Zovirax for colds on the lips, cream 5% 5g

Composition and release form

5 pcs in blister; There are 5 blisters in a box.

in bottles; There are 5 bottles in a box.

in tubes of 4.5 g; 1 tube in a cardboard box.

Description of the dosage form

Tablets: blue, flat, shield-shaped (irregular polygonal) tablets; On one side there is the inscription “ZOVIRAX” and on the other there is a triangle. Minor inclusions may be visible on the surface of the tablet.

Powder for the preparation of solution for injection: sintered mass (porous cake) or lyophilized powder of white or almost white color. The drug is hygroscopic.

Eye ointment: soft, homogeneous, white or almost white, translucent oily mass with a weak characteristic odor, free of grains, lumps and foreign particles.

Composition, indications and contraindications

Cream and ointment for topical use containing the active ingredient acyclovir. Additional ingredients are presented:

• poloxamer 407;
• cetostearyl alcohol;
• sodium lauryl sulfate;
• white soft and liquid paraffin;
• dimethicone 20;
• propylene glycol;
• purified water;
• arlacelom 165.

The white or almost white mass has no lumps, grains, impurities of foreign substances or signs of separation.

The drug is used to treat infectious lesions of the face and lips caused by recurrent labial herpes. If you have a weakened immune system, the medicine is not prescribed; a doctor is consulted before therapy.

The medication is contraindicated in patients with registered allergies:

• to acyclovir;
• valacyclovir;
• propylene glycol;
• any excipient included in the ointment.

Before starting procedures, it is necessary to conduct a test for the development of a spontaneous allergic reaction. A small amount of the drug is applied to the inner surface of the elbow. If after 20 minutes there is no redness, blistering or itching on the skin, then the cream can be applied.

pharmachologic effect

Pharmacological action - antiviral.

After entering virus-infected cells, acyclovir is converted by viral thymidine kinase to acyclovir monophosphate, which is then sequentially phosphorylated to diphosphate and triphosphate by the action of cellular enzymes. Acyclovir triphosphate acts as a nonspecific inhibitor and substrate for viral DNA polymerase, is included in the viral DNA chain, causes chain termination and blocks further replication of viral DNA without damaging host cells.

Pharmacological properties

Zovirax eye ointment is an antiviral drug that is highly active against Varicella zoster and Herpes simplex viruses (types 1, 2).

Penetrating into infected cells, acyclovir is phosphorylated under the influence of viral thymidine kinase to acyclovir triphosphate. Acyclovir triphosphate inhibits viral DNA synthesis but does not damage host cells.

After instillation of the ointment into the eye, acyclovir is absorbed by the corneal epithelium, as well as by the periocular tissues, after which its concentration necessary to neutralize the virus is created in the aqueous humor.

Pharmacokinetics

After oral administration, acyclovir is only partially absorbed from the intestine. When taking 200 mg of acyclovir every 4 hours, the mean maximum steady-state plasma concentration (Cssmax) was 3.1 µmol (0.7 µg/ml), and the mean steady-state minimum plasma concentration (Cssmin) was 1.8 µmol (0.4 µg/ml). When taking 400 and 800 mg of acyclovir every 4 hours, Cssmax was 5.3 µmol (1.2 µg/ml) and 8 µmol (1.8 µg/ml), respectively, and Cssmin was 2.7 µmol (0.6 µg/ml ) and 4 µmol (0.9 µg/ml), respectively.

After intravenous administration of acyclovir to adults, the mean Cmax values ​​1 hour after infusion at doses of 2.5 mg/kg, 5 mg/kg, 10 mg/kg and 15 mg/kg were 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 7 hours after infusion was respectively equal to 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). In children over 1 year of age, similar Cmax and Cmin were observed when administered at a dose of 250 mg/m2 instead of 5 mg/kg (adult dose) and at a dose of 500 mg/m2 instead of 10 mg/kg (adult dose). In neonates (0 to 3 months) who received acyclovir as an infusion over 1 hour every 8 hours, Cmax was 61.2 µmol (13.8 µg/ml) and Cmin was 10.1 µmol (2.3 µg/ml). Their T1/2 was 3.8 hours.

