Acyclovir Sandoz - Instructions For The Use Of Tablets And Cream, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Acyclovir Sandoz

Acyclovir Sandoz: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Aciclovir Sandoz

ATX code: D06BB03

Active ingredient: aciclovir (aciclovir)

Producer: Salutas Pharma (Germany)

Description and photo update: 2018-25-10

Prices in pharmacies: from 70 rubles.

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Acyclovir Sandoz is an antiviral drug.

Release form and composition

Dosage forms:

• tablets: white, round, biconvex, with a dividing line on one side (5 pcs. in blisters, in a cardboard box 1, 2, 3 or 5 blisters);
• cream for external use 5%: a mass of almost white or white color with a homogeneous structure (in aluminum tubes 2 g each, in a cardboard box 1 tube; in aluminum tubes 5 g each, in a cardboard box 1 or 4 tubes).

1 tablet contains:

• active substance: acyclovir - 0.2 g;
• auxiliary components: lactose monohydrate, sodium carboxymethyl starch, microcrystalline cellulose, magnesium stearate, copovidone.

10 g of cream contains:

• active substance: acyclovir - 0.5 g;
• auxiliary components: cetyl alcohol, arlaton 983S - fatty acid ester and macrogol, dimethicone 350, propylene glycol, liquid paraffin, white petrolatum, purified water.

Pharmacological properties

Pharmacodynamics

Acyclovir Sandoz is an antiviral drug for systemic and local use. The active ingredient of the drug is acyclovir, an artificial analogue of the nucleoside deoxythymidine. It has high activity against the Herpes simplex virus type 1 and 2, Varicella zoster (causing chickenpox and shingles), against the Epstein-Barr virus (human herpesvirus type 4). It exhibits moderate activity towards cytomegalovirus infection.

The mechanism of action of acyclovir is aimed at phosphorylation of viral thymidine kinase contained in infected cells and converting it into acyclovir monophosphate, which, under the influence of guanylate cyclase, is converted to diphosphate, then to triphosphate, due to the action of certain cellular enzymes. It is the lack of the necessary enzyme for the formation of acyclovir triphosphate in intact cells of the virus that determines the high selectivity of the drug for humans and its low toxicity.

Acyclovir triphosphate, interacting with the viral DNA polymerase (deoxyribonucleic acid), enters the DNA chain synthesized by the virus and blocks the process of virus replication. The specificity of acyclovir lies in its predominant accumulation in the cells affected by the virus, this causes a very high selectivity of its action to suppress the replication of new generations of viruses.

Therapeutic activity prevents the formation of a new rash, reduces pain in the acute phase of herpes zoster, the likelihood of cutaneous dissemination and visceral complications, accelerates the formation of crusts on the skin. It has an immunostimulating effect.

Pharmacokinetics

When acyclovir is taken orally from the gastrointestinal tract, it is partially absorbed. Due to its low lipophilicity, its absorption is approximately 20%. This is sufficient to create a dose-dependent concentration that provides effective treatment for viral diseases. Simultaneous food intake does not significantly affect the absorption of acyclovir. The bioavailability of the drug decreases with increasing dose. When the drug is taken orally 5 times a day at a dose of 200 mg, its maximum concentration in the blood plasma occurs after 1.5–2 hours and is 0.7 μg / ml.

Plasma protein binding - from 9 to 33%.

Acyclovir penetrates into various organs and tissues, overcomes the placental and blood-brain barrier. Its concentration level in the cerebrospinal fluid is ½ of the level in the blood. Excreted during lactation; after a daily intake of 1000 mg of acyclovir, its concentration in breast milk can reach 4.1% of the concentration in blood plasma. This content of acyclovir in breast milk corresponds to its intake into the child's body at a dose of 0.3 mg per 1 kg of body weight per day.

Metabolism occurs in the liver, resulting in the formation of 9-carboxymethoxy-methylguanine.

Through the kidneys, 62–91% of acyclovir is excreted unchanged, through the intestines - less than 2%, trace amounts of the substance are determined in the air exhaled by the patient.

The half-life (T _1/2) in adults is 3.3 hours, in children 3–18 years old - 2.6 hours.

In severe chronic renal failure, T _1/2 increases to 20 hours. In adults with renal insufficiency, T _1/2 depends on creatinine clearance (CC); with an increase in CC, this indicator decreases. So with anuria, T _1/2 is 19.5 hours; CC 15-50 ml / min - 3.5 hours; 50–80 ml / min - 3 hours; 80 ml / min - 2.5 hours. In patients on hemodialysis, T _1/2 is 5.7 hours, and when using constant peritoneal dialysis - 14-18 hours. It should be borne in mind that after a single hemodialysis session lasting 6 hours, the level of acyclovir in plasma decreases by 60%.

