Medovir - Instructions For Use, Drug Price, Analogues, Reviews

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

Medovir

Medovir: 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: Medovir

ATX code: J05AB01

Active ingredient: acyclovir (Aciclovir)

Manufacturer: Lizafarma S.p. A. (Italy), Anfarm Gellas (Greece)

Description and photo update: 2019-08-10

Medovir is an antiviral drug.

Release form and composition

The drug is produced in the form of a powder for the preparation of a solution for infusion: a hygroscopic mass from almost white to white (250 mg each in glass colorless vials, 10 vials in a cardboard box and instructions for the use of Medovir).

In 1 bottle, the content of acyclovir (in the form of sodium acyclovir) is 250 mg.

Pharmacological properties

Pharmacodynamics

Medovir is an antiviral drug with an immunostimulating effect. Its active ingredient, acyclovir, is a synthetic analogue of purine nucleoside and exhibits high selectivity against Herpes simplex viruses (types I and II), Varicella zoster (a virus that causes chickenpox and shingles) and Epstein - Barr virus. The drug is moderately effective against Cytomegalovirus.

The mechanism of action of acyclovir is due to its sequential transformation under the influence of thymidine kinase of virus-infected cells into acyclovir monophosphate, diphosphate and triphosphate. By inhibiting viral DNA polymerase, acyclovir triphosphate competitively replaces deoxyguanosine triphosphate in the DNA of viruses, forming defective viral DNA (deoxyribonucleic acid). This contributes to the suppression of replication of future generations of viruses.

The use of Medovir for herpes helps to prevent the formation of new elements of the rash, reduce the likelihood of cutaneous dissemination and visceral complications, and accelerate the formation of crusts. In the acute phase of herpes zoster, the drug reduces pain.

Pharmacokinetics

After intravenous (IV) drip of acyclovir for 1 hour at a dose of 2.5; 5 or 10 mg per 1 kg of the patient's body weight (mg / kg), his C _max (maximum concentration) in the blood was 0.005 1; 0.009 8 or 0.020 7 mg / ml, respectively. C _min (minimum concentration) 7 hours after administration of the drug in the same doses - 0.000 5; 0.000 7 or 0.002 3 mg / ml, respectively.

For children over the age of 12 months when assigning acyclovir at the rate of 250 or 500 mg per 1 m ² body surface area (mg / m ²) C _max and C _min were similar to those in adult patients when administered at doses of 5 or 10 mg / kg …

In newborns and infants up to 3 months of age, on the background of intravenous drip of the drug for 1 hour at a dose of 10 mg / kg 3 times a day, C _{max of} acyclovir was 0.013 8 mg / ml, and C _min - 0.002 3 mg / ml.

Plasma protein binding of acyclovir is 9–33%.

Acyclovir crosses the blood-brain and placental barriers. It penetrates well into the contents of herpetic vesicles, organs and tissues, including the brain, kidneys, liver, lungs, intestines, spleen, uterus, muscles, aqueous humor, lacrimal and amniotic fluids, mucous membrane, vaginal secretions, sperm. Excreted in breast milk.

Biotransformation of acyclovir in the liver ends with the formation of a metabolite of 9-carboxymethoxymethylguanine.

The half-life (T _1/2) depends on the patient's age and can be 2.5 hours in adults, 3.8 hours in children under 3 months of age (with intravenous drip for 1 hour at a dose of 10 mg / kg 3 times a day), in children aged 1-18 years - 2.6 hours.

It is excreted through the kidneys by glomerular filtration and tubular secretion, with intravenous administration, 45–79% is excreted unchanged.

In severe chronic renal failure, T _1/2 is 20 hours, with hemodialysis - 5.7 hours (while the concentration of acyclovir in plasma decreases to 60% of the initial value), with continuous outpatient peritoneal dialysis - 14-18 hours.

In renal failure, T _1/2 increases with decreasing creatinine clearance (CC). In patients with CC 80 ml / min it is 2.5 hours, CC 50-80 ml / min - 3 hours, CC 15-50 ml / min - 3.5 hours, with anuria - 19.5 hours.