T1/2 in adults is 2.5–3.3 hours. Most of the drug is excreted unchanged by the kidneys. The renal clearance of acyclovir significantly exceeds the clearance of creatinine, which indicates that acyclovir is eliminated 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 administered 1 hour after taking 1 g of probenecid, the T1/2 of acyclovir and the area under the plasma concentration-time curve increased by 18 and 40%, respectively.

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 slightly.

In patients with chronic renal failure, T1/2 of acyclovir averaged 19.5 hours, and during hemodialysis, the average T1/2 of acyclovir was 5.7 hours, and the concentration of acyclovir in plasma decreased by approximately 60%.

The concentration of acyclovir in the cerebrospinal fluid is approximately 50% of its plasma concentration. Acyclovir binds to plasma proteins to a small extent (9–33%), so drug interactions due to displacement from protein binding sites are unlikely.

When acyclovir and zidovudine were administered simultaneously to HIV-infected patients, the pharmacokinetic characteristics of both drugs remained virtually unchanged.

After applying ophthalmic ointment, acyclovir is quickly absorbed by the corneal epithelium and periocular tissues, resulting in the concentration of the drug necessary to suppress the virus in the intraocular fluid. After using Zovirax ophthalmic ointment, acyclovir is detected only in the urine, and in small quantities.

Zovirax

Zovirax (acyclovir) is an antiviral drug. Effective against herpes simplex virus types 1 (lip blisters), 2 (genital herpes), 3 (varicella zoster virus, chickenpox and shingles), 4 (Epstein-Barr virus) and 5 (cytomegalovirus). Acyclovir provokes the formation of defective DNA viruses, resulting in the suppression of their reproduction. Zovirax is available in both external (cream, ointment) and internal (tablets, lyophilisate for preparing an injection solution) dosage forms. The drug has gained particular popularity in the treatment of herpes simplex virus type 1, which manifests itself as blisters on the lips. Until recently, treatment of infections caused by the herpes simplex virus was aimed solely at the symptoms and not at the cause of the disease. For these purposes, drying, analgesic, and cooling agents were used. There were the first attempts to use antiviral drugs (just remember the same oxolinic ointment), but the effectiveness of those drugs has not been proven to this day. With the entry into the pharmaceutical market of fundamentally new drugs that selectively act directly on the virus itself, the situation has changed radically. One such drug is Zovirax. This is an original pharmaceutical drug.

Despite the identical content of the active component (5%) with generics, Zovirax cream is created on an exclusive branded medicinal base, which ensures higher bioavailability of acyclovir, incl. in infected areas of the skin and mucous membranes. The active component of the drug is selectively absorbed by cells affected by viral infection, where it begins to suppress the process of viral replication. For severe diseases with a tendency to recur, Zovirax forms for internal use are used, and for rare relapses of infections caused by the herpes simplex virus type 1, it is enough to use external forms of the drug for local application. It should be realized that timely initiation of treatment greatly improves the prognosis. If therapeutic measures are started at an early stage of the disease (signs of this include itching, hyperemia, skin tightness, burning), then recovery will occur much faster. But even if you miss the moment and start treatment later, Zovirax shows better results than other drugs. The duration of treatment is determined by the doctor. In severe forms of herpetic infection, consultation with a doctor is required. Patients taking Zovirax tablets should consume increased amounts of fluid to avoid dehydration. External dosage forms of the drug are not subject to systemic absorption.

Clinical pharmacology

In patients with severe immunodeficiency, long-term or repeated courses of acyclovir therapy may lead to the emergence of resistant strains, and therefore further treatment with acyclovir may be ineffective. The majority of isolated strains with reduced sensitivity to acyclovir had a relatively low content of viral thymidine kinase and a disorder in the structure of viral thymidine kinase or DNA polymerase. The effect of acyclovir on HSV strains in vitro can also lead to the formation of strains that are less sensitive to it. A correlation has not been established between the sensitivity of HSV strains to acyclovir in vitro and the clinical effectiveness of the drug.

It has been shown that intravenous administration of Zovirax in high doses reduces the incidence and delays the development of CMV infection. If, after infusion therapy with Zovirax in a high dose, treatment with Zovirax for oral administration in a high dose is carried out for 6 months, then mortality and the incidence of viremia are reduced.

Indications for Zovirax®

Powder for solution for injection:

treatment of infections caused by the herpes simplex virus;

prevention of infections caused by the herpes simplex virus in patients with immunodeficiency;

treatment of infections caused by the varicella zoster virus and herpes zoster;

treatment of infections caused by the herpes simplex virus in newborns;

prevention of CMV infections in bone marrow transplant recipients.

