Zovirax ACICLOVIRUM  pills 200mg №25

Zovirax ACICLOVIRUM pills 200mg №25

Product Code: 8767
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Composition

active substance:acyclovir,

1 tablet contains 200 mg acyclovir

excipients: lactose, microcrystalline cellulose, starch sodium, povidone to 30, magnesium stearate.

The

Dosage form

Pills.

The

drug description

Antiviral agents for systemic use.

PBX code J05A B01.

Reading

The
  • Treatment of viral infections of the skin and mucous membranes caused by herpes simplex virus, including primary and recurrent genital herpes.
  • The
  • the Suppression (prevention of relapses) of infections caused by the herpes simplex virus, in patients with normal immune systems.
  • The
  • Prevention of infections caused by the herpes simplex virus in patients with immunodeficiency.
  • Treatment of infections caused by the virusVaricella zoster(chickenpox and herpes zoster).

Contra

hypersensitivity to acyclovir, valacyclovir or other components of the drug.

Method of application and doses

the Tablet should be taken whole with water. With the use of high doses of acyclovir should maintain an adequate level of hydration.

adults

Treatment of herpes simplex virus infections

for the treatment of infections caused by herpes simplex virus, it is necessary to take Zovirax tablets at a dose of 200 mg 5 times a day at approximately 4-hour intervals, except at night.

Treatment should continue for 5 days, but in the case of severe primary infection it can be continued.

For patients with severe immunodeficiency (e.g., after bone marrow transplantation) or for patients with reduced absorption in the gut the dose can be doubled to 400 mg or applied appropriate dose for intravenous administration.

Treatment should start as soon as possible after the onset of the infection. In the case of recurrent herpes is better to start treatment in prodromal period or after the first signs of skin damage.

Prevention of recurrence (suppressive therapy) infections caused by the herpes simplex virus

In patients with normal immunity to prevent recurrence of infections caused by herpes simplex virus, zovirax tablets at a dose of 200 mg are taken 4 times a day at approximately 6-hour intervals.

for convenience, most patients can take 400 mg of Zovirax twice daily at approximately 12-hour intervals.

Treatment will be effective even after reducing the dose of Zovirax tablets to 200 mg, which are taken 3 times a day with an 8-hour interval or even 2 times a day with a 12-hour interval.

in some patients, a radical improvement is observed after taking a daily dose of Zovirax 800 mg.

to monitor possible changes in the natural course of the disease, Zovirax therapy should be intermittently interrupted at intervals of 6-12 months.

Prevention of herpes simplex virus infections

To prevent infections caused by the herpes simplex virus, in patients with immune deficiency Zovirax tablet dose 200 mg need to take 4 times a day with approximately 6-hour intervals. For patients with significant immunodeficiency (for example, after bone marrow transplantation) or for patients with reduced absorption in the intestine, the dose can be doubled to 400 mg or apply the appropriate dose for intravenous administration.

the duration of prevention depends on the duration of the risk period.

treatment of varicella and herpes zoster

Zovirax tablets should be taken at a dose of 800 mg 5 times daily at approximately 4-hour intervals, except at night, to treat infections caused by varicella virus and herpes zoster. Treatment should continue for 7 days.

patients with severe immunodeficiency (for example, after bone marrow transplantation) or patients with reduced absorption in the intestine is better to use intravenous administration.

Treatment should start as soon as possible after the onset of the disease, the result will be better if the treatment begins immediately after the appearance of rashes.

children

doses can be used for the treatment of infections caused by herpes simplex virus and the prevention of infections caused by herpes simplex virus in children with immunodeficiency between the ages of 2 years. For the treatment of chickenpox in children aged 6 years 800 mg Zovirax 4 times a day, children aged 2 to 6 years can receive 400 mg Zovirax 4 times a day. The duration of treatment is 5 days.

more precisely, a single dose can be calculated on the body weight of the child 20 mg/kg body weight (should not exceed 800 mg) Zoviraksa 4 times a day.

