Zovirax aciclovir (acyclovir) for infusions 250 mg in vials 5 pcs — Made in Italy — Free Delivery
(Zovirax for infusions)
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Description Zovirax aciclovir (acyclovir) for infusions 250 mg in vials 5 pcs — Made in Italy — Free Delivery
Pharmachologic effect
An antiviral prepration, a synthetic analogue of a purine nucleoside, which has the ability to inhibit in vitro and in vivo the replication of Herpes simplex viruses type 1 and 2, Varicella zoster virus, Epstein-Barr virus (EBV) and cytomegalovirus (CMV). In cell culture, acyclovir has the most pronounced antiviral activity against Herpes simplex type 1, then, in decreasing order of activity, follow: Herpes simplex type 2, Varicella zoster, EBV and CMV.
The action of acyclovir on viruses is highly selective. Acyclovir is not a substrate for the enzyme thymidine kinase of uninfected cells, therefore it has low toxicity to mammalian cells. Thymidine kinase of cells infected with Herpes simplex viruses type 1 and 2, Varicella zoster, EBV and CMV converts acyclovir into acyclovir monophosphate - a nucleoside analogue, which is then sequentially converted into diphosphate and triphosphate under the action of cellular enzymes. The incorporation of acyclovir triphosphate into the viral DNA strand and the subsequent termination of the strand blocks further viral DNA replication.
In patients with severe immunodeficiency, prolonged or repeated courses of therapy with acyclovir can lead to the formation of resistant strains, and therefore further treatment with acyclovir may be ineffective. Most of the isolated strains with reduced sensitivity to acyclovir showed a relatively low content of viral thymidine kinase, a violation of the structure of viral thymidine kinase or DNA polymerase. The in vitro effect of acyclovir on strains of the Herpes simplex virus can also lead to the formation of strains that are less sensitive to it. No correlation has been established between the sensitivity of Herpes simplex virus strains to acyclovir in vitro and the clinical efficacy of the prepration.
It has been shown that intravenous administration of Zovirax in high doses reduces the incidence and delays the development of cytomegalovirus infection. If, after such infusion therapy, treatment with acyclovir for oral administration in high doses for 6 months is carried out, then mortality and the incidence of viremia decrease.
Pharmacokinetics
Distribution
In adults, the average Cmax of acyclovir 1 hour after infusion at a dose of 2.5 mg / kg, 5 mg / kg, 10 mg / kg and 15 mg / kg was 22.7 μmol (5.1 μg / ml), 43.6 μmol (9.8 μg / ml), 92 μmol (20.7 μg / ml) and 105 μmol (23.6 μg / ml), respectively. Cmin of the prepration in plasma 7 h after infusion was 2.2 μmol (0.5 μg / ml), 3.1 μmol (0.7 μg / ml), 10.2 μmol (2.3 μg / ml), and 8.8 μmol (2.0 μg / ml), respectively.
The concentration of acyclovir in the cerebrospinal fluid is approximately 50% of its plasma concentration.
Acyclovir binds to a small extent with blood plasma proteins (9-33%).
Withdrawal
In adults, after intravenous administration of acyclovir, T1 / 2 from plasma is about 2.9 hours. Most of the prepration is excreted by the kidneys unchanged. The renal clearance of acyclovir significantly exceeds the clearance of creatinine, which indicates the elimination of acyclovir through not only glomerular filtration, but also tubular secretion. The main metabolite of acyclovir is 9-carboxymethoxy-methylguanine, which accounts for about 10-15% of the administered dose in the urine.
When acyclovir was prescribed 1 hour after taking 1 g of probenecid, T1 / 2 of acyclovir and AUC increased by 18 and 40%, respectively.
Pharmacokinetics in special clinical situations
In children older than 1 year, the value of Cmax and Cmin, corresponding to that in adults, was observed when Zovirax was administered at a dose of 250 mg / m2 instead of 5 mg / kg (dose for adults) and at a dose of 500 mg / m2 instead of 10 mg / kg (dose for adults).
In newborns (from 0 to 3 months), who received acyclovir as an infusion lasting more than 1 hour every 8 hours, Cmax was 61.2 μmol (13.8 μg / ml), and Cmin was 10.1 μmol (2.3 μg / ml), and T1 / 2 - 3.8 h.
In elderly people, the clearance of acyclovir decreases with age in parallel with a decrease in creatinine clearance, but the T1 / 2 of acyclovir changes insignificantly.