When the cream is applied topically, the absorption of the active substance by intact parts of the body practically does not occur. Acyclovir is not detected in blood and urine. Moderate absorption of the drug occurs through the affected skin. The level of its concentration in the blood serum in patients with normal renal function is no more than 0.00028 mg per 1 ml, in chronic renal failure it is about 2.5 times higher.

Up to 9.4% of the daily dose of the cream is excreted through the kidneys.

Indications for use

Indications for the use of Acyclovir Sandoz tablets:

• chicken pox;
• herpes zoster;
• infections of the skin and mucous membranes, including primary and recurrent genital herpes, caused by the herpes simplex virus;
• prevention of recurrence of infections caused by the herpes simplex virus in patients with normal immune status;
• prevention of herpes simplex virus infections, in patients with immunodeficiency;
• as part of the complex therapy of severe immunodeficiency, including patients after bone marrow transplantation and in the late stage of HIV infection with manifestations of the AIDS-associated complex.

Indications for the use of Acyclovir Sandoz cream:

• chicken pox;
• skin infections, including herpes of the lips and genital herpes, caused by Herpes simplex virus types 1 and 2;
• shingles.

Contraindications

• breast-feeding;
• individual intolerance to the components of the drug.

In addition, additional contraindications for the use of tablets:

• lactase deficiency, glucose-galactose malabsorption syndrome, lactose intolerance;
• age up to three years;
• hypersensitivity to valacyclovir.

With caution, Acyclovir Sandoz should be prescribed for chronic renal failure and conditions that are accompanied by dehydration (including vomiting, diarrhea).

During pregnancy, the appointment of tablets and cream is possible only in special cases, if the expected effect of therapy for the mother exceeds the potential threat to the fetus.

Instructions for use of Acyclovir Sandoz: method and dosage

Pills

Acyclovir Sandoz tablets are taken orally with plenty of water, preferably after meals.

The greatest effectiveness is achieved if the drug is started immediately after the diagnosis of the skin symptoms of the virus. During the treatment of relapses of the disease, it is recommended to start taking the drug when a rash appears or already in the prodromal period.

Recommended dosage for taking Acyclovir Sandoz tablets (1 tablet - 0.2 g):

• infections caused by the herpes simplex virus in patients over three years old: 1 pc. every 4 hours 5 times a day (except for the period of night sleep). The duration of the course of treatment is usually 5 days. If necessary, it can be extended;
• severe immunodeficiency or therapy of patients with impaired absorption from the intestine: 2 pcs. 5 times a day;
• prevention of recurrence of herpes simplex virus infection in adult patients with normal immune status: 1 pc. 4 times a day (every 6 hours) or 2 pcs. 2 times a day at intervals of 12 hours. Perhaps the appointment of the drug in a dose of 1 pc. with a frequency of admission 2-3 times a day (every 12 or 8 hours). Course duration up to 12 months;
• prevention of herpes simplex virus infections in immunocompromised patients over the age of three: 1 pc. 4 times a day, at intervals of 6 hours. With severe immunodeficiency caused by bone marrow transplantation, as well as for patients with impaired absorption from the intestine, a single dose can be increased to 2 pcs. The course of prophylactic administration of the drug is determined individually, its duration should correspond to the duration of the period with the existing risk of infection;
• chickenpox: adults - 4 pcs. 5 times a day with an interval of 4 hours between doses (excluding the period of night sleep). Duration of the course is 7 days. Children aged 3 to 6 years are prescribed 2 pcs. 4 times a day, children over 6 years old - 4 pcs. 4 times a day. The dose for children can be more accurately determined at the rate of 0.02 g of acyclovir per 1 kg of the child's body weight, not exceeding a single dose of 0.8 g. The course of treatment for children is 5 days;
• herpes zoster (versicolor) in adults: 4 pcs. 5 times a day with an interval of 4 hours between doses. Duration of the course is 7 days;
• severe immunodeficiency in patients after bone marrow transplantation and at a late stage of HIV infection with manifestations of the AIDS-associated complex: adults and children over three years old - 4 pcs. 4 times a day (every 6 hours). After bone marrow transplantation, intravenous administration of the solution is recommended for 30 days, followed by the transfer of the patient to taking pills.

The risk of developing resistance to Acyclovir Sandoz in immunocompromised patients should be considered.

When prescribing the drug inside to elderly patients, treatment with high doses of acyclovir should be accompanied by the intake of a sufficient amount of fluid, and if they have renal failure, the dose of the drug should be reduced.

