Clinical and pharmacological group: & nbsp

Antiviral drugs

Included in the formulation
  • Acigerpine
    cream externally 
  • Acyclovir
    pills inwards 
    AVVA RUS, OJSC     Russia
  • Acyclovir
    cream externally 
    ATOLL, LLC     Russia
  • Acyclovir
    lyophilizate in / in 
    ALVILS, LTD.     Russia
  • Acyclovir
    pills inwards 
  • Acyclovir
    cream locally externally 
    VERTEKS, AO     Russia
  • Acyclovir
    pills inwards 
  • Acyclovir
    ointment locally externally 
    OZONE, LLC     Russia
  • Acyclovir
    pills inwards 
    AVEKSIMA, JSC     Russia
  • Acyclovir
    ointment externally 
  • Acyclovir
    lyophilizate in / in d / infusion 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Acyclovir
    pills inwards 
    VALENTA PHARM, PAO     Russia
  • Acyclovir
    ointment externally 
  • Acyclovir
    ointment d / eye 
    SYNTHESIS, OJSC     Russia
  • Acyclovir
    ointment externally 
    VERTEKS, AO     Russia
  • Acyclovir
    pills inwards 
  • Acyclovir
    ointment externally 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Acyclovir
    ointment locally externally 
    ALVILS, LTD.     Russia
  • Acyclovir
    ointment locally externally 
    AZT PHARMA KB, LLC     Russia
  • Acyclovir
    ointment externally 
    NIZHFARM, JSC     Russia
  • Acyclovir
    ointment externally 
    ALTAYVITAMINS, CJSC     Russia
  • Acyclovir
    pills inwards 
    NIZHFARM, JSC     Russia
  • Acyclovir
    pills inwards 
    OZONE, LLC     Russia
  • Acyclovir
    ointment externally 
  • Acyclovir
    pills inwards 
    OZONE, LLC     Russia
  • Acyclovir
    pills inwards 
    SYNTHESIS, OJSC     Russia
  • Acyclovir
    ointment externally 
    GREEN DUBRAVA, CJSC     Russia
  • Acyclovir
    pills inwards 
  • Acyclovir Belupo
    cream externally 
  • Acyclovir Belupo
    pills inwards 
  • Acyclovir Sandoz®
    pills inwards 
    Sandoz d.     Slovenia
  • Acyclovir Sandoz®
    cream externally 
    Sandoz d.     Slovenia
  • Acyclovir forte
    pills inwards 
  • Acyclovir-AKOS
    pills inwards 
    SYNTHESIS, OJSC     Russia
  • Acyclovir-Abrichin
    ointment externally 
    AKRIKHIN HFK, JSC     Russia
  • Acyclovir-Ferein
    cream externally 
    BRYNTSALOV-A, CJSC     Russia
  • Acyclostad®
    pills inwards 
  • Vivorax
    cream externally 
  • Vivorax
    pills inwards 
  • Virollex
    cream externally 
  • Virollex
    lyophilizate d / infusion 
  • Gervirax
    cream externally 
  • Gerperax
    ointment externally 
  • Gerperax
    pills inwards 
  • Zovirax ®
    lyophilizate d / infusion 
  • Zovirax ®
    ointment d / eye 
  • Zovirax ®
    pills inwards 
  • Zovirax ®
    cream externally 
  • Medovir
    powder d / infusion 
    Medocemi Co., Ltd.     Cyprus
  • Provirsan®
    pills inwards 
    PRO.MED.CS Prague as.     Czech Republic
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    Minimal chemist's assortment

    АТХ:

    S.01.A.D   Antiviral drugs

    Pharmacodynamics:

    Pharmacological action - antiviral, anti-herpetic.

    It is a synthetic analogue of purine nucleosides. After entering into infected cells containing viral thymidine kinase, acyclovir phosphorylated and converted to acyclovir monophosphate,which under the influence of cellular guanylatkinase is converted into diphosphate and then under the influence of several cellular enzymes - into triphosphate. Acyclovir triphosphate interacts with viral polymerase deoxyribonucleic acid, is included in a chain of viral deoxyribonucleic acid, causes chain termination and blocks further viral replication deoxyribonucleic acid without damaging the host cells.

    Acyclovir inhibits in vitro and in vivo replication of human herpesviruses, including the following (listed in order of decreasing antiviral activity of acyclovir in cell culture): virus Herpes simplex 1 and 2 types, the virus Varicella zoster, Epstein-Barr virus and cytomegalovirus.