In patients with chronic renal failure, the T1 / 2 of acyclovir averaged 19.5 hours, and during hemodialysis, the T1 / 2 averaged 5.7 hours, the plasma concentration of acyclovir decreased by approximately 60%.
Indications for use
- treatment of infections caused by the Herpes simplex virus type 1 and 2;
- prevention of infections caused by the Herpes simplex virus type 1 and 2 in immunocompromised patients;
- treatment of infections caused by the Varicella zoster virus;
- treatment of infections caused by the Herpes simplex virus type 1 and 2 in newborns;
- prevention of cytomegalovirus infection in bone marrow transplant recipients.
Application during pregnancy and lactation
The appointment of Zovirax during pregnancy and lactation (breastfeeding) requires caution and is possible only after assessing the intended benefits to the mother and the potential risk to the fetus and child.
There was no increase in the number of birth defects in children whose mothers received Zovirax during pregnancy compared to the general population.
When using Zovirax in the form of a lyophilisate during lactation (breastfeeding), it should be borne in mind that after taking Zovirax orally at a dose of 200 mg 5 times / day, acyclovir was determined in breast milk at concentrations of 0.6-4.1% of plasma concentrations. At such concentrations in breast milk, children who are breastfed can receive acyclovir at a dose of up to 0.3 mg / kg / day.
Special instructions
In patients with herpes encephalitis receiving high doses of Zovirax, it is necessary to monitor renal function (especially with dehydration or with an initial impairment of renal function).
With caution and under the control of renal function, Zovirax should be used simultaneously with preprations that impair renal function (for example, cyclosporine, tacrolimus).
The prepared solution of Zovirax has a pH of 11, so it cannot be used internally.
Precautions
When prescribing IV infusion of Zovirax to patients with renal insufficiency, the dosage regimen should be adjusted in accordance with the decrease in creatinine clearance.
With hemodialysis: 2.5-5 mg / kg or 250 mg / m2 every 24 hours and after dialysis.
For children aged 3 months to 12 years, doses of Zovirax for intravenous infusion are set depending on the body surface area.
In newborns, the dosage regimen is set depending on body weight; for infections caused by the Herpes simplex virus types 1 and 2, the recommended dose is 10 mg / kg every 8 hours. The duration of treatment for herpes simplex encephalitis and infections caused by the Herpes simplex virus in newborns is usually 10 days.
In elderly patients with reduced creatinine clearance, dose reduction should be considered.
Contraindications
- hypersensitivity to acyclovir or valacyclovir.
It should be used with caution in case of dehydration, renal failure, neurological disorders, as well as during the development of reactions to cytotoxic preprations when administered intravenously (and if there is a history of such reactions).
Method of administration and dosage
The prepration is intended for intravenous infusion.
For adults, for the treatment of infections caused by Herpes simplex viruses (with the exception of herpes encephalitis) and Varicella zoster, the prepration is prescribed at a dose of 5 mg / kg body weight every 8 hours.
For the treatment of infections caused by the Varicella zoster virus and herpetic encephalitis in immunocompromised patients, intravenous infusion is performed at a dose of 10 mg / kg body weight every 8 hours (with normal renal function).
For the prevention of cytomegalovirus infection during bone marrow transplantation, the prepration is used at a dose of 500 mg / m2 of body surface 3 times / day with an interval of 8 hours. The duration of treatment is from 5 days before transplantation and up to 30 days after transplantation.
In obese patients, the same doses are recommended as in patients with normal body weight.
When prescribing IV infusion of Zovirax to patients with renal insufficiency, the dosage regimen should be adjusted in accordance with the decrease in creatinine clearance.
With hemodialysis: 2.5-5 mg / kg or 250 mg / m2 every 24 hours and after dialysis.
For children aged 3 months to 12 years, doses of Zovirax for intravenous infusion are set depending on the body surface area.
In newborns, the dosage regimen is set depending on body weight; for infections caused by the Herpes simplex virus types 1 and 2, the recommended dose is 10 mg / kg every 8 hours. The duration of treatment for herpes simplex encephalitis and infections caused by the Herpes simplex virus in newborns is usually 10 days.
For infections caused by Herpes simplex viruses (except for herpes encephalitis) and Varicella zoster, the prepration is administered at a dose of 250 mg / m2 every 8 hours.
For the treatment of herpes encephalitis and infections caused by the Varicella zoster virus, in children with immunodeficiency, the prepration is prescribed at a dose of 500 mg / m2 every 8 hours (with normal renal function).
Limited data suggest that for the prevention of cytomegalovirus infection in children over 2 years of age who have undergone bone marrow transplantation, Zovirax can be administered at the doses recommended for adults.
