Fillers of a film cover: titanium dioxide (E171), ferrous oxide red (E172), a gidroksipropilmetiltsellyuloz, polysorbate, polyethyleneglycol, water cleared.

Indications to use

Valtsit it is appointed at treatment of a Cytomegaloviral retinitis at patients about AIDS, and also for the purpose of prevention of a Cytomegaloviral infection after organ transplantation.

Contraindications

Number of thrombocytes less than 25 000 C / мкл;
Clearance of creatinine less than 10 ml/min.;
Absolute number of neutrophils less than 500 C / мкл;
Concentration of hemoglobin is lower than 80 g/l;
Hypersensitivity of the patient to a gantsiklovir, a valgantsiklovir, and also to any of drug components (reactions of cross sensitivity to Valtsit, a valatsiklovir and an acyclovir are possible that is explained by a similar chemical structure of these drugs);
Period of pregnancy and lactation;
Age less than 12 years.

With care drug is appointed to patients with a renal failure, and also to elderly people (efficiency and safety for this age category are not established).

Route of administration and dosage

Drug is recommended to be accepted inside during food.

In order to avoid overdose it is necessary to adhere to the dosing mode recommended by the instruction strictly:

Induction therapy to patients with an active Cytomegaloviral retinitis – within 3 weeks to accept 900 mg 2 times a day. At long induction therapy the risk of a miyelotoksichnost increases;
Maintenance therapy after performing induction therapy to patients with an inactive Cytomegaloviral retinitis – 900 mg of 1 times a day. In case of deterioration in a current of a retinitis repeated carrying out a course of induction therapy is allowed;
Prevention of a Cytomegaloviral infection after organ transplantation – to accept from 10 to 100 days after transplantation, 1 time a day 900 mg.

In the course of treatment of the patients having a renal failure it is necessary to control carefully the level of creatinine of serum or the clearance of creatinine (CC). For men the clearance of creatinine is calculated depending on its level in serum on the following formula: (140 – age (years)) × body weight (kg)) / 72 × 0,011 × creatinine of serum, µmol/l. For women of KK = 0,85 × an indicator for men. Further calculation for men is given:

At KK of 10-24 ml/min. the dose for induction therapy makes 450 mg each 2 days, for a maintenance therapy – 450 mg 2 times a week;
At KK of 25-39 ml/min. a dose for induction therapy – 450 mg of 1 times a day, for a maintenance therapy – 450 mg each 2 days;
At KK of 40-59 ml/min. a dose for induction therapy – 450 mg 2 times a day, for a maintenance therapy – 450 mg of 1 times a day;
At KK from 60 ml/min. a dose for induction therapy – 900 mg 2 times a day, for a maintenance therapy – 900 mg of 1 times a day.

It is not necessary to appoint Valtsit to the patients who are on a hemodialysis (KK less than 10 ml/min.).

At a neutropenia, thrombocytopenia, oppression of marrow, a heavy leukopenia, anemia, a pancytopenia, aplastic anemia it is not recommended to begin therapy if concentration of thrombocytes less than 25 000 C / мкл or the maintenance of neutrophils less than 500 C / мкл and also if the level of hemoglobin is lower than 80 g/l.

Side effects

Data of clinical trials:

At patients is after organ transplantation by the most frequent side effects arising against the background of Valtsit's reception are: tremor, hypostases of the lower extremities, dorsodynias, headaches, sleeplessness, graft rejection, nausea, vomiting, diarrhea, hypertensia. The most part of the listed manifestations carries moderately or poorly expressed character.

Among the most often found side reactions at administration of drug by patients about AIDS and a Cytomegaloviral retinitis are noted: neutropenia, fever, weakness and headaches, oral cavity candidiasis, diarrhea.

Among patients after transplantation with a frequency of 2% the undesirable phenomena which were not observed among patients with a Cytomegaloviral retinitis were noted: abnormal liver function, hypertensia, hyperpotassemia, giperkreatinininemiya.