there are no Specific data on the use of Zovirax to prevent (prevent recurrence) infections caused by the herpes simplex virus or to treat infections caused by the herpes zoster virus in children with normal immunity.

for the treatment of infections caused by herpes viruses, in newborns and children up to 3 months, Zovirax, lyophilizate is used to prepare a solution for infusions.

elderly patients

it Should be borne in mind the possibility of renal impairment in elderly patients, and the dose of the drug for them should be changed accordingly (seeRenal failure). It is necessary to maintain an adequate level of body hydration in elderly patients who receive high doses of Zovirax.

renal failure

Zovirax should be used with caution in patients with renal insufficiency. It is necessary to maintain an adequate level of hydration.

in the prevention and treatment of infections caused by herpes simplex virus in patients with renal insufficiency, the recommended oral doses do not lead to the accumulation of acyclovir, the level of which would exceed the safe level set for intravenous administration. However, for patients with severe renal insufficiency (creatinine clearance less than 10 ml/min) it is recommended to set a dose of 200 mg 2 times a day at intervals of about 12 hours.

in the treatment of infections caused by a virusVaricella zoster(chickenpox and shingles), for patients with significantly reduced immunity is recommended in severe renal failure (creatinine clearance less than 10 ml/min) to establish the dose of 800 mg 2 times a day with approximately 12-hour intervals , for patients with moderate renal insufficiency (creatinine clearance in the range 10-25 ml/min) - 800 mg 3 times a day with an interval of about 8 hours.

Side effects

Side effects, details of which are given below, classified by organs and systems and the frequency of their occurrence. Categories of frequency: very common ?1/10 often ?1/100 and<1/10, uncommon ?1/1000 and<1/100, rare ?1/10,000 and<1/1000, very rare<1/10 000 .

Blood and lymphatic system

very rarely anemia, thrombocytopenia, leukopenia.

immune system

Rarely anaphylaxis.

Mental and nervous system disorders

Frequent: headache, dizziness.

very rarely excitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, drowsiness, encephalopathy, coma.

the Above neurological reaction is generally reversible and usually occur in patients with renal insufficiency or other risk factors (see Section "Peculiarities of use").

Respiratory system and the organs of the chest

rarely shortness of breath.

gastroenterological system

Frequent: nausea, vomiting, diarrhea, abdominal pain.

hepatobiliary system

Rarely a reversible increase in bilirubin levels and liver enzymes.

jaundice very rarely, hepatitis.

Leather and subcutaneous tissue

itching Often, rash (including photosensitivity).

Uncommon: urticaria, accelerated diffuse hair loss. Since hair loss may be due to a large number of diseases and the means used, a clear link with acyclovir have not been identified.

Rarely angioedema.

Kidneys and urinary system

Rare: increased blood urea and creatinine levels.

Very rare: acute renal failure, pain in the kidneys.

pain in the kidneys may be associated with renal failure and crystalluria.

common disorders

fatigue, fever Often.

Overdose

symptoms.

Acyclovir is only partially absorbed from the gastrointestinal tract. There were cases of unintentional oral administration of patients up to 20 g of acyclovir without toxic effect. In case of accidental repeated overdose of acyclovir administration, gastroenterological symptoms (such as nausea and vomiting) and neurological symptoms (headache and confusion) occur within a few days.

overdose of intravenous acyclovir increases the level of serum creatinine, urea nitrogen of blood, and, consequently, there is kidney failure. Neurological manifestations of overdose may be mental confusion, hallucinations, agitation, convulsions and coma.

Treatment.

the Patient should be carefully examined to identify symptoms of intoxication. Since the level of acyclovir in the blood is well excreted by hemodialysis, the latter should be used in case of overdose.