Pills:

treatment of skin and mucous membrane infections caused by the herpes simplex virus, including primary and recurrent genital herpes;

prevention of relapses of infections caused by the herpes simplex virus in patients with normal immune status;

prevention of infections caused by the herpes simplex virus in patients with immunodeficiency;

treatment of chickenpox and herpes zoster;

treatment of patients with severe immunodeficiency, mainly with HIV infection (CD4+ cell count < 200/mm3, early clinical manifestations of HIV infection and stage of AIDS) and who have undergone bone marrow transplantation.

Eye ointment: treatment of keratitis caused by the herpes simplex virus.

Zovirax®

Zovirax tablets can be taken with meals, since food intake does not significantly interfere with its absorption. The tablets should be taken with a full glass of water.

Adults

Treatment of infections caused by herpes simplex virus

For the treatment of infections caused by the herpes simplex virus, the recommended dose of Zovirax is 200 mg 5 times a day (every 4 hours, except during nighttime sleep). Usually the course of treatment is 5 days, but can be extended for severe primary infections.

In case of severe immunodeficiency (for example, after bone marrow transplantation) or in case of impaired absorption from the intestine, the oral dose of Zovirax can be increased to 400 mg. As an alternative, the possibility of using Zovirax in a lyophilisate dosage form for the preparation of a solution for infusion may be considered. Treatment should begin as soon as possible after infection occurs; in case of relapses, it is recommended to prescribe the drug already in the prodromal period or when the first elements of the rash appear.

Prevention of recurrence of infections caused by the herpes simplex virus

To prevent recurrence of infections caused by the herpes simplex virus in patients with normal immune status, the recommended dose of Zovirax is 200 mg 4 times a day (every 6 hours).

For many patients, a more convenient therapy regimen of 400 mg 2 times a day (every 12 hours) is suitable.

In some cases, lower doses of Zovirax 200 mg 3 times a day (every 8 hours) or 200 mg 2 times a day (every 12 hours) are effective.

Some patients may experience exacerbation of infection when taking a total daily dose of 800 mg.

Treatment with Zovirax should be periodically interrupted for 6-12 months to identify possible changes in the course of the disease.

Prevention of infections caused by the herpes simplex virus in patients with immunodeficiency

For the prevention of infections caused by the herpes simplex virus in patients with immunodeficiency, the recommended dose of Zovirax is 200 mg 4 times a day (every 6 hours).

In case of severe immunodeficiency (for example, after bone marrow transplantation) or in case of impaired absorption from the intestine, the oral dose of Zovirax can be increased to 400 mg 4 times a day. As an alternative, the possibility of using Zovirax in a lyophilisate dosage form for the preparation of a solution for infusion may be considered. The duration of the preventive course of therapy is determined by the length of the period when there is a risk of infection.

Treatment of chickenpox and herpes zoster

For the treatment of chickenpox and herpes zoster, the recommended dose of Zovirax is 800 mg 5 times a day (every 4 hours, except during night sleep). The course of treatment is 7 days.

In patients with severe immunodeficiency (for example, after bone marrow transplantation) or in cases of impaired absorption from the intestine, it is necessary to consider the possibility of prescribing Zovirax in a lyophilisate dosage form for the preparation of a solution for infusion.

The drug should be prescribed as soon as possible after the onset of infection, since in this case the treatment is more effective.

Special patient groups

Children aged 3 years and older

Treatment of herpes simplex virus infections: prevention of herpes simplex virus infections in immunocompromised patients

- at the age of 3 years and older, the same doses as for adults.

Treatment of chickenpox

- at the age of 6 years and older - 800 mg 4 times a day;

- aged 3 to 6 years - 400 mg 4 times a day.

More precisely, the dose can be determined at the rate of 20 mg/kg body weight (but not more than 800 mg) 4 times a day. The course of treatment is 5 days.

Prevention of recurrence of infections caused by the herpes simplex virus: treatment of herpes zoster

There are no data on dosage regimen.

Elderly patients

The likelihood of renal failure in elderly patients must be taken into account, and doses should be adjusted according to the degree of renal failure (see subsection "Patients with renal failure").

It is necessary to ensure that adequate water balance is maintained.

