Валтрекс

Валтрекс – the drug belonging to group of antiviral means.

Form of release and structure

Drug is produced in the form of tablets, film coated (6 pieces in the blister, 7 blisters in a cardboard pack; 10 pieces in the blister, 1 blister in a cardboard pack).

Active ingredient – a valatsiklovira a hydrochloride, in 1 tablet of 556 mg (there correspond 500 mg of a valatsiklovir).

Auxiliary components: кросповидон – 28 mg; magnesium stearate – 4 mg; K90 povidone – 22 mg; cellulose microcrystallic – 70 mg; silicon dioxide colloid – 2 mg.

Structure of a film cover: опадрай white ~ 14 mg (titanium dioxide – 3,26 mg, polysorbate of 80 - 0,14 mg, a gipromelloza – 9,48 mg, a macrogoal of 400 - 1,12 mg); polish (wax of karnaubskiya ~ 0,016 mg).

Indications to use

For adult patients indications to Valtreks's use are:

• Treatment of infections of the mucous membranes and skin caused by a herpes simplex virus (including labial herpes, and also recurrent and for the first time the revealed genital);
• Treatment of shingles (drug has the effect stopping a pain syndrome, promotes decrease in percent of patients with the pains caused by shingles including post-herpetic and acute neuralgia, reduces disease duration);
• Prevention of transfer to the healthy sexual partner of genital herpes (as suppressive therapy in combination with safe sex);
• Prevention of a recurrence of infections of the mucous membranes and skin caused by a herpes simplex virus (including genital).

Valtreks's appointment to adults and teenagers is aged more senior than 12 years reasonablly for prevention Cytomegaloviral, opportunistic and other herpesviridae infections after organ transplantation, and also reaction of acute graft rejection (at persons with transplants of kidneys).

Contraindications

• Age less than 12 years (at purpose of drug for prevention of a Cytomegaloviral infection after transplantation);
• Age less than 18 years (for all other indications);
• Hypersensitivity of the patient to an acyclovir, a valatsiklovir and other components of drug.

With care drug is appointed to the patients having a renal failure and clinically expressed HIV infection forms and also at simultaneous therapy nefrotoksichny medicines.

Route of administration and dosage

Administration of drug does not depend on meal, it is necessary to wash down tablets with water.

The recommended mode of a drug dosing of Valtreks for:

• Treatments of the infections caused by the herpes simplex virus (HSV) as therapy by the adult – 2 times a day on 500 mg within 5 days. If the beginning of a disease has more severe form, it is recommended to begin therapy as soon as possible, increase in duration of therapy up to 10 days is also possible. At emergence of a recurrence duration of treatment can reach 3-5 days. An optimal variant at a recurrence of VPG is Valtreks's appointment in a prodromal stage or right after manifestation of the first symptoms of a disease;
• Alternative therapy of labial herpes adult – 2 g 2 times a day. The second dose is recommended to be accepted after about 12 hours (but not earlier than in 6 hours) after the first reception. In this case duration of therapy makes 1 days. It is recommended to begin to use drug at emergence of the earliest symptoms of a disease (an itch, tingling, burning);
• Treatments of shingles for adult patients – 3 times a day on 1 g for 7 days;
• Suppressions of a recurrence of the infections caused by VPG adult with the kept immunity – 500 mg of 1 times a day, to patients with an immunodeficiency – 500 mg 2 times a day;
• Prevention of transfer to the healthy sexual partner of genital herpes. To the infected immunocompetent patients with a recurrence 9 times a year – on 500 mg of 1 times a day every day, therapy duration – 1 year and more are not more often;
• After transplantation to adult patients and teenagers 12 years – 2 g 4 times a day are more senior than prevention of a Cytomegaloviral infection, at the same time therapy has to begin right after transplantation. The dose decreases proceeding from indicators of clearance of creatinine. Duration of therapy makes 90 days, however increase in duration of treatment for patients with high risk is allowed.

Correction of a dose of drug is not required to patients with abnormal liver functions, however clinical experience at heavy abnormal liver functions, disturbance of synthetic function of a liver and existence of a porto-caval anastomosis is limited.