Indications for use

• primary and recurrent herpes simplex in patients with reduced immunity, caused by the herpes simplex virus and affecting the skin and mucous membranes;
• primary and recurrent severe genital herpes (including against the background of concomitant immunity disorders);
• encephalitis due to the Herpes simplex virus (types I and II);
• herpes zoster caused by the Varicella zoster virus (including patients with impaired immunity);
• herpes zoster with eye damage;
• chickenpox in immunocompromised patients;
• generalized infection in newborns caused by the Herpes simplex virus.

Contraindications

Absolute:

• severe renal dysfunction;
• breast-feeding;
• hypersensitivity to acyclovir.

It is recommended to administer Medovir with caution to patients with renal insufficiency (the risk of nephrological effects increases), dehydration, neurological disorders, with a history of neurological reactions against the background of taking cytotoxic drugs, during pregnancy.

Medovir, instructions for use: method and dosage

The finished solution is used by intravenous infusion, drip should last 1 hour and have a constant rate.

The solution is prepared immediately before infusion, observing the rules of asepsis.

To dissolve the contents of the vial, 5 ml of 0.9% sodium chloride solution or water for injection are used. After vigorous stirring until complete dissolution, the resulting 5% solution is additionally diluted either in 0.9% isotonic sodium chloride solution, or 0.9% isotonic sodium chloride solution with 5% dextrose solution, or in a combined sodium lactate solution (Hartmann's solution).

The final concentration of acyclovir should not exceed 5 mg / ml (0.5%).

The volume of the infusion fluid in the solution for intravenous administration to children or newborns should be minimized as much as possible, therefore, to dissolve 2 ml (100 mg of acyclovir), no more than 20 ml of the infusion solution should be used, which will allow to obtain a final solution concentration of 5 mg / ml.

At room temperature, the solution remains stable for 12 hours from the moment of preparation. If turbidity or crystallization is found on visual inspection of the finished solution for infusion, it should be disposed of.

Do not allow the solution to freeze. Unused product must be disposed of.

The prescribed dose of Medovir should be administered with an 8 hour interval between procedures.

Recommended dosage of Medovir:

• severe genital herpes: initial therapy in patients over the age of 12 years - at the rate of 5 mg / kg 3 times a day, in children under 12 years of age - at the rate of 250 mg / m ² 3 times a day. Course duration - 5 days;
• herpes simplex with lesions of the skin and mucous membranes in patients with low immune status: patients over the age of 12 years - 5-10 mg / kg 3 times a day, children under 12 years of age - 250 mg / m ² 3 times a day. The duration of the course of treatment is 7 days;
• encephalitis caused by the Herpes simplex virus (types I and II): patients over the age of 12 years - 10 mg / kg 3 times a day, children aged 3 months to 12 years - 20 mg / kg 3 times a day. The treatment lasts an average of 10 days;
• herpes zoster caused by the Varicella zoster virus in patients with impaired immunity: patients over the age of 12 - 10 mg / kg 3 times a day for 7-10 days; children under 12 years old - 20 mg / kg 3 times a day for 7 days;
• generalized infection in newborns caused by the Herpes simplex virus: newborns and children under 3 months of age - 10 mg / kg 3 times a day for 10 days. If necessary, the dose can be increased to 15–20 mg / kg, but the safety and effectiveness of its use have not been established.

For elderly patients, a dose reduction may be required.

In case of impaired renal function, the dose of Medovir, taking into account the CC indicator, should be:

• CC 25-50 ml / min: 5-10 mg / kg or 500 mg / m ² 2 times a day;
• CC 10-25 ml / min: 5-10 mg / kg or 500 mg / m ² once a day;
• CC below 10 ml / min: for patients on peritoneal dialysis - 2.5–5 mg / kg or 250 mg / m ² once a day; on hemodialysis - 2.5–5 mg / kg or 250 mg / m ² once a day and after dialysis.

