Acyclovir-Abrichin (Aciclovir-Akrihin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsppills
Composition:

Active substance: acyclovir in terms of 100 % substance - 200 mg and 400 mg;

Excipients: cellulose microcrystalline 21.46 mg or 42.92 mg, povidone 1.17 mg or 2.34 mg, magnesium stearate 2 mg or 4 mg, indigocarmine 0.1 mg or 0.2 mg, sodium carboxymethyl starch 12.5 mg or 25 mg mg, water purified 12.77 mg or 25.54 mg respectively.

Description:Tablets of blue color with dark and light blue impregnations and possible white spots, flat-cylindrical, with a facet and a risk.
Pharmacotherapeutic group:Antiviral agent
Pharmacodynamics:

The antiviral drug is a synthetic analogue of the acyclic purine nucleoside, which has a highly selective effect on herpes viruses. In infected cells containing viral thymidine kinase, phosphorylation and conversion to acyclovir monophosphate occurs. Under the influence of guanylyl cyclase acyclovir, monophosphate is converted to diphosphate and under the influence of several cellular enzymes - into triphosphate.

Acyclovir triphosphate is inserted into a chain of viral DNA and blocks its synthesis by competitive inhibition of the viral DNA polymerase. Specificity and very high selectivity of action are also due to its predominant accumulation in cells affected by the herpes virus.

Highly active against the virus Herpes simplex 1 and 2 types; a virus that causes varicella and shingles (Varicella zoster); the Epstein-Barr virus. Moderately active against cytomegalovirus.

With herpes, prevents the formation of new elements of the rash, reduces the likelihood of cutaneous dissemination and visceral complications, accelerates the formation of crusts, reduces pain in the acute phase of herpes zoster.

Pharmacokinetics:

When administered orally, the bioavailability is 15-30%. Acyclovir well penetrates into all organs and tissues of the body; concentration in cerebrospinal fluid - 50 % of its concentration in the blood plasma. Penetrates through blood-brain and placental barriers, accumulates in breast milk. The connection with plasma proteins is 9-33%.

Maximum concentration (Cmax) in the blood plasma after ingestion of 200 mg 5 times a day, 0.7 μg / ml. Time to reach the maximum concentration in blood plasma - 1,5 - 2 h.

Metabolized in the liver with the formation of a pharmacologically inactive metabolite - 9-carboxymethoxymethylguanine. The half-life (T1/2) when administered orally - 2-3 hours. In patients with severe renal insufficiency, T1/2 - 20 hours, with hemodialysis - 5.7 hours (with the concentration of acyclovir in the plasma decreases to 60% of the original value).

It is excreted by the kidneys in an unchanged form (about 84%) and in the form of a metabolite (about 14%). Less than 2% is excreted through the gastrointestinal tract; trace amounts are determined in the exhaled air.
Indications:

- LTreatment of infections of the skin and mucous membranes caused by the virus Herpes simplex 1 and 2 types, both primary and secondary, including genital herpes;

- prevention of exacerbations of recurrent infections; caused by a virus Herpes simplex 1 and 2 types in patients with normal immune status;

- prevention of primary and recurrent infections caused by the virus Herpes simplex 1 and 2 types, in patients with immunodeficiency;

- as part of complex therapy in patients with severe immunodeficiency: in HIV infection (stage AIDS, early clinical manifestations and a developed clinical picture) and in patients who underwent bone marrow transplantation

- treatment of primary and recurrent infections caused by the virus Varicella zoster (chicken pox, shingles).

Contraindications:

Increased sensitivity to acyclovir, ganciclovir, valaciclovir or components of the drug, lactation period, children under 3 years.

Carefully:

Pregnancy, old age, dehydration, renal insufficiency, neurological disorders or neurological reactions to the use of cytotoxic drugs (including in the anamnesis).

Pregnancy and lactation:

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

If it is necessary to use the drug during lactation, breastfeeding should be stopped.
Dosing and Administration:

Inside, during or immediately after eating, drink plenty of water. 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 the virus Herpes simplex 1 and 2 types

Adults - 200 mg 5 times a day (every 4 hours during wakefulness, except for night sleep) for 5 days, for treatment genital herpes - 10 days, if necessary, the duration of treatment can be extended. .