At patients with a renal failure:

• Therapy of shingles: at clearance of creatinine of 15-30 ml/min. – 1 g 2 times in knocks, at clearance of creatinine less than 15 ml/min. – 1 g of 1 times a day;
• Therapy of the infections caused by a herpes simplex virus: at clearance of creatinine less than 15 ml/min. – 500 mg of 1 times a day;
• Therapy of labial herpes (according to the scheme of 2 g 2 times within 1 days): at clearance of creatinine of 31-49 ml/min. – 1 g 2 times within a day, at clearance of creatinine of 15-30 ml/min. – 500 mg 2 times within a day, at clearance of creatinine less than 15 ml/min. – 500 mg once;
• Prevention of a recurrence of the infections caused by a herpes simplex virus (correction of a dose is recommended at clearance of creatinine less than 15 ml/min.): for patients with normal immunity – 250 mg of 1 times a day, for patients with reduced immunity – 500 mg of 1 times a day;
• Decrease in risk of infection with genital herpes of the healthy sexual partner: at clearance of creatinine less than 15 ml/min. – 250 mg of 1 times a day;
• Prevention of a Cytomegaloviral infection after transplantation: at clearance of creatinine of 75 ml/min. and more – 2 g 4 times a day, at clearance of creatinine of 50-75 ml/min. – 1,5 g 4 times a day, at clearance of creatinine of 25-50 ml/min. – 1,5 mg 3 times a day, at clearance of creatinine of 10-25 ml/min. – 1,5 g 2 times a day, at clearance of creatinine less than 10 ml/min. or dialysis – 1,5 g of 1 times a day.

At treatment of the patients who are on a hemodialysis, drug is appointed in the same dose as to patients with clearance of creatinine less than 15 ml/min. (it is recommended to accept Valtreks right after the procedure of a hemodialysis).

Correction of a dose is not required to patients of advanced age, except cases of the expressed renal failure.

There are no data on use of drug for children 12 years are younger.

Side effects

On given clinical trials:

• GIT: often – nausea;
• Nervous system: often – a headache.

According to results of post-market researches:

• Immune system: very seldom – an anaphylaxis;
• Liver and biliary tract: very seldom – disturbances of functional hepatic trials (have reversible character), which in certain cases interpret as displays of hepatitis;
• Respiratory system and bodies of a mediastinum: infrequently – an asthma;
• Urinary system: seldom – renal failures; very seldom – renal colic (it can be connected with a renal failure), an acute renal failure;
• Nervous system and mentality: seldom – confusion of consciousness, oppression of consciousness, dizziness, hallucination; very seldom – a tremor, a dysarthtia, spasms, agitation, encephalopathy, an ataxy, psychotic symptoms, a coma. As a rule, the listed symptoms have reversible character and are in most cases noted at patients with a renal failure or against the background of other contributing states;
• Alimentary system: seldom – vomiting, discomfort in a stomach, diarrhea;
• Skin and hypodermic fatty tissue: infrequently – rashes (including manifestations of a photosensitization), it is rare – an itch, is very rare – a Quincke's disease, a small tortoiseshell;
• System of blood and bodies of a hemopoiesis: very seldom – thrombocytopenia, a leukopenia (in most cases at patients with reduced immunity);
• Other: at patients with the expressed immunity disturbances (especially at the adult patients suffering from far come HIV infection stage, and accepting high doses of a valatsiklovir (8 g a day) a long period) cases of development of mikroangiopatichesky hemolitic anemia, thrombocytopenia, renal failure were recorded. The described complications were noted at the patients with the same basic and associated diseases who were not exposed to therapy valatsikloviry.

Special instructions

Correction of a dose of Valtreks has to be carried out according to degree of a renal failure. Careful medical observation as at this category of persons the increased risk of emergence of neurologic complications is noted has to be provided to the patients having a renal failure (in most cases similar manifestations take place after therapy cancellation).

Valtreks's use for decrease in risk of transfer of genital herpes has to be combined with safe sex as drug does not exclude completely risk of infection and does not promote full treatment.

High doses of drug (4 g a day and above) have to be appointed to patients with liver diseases with care.

At Valtreks's appointment patients with risk of dehydration (especially to elderly people) are recommended to provide maintenance of a water balance in an organism.

Ability of the patient to manage the vehicle and other driving mechanisms in the course of therapy is estimated taking into account its clinical condition and a profile of side effects of a valatsiklovir.

Medicinal interaction

Clinically significant interactions are not recorded.

It is recommended to be careful at purpose of simultaneous therapy by Valtreks (in a dose of 4 g a day and above) and the medicines competing with an acyclovir for a way of removal in view of possible risk of increase in concentration in plasma of the used drugs or their metabolites.

Also demands care combined Valtreks's uses (in a dose of 4 g a day and above) with drugs, making impact on other functions of kidneys (for example, такролимус, cyclosporine).

Terms and storage conditions

To store at a temperature not above 30 °C in the place, unavailable to children.

Period of validity – 3 years.