Use in pregnancy and lactation

in the post-registration register of supervision of pregnant women the results of application by pregnant women of various pharmaceutical forms of Zovirax are documented. There was no increase in the number of congenital defects in children whose mothers used Zovirax during pregnancy, compared with the total population. However, the use of tablet Zovirax should be when the potential benefit of the drug viginti outweighs the potential risk to the fetus.

with oral administration of 200 mg of acyclovir 5 times a day acyclovir is in breast milk in concentrations of 0.6-4.1 levels of acyclovir in blood plasma. Potentially, a child who is fed this milk can learn acyclovir at a dose of 0.3 mg/kg body weight per day. Therefore, prescribe acyclovir breast-feeding, it is necessary with caution, given the risk/benefit ratio.

The

Children

Tablet Zovirax use children under the age of 2 years.

application Features

renal insufficiency Patients and elderly patients

Acyclovir is excreted mainly by renal clearance, therefore, patients with renal insufficiency dose should be reduced (see "Method of application and dosage"). Elderly patients are also more likely to have impaired renal function, so this group of patients may also require dose reduction. Both groups (patients with renal insufficiency and elderly patients), are groups at risk of neurological side effects and should therefore be closely monitored to detect these side reactions. According to the obtained data, such reactions are generally negotiable in case of termination of treatment (see section "Adverse reactions").

special attention should be paid to maintaining an adequate level of hydration in patients receiving high doses of acyclovir.

The

Ability to influence the reaction rate when driving motor transport or operating other mechanisms

the clinical status of the patient and the profile of side effects of the drug should be taken into account when deciding on the possibility of driving and other mechanisms. Clinical studies of the effect of acyclovir on the reaction rate in the management of vehicles or work with other mechanisms was not carried out. In addition, the pharmacology of acyclovir does not give reason to expect any negative impact.

The

Interaction with other medicinal products and other forms of interaction

no Clinically important interaction of acyclovir with other drugs was found.

Acyclovir is released mainly unchanged by the kidneys by kanaltsevoy secretion, so any drugs that have a similar mechanism of isolation, can increase the concentration of acyclovir in plasma. Probenecid and cimetidine increase the half-life of the acyclovir and increase the area under the concentration/hour curve. At simultaneous application of acyclovir with immunosuppressants used in the treatment of patients after organ transplantation - mycophenolate mofetil in the blood plasma also increases the level of acyclovir and the inactive metabolite of mycophenolate mofetil, but given the wide therapeutic index of acyclovir to adjust the dose.

The

Pharmacological properties

Pharmacodynamics.

Acyclovir is a synthetic analogue of purine nucleoside with inhibitory activityin vivoandin vitrofor the human herpes virus, including the herpes simplex virus type I and II, varicella virus and herpes zoster, Epstein-Barr virus and cytomegalovirus. In cell culture acyclovir is the most active against simple herpes virus type I and then, in descending order of activity against herpes simplex virus type II, varicella and herpes zoster, Epstein-Barr and cytomegalovirus.

the inhibitory activity of acyclovir against the aforementioned viruses is highly selective. Enzyme thymidincinase in a normal non-infected cell does not use acyclovir as a substrate, so the toxic effect relative to the cells of the host organism is minimal. However timidinkinaza encoded in the viruses herpes simplex, varicella, herpes zoster and Epstein-Barr turns acyclovir in monophosphate of acyclovir, a nucleoside analogue, which is then transformed successively to the diphosphate and triphosphate by enzymes of the cell. After embedding into the viral DNA of acyclovir, the triphosphate interacts with viral DNA polymerase, resulting in the termination of the synthesis of the viral DNA chain.

with prolonged or repeated treatment of severe immune-impaired patients, it is possible to reduce the sensitivity of individual strains of the virus that do not always respond to treatment with acyclovir. Most clinical cases of insensitivity associated with a deficiency in viral thymidine kinase, however, there are reports of damage to viral thymidine kinase and DNA.in vitrothe interaction of individual herpes simplex viruses with acyclovir can also lead to the formation of less sensitive strains. The relationship between the sensitivity of individual herpes simplex virusesin vitroand the clinical results of acyclovir treatment has not been fully clarified.

