Valcicon, 500 mg 10 pcs

Herpes, Itching and dryness in the genital area, Skin itching

Adults:

– Treatment of herpes zoster (Herpes zoster) (the drug helps relieve pain, reduces its duration and the percentage of patients with pain caused by shingles, including acute and post-herpetic neuralgia);

– Treatment of skin and mucous membrane infections caused by Herpes simplex virus type 1,2, including newly diagnosed and recurrent genital herpes (Herpes genitalis), and labial herpes (Herpes labialis);

– prevention (suppression) of recurrent infections of the skin and mucous membranes caused by Herpes simplex virus type 1,2, including genital herpes;

– Prevention of genital herpes virus transmission to a healthy partner when the drug is used as suppressive therapy in combination with safe sex;

Adults and children 12 years of age and older:

Prevention of cytomegalovirus (CMV) infection and acute transplant rejection reactions (in patients with kidney transplants), opportunistic infections and other herpesvirus infections (HPV, VZV) after organ transplants.

Active ingredient

Composition

1 tablet contains:

Active substance:

Valacyclovir hydrochloride – 556.00 mg (in terms of valacyclovir 500.00 mg).

Auxiliary substances:

Microcrystalline cellulose – 95.00 mg,

Hyprolose (hydroxypropyl cellulose) – 14.00 mg,

Crospovidone – 28.00 mg,

Magnesium stearate – 7.00 mg.

Film coating:

. [hypromellose – 10.50 mg, hyprolose (hydroxypropyl cellulose) – 4.07 mg, talc – 4.12 mg, titanium dioxide – 2.31 mg] or [dry film coating mixture – white, containing hypromellose (50%), hydroxypropyl cellulose (19.4%), talc (19.6%), titanium dioxide (11%)] – 21.00 mg.

How to take, the dosage

Ingestion, regardless of meals, with water.

The treatment of shingles (Herpes zoster)

Adults:

The recommended dose is 1000 mg 3 times daily for 7 days.

Treatment of infections caused by HPV

Adults:

The recommended dose for episode therapy is 500 mg 2 times daily for 5 days.

In more severe cases of onset, treatment should be started as early as possible, and its duration may be extended from 5 to 10 days. In cases of relapses, treatment should be continued for 3 or 5 days. In relapsed HPV cases, it is ideal to prescribe valacyclovir in the prodromal period or immediately after the onset of the first symptoms of the disease.

As an alternative treatment for labial herpes, it is effective to prescribe valacyclovir at a dose of 2 g twice daily. The second dose should be taken approximately 12 hours (but not earlier than 6 hours) after the first dose. With this dosing regimen, the duration of treatment is 1 day. Therapy should be started when the earliest symptoms of labial herpes (i.e., tingling, itching, burning) appear.

Prevention (suppression) of recurrent infections caused by HPV

Adults:

In immunocompromised patients, the recommended dose is 500 mg once daily.

In immunocompromised patients, the recommended dose is 500 mg twice daily.

Prevention of genital herpes transmission to a healthy partner

Infected immunocompetent individuals with no more than 9 recurrences per year, the recommended dose of valacyclovir is 500 mg once daily for one year or more each day.

There are no data on prevention of infection in other patient populations.

Prophylaxis of cytomegalovirus (CMV) infection after transplantation

Adults and adolescents ages 12 years and older:

The recommended dose is 2 g 4 times daily, administered as soon as possible after transplantation.

The dose should be reduced depending on creatinine clearance.

The duration of treatment is 90 days, but in high-risk patients the course of treatment may be extended.

Special patient groups

Patients with impaired renal function

Treatment of shingles and infections caused by HPV, prevention (suppression) of recurrent HPV infection, prevention of genital herpes transmission to a healthy partner

The dose of valacyclovir is recommended to decrease in patients with significant impairment of renal function (see dosing regimen in Table 1). Adequate hydration should be maintained in these patients.

There is no experience with valacyclovir in children with creatinine clearance values less than 50 mL/min/1.73 m2.

Interaction

Cimetidine and tubule secretion blockers reduce the effect (reduce the rate, but not the completeness of conversion to acyclovir). There is no need to adjust the dosing regimen in persons with normal creatinine clearance.

Nephrotoxic drugs increase the risk of renal dysfunction. Caution should be exercised (monitoring for changes in renal function) when combining Valcicon at higher doses (4 g daily or more) with drugs that affect other renal functions (e.g.: cyclosporine, tacrolimus).

Acyclovir is excreted by the kidneys, mostly unchanged, through active renal secretion. Concomitant use of drugs with this excretion mechanism may lead to increased plasma concentrations of acyclovir.