The side effects recorded more than at 5% of patients after organ transplantation and with a Cytomegaloviral retinitis:

From an organism in general: weakness, peripheral hypostases, hypostases of the lower extremities, fever, anorexia, loss of appetite, dehydration, cachexia, weight reduction, reaction of graft rejection;
Infectious complications: oral cavity candidiasis, pharyngitis, nasopharyngitis, upper respiratory tract infection, sinusitis, pneumonia, infections of urinary tract;
Dermatological reactions: the strengthened sweating (at night days), an acne, dermatitis, an itch;
From an organ of sight: indistinct sight, peeling of a retina;
From an urinary system: dysuria, renal failure, infections of uric ways;
From the alimentary system: nausea and vomiting, lock, dyspepsia, diarrhea, ascites, abdominal pains, abnormal liver function;
From system of a hemopoiesis: anemia, leukopenia, neutropenia, thrombocytopenia;
From the central and peripheral nervous system: sleeplessness, tremor, paresthesias, headaches and dizziness, peripheral neuropathy, depression;
From respiratory system: productive cough, a pleural exudate, a nasopharyngitis, pharyngitis, allocations from a nose, sinusitis, pneumonia, pneumocystic pneumonia, upper respiratory tract infections, short wind;
From a musculoskeletal system: arthralgias, spasms in muscles, a dorsodynia, extremity pains;
From cardiovascular system: arterial hypotension, arterial hypertension;
Laboratory indicators: hyperpotassemia, hypopotassemia, hyperglycemia, hypocalcemia, giperkreatinininemiya, hypomagnesiemia, hypophosphatemia;
Others: during the postoperative period complications, strengthening of a drainage of a wound, a bad wound repair, infectious complications of a postoperative wound, pain after operation can be noted.

The serious undesirable effects caused by Valtsit's reception, meeting with frequency less than 5%:

From an urinary system: giperkreatinininemiya, decrease in clearance of creatinine;
From the central and peripheral nervous system: mental deviations, confusion of consciousness, hallucination, agitation, spasms;
From system of a hemopoiesis: oppression of function of marrow, pancytopenia, aplastic anemia;
From coagulant system of blood: life-threatening bleedings;
Others: hypersensitivity to a valgantsiklovir.

Valtsit quickly it is synthesized in ганцикловир therefore in the course of therapy the side effects characteristic of a gantsiklovir can be noted.

Special instructions

Children as its efficiency, safety and pharmacological characteristics are not established for this age category are not recommended to appoint drug.

In the course of therapy it is necessary to control regularly developed blood count with thrombocytes. To the patients suffering from a neutropenia, thrombocytopenia, a leukopenia, anemia growth factors are appointed and/or administration of drug is cancelled.

Gantsiklovir cannot be replaced with Valtsit in the ratio 1:1 as bioavailability of a gantsiklovir from Valtsit exceeds that of capsules of a gantsiklovir by 10 times. The patients transferred from capsules of a gantsiklovir have to be informed on risk of overdose if they accept Valtsin in the doses exceeding recommended.

Pilot studies on animals showed teratogenic, cancerogenic, mutagen, spermatocidal action of a gantsiklovir. Valtsit it is considered for the person potential carcinogen and teratogen which use is accompanied by risk of developing of cancer and inborn malformations. There is a probability that drug can forever or is temporary suppress a spermatogenesis.

Ability to driving of the car and control of mechanisms can be broken at emergence at the patient of such side reactions as sedations, confusion of consciousness an ataxy or dizzinesses.

The razlamyvaniye or crushing of a tablet as Valtsit – potential carcinogen and teratogen for the person is not allowed. It is impossible to allow direct contact of a tablet which integrity was broken, with mucous membranes and skin. If such contact happened, it is necessary to wash out immediately skin water with soap (eyes carefully wash out water).

Medicinal interaction

As Valtsit is synthesized in ганцикловир, the interactions characteristic of a gantsiklovir can be expected also at Valtsit's appointment.

The concomitant use of a gantsiklovir and tsilastatina/imipenem should be allowed only if the advantage of such therapy exceeds potential risk – the combined reception of these drugs can cause spasms.

AUC of a zidovudine can slightly, but is statistically significant increase (to 17%) at simultaneous oral administration of a gantsiklovir. Also the tendency (statistically doubtful) to decrease in concentration of a gantsiklovir can be noted. Some patients cannot transfer a concomitant use of both drugs in full doses as ганцикловир and a zidovudine can cause anemia and a neutropenia.

Co-administration of a mikofenolat of a mofetil and gantsiklovir can increase the maintenance of a gantsiklovir and phenolic glucuronide of mikofenolny acid.

At the patients undergoing therapy by cyclosporine after the beginning of use of a gantsiklovir some increase in the maximum level of creatinine in serum was revealed.

At at the same time reception of Valtsit and a probenetsid of patients it is recommended to inspect regarding toxicity of a gantsiklovir.

Concentration of a didanozin at simultaneous use with gantsikloviry with firmness increases therefore patients at such therapy should be observed regarding emergence of signs of toxic influence of a didanozin.

Simultaneous therapy of a gantsiklovir with other drugs breaking function of kidneys or rendering myelosuppressive effect can increase their toxic influence therefore such treatment can be appointed only in cases when the possible advantage exceeds potential risk.