2010/06/07

VIROLEX powder pro infusionibus

Pharmacological properties: acyclovir - antiviral drug active against herpes simplex virus type 1 and type-2 virus, and herpes zoster. Has virostaticheskoe action. Inhibit the synthesis of viral DNA, not impacting on the physiological processes in the cell.

The half-life in patients with normal renal function is 2.9 h after i / v infusion. Acyclovir penetrates well into tissues, organs and parts of the body: the brain, kidneys, lungs, liver, muscle, spleen, uterus, vaginal mucosa, vaginal secretions, CSF, and the contents of herpetic vesicles. Since plasma proteins binds 15,4% acyclovir. In healthy individuals acyclovir derived mainly from the urine in unchanged form. Pharmacokinetics in children aged over 1 year is similar to that in adults.

Indications: infections caused by the virus Herpes simplex: a primary genital herpes, recurrent genital herpes, herpes encephalitis and generalized infection, herpes of the skin and mucous membranes in patients with immunodeficiency, neonatal herpes and other infections (herpes eczema, hepatitis, proctitis, esophagitis, pneumonia).

Prevention of infections caused by the virus Herpes simplex: after transplantation of bone marrow or kidneys, with aplasia of the bone marrow after treatment with cytotoxic drugs, recurrent genital herpes (with a frequency of 6 times a year and more), frequent recurrent infections in patients with normal immune status, infection patients with immunodeficiencies.

Infections caused by the virus Varicella zoster: varicella in immunocompromised patients, severe or prolonged forms of varicella in patients with normal immune status, complications of varicella caused by the direct action of virus, Varicella zoster; zoster in immunocompromised patients, complications of shingles caused by the direct action of the virus Varicella zoster; eye and ear shape zoster, herpes zoster in individuals aged over 50 years.

APPLICATION: treatment with acyclovir should be started as early as possible, immediately after the first signs of the disease.

The drug is introduced into / in slowly for 1 h.
Infection

Dosage for adults and children over 12 years

Dosage for children aged 3 months to 12 years

Duration of treatment


Herpes simplex

5 mg / kg every 8 h

250 mg / m 2 every 8 h

5 days


Herpes encephalitis

10 mg / kg every 8 h

500 mg / m 2 every 8 h

10 days


Varicella in patients with normal immune status

5 mg / kg every 8 h

250 mg / m 2 every 8 h

7 days


Varicella in immunocompromised patients

10 mg / kg every 8 h

500 mg / m 2 every 8 h

from 7 to 10 days


Preventing infections

250 mg / m 2 every 8 h




Doses for infants: 10 mg / kg every 8 hours dosing regimens for patients with impaired renal function is shown below:
Creatinine clearance

Dosage regimen


25-50 ml / min (0,41-0,83 ml / s)

The usual dose every 12 hours


10-25 ml / min (0,16-0,41 ml / s)

The usual dose every 24 hours


0-10 ml / min (0-0,16 ml / s)

Half the usual dose every 24 hours and immediately after dialysis




Before using the contents of 1 vial should be dissolved in 10 ml water for injection or isotonic p-ra sodium chloride; entered by infusion pump. To prepare the infusion of p-ra contents of two vials of ex tempore dissolved in 100 ml isotonic p-ra sodium chloride or lactate Ringer p-ra, if necessary, dose exceeding 500 mg, add an adequate amount of solvent.

Preparation of infusion p-ra for children who need doses of 10 mg and below, are performed in two stages: first the contents of the vial dissolved in 10 ml water for injection or isotonic p-ra sodium chloride, and then add the appropriate dose for infusion of p-py at a ratio of 1:5 (such as 4 ml in 20 ml).

The product contains no preservatives. Ready rr stable for 12 hours at a temperature from 15 to 25 ° C. Do not use the p-p, which appeared blurred or formed crystals. To prepare the infusion of p-ditch can use isotonic rr sodium chloride or p-p Ringer.

Water for injection should not contain preservatives (benzyl alcohol or parabens).

CONTRAINDICATIONS: Hypersensitivity to the drug.

SIDE EFFECTS: at too fast a / in the introduction of acyclovir and dehydration may be a transitory increase in the level of urea and creatinine in serum, so the injection should be done slowly and ensure adequate hydration of the body. Acute renal failure in the application of the drug occurs very rarely. With the development of renal failure during treatment with acyclovir should appoint adequate hydration, reduce the dose or stop treatment.

Rarely observed neurological symptoms (only in the treatment of complicated forms of the disease), which had a reversible character: convulsions, confusion, hallucinations, tremors, drowsiness, psychosis, coma. There may also be observed nausea, vomiting, skin rashes, increased liver enzymes, anemia, neutropenia, thrombocytopenia.

Cautions: The drug should be used with caution in renal failure, elderly patients, as well as the appointment in high doses, especially in patients with dehydration. Dosage should be corrected in the light of creatinine clearance.

Purpose of the drug during pregnancy can only be life-threatening infections, where the expected benefit to the mother outweighs the potential risk to the fetus. Acyclovir penetrates into the breast milk, so at the time of treatment the drug should be stopped breastfeeding.

Avoid contact with p-pa drug in the eye.

INTERACTIONS: Probenecid, while the application increases the concentration of acyclovir in plasma and lengthens the period of its half-life. The simultaneous use of acyclovir and mycophenolate mofetil leads to increased concentrations of both ingredients in the blood plasma. With simultaneous application of acyclovir and nephrotoxic or neurotoxic drugs should be careful.

OVERDOSE: It is recommended to monitor renal function. It is important to maintain sufficient urine output to prevent crystalluria. Must be active hydration body. Acyclovir is excreted in hemodialysis, peritoneal dialysis is less efficient.

STORAGE CONDITIONS: Powder in vials should be stored at temperatures not above 25 ° C; ready infusion of p-p is stable for 12 hours at a temperature not exceeding 25 ° C; p-p should not be stored in the refrigerator.