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Gerpevir of a tablet

Препарат Герпевир таблетки. Arterium (Артериум) Украина

Producer: Arterium (Arterium) Ukraine

Code of automatic telephone exchange: J05AB01

Release form: Firm dosage forms. Tablets.

Indications to use: Chicken pox (Chicken pox). Genital herpes. Herpes infection (Herpes). (Deprive) the surrounding herpes.

General characteristics. Structure:

Active ingredient: 1 tablet of a soderzhitatsiklovir in terms of 100% substance of 200 mg or 400 mg;

auxiliary veshchestva:krakhmat potato, povidone, calcium stearate.

Pharmacological properties:

Pharmacodynamics. The acyclovir is a synthetic analog of a purine nucleoside with inhibitory activity concerning a virus of herpes of the person, includes a virus of a herpes simplex of I and II types, a virus of chicken pox and the surrounding herpes, Epstein-Burra's virus and a cytomegalovirus.

Inhibitory activity of an acyclovir against above-mentioned viruses is the high-selection. Enzyme the thymidinekinase in the normal not infected cell does not use an acyclovir as substrate therefore toxic action concerning cells of an organism owner is minimum. However the thymidinekinase coded in herpes simplex viruses, viruses of chicken pox, the surrounding herpes and Epstein-Burra's viruses turns an acyclovir on acyclovir monophosphate – an analog of a nucleoside which then turns consistently on diphosphate and triphosphate by means of cell enzymes. After embedding in virus DNA of an acyclovir triphosphate interacts with a virus DNA polymerase what the termination of synthesis of a chain of virus DNA is result of.

At long or repeated courses of treatment of heavy patients with the lowered immunity cases of the reduced sensitivity of separate virus strains which not always answer treatment with an acyclovir can come across. The majority of clinical cases of nonsensitivity connected with deficit of a virus thymidinekinase however are available messages on damage of a virus thymidinekinase and DNA. Interaction of separate viruses of a herpes simplex with an acyclovir can lead to formation of less sensitive strains also.

Use of the tableted acyclovir together with anti-retrovirus drugs reduces a lethality of patients with the developed HIV infection stage, and also, on condition of preliminary use within 1 month of an acyclovir for intravenous administration, reduces a lethality of patients after transplantation of marrow.

Pharmacokinetics. The acyclovir is only partially absorbed in intestines.

At adults the final elimination half-life at intravenous administration of an acyclovir makes about 2,9 hours. The majority of drug is removed in not changed look by kidneys. Drug removal by kidneys is carried out by not only glomerular filtering, but also tubular secretion.

9-karboksimetoksimetilguanin is the only important metabolite of an acyclovir and makes about 10-15% of the applied dose which can be defined in urine.

At patients with a chronic renal failure the average final level of semi-removal makes 19,5 hours. The average level of semi-removal of an acyclovir during a hemodialysis makes 5,7 hours. Acyclovir level in plasma during dialysis decreases approximately by 60%.

Concentration of drug in cerebrospinal liquid makes about 50% of the corresponding concentration in plasma. Level of linkng with proteins of a blood plasma rather low (from 9 to 33%) and at interaction with other medicines it does not change.

At simultaneous use of an acyclovir and zidovudine for treatment of HIV-positive patients no changes of pharmacokinetics of these drugs were revealed.

Pharmaceutical characteristics.

Main physical and chemical properties: tablets till 200 mg:bely or almost white colors, a round form with a flat surface, with a facet; tablets on 400 mg: white or almost white color, a round form with a flat surface, with a facet and risky.

Indications to use:

- Treatment of viral infections of skin and the mucous membranes caused by a herpes simplex virus including primary and recurrent genital herpes;

- prevention of a recurrence of the infections caused by a herpes simplex virus at patients with normal immunity;

- prevention of the infections caused by a herpes simplex virus at patients with an immunodeficiency;

- treatment of the infections caused by the Varicella zoster virus (chicken pox and the surrounding herpes);

- prevention and treatment of the infections caused by a herpes virus at patients with a heavy immunodeficiency, namely: with the developed HIV infection stage (quantity of CD4+ <200/mm3, including the patients sick with AIDS or with the AIDS-associated complexes) and after transplantation of marrow.