Patients with nocturnal dysfunction

Caution must be exercised when prescribing Zovirax to patients with impaired nocturnal function. It is necessary to ensure that adequate water balance is maintained.

In patients with renal failure, oral administration of acyclovir at recommended doses for the treatment and prevention of infections caused by the herpes simplex virus does not lead to accumulation of the drug to concentrations exceeding established safe levels. However, in patients with creatinine clearance less than 10 ml/min, the dose of Zovirax is recommended to be reduced to 200 mg 2 times a day (every 12 hours).

For the treatment of chickenpox and herpes zoster, the recommended doses of Zovirax tablets are:

- with creatinine clearance less than 10 ml/min - 800 mg 2 times a day (every 12 hours);

- with creatinine clearance 10-25 ml/min - 800 mg 3 times a day (every 8 hours).

Use during pregnancy and breastfeeding

An analysis of acyclovir treatment of women during pregnancy did not reveal an increase in the number of birth defects in their children compared to the general population. However, caution should be exercised when prescribing Zovirax to women during pregnancy and assess the expected benefit to the mother and the possible risk to the fetus.

After taking Zovirax orally at a dose of 200 mg 5 times a day, acyclovir was detected in breast milk in concentrations ranging from 0.6 to 4.1 of plasma concentrations. At such concentrations in breast milk, breastfed children can receive acyclovir at a dose of up to 0.3 mg/kg/day. Given this fact, caution should be exercised when prescribing Zovirax to nursing women.

Dosages and methods of application

The medicine is used only externally:

1. Adult patients - applied every 4 hours, up to 5 times a day. Treatment should be carried out with the first appearance of symptoms of the pathology, with redness of the skin. Therapy is also allowed if papules and vesicles appear on the dermis. The duration cannot exceed 4 days; in difficult cases, an increase to 10 days is allowed.
2. Children - the lack of comprehensive research does not allow use by minors under 12 years of age. Therapeutic manipulations are carried out according to a standard algorithm.

To prevent transmission of infection, the patient should wash their hands with soap before applying the ointment and after treatment. Patients with renal or hepatic insufficiency do not require special dosage adjustments - the drug has insignificant systemic absorption.

Use for pregnant women is justified if the benefit to the mother exceeds the potential risk to the fetus. Studies have shown that taking acyclovir in different dosage forms did not cause congenital anomalies in children.

Restrictions on therapy are indicated only for nursing women, when using systemic agents with an active component. The choice of medication is decided by the doctor. Self-medication during pregnancy and breastfeeding is unacceptable due to the risk of allergic reactions to any medications, even previously used ones.

Side effects

Powder for solution for injection, tablets

Gastrointestinal tract: nausea, vomiting; when taken orally - diarrhea, abdominal pain.

Blood system: anemia, leukopenia and thrombocytopenia.

Hypersensitivity reactions and skin: rash, photosensitivity, urticaria, itching, fever; rarely - shortness of breath, angioedema, anaphylaxis; with intravenous administration - severe local inflammatory reactions leading to necrosis of the skin when Zovirax solution gets under the skin.

Kidneys: rarely - increased levels of urea and creatinine in the blood. This complication is believed to be related to plasma Cmax and the patient's hydration status. To avoid such phenomena, instead of an IV bolus injection, a slow infusion over 1 hour should be prescribed. Patients should be maintained in fluid balance. Renal failure that develops during treatment with Zovirax for intravenous infusion usually resolves quickly when patients are rehydrated and/or the dose of the drug is reduced or discontinued. Progression to acute renal failure occurs in exceptional cases.

Liver: reversible increase in bilirubin levels and liver enzyme activity; with intravenous administration - hepatitis and jaundice (very rare).

CNS: when administered intravenously, reversible neurological deficits such as confusion, hallucinations, agitation, tremor, somnolence, psychosis, seizures and coma have commonly been observed in patients with predisposing conditions; when taken orally - headache; rarely - reversible neurological disorders.

Others: fatigue; rarely - rapid diffuse hair loss (no connection with taking acyclovir has been established).

In patients receiving antiretroviral drugs (mainly Retrovir orally), additional use of Zovirax did not cause a significant increase in toxic effects.

Eye ointment

From the immune system: very rarely (<1/10000) - immediate hypersensitivity reaction, including angioedema.