As part of complex therapy with severe immunodeficiency, including in the unfolded clinical picture of HIV infection (including early clinical manifestations HIV infection and AIDS stage), after the bone marrow implantation 400 mg 5 times a day.

To prevent the recurrence of infections caused by the virus Herpes simplex 1 and 2 types in patients with normal immune status

Adults - 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 the virus Herpes simplex 1 and 2 types, in patients with immunodeficiency

Adults - 200 mg 4 times a day every 6 hours, the maximum dose - up to 400 mg 5 times a day, depending on the severity of the infection.

In the treatment shingles - 800 mg 5 times a day (every 4 hours during waking hours, except for a night's sleep) for 7-10 days.

Children over the age of 3 years of age are prescribed the drug at the same dose as adults. Treatment chicken pox: adults and children over 6 years - 800 mg 4 times a day; children 3-6 years - 400 mg 4 times a day. More precisely, the dose can be determined from the calculation of 20 mg / kg. The course of treatment is 5 days.

In patients with impaired renal function, dose adjustments and dosing regimens are required, depending on the amount of creatinine clearance and the type of infection. For the treatment of infection caused by Herpes simplex, with creatinine clearance less than 10 ml / min, the daily dose of the drug should be reduced to 400 mg,dividing it into 2 divided doses (with intervals of at least 12 hours, ie 200 mg twice a day).

In the treatment of infections caused by Varicella zoster, and with maintenance therapy of patients with severe immunodeficiency, patients with a creatinine clearance of 10-25 ml / min are prescribed 800 mg 3 times a day at an interval of 8 hours, with creatinine clearance less than 10 ml / min - 800 mg twice a day with an interval of 12 hours.

Side effects:

From the digestive system: nausea, vomiting, diarrhea, abdominal pain; rarely - a reversible increase in bilirubin and hepatic enzyme activity.

On the part of the hematopoiesis system: very rarely - anemia, leukopenia, thrombocytopenia.

From the urinary system: rarely - an increase in urea and creatinine in the blood; very rarely acute renal failure.

From the central nervous system: headache, weakness, dizziness, fatigue, confusion, hallucinations, drowsiness, paresthesia, convulsions, decreased concentration, agitation.

Allergic reactions: itching, rash, Lyell's syndrome, urticaria, multiforme exudative erythema, incl. syndrome Stevens-Johnson, angioedema, anaphylaxis.

Other: fever, lymphadenopathy, peripheral edema, visual impairment, myalgia, alopecia.

Overdose:

Symptoms: agitation, coma, cramps, lethargy. It is possible to precipitate acyclovir in the renal tubules if its concentration exceeds the solubility in the renal tubules (2.5 mg / ml).

Treatment: symptomatic.

Interaction:

With simultaneous application with probenecid, the average half-life increases and acyclovir clearance decreases.

With simultaneous use with nephrotoxic drugs, the risk of kidney impairment increases.
Special instructions:

When taking the drug should monitor the function of the kidneys (blood urea and blood plasma creatinine).

When using the drug, it is necessary to ensure the supply of a sufficient amount of liquid.

Long-term or repeated treatment with acyclovir patients with reduced immunity can lead to the appearance of strains of viruses that are insensitive to its action. In most isolated strains of viruses, insensitive to acyclovir,there is a relative lack of viral thymidine kinase; strains with altered thymidine kinase or with altered DNA polymerase were isolated. In vitro action of acyclovir on isolated strains of the virus Herpes simplex may cause the appearance of less sensitive strains.

Acyclovir does not prevent the transmission of herpes by sex, so during treatment it is necessary to abstain from sexual contacts, even in the absence of clinical manifestations.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities / requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets 200 mg and 400 mg.
Packaging:For 10 tablets in a planar cell package. 2 contour mesh packages together with instructions for use in a pack of cardboard.
Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:LS-000044
Date of registration:24.03.2010 / 09.06.2015
Expiration Date:Unlimited
The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
Manufacturer: & nbsp
Information update date: & nbsp21.09.2017
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