Acyclovir forte-Alium pills 400mg, 20pcs

Composition

One tablet contains: Active ingredient: acyclovir-400 mgsupport substances: potato starch, lactose (milk sugar), povidone, sugar (sucrose), sodium lauryl sulfate, magnesium stearate.

Pharmacological action

Antiviral drug, a synthetic analog of acyclic purine nucleoside, which has a highly selective effect on herpes viruses. Inside virus-infected cells, viral thymidine kinase undergoes a series of sequential reactions of transformation of acyclovir into mono -, di-and triphosphate of acyclovir. Acyclovir a triphosphate is incorporated into the viral DNA chain and blocks its synthesis by competitive inhibition of viral DNA polymerase. In vitro, acyclovir is effective against herpes simplex virus-Herpes simplex type I and II, against Varicella zoster virus; higher concentrations are required to inhibit Epstein-Barr virus. Pharmacokinetics: When taken orally, bioavailability is 15-30%. Acyclovir penetrates well into all organs and tissues of the body, including the brain and skin. Binding to plasma proteins is 9-33% and does not depend on its concentration in plasma. The concentration in the cerebrospinal fluid is about 50% of its concentration in plasma. Acyclovir crosses the placental barrier and accumulates in breast milk. The maximum concentration after oral use of 200 mg 5 times a day is 0.7 mcg / ml, the time to reach the maximum concentration is 1.5-2 hours. It is metabolized in the liver to form the pharmacologically inactive compound 9-carboxymethoxymethylguanine. The elimination half-life in adults with normal renal function is 2-3 hours. In patients with severe renal insufficiency, the half-life is 20 hours, with hemodialysis-5.7 hours (while the concentration of acyclovir in plasma decreases to 60% of the initial value). About 84% is excreted unchanged by the kidneys and 14% in the form of a metabolite. The renal clearance of acyclovir is 75-80% of the total plasma clearance. Less than 2% of acyclovir is eliminated from the body through the intestines.

Indications

• Treatment of skin and mucosal infections caused by Herpes simplex viruses type I and II, both primary and secondary, including genital herpes.
• Prevention of exacerbations of recurrent infections caused by Herpes simplex viruses type I and II in patients with normal immune status.
• Prevention of primary and recurrent infections caused by Herpes simplex viruses type I and II in patients with immunodeficiency.
• As part of the complex therapy of patients with severe immunodeficiency: in HIV infection (AIDS stage, early clinical manifestations and detailed clinical picture) and in patients who have undergone bone marrow transplantation.
• Treatment of primary and recurrent infections caused by Varicella zoster virus (chickenpox and shingles – Herpes zoster).

Use during pregnancy and lactation

Acyclovir penetrates the placental barrier and accumulates in breast milk.

Use during pregnancy is only possible if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to take acyclovir during lactation, discontinuation of breastfeeding is required.

Contraindications

• Hypersensitivity to acyclovir, ganciclovir or any excipient of the drug.
• Taking the drug is contraindicated during lactation.
• Children under 3 years of age (for this dosage form).
• Galactose intolerance, lactase deficiency, glucose-galactose malabsorption.

With caution: Pregnancy; elderly people and patients receiving high doses, especially in the presence of dehydration; impaired renal function; neurological disorders or neurological reactions to the use of cytotoxic drugs (including in the anamnesis).

Side effects

The drug is usually well tolerated. From the gastrointestinal tract: in isolated cases – abdominal pain, nausea, vomiting, diarrhea. In the blood: transient slight increase in the activity of liver enzymes, rarely-a slight increase in urea and creatinine levels, hyperbilirubinemia, leukopenia, erythropenia. From the central nervous system: rarely-headache; weakness; in some cases, tremor, dizziness, fatigue, exhaustion, drowsiness, insomnia, paresthesia, confusion, hallucinations, decreased concentration, agitation. Allergic reactions: anaphylactic reactions, skin rash, pruritus, Lyell’s syndrome, urticaria, erythema multiforme, including Stevens-Johnson syndrome, fever. Other: rarely-alopecia, peripheral edema, visual impairment, lymphadenopathy, myalgia, malaise.

Interaction

When used concomitantly with probenecid, the average half-life increases and the clearance of acyclovir decreases.

When taken concomitantly with nephrotoxic drugs, the risk of developing impaired renal function increases.

How to take, course of use and dosage

Inside. The drug is taken during or immediately after a meal and washed down with a sufficient amount of water. The dosage regimen is set individually depending on the severity of the disease. In the treatment of skin and mucosal infections caused by Herpes simplex type 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 for up to 10 days. As part of complex therapy for severe immunodeficiency, including with a detailed 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. To prevent relapses of infections caused by Herpessimplex viruses type I and II, patients with normal immune status and with relapse of the disease are prescribed 200 mg 4 times a day every 6 hours, the course duration is from 6 to 12 months. For the prevention of infections caused by Herpessimplex viruses type I and II, adults with immunodeficiency, the drug is recommended to be prescribed 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 Herpessimplex infection and prevention of this infection in patients with weakened immune defenses, children over 3 years of age receive the same dose as adults. In the treatment of Varicella Zoster infections: Adults: the drug is prescribed 800 mg 5 times a day every 4 hours during the day and at 8-hour intervals at night. The duration of treatment is 7-10 days. Children: with chickenpox,20 mg/kg is prescribed 4 times a day for 5 days (the maximum single dose is 800 mg), children from 3 to 6 years: 400 mg 4 times a day, older than 6 years: 800 mg 4 times a 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 Varicella zoster infections 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 with 12-hour intervals; with creatinine clearance up to 25 ml / min,800 mg 3 times a day with 8-hour intervals is prescribed.

Overdose

Oral use of 20 g of acyclovir has been reported. Symptoms: agitation, coma, convulsions, lethargy. Precipitation of acyclovir in the renal tubules is possible if its concentration exceeds the solubility in the renal tubules (2.5 mg / ml).

Overdose with parenteral use (with bolus use, or use in high doses, or in patients whose water-electrolyte balance was not properly controlled): increased urea nitrogen, hypercreatininemia, impaired renal function, lethargy, convulsions, coma.

Treatment: maintenance of vital functions, hemodialysis.

Special instructions

Use strictly as prescribed by a doctor to avoid complications in adults and children over 3 years of age. Caution should be used in patients with impaired renal function, elderly patients due to an increase in the half-life of acyclovir. When using the drug, it is necessary to ensure the intake of a sufficient amount of fluid. When taking the drug, renal function (blood urea and plasma creatinine levels) should be monitored. Acyclovir does not prevent sexual transmission of herpes, so during treatment it is necessary to refrain from sexual contact, even in the absence of clinical manifestations. Due to the presence of lactose in the composition, patients with rare hereditary diseases such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption should not take the drug.

Form of production

Tablets of 400 mg.

5,10,12,15,20 or 30 tablets in a contour cell package.

1,2 or 3 contour cell packages with instructions for use are placed in a pack of cardboard.

Storage conditions

Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Acyclovir

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor, Children as prescribed by a doctor, Children over 3 years of age

Indications

Cold, Cold Sores