After administration of Valcicon at a dose of 1000 mg, cimetidine and probenecid, which are excreted by the same route as Valacyclovir, increase the AUC of acyclovir and thus decrease its renal clearance. Because of the broad therapeutic index of acyclovir, no dose adjustment of Valcyclovir is necessary in this case.

Caution should be exercised in the case of concomitant use of valacyclovir at higher doses (4 g per day or more) and drugs that compete with acyclovir for the elimination pathway, because there is a potential risk of increased plasma levels of one or both drugs or their metabolites. An increase in the AUC of acyclovir and the inactive metabolite mycophenolate mofetil has been noted when these drugs are used simultaneously.

The pharmacokinetics of valacyclovir does not change with concomitant use of digoxin, aluminum/magnesium-containing antacids, thiazide diuretics.

Special Instructions

In patients at risk of dehydration, especially in elderly patients, adequate fluid replenishment should be provided during treatment.

As acyclovir is excreted by the kidneys, the dose of Valcicon should be adjusted according to the degree of renal impairment. Patients with renal impairment have an increased risk of developing neurological complications; these patients should be closely monitored. As a rule, these reactions are reversible and disappear after discontinuation of the drug.

In patients with chronic renal failure (CKD), creatinine clearance should be measured frequently, particularly during a period when renal function changes rapidly (such as immediately after transplantation or graft engraftment), and the dose of valacyclovir should be adjusted according to creatinine clearance rates.

There is no data on the use of Valacyclovir in high doses (4 g or more per day) in patients with liver disease; therefore high doses of Valcyclovir should be used with caution.
Suppressive therapy with Valacyclovir reduces the risk of genital herpes transmission but does not eliminate the risk of infection and does not lead to complete cure. Valcyclone therapy is recommended in combination with safe sex.

The use of the drug in high doses for a long time in conditions accompanied by severe immunodeficiency (bone marrow transplantation, clinically evident forms of HIV infection, kidney transplantation) has led to the development of thrombocytopenic purpura and hemolytic-uremic syndrome, up to and including death.

In case of side effects of the central nervous system (including agitation, hallucinations, confusion, delirium, convulsions and encephalopathy) the drug is stopped.

Contraindications

Hypersensitivity to valacyclovir, acyclovir and any other component of the drug; HIV infection with CD4+ lymphocyte counts less than 100 per 1 µl; childhood (under 12 years for prevention of cytomegalovirus infection after transplantation, under 18 years for other indications).

Side effects

Central nervous system: headache, dizziness, psychotic symptoms, agitation, diminished mental capacity, ataxia, coma, confusion or depression of consciousness, dysarthria, encephalopathy, mania, hallucinations, convulsions, tremors. The above reactions are reversible and are usually observed in patients with impaired renal function or against the background of other predisposing conditions. In patients with an organ transplant who receive valacyclovir in high doses (8 g/day) for the prevention of cytomegalovirus infection, neurological reactions develop more frequently than when taken in lower doses.

Respiratory system: dyspnea.

Digestive system disorders: nausea, abdominal discomfort, vomiting, diarrhea, reversible liver function tests (increased alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase activity), which are sometimes regarded as manifestations of hepatitis.

Hematopoietic system disorders: leukopenia (occurs mainly in patients with lowered immunity), thrombocytopenia, anemia, thrombotic thrombocytopenic purpura.

Skin disorders: erythema multiforme, rash, photosensitization, alopecia.

Allergic reactions: itching, urticaria, angioedema, anaphylaxis.

Urinary system disorders: pain in the renal projection, renal dysfunction, including acute renal failure, renal colic. Renal colic may be associated with renal dysfunction.

Sensory organs: visual impairment.

Laboratory findings: decreased hemoglobin, hypercreatininemia.

Others: Dysmenorrhea, nasopharyngitis, respiratory tract infections, increased blood pressure, tachycardia, fatigue;

In patients with severe immune disorders, especially in adult patients with advanced HIV infection receiving valacyclovir at high doses (8 g/day daily) for a long time, cases of renal failure, microangiopathic hemolytic anemia and thrombocytopenia (sometimes in combination) have been observed.

Similar adverse reactions have been noted in patients with the same disease but not receiving valacyclovir.

Overdose

Symptoms:

Valacyclovir overdose may cause acute renal failure and development of neurological symptoms, including confusion, hallucinations, agitation, depression of consciousness and coma; nausea and vomiting have also been reported. Caution should be exercised when using the drug to prevent overdose. Many cases of overdose have been associated with the use of the drug to treat patients with impaired renal function and elderly patients, due to non-compliance with the dosing regimen (who repeatedly received doses of valacyclovir greater than recommended).

Treatment.

Patients should be closely monitored for timely diagnosis of toxic manifestations. Hemodialysis significantly accelerates excretion of acyclovir from the blood plasma and may be considered the optimal treatment for symptomatic overdose.

Similarities