Tablets "Acik" (200 mg), instructions for use
"Acik" - tablets for the treatment of herpes infection. Acyclovir, which is the basis of the drug, is effective against herpes simplex virus types I and II.
Composition
1 tablet of "Acik" (200 mg) contains:
active ingredient: 200 mg acyclovir; auxiliary components: microcrystalline cellulose, magnesium stearate, lactose, sodium starch (type A), copolyvidone.
Dosage form
"Acik" (200 mg) - white, round tablets, with a break line on one side.
Pharmacotherapeutic group
Direct-acting antiviral drugs.
Pharmacological properties
Pharmacodynamics
Antiviral agent. Active against herpes simplex virus types 1 and 2 (herpes simplex), shingles virus (varicella zoster), Epstein-Barr virus, cytomegalovirus.
The antiviral activity of the drug is highly selective and is due to its competitive interaction with the virus enzyme - thymidine kinase. Under the influence of thymidine kinase, acyclovir is converted into mono-, di-, and then triphosphate of acyclovir, the latter being incorporated into the DNA synthesized for new viruses. Thus, viral DNA is formed, the structure of which contains a defect, which leads to inhibition of replication of new generations of viruses.
Pharmacokinetics
After oral administration, acyclovir is partially absorbed in the intestine. A day after administration, it is not detected in the body.
Plasma protein binding is 9-33%. The concentration of acyclovir in the CSF is 50% of the concentration of the drug in blood plasma.
The only metabolite of the drug is 9-carboxymethoxymethylguanine. Most of acyclovir is excreted by the kidneys unchanged, 10–15% as a metabolite. The rate of drug excretion slows with age, but the half-life increases slightly.
In chronic renal failure, the half-life is 19.5 hours; in the case of hemodialysis, the figure is reduced to 5.7 hours, and the concentration in the blood plasma is reduced to 60% of the initial value.
In the treatment of patients with HIV infection, the simultaneous use of acyclovir and zidovudine did not cause changes in the pharmacokinetic properties of the drugs.
Clinical characteristics
Indication
Treatment of infections of the skin and mucous membranes caused by Herpes Simplex viruses types 1 and 2, both primary and recurrent, including genital herpes.
Prevention of infections caused by Herpes Simplex viruses types 1 and 2.
Prevention of the development of primary infection and recurrence of infections caused by Herpes Simplex viruses of types 1 and 2 in patients with reduced immunity, including recipients of organ or bone marrow transplantation, severe forms of immunodeficiency, including HIV infection.
Infections caused by Varicella zoster viruses (chickenpox and shingles).
Contraindication
Hypersensitivity to acyclovir and/or any of the excipients. Prophylactic use is contraindicated in patients with severe renal insufficiency or patients with marked urinary retention (anuria).
Application features
Treatment with the drug should be prescribed as early as possible, if possible - in the prodromal period. The state of the body's immune system is important for the implementation of the therapeutic effect. The drug is more effective in patients with unchanged immunity. In patients with reduced immunity, with multiple repeated courses of treatment, the formation of virus resistance to acyclovir sometimes occurs.
Since the main route of excretion of the drug components is through the kidneys, patients with renal insufficiency should reduce the dose of the drug. Elderly patients with a high degree of probability have a history of impaired renal function, so a reduction in dosage is necessary for them. These categories of patients also require close medical supervision during treatment, since they have an increased risk of developing side effects in the form of neurological disorders. When stopping taking "Acik" tablets, such disorders are reversible.
The tablets contain lactose, so patients with hereditary lactose intolerance, glucose-galactose malabsorption syndrome, and lactase deficiency are not prescribed "Acik".
Interaction with other medicinal products and other types of interactions
Acyclovir is excreted from the body mainly through the kidneys in unchanged form, so its concentration in the blood may increase when taken simultaneously with any drugs that have a similar elimination mechanism.
With simultaneous use of the drug with probenecid, the concentration of acyclovir in the plasma increases. In patients who have undergone organ transplantation, taking immunosuppressants can also increase the content of acyclovir in the blood.
Use during pregnancy and breastfeeding
The use of the drug during pregnancy is possible only if absolutely necessary. Breastfeeding is discontinued if the drug is necessary.
Ability to influence reaction speed when driving vehicles and other mechanisms
Given the possibility of developing side effects from the nervous system, caution should be exercised when working with complex mechanisms that require concentration of attention and speed of psychomotor reactions, as well as when driving vehicles until an individual reaction to the drug is identified.
The tablets are taken whole with water. The recommended time of administration is after meals. If it is necessary to take large doses, the patient should drink enough fluids to prevent dehydration.
Adults
For infections caused by the herpes simplex virus, adults are prescribed 200 mg of "Acik" 5 times a day for 5-10 days.
For the prevention of recurrent genital herpes, the drug is prescribed at 400 mg 2 times a day or 200 mg 4 times a day; the course of treatment is from 6 months to 1 year.
For the prevention of herpetic infection in patients with immunodeficiency or after bone marrow transplantation, "Acik" is prescribed at 400 mg 4 times a day throughout the entire period of risk of infection.
When treating Herpes Zoster Ophthalmicus, the dose of the drug is 800 mg, taken 5 times a day for 7-10 days.
Children
For infections caused by the herpes simplex virus, children from 2 years of age are prescribed 200 mg of "Acik" 5 times a day for 5-10 days.
The doses of the drug in the treatment of chickenpox depend on the child's age (on average 20 mg/kg per dose, but not more than 800 mg) and are:
from 2 to 6 years - 400 mg 4 times a day for 5 days; from 6 years - 800 mg 4 times a day for 5 days.
This dosage form of the drug "Acik" is not prescribed to children under the age of 2 years.
Special patient groups
Patients with chronic kidney disease with creatinine clearance less than 10 ml/min are prescribed the drug at a dose of 200 mg every 12 hours for the treatment of infections caused by the Herpes Simplex virus, and up to 800 mg every 12 hours for the treatment of infections caused by the Herpes Zoster virus.
Elderly patients may experience impaired renal function, so it is necessary to consider the possibility of reducing the dose of the drug.
Overdose
Symptoms
In case of oral administration of more than 5 g of acyclovir, it is recommended to monitor the condition of the kidneys. In case of overdose, gastrointestinal disorders may occur, namely nausea and vomiting, as well as neurological symptoms (headache, nervous excitement, confusion, hallucinations, convulsions, coma).
Treatment
In cases of overdose, measures are taken to remove the drug (gastric lavage, administration of adsorbents), in severe cases - by hemodialysis.
Adverse reactions
Gastrointestinal: nausea, vomiting, diarrhea, intestinal colic, moderate short-term increase in bilirubin and transaminase levels are possible.
On the part of the kidneys: in very rare cases - a slight increase in the concentration of urea and creatinine in the blood.
Skin: rashes are possible, which quickly disappear after discontinuation of the drug.
From the side of the central nervous system: in very rare cases, headache, chronic fatigue syndrome, drowsiness or psychomotor agitation, hallucinations, confusion have been noted.
On the part of the urinary system: increased levels of urea and creatinine in the blood (rare), renal failure (very rare).
Expiration date
5 years.
Storage conditions
In a dry, dark place at a temperature not exceeding 25°C. Keep out of reach of children.
Packaging
200 mg tablets in a blister of 5 pieces. 5 blisters are placed in a cardboard box together with instructions for use.
Vacation category
According to the recipe.
Producer
"Salutas Pharma GmbH" / Salutas Pharma GmbH (Germany).
List of used literature
Compendium - medicines; "Medicine from A to Z". Drug directory; National list of medicines - Medicines Control.