On the part of the organ of vision: very often (>1/10) - punctate superficial keratopathy (does not require cessation of treatment and disappears without consequences); often (from >1/100 to <1/10) - mild burning sensation that goes away with time, conjunctivitis; rarely (>1/10000 to <1/1000) - blepharitis.

Interaction

No clinically significant interactions were observed with Zovirax.

Acyclovir is excreted unchanged into the urine by active tubular secretion. All drugs with a similar route of elimination may increase plasma concentrations of acyclovir. CCBs and cimetidine increase the AUC of acyclovir and reduce its renal clearance (no dose adjustment is required due to the wide range of therapeutic doses of acyclovir).

In patients receiving IV Zovirax, caution is required when coadministering drugs that compete for elimination due to the potential for increased plasma levels of one, both drugs, or their metabolites. The combined use of acyclovir and mycophenolate mofetil leads to an increase in the AUC for acyclovir and the inactive metabolite mycophenolate mofetil.

Caution should be used when combining intravenous administration of Zovirax (monitoring of renal function is necessary) with drugs that impair renal function (for example, cyclosporine, tacrolimus).

Directions for use and doses

Inside, during meals, with a full glass of water.

For adults

Treatment of infections caused by the herpes simplex virus: the recommended dose of Zovirax is 200 mg 5 times a day every 4 hours, with the exception of the period of night sleep. Usually the course of treatment is 5 days, but can be extended for severe primary infections.

In case of severe immunodeficiency (for example, after bone marrow transplantation) or in case of impaired absorption from the intestine, the oral dose of Zovirax can be increased to 400 mg 5 times a day. Treatment should begin as soon as possible after infection occurs; in case of relapses, it is recommended to prescribe the drug already in the prodromal period or when the first elements of the rash appear.

Prevention of recurrence of infections caused by the herpes simplex virus. In patients with normal immune status, the recommended dose of Zovirax is 200 mg 4 times a day (every 6 hours). For many patients, a more convenient treatment regimen is suitable - 400 mg 2 times a day (every 12 hours). In some cases, lower doses of Zovirax are effective - 200 mg 3 times a day (every 8 hours) or 2 times a day (every 12 hours). In some patients, interruption of the infection may occur when taking a total daily dose of 800 mg.

Treatment with Zovirax should be periodically interrupted for 6–12 months to identify possible changes in the course of the disease.

Prevention of infections caused by the herpes simplex virus. In patients with immunodeficiency, the recommended dose of Zovirax is 200 mg 4 times a day (every 6 hours). In case of severe immunodeficiency (for example, after bone marrow transplantation) or in case of impaired absorption from the intestine, the oral dose of Zovirax can be increased to 400 mg 5 times a day. The duration of the preventive course of therapy is determined by the length of the period when there is a risk of infection.

Treatment of chickenpox and herpes zoster: the recommended dose of Zovirax is 800 mg 5 times a day; The drug is taken every 4 hours, with the exception of the period of night sleep. The course of treatment is 7 days. The drug should be prescribed as soon as possible after the onset of infection, because in this case, treatment is more effective.

Treatment of patients with severe immunodeficiency: the recommended dose of Zovirax is 800 mg 4 times a day (every 6 hours). For patients who have undergone a bone marrow transplant, it is usually recommended to undergo a course of IV therapy with Zovirax for 1 month before prescribing Zovirax for oral administration. In clinical studies, the maximum duration of treatment for bone marrow transplant recipients was 6 months (from the 1st to the 7th month after transplantation). In patients with an advanced clinical picture of HIV infection, the course of treatment with Zovirax was 12 months, but there is reason to believe that longer courses of therapy may be effective in such patients.

For children

Treatment and prevention of infections caused by the herpes simplex virus in children with immunodeficiency:

from 2 years and older - the same doses as for adults;

under 2 years of age - half the dose for adults.

Treatment of chickenpox:

over 6 years old - 800 mg 4 times a day;

from 2 to 6 years - 400 mg 4 times a day;

under 2 years - 200 mg 4 times a day.

More precisely, the dose can be determined at the rate of 20 mg/kg body weight (but not more than 800 mg) 4 times a day. The course of treatment is 5 days.

There are no data on the prevention of recurrence of infections caused by the herpes simplex virus and on the treatment of herpes zoster in children with normal immunity. According to the very limited information available, the same doses of Zovirax can be used to treat children over 2 years of age with severe immunodeficiency as for the treatment of adults.