In children with reduced renal function, dose adjustment is required in accordance with the degree of renal failure.
In elderly patients with reduced creatinine clearance, dose reduction should be considered.
The course of treatment with Zovirax in the form of intravenous infusion is usually 5 days, but may vary depending on the patient's condition and response to therapy.
The duration of the prophylactic use of Zovirax in the form of intravenous infusion is determined by the duration of the period of existence of the risk of infection.
Rules for the preparation and administration of the solution
The recommended dose of Zovirax should be administered as a slow intravenous infusion over 1 hour.
The recommended volume of the dilution solution must be added to the ampoule with Zovirax powder and shake gently until the contents of the ampoule are completely dissolved.
The Zovirax solution obtained after dilution can be administered using a special infusion pump that regulates the rate of administration of the prepration. Another method of administration is possible, while the prepared Zovirax solution is diluted to obtain an acyclovir concentration not exceeding 5 mg / ml (0.5%). To do this, add the prepared solution to the selected infusion solution, which is recommended below, and shake well to completely mix the solutions.
For children and newborns who need to inject the minimum volumes of solutions, it is recommended to add 4 ml of the prepared Zovirax solution (100 mg of acyclovir) to 20 ml of the solvent.
For adults, it is recommended to use infusion solutions in packages of 100 ml, even if this will give an acyclovir concentration significantly below 0.5%. Thus, a 100 ml infusion solution can be used to administer any dose of acyclovir between 250 mg and 500 mg (10 and 20 ml diluted solution). For doses between 500 mg and 1000 mg of acyclovir, a second infusion solution of this volume should be used.
Zovirax for intravenous infusion is compatible with the following infusion solutions and remains stable when diluted for 12 hours at room temperature (15 ° to 25 ° C): 0.45% and 0.9% sodium chloride solutions for intravenous infusion; 0.18% sodium chloride solution and 4% glucose solution for intravenous infusion; 0.45% sodium chloride solution and 2.5% glucose solution for intravenous infusion; Hartmann's solution.
Since no antibacterial preservative is included in the composition of the solutions, dissolution and dilution should be carried out completely under aseptic conditions immediately before the administration of the prepration.
Unused solution is destroyed.
If the solution becomes cloudy or crystals fall out, it should be destroyed.
Overdose
Symptoms: increased levels of serum creatinine, blood urea nitrogen, renal failure. Neurological symptoms include confusion, hallucinations, agitation, seizures, and coma.
Treatment: symptomatic therapy is performed. Hemodialysis is shown.
Side effect
From the digestive system: nausea, vomiting, reversible increase in the level of bilirubin and the activity of liver enzymes; very rarely - hepatitis, jaundice.
From the hematopoietic system: anemia, leukopenia and thrombocytopenia.
From the urinary system: rarely - an increase in the level of urea and creatinine in the blood, which is associated with the value of Cmax and the state of the patient's water balance. To avoid such phenomena, the prepration should be administered in the form of a slow infusion over 1 hour and the patient's water balance should be maintained. Signs of renal failure that appeared during therapy with Zovirax usually quickly stop when patients are rehydrated and / or the dose of the prepration is reduced or canceled. Progression to acute renal failure occurs in exceptional cases.
From the side of the central nervous system: reversible neurological disorders such as confusion, hallucinations, agitation, tremors, drowsiness, psychosis, convulsions and coma (usually in predisposed patients).
Allergic reactions: rash, photosensitivity, urticaria, pruritus, fever; rarely - shortness of breath, angioedema, anaphylaxis.
Local reactions: severe inflammatory reactions leading to necrosis were observed when Zovirax solution got under the skin.
Composition
1 fl.
acyclovir 250 mg
Excipients: sodium hydroxide.
250 mg - glass bottles (5) - plastic trays (1) - cardboard packs.
Interaction with other preprations
There were no clinically significant interactions of Zovirax with other preprations.
Calcium channel blockers and cimetidine increase the AUC of acyclovir and reduce its renal clearance (no correction of the Zovirax dosage regimen is required).
With the simultaneous use of Zovirax with preprations excreted by active tubular secretion, it is possible to increase the concentration of active substances or their metabolites in plasma (caution is needed when prescribing such combinations).
The combined use of acyclovir and mycophenolate mophenil, an immunosuppressant used in organ transplantation, leads to an increase in the AUC of acyclovir and the inactive metabolite of mycophenolate mophenyl.
Tags: Zovirax
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