Acyclovir Sandoz - instructions for use, dose, side effects, contraindications

Excipients: macrogol and fatty acids ether (arlaton 983S) - 5.0 g; dimethicone 350 - 0.3 g; cetyl alcohol - 1.5 g; Petroleum jelly white - 9,0 g; paraffin liquid - 5.0 g; propylene glycol 15.0 g; purified water - 59.2 g.

Description:

Homogeneous cream white or almost white.

Pharmacotherapeutic group:Antiviral for topical use

ATX: & nbsp

S.01.A.D Antiviral drugs

Pharmacodynamics:

Acyclovir is active against Herpes simplex 1 and 2 types, virus Varicella zoster, the Epstein-Barr virus and cytomegaloviruses. Thymidine kinase virus-infected cells through a series of consecutive reactions actively converts acyclovir in mono-, di- and triphosphate of acyclovir. The latter interacts with the viral DNA polymerase and is embedded in DNA, which is synthesized for new viruses. Thus, "defective" viral DNA is formed, which leads to suppression of replication of new generations of viruses.

Pharmacokinetics:

With topical use, it is almost not absorbed through intact skin, it is not detected in blood and urine. When applied to the affected skin, the absorption is moderate; in patients with normal renal function, serum concentrations of up to 0.28 μg / ml, in patients with chronic renal failure - up to 0.78 μg / ml. It is excreted by the kidneys (up to 9.4% of the daily dose).

Indications:

- skin infections caused by a virus Herpes simplex types 1 and 2, including genital herpes and herpes lips;

- shingles;

- chickenpox.

Contraindications:

Hypersensitivity to acyclovir and other components of the drug.

Carefully:Pregnancy, lactation, dehydration, renal failure.

Pregnancy and lactation:

Adequate and controlled clinical studies of safety of the drug during pregnancy were not conducted. The application is indicated only in cases where the intended use for the mother exceeds the potential risk to the fetus. During the treatment period, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Outwardly.

The drug is applied 5 times a day (every 4 hours) in a thin layer on the affected and adjacent areas of the skin.

The cream is applied either with a cotton swab or with clean hands to avoid additional infection of the affected areas.

Therapy should be continued until the time when no bubbles form on the vesicles, or until they completely heal.

The duration of therapy is an average of 5 days and should not exceed 10 days.

If the symptoms persist for more than 10 days, you should consult your doctor.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (> 1/10),often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the skin:

infrequently: a burning sensation after applying the cream, passing with time, dry skin, itching;

rarely: erythema, contact dermatitis at the site of application.

From the immune system:

rarely: anaphylactic reactions, including angioedema and urticaria.

Overdose:

To date, there have been no reported cases of drug overdose.

Interaction:

With external application, no interaction with other drugs has been identified. An increase in the effect is noted with the simultaneous appointment of immunostimulants.

Special instructions:

To achieve the maximum therapeutic effect, it is necessary to start using the drug as soon as possible after the onset of infection (when first signs of the disease: burning, itching, tingling, sensation of tension and redness).

When pronounced manifestations of herpes lips is recommended to consult a doctor.

The cream is not recommended to be applied to the mucous membranes of the mouth and eyes, as it is possible to develop pronounced local inflammation.

In the treatment of genital herpes, sexual intercourse or condom use should be avoided, since the use of acyclovir does not prevent the transmission of the virus to partners.

Patients with immunodeficiency states in the treatment of any infectious diseases should follow the recommendations of the doctor.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).

Form release / dosage:

Cream for external use 5%.

Packaging:

By 2 g or 5 g in an aluminum tube, the neck of the tube is sealed with a protective aluminum membrane and covered with a screwed plastic lid with a recessed pin.

For 1 tube (with 2 g of the drug) in a cardboard pack together with instructions for use.

For 1, 4 tubes (with 5 g of the drug) in a cardboard pack together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use the product after the expiration date stated on the package!

Terms of leave from pharmacies:Without recipe

Registration number:П N013198 / 01

Date of registration:07.12.2007

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp19.12.2013

Illustrated instructions

Instructions

Acyclovir Sandoz® (Aciclovir Sandoz®)