    With long-term treatment or repeated use of acyclovir in patients with severe immunodeficiency, the development of viruses Herpes simplex and Varicella zoster to acyclovir. In most clinical isolates obtained from acyclovir-resistant patients, a relative deficiency of viral thymidine kinase or a disruption of the structure of viral thymidine kinase or polymerase deoxyribonucleic acid.

    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. It has an immunostimulating effect.

    Pharmacokinetics:

    When taken orally acyclovir only partially absorbed in the intestine. After a dose of 200 mg 5 times a day, the maximum concentration Acyclovir in blood plasma is 3.2 μmol (0.7 μg / ml), the minimum concentration is 1.8 μmol (0.4 μg / ml).

    The concentration of acyclovir in the cerebrospinal fluid is 50% of the concentration in the blood plasma. Binding to plasma proteins is relatively low (9-33%). Acyclovir basically excreted from the body in an unchanged form through the kidneys. The renal clearance of acyclovir is significantly higher than the creatinine clearance, which indicates that it is eliminated not only by glomerular filtration, but also by tubular secretion.

    The only metabolite found in the urine is 9-carboxymethoxymethyl guanine (10-15% of the prescribed dose).

    When ingested partially absorbed from the gastrointestinal tract, bioavailability - 20% (15-30%),does not depend on the dosage form, decreases with increasing dose; food has no significant effect on the absorption of acyclovir. After oral administration of 200 mg of acyclovir every 4 hours in adults, the average equilibrium values ​​of the maximum concentration of the substance in plasma (serum) of blood - 0,7 mkg / ml and the minimum concentration - 0,4 mkg / ml; the time of maximum concentration in blood plasma is 1.5-2 hours.

    After intravenous drip introduction to adults, the mean maximum concentration of the substance in plasma (serum) of blood 1 hour after infusion in a dose of 2.5; 5 and 10 mg / kg were 5.1; 9.8 and 20.7 μg / ml, respectively. The minimum concentration of substance in blood plasma (serum) 7 hours after the infusion, respectively, were 0.5; 0.7 and 2.3 μg / ml. In children older than 1 year, the maximum and minimum concentrations when administered at a dose of 250 and 500 mg / m2 were similar to those in adults at doses of 5 and 10 mg / kg, respectively. In newborns and infants up to 3 months of age, acyclovir was administered at a dose of 10 mg / kg intravenously drip for 1 hour every 8 hours, the maximum concentration in the blood plasma was 13.8 μg / ml, the minimum concentration was 2.3 μg / ml.

    Binding to proteins is low (9-33%).Passes through the blood-brain barrier, the placental barrier, is found in breast milk (at a dose of 1 g per day inside with the mother's milk, the child receives 0.3 mg / kg). It penetrates well into the organs, tissues and body fluids, including the brain, kidneys, liver, lungs, watery moisture, lacrimal fluid, intestine, muscles, spleen, uterus, mucous membrane and vaginal secretion, semen, cerebrospinal fluid, the contents of herpetic vesicles . The highest concentrations are found in the kidneys, liver and intestines. The concentration in the cerebrospinal fluid is 50% of that in the blood plasma. Metabolised in the liver, under the influence of alcohol and aldehyde dehydrogenase and, to a lesser extent, aldehyde oxidase in inactive metabolites. Metabolism of acyclovir is not associated with cytochrome P450 enzymes.

    The main way of elimination is through the kidneys through glomerular filtration and tubular secretion. When ingested unchanged, about 14% is withdrawn, with intravenous administration - 45-79%. The main metabolite found in urine is 9-carboxymethoxymethylguanine. The share of the main metabolite is up to 14% (with normal kidney function).Less than 2% is excreted with feces, trace amounts are determined in the exhaled air.

    Half-Elimination (half-life) when administered orally in adults - 2,5-3,3 hours. PThe half-elimination period (half-life) with intravenous administration: in adults - 2.9 hours, in children and adolescents from 1 to 18 years - 2.6 hours, in children under 3 months - 3.8 hours (with intravenous injection of 10 mg / kg in for 1 hour 3 times a day). In patients with chronic renal insufficiency half-elimination period (half-life) - 19.5 hours, during hemodialysis - 5.7 hours, with constant outpatient peritoneal dialysis - 14-18 hours. With a single hemodialysis session for 6 hours, the concentration of acyclovir in the plasma is reduced by 60%, with peritoneal dialysis, the clearance of acyclovir does not change significantly.

    When applied to the affected skin (for example, with herpes zoster), the absorption is moderate; in patients with normal renal function, serum concentrations of up to 0.28 μg / ml, with renal dysfunction up to 0.78 μg / ml. It is excreted by the kidneys (approximately 9% of the daily dose).