In patients with renal insufficiency with CC more than 10 ml / min in the treatment and prevention of infections caused by the herpes simplex virus, dose adjustment is not required. In severe renal failure with CC less than 10 ml / min, the dose of Acyclovir Sandoz should be 1 pc. 2 times a day.

When prescribing a drug for the treatment of chickenpox, herpes zoster, severe immunodeficiency in patients with renal failure, the dose depends on the CC and may be:

• CC 10-25 ml / min: 4 pcs. 3 times a day with an interval of 8 hours between doses;
• QC less than 10 ml / min: 4 pcs. 2 times a day, every 12 hours.

Cream for external use

Acyclovir Sandoz cream is applied externally, applying a thin layer with a cotton swab to the affected area, capturing the adjacent skin.

The procedure for applying the cream should be carried out in compliance with antiseptic requirements in order to prevent additional infection from entering the affected areas.

Recommended frequency of applications: 5 times a day, every 4 hours. The application of the cream should be continued until a crust forms on the vesicles or until they are completely healed. Duration of the course is 5 days. If necessary, treatment can be continued, but not more than up to 10 days.

If there is no clinical effect after 10 days of therapy, you must consult a doctor to clarify the diagnosis.

Side effects

Possible negative side reactions from systems and organs when taking Acyclovir Sandoz tablets:

• from the digestive system: often - nausea, vomiting, abdominal pain, diarrhea; rarely - a transient increase in the concentration of bilirubin, the activity of liver enzymes; very rarely - jaundice, hepatitis;
• from the immune system: rarely - anaphylaxis;
• from the nervous system: often - headache, dizziness; very rarely - tremor, drowsiness, ataxia, psychotic disorders, dysarthria, encephalopathy, convulsions, hallucinations, agitation, confusion, paresthesia, coma;
• from the lymphatic system and blood: very rarely - thrombocytopenia, anemia, leukopenia;
• from the genitourinary system: rarely - a transient increase in blood plasma levels of urea and / or creatinine; very rarely - renal colic, acute renal failure;
• from the respiratory system, chest and mediastinal organs: rarely - shortness of breath;
• dermatological reactions: often - rash, pruritus, photosensitivity; infrequently - urticaria, rapid diffuse hair loss (the exact relationship has not been established); rarely - angioedema; very rarely - exudative erythema multiforme, including Lyell's syndrome, Stevens-Johnson syndrome;
• other reactions: often - fatigue, fever; rarely - malaise.

When applied externally, Acyclovir Sandoz cream may have the following side effects:

• dermatological reactions: infrequently - transient burning sensation, itching, dry skin; rarely - erythema, contact dermatitis in the area of application;
• immune responses: very rarely - urticaria, angioedema and other anaphylactic reactions.

Overdose

Symptoms of a pill overdose: nausea, vomiting, shortness of breath, agitation, neurological symptoms, impaired renal function, seizures, lethargy, coma. If the concentration of acyclovir in the renal tubules exceeds 2.5 mg / ml, precipitation is possible.

Treatment: the appointment of hemodialysis, monitoring of basic vital functions.

The toxic effect of acyclovir with a single oral dose of up to 5 g has not been established.

Overdose symptoms while using the cream have not been established.

special instructions

During the period of oral administration of Acyclovir Sandoz in high doses, sufficient fluid intake is required.

When treating patients with reduced immunity, one should take into account the risk of viral strains insensitive to the action of acyclovir against the background of prolonged or repeated use of the drug. Patients with severe immunodeficiency should strictly follow all the doctor's recommendations.

Unprotected sex is contraindicated during the treatment of genital herpes, including in the absence of symptoms of the clinical manifestation of the disease. Since the use of Acyclovir Sandoz does not prevent infection with the virus of the sexual partner, it is necessary to use condoms during sexual intercourse.

Achieving the maximum therapeutic effect of the cream is most likely if you start using it when the first signs of herpesvirus infection appear - a feeling of tension, burning, tingling, itching, redness of the skin.

It is necessary to obtain a doctor's recommendation for the treatment of severe manifestations of herpes of the lips.

It is not recommended to apply the cream to the mucous membranes of the mouth and eyes, this can cause the development of severe inflammation.

Influence on the ability to drive vehicles and complex mechanisms

The use of the recommended doses of Acyclovir Sandoz does not have a negative effect on the patient's ability to work with complex mechanisms and drive vehicles. But due to the possible development of drowsiness or dizziness while taking pills, care must be taken when performing potentially hazardous activities that require concentration of attention and high speed of psychomotor reactions.