Route of administration and doses:

Adults

Treatment of the infections caused by a herpes simplex virus

For treatment of the infections caused by a virus of a herpes simplex, Gerpevir® appoint in a dose 200 mg of 5 times a day with a 4-hour interval, except for the night period. Treatment has to last 5 days, but at heavy primary infection can be prolonged up to 10 days.

For some patients with an immunodeficiency (for example, after transplantation of marrow) or for patients with reduced comprehensibility in intestines it is possible to double a dose to 400 mg or to apply the corresponding dose to intravenous administration.

Treatment needs to be begun as soon as possible after the beginning of development of an infection. In case of recurrent herpes it is better to begin treatment in a prodromal stage or after emergence of the first signs of damage of skin.

Prevention of a recurrence of the infections caused by a herpes simplex virus

At patients with normal immunity for prevention of a recurrence of the infections caused by a virus of a herpes simplex, the pill Gerpevir® is taken in a dose on 200 mg 4 times a day with a 6-hour interval or 400 mg by 2 times a day with a 12-hour interval.

Treatment will be effective even after reduction of a dose to 200 mg 3 times a day with a 8-hour interval or even to 2 times a day with a 12-hour interval.

At some patients radical improvement is observed after reception of a daily dose of 800 mg.

Duration of preventive use of an acyclovir depends on the frequency of a recurrence, is defined by risk period duration, but treatment should not exceed 6-12 months.

Prevention of developing of the infections caused by a herpes simplex virus

For prevention of the infections caused by a herpes simplex virus in patients with an immunodeficiency, the tablets Gerpevir® appoint in a dose 200 mg 4 times a day with a 6-hour interval. At patients with a considerable immunodeficiency (for example, after transplantation of marrow) or at patients with reduced comprehensibility in intestines it is possible to double a dose to 400 mg or to apply a corresponding dose to intravenous administration.

Duration of preventive use is defined by risk period duration.

Treatment of chicken pox and the surrounding herpes

For treatment of the infections caused by viruses of chicken pox and the surrounding herpes, it is necessary to take the pill Gerpevir® in a dose of 800 mg of 5 times a day with a 4-hour interval, except for the night period. Treatment has to last 7 days.

With a heavy immunodeficiency (for example, after transplantation of marrow) or the patient with reduced comprehensibility in intestines it is better for patient to apply intravenous administration.

Prevention and treatment of the infections caused by a herpes virus at patients with a considerable immunodeficiency

For treatment of patients with a considerable immunodeficiency it is necessary to accept 800 mg Герпевира® 4 times a day with a 6-hour interval. Intravenous therapy of Gerpevirom® for 1 month has to precede treatment of patients after transplantation of marrow.

Duration of treatment of patients after transplantation of marrow makes 6 months (from 1 to 7 months after transplantation). At patients with the developed HIV infection stage the course of treatment makes 12 months, for preservation of positive effect it is desirable to continue a course of treatment.

Children

For treatment and prevention of the infections caused by a herpes simplex virus, to children 2 years with an immunodeficiency are more senior it is possible to apply the same doses, as well as to adults.

For treatment of chicken pox to children aged from 6 years appoint 800 mg Герпевира® 4 times a day, to children aged from 2 up to 6 years – 400 mg 4 times a day. Duration of treatment makes 5 days.

For prevention (prevention of a recurrence) of the infections caused by a herpes simplex virus or for treatment of the infections caused by a virus of the surrounding herpes children with normal immunity have no special data on use of Gerpevira®.

Patients of advanced age

It is necessary to consider a possibility of a renal failure at patients of advanced age therefore the drug dose for them should be changed respectively. It is necessary to support the adequate level of hydration of an organism.

Renal failure

ГерпевирÒследует with care to appoint the patient with a renal failure. It is necessary to support the adequate level of hydration of an organism.

At treatment of the infections caused by a herpes simplex virus at patients with a renal failure the recommended peroral doses do not lead to accumulation of an acyclovir which level would exceed the safe level established for intravenous administration. However for patients with a heavy renal failure (clearance of creatinine less than 10 ml/min.) 2 times a day with an interval of about 12 hours are recommended to establish a dose of 200 mg.

