Geviran tablets 400 mg №30

Description Geviran tablets 400 mg №30

Pharmacological properties.

Geviran is an antiviral drug. It is active against herpes simplex virus (HSV-1 i HSV-2), varicella zoster (VZV) and to a lesser extent by the Epstein-Barr virus (EBV) and cytomegalovirus (CMV). When CMV phosphorylation of acyclovir in part by using a specific enzyme.

Pharmacokinetics

Suction.

Acyclovir is partially (15-30%) is absorbed in the small intestine. Food intake does not affect the absorption preparata.Maksimalnaya concentration Cmax after taking the drug at a dose of 800 mg 702.44 mg / l after tmax 1,7 h.

Distribution

Acyclovir is widely distributed in tissues and body fluids, brain, kidney, salivary, lung, liver, muscle, spleen, uterus, vaginal mucosa and vaginal secretions, cerebrospinal fluid and the fluid herpes blisters, as well as in semen, reaching a concentration of approximately 1.4 and 4 times higher than in plasma after oral administration of the drug in doses of 400 mg and 1 g

The volume of distribution is 1.4 l / kg. 9-33% of acyclovir bound to plasma proteins.

The drug crosses the placental barrier. Some data indicate that the drug is excreted in breast milk in concentrations greater than the concentration in maternal plasma.

Metabolism.

Acyclovir is biotransformed mainly to the formation of 9-methylguanine carboxymethoxy, to a lesser extent - to 8-hydroxy-9-(2-hydroxy-etoksimetilguaninu)-guanine.

In vitro studies on cells infected with herpes, acyclovir also biotransformed to form phosphate, diphosphate and triphosphate of acyclovir, mainly through the intracellular phosphorylation with thymidine kinase.

The output.

Acyclovir appears mainly in the urine by glomerular filtration and tubular secretion of 89-90% in an unmodified form, 8-14% as metabolite 9-карбоксиметоксиметилгуанина, less than 0.2% - in the form of 8-hydroxy-9-(2 -hydroxy-ethoxymethyl)-guanine within 72 hours, less than 2% of the dose excreted in the feces.

In patients with normal renal function the half-life (t0, 5) after ingestion of an average 3-6 hours

In adults with renal failure t0, 5 may be extended depending on the degree of renal failure.

Senior Children 1 year half-life of acyclovir is close to the half-life in adults.

 

INDICATIONS

With the purpose of treatment:

· Acute infection caused by the varicella-zoster virus and herpes zoster (Varicella Zoster);

· Infections caused by herpes simplex virus (Herpes simplex) Skin and mucous membranes; including herpes simplex lesion of the reproductive system (primary and recurrent genital herpes).

 In order to prevent:

infections caused by herpes simplex virus (Herpes simplex) Skin and mucous membranes in patients with immunodeficiency.

 

APPLICATION Geviran Table. 800 mg. № 30.

Treatment should begin as soon as possible, immediately after the first symptoms of infection.

The drug is used orally.

Dosage in adults.

In acute infection caused by varicella-zoster virus and herpes zoster (Varicella Zoster).

Chickenpox.

 800 mg (4 tablets of 200 mg or 2 tablets of 400 mg or 1 tablet of 800 mg) 4 times a day for 5-7 dney.Lechenie should begin in the first 24 hours of the onset of rash.

Shingles.

 800 mg (4 tablets of 200 mg or 2 tablets of 400 mg or 1 tablet of 800 mg) 4 times daily for 7 days.

Infection with herpes simplex virus.

200 mg 5 times daily at intervals of 4 hours between doses, and the night break, usually for 5 days. In severe cases of infectious disease drug should be used up to 10 days. In patients with lowered immunity can increase the dose to 400 mg per reception.

Herpes infection of genitals.

· In primary infection prescribed 200 mg (1 tablet of 200 mg) every 4 hours (5 times a day) for 10 days.

· In order to prevent recurrence of infection in cases prescribed 400 mg (1 tablet of 400 mg or two 200 mg tablets), 2 times per day or 200 mg 3-4 times a day. Used for 6-12 months.

The recurrence rate of herpes infection untreated can change over time. Treatment should stop every 6-12 months to assess the feasibility of further drug therapy.

· Periodic treatment

200 mg every 4 hours (5 times a day) for 5 days after the first symptoms of relapse of infection.

 

Renal failure:

 

Dosing in patients with normal renal function

Creatinine clearance (ml/min/1, 73 m ²)

Renal failure

Dose (mg) time interval

200 mg every 4 hours

> 10

0-10

200 every 4 hours

(5 times a day)

200 in 12 hours

400 mg every 12 hours

> 10

0 -10

400 in 12 hours

200 in 12 hours

800 mg every 4 hours

> 25

10-25

0-10

Every 800 4:00

(4 times a day)

Every 800 8:00

Every 800 12:00

 

Dosing in elderly patients.

In elderly patients the total body clearance of acyclovir decreases in parallel with creatinine clearance so the treatment should start with small doses of the drug. Large doses of acyclovir should be used a lot of fluids.

Especially cautious use in patients in elderly patients with renal insufficiency.

The dosage in children.

Treatment and prevention of infections caused by herpes simplex virus in immunocompromised children:

Children under 2 years old - use half the adult dosage.

Children older than 2 years - dosage as for adults.

Infection with varicella-zoster virus.

Children under 2 years - 200 mg of acyclovir four times a day.

Children from 2 years to 5 years - 400 mg of acyclovir four times a day.

Children over 6 years - 800 mg of acyclovir four times a day.

Treatment should continue for 5 days. The dosage should be accurately calculated, the average rate of 20 mg / kg per reception (but not more than 800 mg acyclovir) 4 times a day.

Children weighing over 40 kg - dose as in adults with chickenpox.

Data regarding the treatment of tinea infections in children with immunodeficiency no.

 

Side effects.

Nausea, vomiting, diarrhea, abdominal pain, headache, rare - dizziness, hallucinations, drowsiness, confusion, blurred vision, itching, rash, slight increase in bilirubin and aminotransferase activity, a slight increase in urea and creatinine levels, a slight decrease hematological parameters, increased fatigue.

 

Contraindications.

Increased susceptibility to acyclovir, and other ingredients.

 

Overdose.

 In case of overdose observed in the gastro-intestinal disorders (nausea, vomiting), neurological disorders (headache, dizziness, cramps). Treatment is symptomatic. Acyclovir can be removed from the body by hemodialysis.

 

Features of the application.

· The drug should be used with caution in patients with renal insufficiency, especially in dehydrated patients, and those who were treated with high doses of acyclovir, or in patients taking concomitant medications that can damage the kidneys.

· It should inform the patient that if symptoms of herpes infection of genitals should refrain from sexual intercourse.

· During the treatment it is necessary to use plenty of fluids.

Pregnancy and lactation.

There are no controlled trials of acyclovir in pregnant women. Therefore, during pregnancy, the drug is used only when the expected benefit to the mother outweighs the potential risk to the fetus.

Acyclovir passes into breast milk, so do not take the medication during breastfeeding. If necessary, use during lactation should be discontinued.

Effects on ability to drive or work with Geviran Table. 800 mg. Number 30nimy mechanisms.

During treatment due to side effects of acyclovir may affect the management of vehicles and servicing arrangements.

 

Interaction with other medicinal products.

Drugs affecting renal function may alter the pharmacokinetics of acyclovir. Probenecid and cimetidine increase the area of ​​the curve of concentration of acyclovir in plasma and reduce the renal clearance of acyclovir.

 

Storage conditions.

Store in a dry, dark place below 25 º C.

Shelf Life - 3 years.