Elderly patients. In old age, there is a decrease in the clearance of acyclovir in the body in parallel with a decrease in creatinine clearance.

Elderly patients should receive a sufficient amount of fluid while taking high doses of Zovirax orally; if they have renal failure, it is necessary to consider reducing the dose of Zovirax.

Patients with renal failure. In patients with renal failure, oral administration of acyclovir at recommended doses for the treatment and prevention of infections caused by the herpes simplex virus does not lead to accumulation of the drug to concentrations exceeding established safe levels. However, in patients with severe renal failure (Cl creatinine <10 ml/min), the dose of Zovirax is recommended to be reduced to 200 mg 2 times a day (every 12 hours).

When treating chickenpox, herpes zoster, as well as when treating patients with severe immunodeficiency, the recommended doses of Zovirax are:

severe renal failure (Cl creatinine <10 ml/min): 800 mg 2 times a day every 12 hours;

moderate renal failure (Cl creatinine 10–25 ml/min) 800 mg 3 times a day every 8 hours.

IV, adults. In obese patients, dosages are recommended as in adults with normal body weight.

Treatment of infections caused by HSV (with the exception of herpetic encephalitis) and FOG - intravenous infusion at a dose of 5 mg/kg every 8 hours.

Treatment of infections caused by FOG and herpetic encephalitis in patients with immunodeficiency - intravenous infusion at a dose of 10 mg/kg every 8 hours with normal renal function.

Prevention of CMV infection during bone marrow transplantation - iv 500 mg/m2 3 times a day with an interval of 8 hours. The duration of treatment is from 5 days before transplantation and up to 30 days after transplantation.

For children

Doses for IV infusions in children aged 3 months to 12 years are calculated depending on body surface area. In newborns, doses are calculated depending on body weight. For infections caused by HSV, a dose of 10 mg/kg every 8 hours is recommended.

Treatment of infections caused by HSV (except herpetic encephalitis) and FOG - intravenous infusion at a dose of 250 mg/m2 every 8 hours.

Treatment of herpetic encephalitis and infections caused by FOG in children with immunodeficiency - intravenous infusion at a dose of 500 mg/m2 every 8 hours with normal renal function.

Prevention of CMV infection in children over 2 years of age. Limited data suggest that children over 2 years of age who have undergone bone marrow transplantation may be given the adult dosage of Zovirax IV. In children with reduced renal function, dose adjustment is required according to the degree of renal failure.

In elderly patients, the clearance of acyclovir in the body decreases in parallel with a decrease in creatinine clearance. Particular attention should be paid to reducing doses of Zovirax in the elderly with reduced creatinine clearance.

In patients with renal failure, IV infusions of Zovirax should be administered with caution. The dose is adjusted depending on the degree of decrease in creatinine clearance:

with creatinine Cl 25–50 ml/min, the dose is 5–10 mg/kg or 500 mg/m2 every 12 hours;

with creatinine Cl 10–25 ml/min, the dose is 5–10 mg/kg or 500 mg/m2 every 24 hours;

with creatinine Cl 0 (anuria) - 10 ml/min: with continuous ambulatory peritoneal dialysis, the dose is 2.5–5 mg/kg or 250 mg/m2 every 24 hours; for hemodialysis - 2.5–5 mg/kg or 250 mg/m2 every 24 hours and after dialysis.

The course of treatment with Zovirax by intravenous infusion is usually 5 days, but may vary depending on the patient's condition and response to therapy. The duration of treatment for herpetic encephalitis and HSV infections in newborns is usually 10 days. The duration of prophylactic use of Zovirax for intravenous infusion is determined by the duration of the period when there is a risk of infection.

Preparation of solution and method of administration

The recommended dose of Zovirax should be administered as a slow IV infusion over 1 hour.

To prepare a Zovirax solution with an acyclovir concentration of 25 mg/ml, add 10 ml of water for injection or sodium chloride solution for injection (0.9%) to the ampoule with Zovirax powder and shake gently until the contents of the ampoule are completely dissolved. After dilution, the Zovirax solution can be administered as an intravenous infusion using a special infusion pump that regulates the rate of drug administration.

