DANOVIR [Danovir] 400 mg Film-coated tablets
DANOVIR
instructions for medical use of the medicinal product
Tradename
Danovir, Danovir
International non-proprietary name
Aciclovir , Aciclovir
Composition
Each film-coated tablet contains:
active substance: acyclovir BP 400 mg
excipients: microcrystalline cellulose, sodium starch glycolate.
Dosage form
Tablets.
Pharmacotherapeutic group
Antiviral agent.
Pharmacological properties
Danovir is an antiviral drug, a synthetic analogue of the acyclic purine nucleoside, which has a highly selective effect on herpes viruses. The active substance is acyclovir.
Pharmacodynamics
In virus-infected cells under the action of viral thymidine kinase, phosphorylation and further sequential transformation of acyclovir into mono-, di- and triphosphate occur. Acyclovir triphosphate is integrated into the viral DNA chain and blocks its synthesis through competitive inhibition of the viral DNA polymerase.
In vitro, acyclovir is effective against herpes simplex virus - Herpes simplex types 1 and 2; against the Varicella zoster virus, which causes chicken pox and shingles; higher concentrations are required to inhibit the Epstein-Barr virus. Moderately active against cytomegalovirus.
In vivo, acyclovir is therapeutically and prophylactically effective, primarily in viral infections caused by the Herpes simplex virus types 1 and 2. Prevents the formation of new elements of the rash, reduces the likelihood of skin dissemination and visceral complications, accelerates the formation of crusts, reduces pain in the acute phase of herpes zoster.
Pharmacokinetics
After oral administration, the bioavailability is 15-30%, while dose-dependent concentrations are created that are sufficient for the effective treatment of viral diseases. Food does not significantly affect the absorption of acyclovir. Acyclovir penetrates well into many organs, tissues and body fluids. Plasma protein binding is 9-33% and does not depend on its plasma concentration. The concentration in the cerebrospinal fluid is about 50% of its plasma concentration. Acyclovir crosses the blood-brain and placental barriers and accumulates in breast milk. After oral administration of 1 g / day, the concentration of acyclovir in breast milk is 60-410% of its concentration in plasma (acyclovir enters the child's body with mother's milk at a dose of 0.3 mg / kg / day).
It is metabolized in the liver with the formation of a pharmacologically inactive compound 9-carboxymethoxymethylguanine. It is excreted by the kidneys by glomerular filtration and tubular secretion: about 84% is excreted by the kidneys unchanged, 14% - in the form of a metabolite. The renal clearance of acyclovir is 75-80% of the total plasma clearance. T 1/2 in adults with normal renal function is 2-3 hours. In patients with severe renal insufficiency T 1/2 - 20 hours, with hemodialysis - 5.7 h, while the concentration of acyclovir in plasma decreases to 60% of the initial value. Less than 2% of acyclovir is excreted from the body through the intestines.
Indications for use
· Treatment of infections of the skin and mucous membranes caused by Herpes simplex type I and II viruses, both primary and secondary, including genital herpes.
· Prevention of exacerbations of recurrent infections caused by Herpes simplex type I and II viruses in patients with normal immune status.
· Prevention of primary and recurrent infections caused by Herpes simplex type I and II viruses in immunocompromised patients.
· As part of the complex therapy of patients with severe immunodeficiency: with HIV infection and in patients who have undergone bone marrow transplantation.
· Treatment of primary and recurrent infections caused by the Varicella zoster virus (chickenpox, as well as herpes zoster - Herpes zoster ).
Contraindications
· Hypersensitivity to acyclovir.
· Pregnancy.
· lactation period.
· Children's age up to 3 years (for this dosage form).
Dosage and administration
inside. Tablets should be swallowed whole, without chewing, with plenty of liquid during or immediately after a meal.
The dosage regimen is set individually depending on the severity of the disease.
