Valaciclovir

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Available since: 2019-09-19

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Clinical Pharmacology

Antiviral agent.

Indications

Adults and teenagers aged 12 to 18 years

treatment of infections of the skin and mucous membranes caused by HSV, including newly diagnosed and recurrent genital herpes (Herpesgenitalis, as well as cold sores (Herpeslabialis);

prevention (suppression) of recurrent infections of the skin and mucous membranes caused by HSV, including genital herpes, including in adults with immunodeficiency;

prevention of cytomegalovirus (CMV) infections and diseases after transplantation of parenchymal organs.

Adults

treatment of herpes zoster (Herpeszoster) and ophthalmic herpes zoster.

Composition

1 tablet, film coated, contains:

The composition of the core tablet:

Active ingredient: valaciclovir hydrochloride - 556.2 mg (in terms of valaciclovir 500.0 mg).

Excipients: microcrystalline cellulose - 84.3 mg, hypromellose - 42.0 mg, crospovidone - 7.0 mg, magnesium stearate - 7.0 mg, colloidal silicon dioxide -
3.5 mg.

The composition of the shell of the tablet:

Opadry II white (33G28435) - 25.0 mg (hypromellose - 40.0%, titanium dioxide - 25.0%, macrogol 3350 - 8.0%, lactose monohydrate - 21.0%, triacetin - 6.0%) .

Valaciclovir is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Valaciclovir	Izvarino Pharma	Russia	pills
Valcicon	Vertex	Russia	pills
Vayrova	Ranbaxy Laboratories Ltd	India	pills
Valvir	Actavis Ltd	Iceland	pills
Valtrex	GlaxoSmithKline	UK	pills

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Dosage and Administration

For oral use. Adults.

Herpes Zoster - 1000 mg 3 times a day for 7 days.

Herpes simplex - 500 mg 2 times a day. In case of relapse, the course should be 3 or 5 days. In the first episode with a severe course, the duration of treatment can be extended up to 10 days (for relapses, it is ideal to prescribeValvir in the prodromal period or when the first symptoms of the disease appear, i.e. tingling, itching, burning).

For therapycold sores effective administration of the drug in a dose of 2 g 2 times within 1 day: the second dose should be taken approximately 12 hours (but not earlier than 6 hours) after the first dose (do not use this dosing regimen for more than 1 day, because, as shown , it does not give additional clinical advantages). Prevention of recurrence of infections caused by the herpes simplex virus: in patients with preserved immunity, 500 mg once a day; with very frequent relapses (10 or more per year) - 250 mg 2 times a day; for adult patients with immunodeficiency - 500 mg 2 times a day. Course duration - 4-12 months.

Prevention of infection with genital herpes of a healthy partner: infected heterosexual adults with preserved immunity and with the number of exacerbations up to 9 per year - 500 mg once a day for 1 year or more, every day with regular sex, with irregular sex contactsValvira It is necessary to start 3 days before the intended sexual contact (data on infection prevention in other patient populations are not available). Prevention of cytomegalovirus infection: adults and adolescents over 12 years old - 2 g 4 times a day (as soon as possible after transplantation). The course duration is 90 days, but in patients with high risk, treatment may be longer.

Adverse reactions

The most common adverse reactions with valaciclovir are: headache and nausea, more serious adverse reactions: thrombotic thrombocytopenic purpura / hemolytic uremic syndrome, acute renal failure and neurological disorders.

Undesirable reactions are listed below in accordance with the classification of the main systems and organs and the frequency of occurrence: very often - ≥ 1/10; often - ≥1 / 100 or <1/10; sometimes ≥ 1/1000 or <1/100; rarely 1/10000 or <1/1000; very rarely - <1/10000.

On the part of the digestive tract: often nausea; rarely, abdominal discomfort, including abdominal pain; vomiting, diarrhea; very seldom - reversible violations of functional hepatic tests, which are sometimes regarded as manifestations of hepatitis.

From the side of blood and lymphatic system: very rarely - leukopenia (mainly in patients with reduced immunity), thrombocytopenia.

On the part of the immune system: very rarely - anaphylaxis.

Mental and nervous system disorders: often - headache; sometimes agitation, including aggressive behavior; rarely - dizziness, confusion, hallucinations, mental decline; very rarely - excitement, tremor, ataxia, dysarthria; psychotic symptoms, including mania; depression, convulsions, encephalopathy, coma. These symptoms are reversible and are usually observed in patients with impaired renal function or in comparison with other diseases. In patients with a transplanted organ, receiving high doses of valaciclovir (8 g / day) for the prevention of CMV infection, neurological reactions develop more often than when receiving lower doses.

On the part of the respiratory and mediastinal organs: sometimes dyspnea.

