Valcycon pills 500mg 10pcs

Composition

1 tablet contains:

Active ingredient:

valacyclovir hydrochloride – 556.00 mg (based on valacyclovir 500.00 mg).

Auxiliary substances:

microcrystalline cellulose-95.00 mg,

hyprolose (hydroxypropylcellulose) – 14.00 mg,

crospovidone-28.00 mg,

magnesium stearate-7.00 mg.

Film shell:

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

Indications

Adults:

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

– treatment of infections of the skin and mucous membranes caused by Herpes simplex virus 1,2 type including first diagnosed and recurrent genital herpes (Herpes genitalis), and labially herpes (Herpes labialis);

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

– prevention of transmission of genital herpes to a healthy partner for the use of the drug as a suppressive therapy in combination with safe sex;

Adults and children aged 12 years and older:

– prevention of cytomegalovirus (CMV) infection, as well as acute graft rejection reactions (in patients with kidney transplants), opportunistic infections and other herpesvirus infections (HSV, VZV) after organ transplantation.

Contraindications

Hypersensitivity to valacyclovir, acyclovir and any other component included in the drug; HIV infection with a CD4+ lymphocyte content of less than 100 in 1 µl; children (up to 12 years in the prevention of cytomegalovirus infection after transplantation, up to 18 years – for other indications).

Side effects

From the central nervous system: headache, dizziness, psychotic symptoms, restlessness, decreased mental abilities, ataxia, coma, confusion or depression of consciousness, dysarthria, encephalopathy, mania, hallucinations, convulsions, tremor. These reactions are reversible and usually occur in patients with impaired renal function or other predisposing conditions. In organ transplant patients receiving high-dose valacyclovir (8 g / day) to prevent cytomegalovirus infection, neurological reactions develop more frequently than when taken at lower doses.

Respiratory system disorders: dyspnoea.

From the digestive system: nausea, abdominal discomfort, vomiting, diarrhea, reversible violations of functional liver tests (increased activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), which are sometimes regarded as manifestations of hepatitis.

From the hematopoietic system: leukopenia (mainly observed in patients with reduced immunity), thrombocytopenia, anemia, thrombotic thrombocytopenic purpura.

From the skin: erythema multiforme, rashes, photosensitization, alopecia.

Allergic reactions: pruritus, urticaria, angioedema, anaphylaxis.

From the urinary system: pain in the projection of the kidneys, impaired renal function, including acute renal failure, renal colic. Renal colic may be associated with impaired renal function.

From the side of the senses: visual impairment.

Laboratory parameters: decreased hemoglobin content, hypercreatininemia.

Other: dysmenorrhea, nasopharyngitis, respiratory tract infections, increased blood pressure, tachycardia, fatigue;

patients with severely impaired immunity, particularly in adult patients with advanced stage of HIV infection receiving valacyclovir at high doses (8 g/day, daily) for a long time, there have been cases of renal failure, microangiopathic hemolytic anemia and thrombocytopenia (sometimes in combination).

Similar adverse reactions have been reported in patients with the same medical conditions but not treated with valacyclovir.

Interaction

Cimetidine and tubular secretion blockers reduce the effect (reduce the rate, but not the completeness of conversion to acyclovir). Correction of the dosage regimen in individuals with normal creatinine clearance is not required.

Nephrotoxic medications increase the risk of developing impaired renal function. Caution should be exercised (to monitor changes in renal function) when combining Valcycone in higher doses (4 g per day or more) with drugs that affect other renal functions (for example: cyclosporine, tacrolimus).

Acyclovir is mainly excreted unchanged by the kidneys through active renal secretion. The combined use of drugs with this elimination mechanism may lead to an increase in the concentration of acyclovir in blood plasma.

After prescribing Valcycone at a dose of 1000 mg, cimetidine and probenecid, which are eliminated in the same way as valacyclovir, increase the AUC of acyclovir and thus reduce its renal clearance. Due to the broad therapeutic index of acyclovir, dose adjustment of Valcycone is not required in this case.

Caution should be exercised in the case of concomitant use of valacyclovir in higher doses (4 g per day or higher) and drugs that compete with acyclovir for the elimination pathway, since there is a potential threat of increased plasma levels of one or both drugs or their metabolites. There was an increase in the AUC of acyclovir and the inactive metabolite mycophenolate mofetil with simultaneous use of these drugs.

The pharmacokinetics of valacyclovir do not change when administered concomitantly with digoxin, aluminum / magnesium-containing antacids, and thiazide diuretics.

How to take, course of use and dosage

Inside, regardless of food intake, washed down with water.

Treatment of shingles (Herpes zoster)

Adults:

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

Treatment of HSV infections

Adults:

The recommended dose for treating an episode is 500 mg twice daily for 5 days.

In more severe cases, the onset of the disease should begin as early as possible, and its duration can be increased from 5 to 10 days. In case of relapses, treatment should continue for 3 or 5 days. When HSV relapses, valacyclovir is considered ideal in the prodromal period or immediately after the first symptoms of the disease appear.

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

Prevention (suppression) of recurrent HSV infections

Adults:

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

In patients with immunodeficiency, the recommended dose is 500 mg 2 times a day.

Prevention of transmission of genital herpes to a healthy partner

to Infected immunocompetent individuals with relapses no more than 9 times a year the recommended dose of valacyclovir is 500 mg 1 time a day for a year or more every day.

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

Prevention of cytomegalovirus (CMV) infection after transplantation

Adults and adolescents aged 12 years and older:

The recommended dose is 2 g 4 times a day, prescribed as early 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 can be extended.

Special patient groups

Patients with impaired renal function

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

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

There is no experience of using valacyclovir in children with creatinine clearance values less than 50 ml/min/1.73 m%^%2.

Overdose

Symptoms:

an overdose of valacyclovir may cause acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, depression of consciousness and coma, as well as nausea and vomiting. To prevent overdose, caution should be exercised when using the drug. Many cases of overdose were associated with the use of the drug for the treatment of patients with impaired renal function and elderly patients, due to non-compliance with the dosage regimen (re-received doses of valacyclovir exceeding the recommended ones).

Treatment.

Patients should be closely monitored for timely diagnosis of toxic symptoms. Hemodialysis significantly accelerates the elimination of acyclovir from the blood plasma and can be considered the optimal treatment method in the case of symptomatic overdose.

Special instructions

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

Since acyclovir is excreted by the kidneys, the dose of Valcycone should be adjusted depending on the degree of impaired renal function. Patients with renal insufficiency have an increased risk of developing neurological complications, and such 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 (CRF), it is recommended to frequently determine creatinine clearance, especially when renal function changes rapidly (in particular, immediately after transplantation or graft engraftment), and the dose of valacyclovir is adjusted according to creatinine clearance indicators.

There are no data on the use of valacyclovir in high doses (4 g or more per day) in patients with liver disease, so high doses of Valcycone should be prescribed with caution. Suppressive therapy with valacyclovir reduces the risk of transmission of genital herpes, but does not eliminate the risk of infection and does not lead to a complete cure. Valcycone therapy is recommended in combination with safe sex.

Taking the drug in high doses for a long time in conditions accompanied by severe 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 side effects from the central nervous system occur (including agitation, hallucinations, confusion, delirium, convulsions and encephalopathy), the drug is discontinued.

Form of production

Round biconvex tablets, film-coated in white or almost white color.

On a cross-section, the core is white or almost white in color.

Storage conditions

 In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Valacyclovir

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children over 12 years of age, Adults by doctor’s prescription, Children by doctor’s prescription, Adults

Indications

Cold, Cytomegalovirus Infection, Herpes