Pharmacokinetics.

Acyclovir is only partially absorbed in the intestine. The average peak stable concentration (ssmax) in plasma after taking a dose of 200 mg with a 4-hour interval is 3.1 µmol (0.7 µg/ml), and the plasma level (Cssmin) - 1.8 µmol (0.4 µg/ml). The corresponding levels WITHssmaxafter doses of 400 mg and 800 mg at 4-hour intervals are 5.3 µmol (1.2 µg/ml) and 8 µmol (1.8 µg/ml) and the equivalent Cssminlevels were 2.7 µmol (0.6 µg/ml) and 4 µmol (0.9 µg/ml).

in adults, the end period of half-life with intravenous administration of acyclovir is about 2.9 h. Most of the excreted unchanged kidneys. Renal clearance of acyclovir is significantly higher than creatinine clearance, which indicates that the removal of the drug by the kidneys is carried out not only by glomerular filtration, but also by kanaltsevoy secretion.

9 carboxymethoxymethylguanine is the only significant metabolite of acyclovir which can be identified in the urine and accounts for approximately 10-15% of the dose. If acyclovir is used an hour after taking 1 g of probenecide, the final half-life and the area under the curve concentration/time increased by 18% and 40% respectively.

in patients with chronic renal failure the average ultimate level of half-life is 19.5 h. the Average half-life of acyclovir during hemodialysis is 5.7 h. the Level of acyclovir in the plasma during dialysis is reduced by about 60%.

the Concentration in cerebrospinal fluid is approximately 50% of the corresponding plasma concentration. The level of binding to plasma proteins is relatively low (from 9 to 33%) and does not change when interacting with other drugs.

with simultaneous use of acyclovir and zidovudine for the treatment of HIV-infected patients, no changes in the pharmacokinetics of these drugs were detected.

Basic physical and chemical properties

white, rounded, biconvex with the words "GXCL3" on one side.

The

shelf Life

5 years.

storage Conditions

keep out of reach of children. Store at a temperature not exceeding 25 ° C in a dry place.

The

Packaging

5 tablets in a blister of polyvinyl chloride and aluminum; 5 blisters in a cardboard box.

The

Category vacation

According to the recipe.

The

Manufacturer

Glaxo Wellcome sa (Spain)/Glaxo Wellcome SA (Spain).

The

the Packer and the release of the series.

GlaxoSmithKline Pharmaceuticals S. A. (Poland).

GlaxoSmithKline Pharmaceuticals SA (Poland).

The

Location

Glaxo Wellcome S. A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain Glaxo Wellcome SA, Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain;

GlaxoSmithKline pharmaceuticals S. A., 189, Grunwald St., 60-322 Poznan, Poland/GlaxoSmithKline Pharmaceuticals SA, 189 Grunwaldzka str. 60-322 Poznan, Poland.

PILL ZOVIRAX 200MG

Zovirax tablets 200mg No. 25 is an active antiviral drug that is used in the treatment of various skin infections. Also infections which were caused by the Hepres virus 2-th and 1-th type, including primary and recurrent genital herpes. The main ingredient of the drug is acyclovir. The action of the substance is directed against viruses as chickenpox and common or herpes zoster.

Assignment

the Drug is designed to treat:

The
  • HIV infections.
  • Herpes, chicken pox.

in order to prevent possible recurrence of infections, the drug is prescribed to patients with immunodeficiency who have been diagnosed with Simplex Hepres virus of the 1st and second types.

Dosage and mode of use

Tablets are used for oral administration. For the treatment of various infections caused by the virus Hepres Simplex, it is recommended to use one tablet up to 5 times a day. Patients to prevent to avoid possible occurrence of infections that can cause Hepres Simplex virus, you should take 1 tablet of the drug twice a day from 5 to 7 days. The usual course of therapy should be 5 days, but with the identification of severe primary infections treatment can be extended to 10 days.

& nbsp;

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