From the skin and subcutaneous tissue: sometimes - rashes, including manifestations of photosensitivity; rarely - itching.

Allergic reactions: very rarely - urticaria, angioedema.

From the urinary system: rarely impaired renal function; very rarely, acute renal failure, renal colic (may be associated with impaired renal function).

Other: in patients with severe impaired immunity, especially in patients with advanced stage of acquired immune deficiency syndrome, receiving high doses of valaciclovir (8 g / day) for a long time, there have been cases of renal failure, microangiopathic hemolytic anemia and thrombocytopenia (sometimes in combination).Similar complications were noted in patients with the same diseases, but not receiving valacyclovir.

To establish the frequency of manifestations of some adverse reactions according to the available data is not possible.

From the senses: visual impairment.

From the side of blood-forming organs: neutropenia, aplastic anemia, leukoplastic vasculitis, thrombotic thrombocytopenic purpura.

On the part of the skin: erythema multiforme.

Laboratory indicators: decrease in hemoglobin, hypercreatininemia.

Other: dysmenorrhea, arthralgia, nasopharyngitis, respiratory infections, swelling of the face, high blood pressure, tachycardia, fatigue; additionally in children, fever, dehydration, rhinorrhea.

Contraindications

- hypersensitivity to valacyclovir, acyclovir and other components of the drug;

- clinically expressed forms of HIV infection with a CD4 + lymphocyte content of less than 100 / μl;

- bone marrow transplantation;

- kidney transplantation;

- children's age (up to 12 years with CMV, up to 18 years - according to other indications).

Carefully: liver failure (high doses of the drug), renal failure, pregnancy, lactation.

Drug interactions

Clinically significant interactions not established.

Zimetidine and probenecid after taking 1 g of valaciclovir increase the AUC of acyclovir, reducing its renal clearance (however, dose adjustment of valaciclovir is not required due to the wide therapeutic index of acyclovir).

Care must be taken in the case of simultaneous use of valaciclovir in high doses (4 g /) and drugs that compete with acyclovir for the elimination path (the latter is eliminated with the urine unchanged as a result of active tubular secretion), since there is a potential threat of an increase in plasma level one or both drugs or their metabolites. With simultaneous use of acyclovir with mycophenolate mofetil, an increase in the AUC of the first and inactive metabolite of the second was noted.

Care must also be taken when combining valaciclovir in high doses (4 g / and above) with drugs that affect kidney function (for example, cyclosporine, tacrolimus).

Special instructions

Taking the drug in high doses for a long time in conditions accompanied by pronounced immunodeficiency (bone marrow transplantation, clinically expressed forms of HIV infection, kidney transplantation) led to the development of thrombocytopenic purpura and hemolytic uremic syndrome, up to a fatal outcome. If the side effects of the central nervous system (including agitation, hallucinations, confusion, delirium, seizures and encephalopathy) occur, the drug is canceled.

Patients at risk of dehydration, especially elderly patients, during the period of drug treatmentValvir necessary to ensure adequate hydration of the body. Patients with renal failure have an increased risk of developing neurological complications.

With abnormal liver function in patients with mild or moderate liver cirrhosis (synthetic liver function is maintained), dose adjustmentValvir not required. In the study of pharmacokinetics in patients with severe cirrhosis of the liver (with a violation of the synthetic function of the liver and the presence of shunts between the portal system and the common vascular bed), there is also no evidence of the need to correct the dosage regimen; however, clinical experience with the drugValvir this category of patients is organic. No data on the use of the drugValvir in high doses (4 g / or more) in patients with liver disease, so you should be careful to prescribe the drug in high doses of this category of patients.

Elderly patients do not require dose adjustment, except in cases of significant impaired renal function. It is necessary to maintain an adequate water-electrolyte balance.

Special studies on the action of the drugValvir in patients with liver transplantation was not performed. However, it has been shown that prophylactic administration of high doses of acyclovir reduces cytomegalovirus infection. Suppressive drug therapyValvir reduces the risk of transmitting genital herpes, but does not exclude it completely and does not lead to a complete cure. During drug therapyValvirthe patient must take measures to ensure the safety of the partner during sexual intercourse.

Overdosage

Currently, overdose with valaciclovir is insufficient.

Symptoms: A single overdose of acyclovir up to 20 g, which was partially absorbed from the gastrointestinal tract, was not accompanied by the toxic effect of the drug. When administered within a few days of ultra-high doses of acyclovir, nausea, vomiting, headache, confusion developed; with a / in the introduction - an increase in the concentration of serum creatinine, the development of renal failure, confusion, hallucinations, agitation, convulsions, coma.

Treatment: Patients should be carefully monitored for signs of toxic effects. Hemodialysis significantly enhances the removal of acyclovir from the blood and can be considered the method of choice when managing patients with an overdose of valacyclovir.