In the treatment of infections of the skin and mucous membranes caused by Herpes simplex types I and II:
Adults: the drug is prescribed 200 mg 5 times a day for 5 days at 4-hour intervals during the day and at 8-hour intervals at night. In more severe cases of the disease, the course of treatment can be extended by a doctor's prescription up to 10 days. As part of complex therapy for severe immunodeficiency, including with an advanced clinical picture of HIV infection (including early clinical manifestations of HIV infection and the stage of AIDS), after bone marrow implantation, 400 mg is prescribed 5 times a day.
For the prevention of recurrence of infections caused by Herpes simplex type I and II viruses, patients with a normal immune status and with a relapse of the disease are prescribed 200 mg 4 times a day every 6 hours, the duration of the course is from 6 to 12 months.
For the prevention of infections caused by Herpes simplex type I and II viruses, adults with immunodeficiency, the drug is recommended to prescribe 200 mg 4 times a day every 6 hours, the maximum dose is up to 400 mg of acyclovir 5 times a day, depending on the severity of the infection.
Children: For Herpes simplex infection and the prevention of this infection in immunocompromised patients, children over 3 years of age receive the same dose as adults.
In the treatment of infections caused by Varicella zoster:
Adults: the drug is prescribed 800 mg 5 times a day every 4 hours during the day and with an 8-hour interval at night. The duration of the course of treatment is 7-10 days.
Children: for chickenpox, 20 mg / kg are prescribed 4 times a day for 5 days (maximum single dose 800 mg), children from 3 years to 6 years: 400 mg 4 times a day, over 6 years: 800 mg 4 times per day for 5 days.
In the treatment of infections caused by Herpes zoster , adults are prescribed 800 mg 4 times a day every 6 hours for 5 days.
In patients with impaired renal function:
In the treatment and prevention of infections caused by Herpes simplex in patients with creatinine clearance less than 10 ml / min, the dosage of the drug should be reduced to 200 mg 2 times a day at 12-hour intervals.
In the treatment of infections caused by Varicella zoster , in patients with creatinine clearance less than 10 ml / min, it is recommended to reduce the dosage of the drug to 800 mg 2 times a day at 12-hour intervals; with creatinine clearance up to 25 ml / min, 800 mg is prescribed 3 times a day at 8-hour intervals.
Special instructions and precautions
Dosing regimen for patients with impaired renal function should be adjusted.
Special care should be taken in patients taking large doses of Danovir, especially dehydrated patients or patients with impaired renal function.
Use with caution in the elderly
Influence on the ability to drive vehicles and mechanisms
During the treatment period, dizziness, drowsiness may develop, therefore, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and psychomotor speed.
Use during pregnancy and during breastfeeding
Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to take Danovir during lactation, interruption of breastfeeding is required.
Interaction with other drugs
With simultaneous use with probenecid, the mean half-life increases and the clearance of acyclovir decreases.
When taken simultaneously with nephrotoxic drugs, the risk of developing renal dysfunction increases.
Side effect
From the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain.
From the side of the central nervous system: headache, weakness, dizziness, fatigue, exhaustion, drowsiness, insomnia, paresthesia, confusion, hallucinations, decreased concentration.
Allergic reactions: skin rash, itching, anaphylactic reactions, Lyell's syndrome, urticaria, erythema multiforme exudative, incl. Stevens-Johnson syndrome, fever.
On the part of the blood system : a transient slight increase in the activity of liver enzymes, a slight increase in the levels of urea and creatinine, hyperbilirubinemia, leukopenia, erythropenia.
Other: alopecia, peripheral edema, blurred vision, lymphadenopathy, myalgia, malaise.
Overdose
Symptoms: nausea, vomiting, headache.
Treatment: it is necessary to carry out a gastric lavage, to ensure sufficient fluid intake. Hemodialysis significantly accelerates the elimination of acyclovir from the blood and can be considered a method of symptomatic treatment in case of overdose.
Storage conditions
Store in a dry place, at a temperature not exceeding 30º C.
Keep out of the reach of children!
Best before date
3 years. Do not use after the expiry date stated on the package.
Holiday conditions
Released by prescription.
Release form
10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.