Another method of infusion administration is possible, when the prepared Zovirax solution is diluted further to obtain an acyclovir concentration not exceeding 5 mg/ml (0.5%). To do this, add the prepared solution to the selected infusion solution (see below) and shake well to completely mix the solutions. For children and newborns in whom minimum infusion volumes must be observed, it is recommended to add 4 ml of prepared Zovirax solution (100 mg acyclovir) to 20 ml of infusion solution.

For adults, it is recommended to use infusion solutions in 100 ml packs, even if this will give an acyclovir concentration significantly lower than 0.5%. Thus, one 100 ml infusion solution can be used for any dose of acyclovir between 250 and 500 mg (10 and 20 ml diluted solution). For doses between 500 and 1000 mg of acyclovir, a second infusion of that volume should be used.

Zovirax for IV infusion is compatible with the following infusion solutions and, when diluted with them, remains stable for 12 hours at room temperature (15 to 25 °C):

sodium chloride for intravenous infusion (0.45% and 0.9%);

sodium chloride (0.18%) and glucose (4%) for intravenous infusion;

sodium chloride (0.45%) and glucose (2.5%) for intravenous infusion;

Hartmann's solution.

Since no antibacterial preservative is included in the solutions, dissolution and dilution must be carried out completely under aseptic conditions immediately before administration of the drug, and the unused solution is destroyed.

If the solution becomes cloudy or crystals fall out, it should be destroyed.

Eye ointment: for adults and children, a strip of ointment 10 mm long is placed in the lower conjunctival sac 5 times a day with an interval of about 4 hours. Treatment must be continued for at least 3 days after recovery.

Zovirax for colds on the lips, cream 5% 5g

A country

Great Britain, United Kingdom
Country of origin may vary depending on product batch. Please check with the operator for detailed information when confirming your order.

Active substance

Acyclovir

Description

Zovirax cream is used to treat cold sores (herpes).
To achieve maximum effect, it is necessary to use Zovirax cream at the first signs of the disease: - Burning - Itching - Tingling - Sensation of tension - Redness* Zovirax cream is convenient to take with you thanks to its compact packaging (5g). * Instructions for medical use, RU No. P N014304/01 dated December 25, 2007

Compound

Active substance: acyclovir 5.00 g. Excipients: poloxamer 407 1.00 g, cetostearyl alcohol 6.75 g, white soft paraffin 11.50 g, sodium lauryl sulfate 0.75 g, liquid paraffin 5.00 g, glycerol monostearate 0.75 g, macrogol stearate 0.75 g, propylene glycol 40.00 g, dimethicone 1.00 g, purified water up to 100.00 g.

Product description

A homogeneous cream of white or almost white color, without small, large or foreign particles, without signs of separation.

pharmachologic effect

Acyclovir, an antiviral drug, is highly active in vitro against Herpes simplex virus (HSV) types 1 and 2. Low toxicity to mammalian host cells. After entering cells infected with the herpes virus, acyclovir is phosphorylated to the active compound acyclovir triphosphate. The first step of this process depends on the presence of the HSV-encoded thymidine kinase enzyme. Acyclovir triphosphate acts as an inhibitor and substrate of herpes-specific DNA polymerase, preventing further synthesis of viral DNA, without affecting normal cellular processes.

Pharmacokinetics

Pharmacological studies have shown minimal systemic absorption with repeated use of acyclovir cream.

Indications for use

Treatment of viral infections caused by the Herpes simplex virus, lips and facial skin (recurrent herpes of the lips).

Contraindications

Hypersensitivity to acyclovir, valacyclovir, propylene glycol or other components of the drug.

Use during pregnancy and lactation

Pregnancy: Use is only possible in cases where the expected benefit outweighs the potential and unknown risk, however, systemic exposure with topical application of the cream is very low. As a result of post-registration experience with the use of acyclovir, data were obtained containing information on the results of pregnancy in women receiving Zovirax in any dosage form. The data do not demonstrate an increase in the incidence of congenital malformations among patients treated with acyclovir compared with the general population, and no birth defects have been reported that are unique or have a consistent pattern of features suggestive of a common cause. Before use, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, or while breastfeeding, you should consult your doctor. Lactation: Limited data show that with regular use the drug passes into breast milk. However, the dosage that a breastfed infant receives will be negligible.