    Eye ointment easily penetrates the epithelium of the cornea and creates a therapeutic concentration in the eye fluid.

    Indications:

    For systemic use: primary and recurrent skin and mucous membrane infections caused by herpes simplex virus (type 1 and type 2), including genital herpes, herpetic lesions in immunodeficiency patients (treatment and prevention); shingles, chicken pox.

    For external use: herpes simplex skin and mucous membranes, genital herpes (primary and recurrent); localized shingles (ancillary treatment).

    For topical application in ophthalmology: herpetic keratitis.

    I.B00-B09.B00   Infections caused by the herpes simplex virus [herpes simplex]

    I.B00-B09.B00.2   Herpetic gingivostomatitis and pharyngotongsillitis

    I.B00-B09.B00.1   Herpetic vesicular dermatitis

    I.B00-B09.B00.0   Herpetic eczema

    I.B00-B09.B01   Chicken Pox [varicella]

    I.B00-B09.B02.9   Shingles without complications

    III.D80-D89.D84.9   Immunodeficiency, unspecified

    Contraindications:

    Hypersensitivity to acyclovir and valacyclovir; at intravenous introduction - a lactemia (thoracal feeding).

    Carefully:

    Dehydration, renal insufficiency, neurologic disorders (including in the anamnesis), caused by intravenous administration of cytotoxic drugs, pregnancy, breast-feeding.

    Pregnancy and lactation:

    Recommendations Food and Drug Administration (US Food and Drug Administration) category B.

    Pregnancy. Perhaps, if the expected effect of therapy exceeds the potential risk for the fetus (adequate and strictly controlled studies of safety of use in pregnant women are not conducted). Acyclovir passes through the placenta. Data on the outcome of pregnancy in women who took acyclovir systemic action in the first trimester of pregnancy, did not show an increase in the number of congenital malformations in children compared with the general population. Since a small number of women were included in the surveillance, it is impossible to make reliable and definite conclusions about the safety of acyclovir during pregnancy.

    Lactation. Acyclovir penetrates into breast milk. After taking acyclovir inwards, it was determined in breast milk in concentrations whose ratio to plasma concentrations was 0.6-1.4. At such concentrations in breast milk, breastfed infants may receive acyclovir in a dose of 0.3 mg / kg per day. Given this, acyclovir lactating women with caution, only if necessary.

    Dosing and Administration:

    Inside. Adult patients for the treatment of primary infections and relapses Herpes simplex skin and mucous membranes - 1 tablet (200 mg) of acyclovir 5 times a day. The duration of treatment is usually 5 days. In serious cases, longer treatment may be required. In patients with a significantly weakened immune system (eg, after bone marrow transplantation) or in patients with insufficient intestinal absorption, an increase in the single dose to 400 mg or intravenous administration of the drug is necessary. To suppress recurrence of infection caused by Herpes simplex, in patients with normal immune system - 1 tablet of acyclovir (200 mg) 4 times a day or 2 tablets 2 times a day. To prevent infection Herpes simplex in patients with a weak immune system - 1 tablet (200 mg) 4 times a day.

    Children: to treat infection caused by Herpes simplex, and the prevention of this infection against a weakened immune defense, children over 2 years old receive the same dose as adults; less than 2 years - half the dose for adults.

    Elderly patients: in elderly patients the rate of general excretion of acyclovir is reduced. In the course of therapy with high oral doses of the drug, a sufficient supply of fluid to the patient's body should be ensured. In cases of impaired renal function, special attention should be paid to reducing the dose.The decision on the use of the drug in patients with limited renal function is taken by the doctor.

    Intravenously drip, inside, topically. The dosage regimen is set individually, depending on the indications and severity of the process. The dose for children is calculated depending on the indications, age, surface area / body weight. Treatment should be started as early as possible, with the appearance of the first signs and symptoms of the disease.

    Intravenously drip (injected at a constant rate for at least 1 hour): for herpetic infection, severe herpetic infection of the genitalia and shingles adult - 5 mg / kg 3 times a day (every 8 hours) 5 days; patients with disorders of the immune system, with herpetic encephalitis - 10 mg / kg every 8 hours for 10 days. The maximum dose for adults with intravenous administration is 30 mg / kg or 1.5 g / m2 per day.

    Outer: cream or ointment is applied to the affected surface 5 times a day for 5-10 days.

