of liver enzymes, anemia, a neutropenia, thrombocytopenia can be also noted. 

Interaction with other medicines:

Probenetsid at simultaneous use increases concentration of a biotsiklovir in a blood plasma and extends the period of its semi-removal. Simultaneous use of a biotsiklovir and mikofenolat of a mofetil leads to increase in concentration of both ingredients in a blood plasma.

Contraindications:

Hypersensitivity to drug.

Overdose:

Single intravenous administration in a dose of 30 mg/kg does not cause overdose signs. It is recommended to control a functional condition of kidneys. It is important to support a sufficient diuresis for the prevention of a crystalluria. It is necessary to carry out active hydration of an organism. Biotsiklovir is brought from an organism at a hemodialysis, peritoneal dialysis is less effective.

Storage conditions:

To store at a temperature not above 25 °C. Ready infusion solution is stable within 12 hours at a temperature from 15 °C to 25 °C. Solution should not be stored in the refrigerator. A period of validity – 4 years.

Issue conditions:

According to the recipe

Packaging:

On 250 mg in a bottle No. 1.