At treatment of the infections caused by the Varicella zoster virus (chicken pox and the surrounding herpes) for patients with considerably reduced immunity it is recommended at a heavy renal failure (clearance of creatinine – less than 10 ml/min.) to establish a dose of 800 mg 2 times a day with approximately 12-hour interval, and for patients with a moderate renal failure (clearance of creatinine – within 10-25 ml/min.) – 800 mg 3 times a day with an interval about 8 hours.

At use of high peroral doses of an acyclovir it is necessary to support adequate hydration of these patients.

Features of use:

At use of Gerpevira® it is necessary to control function of kidneys (determination of level of an urea nitrogen in blood and creatinine in a blood plasma). The acyclovir is brought out of an organism mainly by renal clearance therefore to patients with a renal failure, and also the patient of advanced age with a high probability of a renal failure recommends reduction of a dose. These categories of patients concern to risk group on development of neurologic side reactions and therefore have to be under fixed control for identification of these side reactions. It is noted that these reactions have reversible character in case of the treatment termination by drug.

If at patients with herpes of generative organs for 1 week the state does not improve, it is necessary to consult with the doctor (patients with herpes of generative organs have an increased risk of development of cancer of neck of uterus therefore it is necessary to carry out Papanikolau's test for identification of initial changes of a neck of uterus once a year).

At treatment of genital herpes it is necessary to avoid sexual contacts.

At chicken pox therapy is more effective if to begin it for 24 hours after emergence of rash, typical for it.

Герпевир® it is possible to accept with food.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

It is necessary to take with caution drug to the persons managing motor transport or working with other mechanisms in connection with risk of development of possible undesirable reactions from a nervous system.

Side effects:

From blood and lymphatic системы:очень it is rare – anemia, thrombocytopenia, a leukopenia.

From a nervous sistemy:chasto – a headache, dizziness; very seldom – excitement, confusion of consciousness, a tremor, an ataxy, a dysarthtia, hallucinations, psychotic symptoms, spasms, drowsiness, encephalopathy, a coma.

The above-stated neurologic reactions are generally reversible and usually arise at use for treatment of patients with a renal failure or other risk factors.

From respiratory system: very seldom – an asthma.

From a digestive trakta:chasto – nausea, vomiting, diarrhea, an abdominal pain; seldom – anorexia.

From a gepatobilliarny sistemy:redko – reversible increase in level of bilirubin and liver enzymes; very seldom – jaundice, hepatitis.

From skin and hypodermic клетчатки:часто – an itch, rash (including a photosensitivity); infrequently – a small tortoiseshell, an allopecia (accurate communication with an acyclovir is not revealed).

From immune system: seldom – a Quincke's disease, an anaphylaxis.

From an urinary sistemy:redko – increase in level of urea and creatinine in a blood plasma; very seldom – an acute renal failure, kidney pain that can be associated with a renal failure.

General disturbances: very seldom – increased fatigue, fever.

Interaction with other medicines:

The acyclovir is allocated mainly in not changed look with kidneys by canalicular secretion therefore any medicines which have the similar mechanism of allocation can increase concentration of an acyclovir in a blood plasma.

At simultaneous use with probenetsidy or Cimetidinum drug removal is slowed down. At use with nefrotoksichny drugs nephrotoxic action can amplify, especially at renal failures.

At simultaneous use with immunosuppressants at treatment of patients after organ transplantation in a blood plasma the level of an acyclovir and inactive metabolite of immunosuppressive drug also increases, but owing to a wide therapeutic index of an acyclovir dose adjustment is not required.

Contraindications:

The increased individual sensitivity to an acyclovir, a valatsiklovir or to other components of drug.

Use during pregnancy or feeding by a breast.

Use of drug during pregnancy is possible in case the expected advantage for mother exceeds potential risk for a fruit. The acyclovir gets into breast milk therefore for treatment by drug feeding by a breast should be stopped.

Children. To children up to 2 years this dosage form drug is not used.