    Eye ointment: for adults and children, a strip of ointment 10 mm long is placed in the lower conjunctival sac 5 times a day (every 4 hours) for 7-10 days (treatment should be continued at least 3 days after complete cure).

    Side effects:

    Dermatological reactions: in rare cases, rashes on the skin are observed, which disappear after the drug is discontinued.

    With systemic application

    On the part of the organs of the gastrointestinal tract: with intravenous administration - anorexia, nausea and / or vomiting; when ingested - nausea and / or vomiting, diarrhea, abdominal pain.

    From the nervous system: when administered intravenously - dizziness, signs of encephalopathy (confusion, hallucinations, convulsions, tremors, coma), delirium, depression or psychosis (neurological disorders are commonly observed in patients with predisposing conditions); when ingested - malaise, headache, dizziness, agitation, drowsiness.

    Cardio-vascular and blood: when administered intravenously - anemia, neutropenia / neutrophilia, thrombocytopenia / thrombocytosis, leukocytosis, hematuria, disseminated intravascular coagulation, hemolysis, in blood pressure.

    From the urogenital system: when administered intravenously - transient increase in levels of blood urea nitrogen and creatinine in blood serum (related to the maximum concentration value of the substance in the plasma state and the aqueous patient balance)acute renal failure (usually with rapid intravenous injection).

    Other: anaphylactic reactions, skin allergic reactions (pruritus, rash, Lyell syndrome, urticaria, erythema multiforme, etc.), visual impairment, fever, leukopenia, lymphadenopathy, peripheral edema, transient increase in hepatic transaminase and bilirubin levels; with intravenous administration - reactions at the site of intravenous administration: phlebitis or local inflammation (pain, swelling or redness), necrosis (if the drug gets under the skin); when ingested - myalgia, paresthesia, alopecia.

    With external application: soreness, burning, itching, skin rash, vulvitis.

    When applying ophthalmic ointment: burning in the place of application, blepharitis, conjunctivitis, spot surface keratopathy.

    Overdose:

    Symptoms: headache, neurologic disorders, dyspnea, nausea, vomiting, diarrhea, renal failure, lethargy, convulsions, coma.

    Treatment: symptomatic therapy, maintenance of vital functions, sufficient hydration, hemodialysis (especially in acute kidney failure and anuria).

    There is no evidence of an overdose in topical application.

    Interaction:

    With the simultaneous use of probenecid reduces the tubular secretion of acyclovir and thereby increases the concentration in the blood plasma and the half-life of acyclovir.

    Other nephrotoxic drugs increase the risk of nephrotoxicity. With simultaneous application with probenecid (blocks tubular secretion) increase half-elimination period (half-life) and area under the curve "concentration - time" acyclovir, reduced renal clearance and slowed down excretion, possibly increasing the toxic effect.

    Strengthening the effect of acyclovir is noted with the simultaneous administration of immunostimulants.

    When mixing solutions, it is necessary to take into account the alkaline reaction of acyclovir for intravenous administration (hydrogen index 11).

    Special instructions:

    The effectiveness of treatment will be higher the earlier it was started. In patients with immunodeficiency, with multiple repeated courses of treatment, viruses are sometimes resistant to acyclovir.

    In the treatment with acyclovir, a large amount of liquid is recommended (to prevent the formation of a precipitate of acyclovir in the renal tubules).

    Caution should be exercised when intravenously administered to patients with neurological disorders, impaired liver function, impaired electrolyte balance, pronounced hypoxia, and with impaired renal function (and when administered internally). To reduce the risk of kidney damage with intravenous administration, the drug should be administered slowly, for 1 hour. When the symptoms of nephropathy appear, the drug is canceled.

    In the treatment with acyclovir, thrombocytopenic purpura and / or hemolytic uremic syndrome, in rare cases with a fatal outcome, in patients with clinically expressed forms of human immunodeficiency virus infection were recorded in clinical practice.

    It is not recommended for prescribing to children for the treatment of chicken pox if the disease is mild.

    In the treatment of genital herpes, sexual intercourse should be avoided or condoms should be used. The use of acyclovir does not prevent the transmission of the virus to the partner.

    Cream and ointment for external use (5%) is not recommended to be applied to the mucous membranes of the mouth and eyes. possible development of pronounced local inflammation.

    In the treatment of ophthalmic ointment, contact lenses should not be worn.

    When using acyclovir, it is necessary to monitor the kidney function (determining the level of urea nitrogen in the blood and creatinine in the blood plasma).

    Treatment of elderly patients should be carried out with sufficient increase in water load and under the supervision of a physician, since in this category of patients the half-life of acyclovir is increased.

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