Side effects

• from the central nervous system: weakness, headache, dizziness, agitation or drowsiness, signs of encephalopathy (confusion, hallucinations, convulsions, tremors, coma), fever, psychosis;
• from the hematopoietic system: leukopenia, lymphocytopenia, erythropenia;
• on the part of the blood and the vascular system: lowering blood pressure (BP), leukocytosis, neutropenia, hematuria, hemolysis, thrombocytopenia, anemia, disseminated intravascular coagulation syndrome (disseminated intravascular coagulation syndrome);
• from the gastrointestinal tract: nausea, vomiting, decreased appetite;
• on the part of the kidneys: sometimes - a slight increase in the concentration of urea and creatinine in the blood; against the background of long-term use in high doses - renal failure;
• from the immune system: anaphylactic reactions, allergic reactions in the form of pruritus, rash, Lyell's syndrome, urticaria, erythema multiforme (including Stevens-Johnson syndrome);
• local reactions: possibly - inflammation or development of phlebitis at the injection site;
• others: visual impairment, peripheral edema, lymphadenopathy.

Overdose

Symptoms: possibly impaired renal function, increased urea nitrogen, hypercreatininemia, convulsions, lethargy, coma.

Treatment: appoint activities aimed at maintaining vital functions of the body, hemodialysis.

special instructions

Medovir is usually well tolerated by patients, the development of undesirable effects is noted only in some cases. The reactions from the nervous system are reversible. Most often they occur with intravenous administration of high doses of the drug or in patients with renal failure and acquired immunodeficiency syndrome (AIDS).

It should be borne in mind that the risk of developing acute renal failure, as a consequence of the formation of a precipitate from acyclovir crystals, increases with a high drip rate of intravenous injection, concomitant therapy with nephrotoxic agents, dehydration or impaired renal function.

Treatment with Medovir must be accompanied by regular monitoring of the concentration of creatinine and urea in the blood plasma.

In patients with reduced immunity against the background of long-term therapy with Medovir, strains that are insensitive to its action may appear.

During the period of treatment of genital herpes, patients should refrain from unprotected sexual intercourse, even if there are no clinical manifestations of the disease.

Application during pregnancy and lactation

Prescribing Medovir during pregnancy is possible only in cases where, in the opinion of the doctor, the expected benefit from therapy for the mother outweighs the potential risk to the fetus.

It is impossible to inject the acyclovir solution intravenously during lactation, if it is necessary to use Medovir, breastfeeding should be stopped.

Pediatric use

When prescribing Medovir for the treatment of children under 12 years of age, one should strictly adhere to the dosage regimen appropriate to the child's age.

With impaired renal function

The use of Medovir is contraindicated in case of severe renal dysfunction.

The drug should be prescribed with caution in patients with renal insufficiency. In case of renal failure, correction of the Medovir dosage regimen is required, taking into account QC.

Use in the elderly

Treatment of elderly patients should be carried out under the supervision of a physician and with a sufficient increase in water load. The dose of the drug may be reduced.

Drug interactions

With simultaneous use with probenecid, the tubular secretion of acyclovir decreases, which leads to an increase in its T _1/2 and blood plasma content.

The combination of Medovir with nephrotoxic drugs increases the risk of nephrotoxic effects, especially if the patient has renal dysfunction.

When preparing solutions for intravenous administration, the alkaline reaction of acyclovir after dissolution [pH (acidity) 11] should be taken into account.

Acyclovir sodium is pharmaceutically incompatible with colloidal or biological solutions, parabens (hydroxybenzoic esters); when mixed with them, a precipitate may appear.

Analogs

Medovir analogues are: Acyclovir, Acyclovir forte, Atsigerpine, Acyclovir Avexima, Acyclovir Belupo, Acyclovir Sandoz, Acyclovir-Akrihin, Acyclovir-SZ, Acyclostad, Vivorax, Viroleks, Provirsan, Herperax, Zovirax.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Medovir

There are no reviews about Medovir.

The price of Medovir in pharmacies

The price of Medovir for a package containing 10 powder vials for preparing a solution for infusion can range from RUB 1,834.

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!