Directions for use and doses

For external use only. Use the drug only according to the indications, method of administration and in the doses indicated in the instructions. Adults and children: The drug is recommended to be applied 5 times a day, approximately every 4 hours, with the exception of night time, to the affected and adjacent areas of the skin. It is important to start treatment as early as possible, preferably when the first signs and symptoms appear (in the prodromal period or with redness). Treatment can also begin at later stages (papule or blister). The duration of treatment is at least 4 days. If there is no healing, treatment can be continued for up to 10 days. If symptoms persist for more than 10 days, you should consult a doctor. To prevent the condition from worsening and to prevent the spread of infection, you must wash your hands before and after applying the drug, do not rub or touch the affected areas of the skin with a towel.

Side effect

Side effects are classified by organ system and frequency. The frequency of side effects is determined as follows: very often ≥ 1/10, often ≥ 1/100 and From the skin and subcutaneous tissues Uncommon - short-term burning, tingling in the areas where the drug was applied, slight dryness or peeling, itching; Rarely – redness; contact dermatitis after application, more often associated with a reaction to excipients than to acyclovir. Immune system disorders Very rare - immediate hypersensitivity reactions, including angioedema, urticaria. If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Due to minimal systemic exposure, no adverse effects are expected to occur when taken orally or when applied topically to the entire contents of the consumer package of Zovirax Cream. You should consult a doctor if you suspect an overdose.

Interaction with other drugs

When used externally, no interactions with other drugs have been identified.

special instructions

Zovirax cream for external use should be used exclusively for herpes of the skin of the lips and face. It is not recommended to use on the mucous membranes of the mouth, eyes and vagina. Do not use for the treatment of genital herpes. Avoid getting the cream into your eyes. In case of severe manifestations of recurrent herpes, it is recommended to consult a doctor. Patients with herpes labialis should avoid transmitting the virus, especially if active lesions are present. Patients with immunodeficiency conditions are not recommended to use Zovirax cream for external use. Such patients should follow the doctor's recommendations when treating any infectious diseases. Patients with renal and hepatic insufficiency: Despite the fact that acyclovir is mainly excreted by the kidneys, the systematic absorption of acyclovir after external use is negligible. Accordingly, there is no need to change the dose in patients with renal or hepatic impairment

Release form

Cream for external use, 5%. 5 g of the drug in an aluminum tube with a screw-on plastic cap or 2 g in a plastic bottle with a dosing device, sealed with a plastic cap. An aluminum tube or plastic bottle is placed in a cardboard box along with instructions for medical use. Secondary packaging is allowed to have a first-opening control.

Storage conditions

Store at a temperature not exceeding 25 C. Do not freeze. Keep out of the reach of children

Best before date

In an aluminum tube - 3 years, in a plastic bottle with a dispensing device - 2 years. Do not use after the expiration date stated on the packaging.

Precautionary measures

In case of renal failure, Zovirax doses should be adjusted according to its degree to prevent the accumulation of acyclovir in the body.

In patients receiving IV Zovirax in high doses for herpetic encephalitis, it is necessary to monitor renal function, especially if it is initially impaired or there is dehydration.

Patients taking high doses of Zovirax by mouth should receive sufficient fluids.

The prepared Zovirax solution has a pH of 11.0 and cannot be used orally.

Patients should be informed of the possibility of a transient mild burning sensation after application of Zovirax ophthalmic ointment. During treatment with the drug, patients should not wear contact lenses.

Directions and overdose

The drug is intended for the treatment of herpes, which manifests itself on the skin of the face and lips. It is not used to treat the mucous membranes of the mouth or eyes, or genital herpes. The exception is Zovirax eye ointment.

The manufacturer recommends handling with extreme caution and avoiding contact of the composition with the organs of vision. Severe symptoms of a herpetic infection on the lips require additional consultation with a local doctor.

If an opening of the lesion is present, the patient must follow precautions to prevent accidental infection of bystanders. The patient should use separate care items, and do not forget to wash their hands before and after each manipulation.

Cetyl alcohol included in the composition can provoke the occurrence of local skin reactions - contact dermatitis, etc. The propylene glycol present becomes a source of local irritation on the skin.

The drug has no significant interactions with other medications. The medicine does not affect the speed of reactions and can be used when working with moving mechanisms and when driving a car.

No pronounced consequences of an overdose of ointment have been identified. Accidental ingestion or application of large volumes of medication did not cause serious complications. The appearance of non-standard reactions to the drug requires consultation with a doctor and replacement of the previously recommended therapy regimen.