Application during pregnancy and lactation

According to the instructions, Acyclovir Sandoz during gestation can be used in exceptional cases when the expected effect of therapy for the mother, in the opinion of the doctor, exceeds the potential threat to the fetus.

The use of tablets and cream is contraindicated during breastfeeding. If necessary, the appointment of the drug during lactation should temporarily stop breastfeeding.

Pediatric use

The appointment of Acyclovir Sandoz tablets for children under the age of three is contraindicated.

For children over three years of age, in the treatment of herpes simplex virus infections, the prevention of infections caused by the herpes simplex virus, in children with immunodeficiency and in the treatment of severe immunodeficiency, the use of the recommended doses of the drug for adults is indicated.

When treating chickenpox, children aged 3–6 years are prescribed 2 tablets, and children over 6 years old - 4 tablets 4 times a day. The duration of the course of treatment is 5 days. A single dose for children can be determined at the rate of 0.02 g per 1 kg of the child's body weight (but not more than 0.8 g).

No information is available on the dosing regimen for the prevention of recurrence of herpes simplex virus infections and the treatment of herpes zoster in children with normal immune status.

With impaired renal function

Care should be taken when prescribing Acyclovir Sandoz to patients with chronic renal failure.

In patients with renal insufficiency with CC more than 10 ml / min in the treatment and prevention of infections caused by the herpes simplex virus, dose adjustment is not required. With severe renal failure with CC less than 10 ml / min, the dose of Acyclovir Sandoz should be 0.2 g 2 times a day.

When prescribing a drug for the treatment of chickenpox, herpes zoster, severe immunodeficiency in patients with renal failure, the dose depends on the CC and may be:

• CC 10-25 ml / min: 0.8 g 3 times a day with an interval between doses of 8 hours;
• CC less than 10 ml / min: 0.8 g 2 times a day, every 12 hours.

Use in the elderly

When prescribing tablets to elderly patients, treatment with high doses of Acyclovir Sandoz should be accompanied by the intake of a sufficient amount of liquid, and if they have renal failure, the dose of the drug should be reduced.

Drug interactions

No clinically significant interaction of acyclovir with other drugs has been established.

With the simultaneous use of Acyclovir Sandoz tablets with immunosuppressive drugs, cimetidine, probenecid and other drugs blocking tubular secretion, an increase in the concentration of acyclovir in blood plasma occurs, which does not require dose adjustment of the drug.

The combination of the cream with immunostimulants can increase its effect.

Analogs

Analogs of Acyclovir Sandoz tablets are Arviron, Valtrex, Vero-Ribavirin, Valacyclovir, Valcyte, Ribavin, Rebetol, Vacirex, Minaker, Ribamidil, Famvir, Trivorin, Tsimeven, Familar; cream for external use - Alpizarin, Lomagerpan, Gerpferon, Epigen, Bonafton, Viru-Merz, Hyporamine, Gossypol, Poludan, Devirs, Kondilin, Oxolin, Imiquimod, Fladex.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life is 4 years.

Terms of dispensing from pharmacies

The tablets are available with a prescription.

Topical cream - over the counter.

Reviews of Acyclovir Sandoz

Reviews of Acyclovir Sandoz are only positive. Patients note the rapid onset of the therapeutic effect, since within a few hours after taking the first pill, the feeling of pain subsides. Against the background of taking the pills, the appearance of new rashes stops for several days, and the blisters, including those that have already burst, dry up successfully, leaving no traces after healing.

Some reviews express warnings about the toxic effects of Acyclovir Sandoz on the body and recommendations without much need not to resort to taking pills, but to use a cream. This will avoid additional unwanted stress on the liver.

Basically, they indicate good tolerance of the drug, comparing with other dosage forms of acyclovir.

Price for Acyclovir Sandoz in pharmacies

The price of Acyclovir Sandoz for a package containing 25 tablets can be from 145 rubles, for a tube of cream 5 g - from 152 rubles, 2 g - from 78 rubles.

Acyclovir Sandoz: prices in online pharmacies

Drug name Price Pharmacy

Acyclovir Sandoz (cream) 5% cream for external use 2 g 1 pc. RUB 70 Buy

Acyclovir Sandoz cream 5% 2g RUB 75 Buy

Acyclovir Sandoz tablets 200mg 25 pcs. 126 RUB Buy

Acyclovir Sandoz 200 mg tablets 25 pcs. 126 RUB Buy

Acyclovir Sandoz cream 5% 5g 127 RUB Buy

Acyclovir Sandoz (cream) 5% cream for external use 5 g 1 pc. 127 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!