Instructions for Acik cream 5% tube 2 g
Composition
active ingredient: acyclovir;
1 g of cream contains acyclovir 50 mg;
Excipients: stearyl polyoxylglyceride, dimethicone 350, cetyl alcohol, white soft paraffin, mineral oil, propylene glycol, purified water.
Dosage form
Cream.
Main physicochemical properties: white or almost white homogeneous cream without lumps and foreign particles, without signs of phase separation.
Pharmacotherapeutic group
Antivirals. Acyclovir. ATX code D06B B03.
Pharmacological properties
Pharmacodynamics
Acyclovir is an antiviral drug that has high in vitro activity against herpes simplex virus types I and II. Toxicity to host cells is minimal. Penetrating into cells infected with herpes virus, acyclovir is phosphorylated to form the active compound acyclovir triphosphate. The first stage of this process depends on the presence of virus-encoded thymidine kinase. Acyclovir triphosphate acts as an inhibitor and substrate for viral DNA polymerase, preventing further synthesis of viral DNA without affecting normal cellular processes.
Pharmacokinetics
Pharmacokinetic studies have shown minimal systemic absorption of acyclovir after repeated topical application of the cream.
Indication
Treatment of infections of the lips and face caused by the herpes simplex virus (Herpes labialis).
Contraindication
Hypersensitivity to acyclovir, valacyclovir, propylene glycol or other components of the cream.
Interaction with other medicinal products and other types of interactions
No interaction was detected.
Application features
The cream should only be used to treat herpes on the lips and face. It is not recommended to apply the cream to the mucous membranes of the oral cavity, eyes, or to treat genital herpes. Accidental contact of the cream with the eyes should be avoided.
Persons suffering from particularly severe and recurrent manifestations of Herpes labialis should consult a doctor. Persons suffering from herpes should be warned against contact transmission of the virus to other people, especially if there are open lesions (e.g. wash hands before and after using the cream). It is not recommended for use in immunocompromised patients. Such persons should consult a doctor regarding the treatment of any infection.
The medicinal product contains propylene glycol, which may cause skin irritation, and cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Once opened, use the cream within 36 months. Do not use after the expiration date indicated on the packaging.
Ability to influence reaction speed when driving vehicles or other mechanisms
No data.
Use during pregnancy or breastfeeding
Pregnant and breastfeeding women are recommended to use the drug only if the benefit, in the opinion of the doctor, outweighs the risk. It should be borne in mind that the systemic penetration of acyclovir after external application of the cream is very low.
In clinical trials, the use of acyclovir in preparations of any composition did not lead to an increase in fetal developmental defects.
Some clinical data suggest that acyclovir passes into breast milk when applied as a cream. However, the amount of acyclovir that may enter the infant's body when breastfed after application of this drug is insignificant.
There are no data on the effect of acyclovir on female fertility. In clinical studies, it has been shown that acyclovir after oral administration has no clinically significant effect on male fertility. Thus, when acyclovir was administered orally to men at a dose not exceeding 1 g per day for a period of up to 6 months, no clinically significant effect on sperm count, motility, or morphology was observed.
Method of administration and doses
The drug is intended for external use only.
Adults and children over 12 years of age: apply the cream 5 times a day at approximately 4-hour intervals, except at night. It is important to start treatment as early as possible at the onset of infection, preferably during the prodromal period or erythema stage. Treatment can also be started in the later stages of the disease, such as papules or blisters.
Treatment lasts at least 4 days. If healing has not occurred, treatment can be continued for up to 10 days. If the symptoms of the disease do not disappear after 10 days of treatment, the patient should consult a doctor.
For the best treatment success, the cream should be applied at the first signs of herpes infection (burning, itching, tightness and redness). Virostatic treatment with Acik® cream is not advisable when the skin becomes crusted.
Children
There is insufficient data on the safety of the drug in children under 12 years of age, therefore it is recommended to use it in children over 12 years of age.
Overdose
In case of accidental oral or topical application of the entire contents of a tube of cream, no adverse effects were observed due to minimal systemic exposure. In case of suspected overdose, medical attention should be sought.
Adverse reactions
On the part of the immune system
Very rare (< 1/10,000): immediate hypersensitivity reactions, including angioedema and urticaria.
Skin and connective tissue disorders
Uncommon (≥ 1/1000; < 1/100): transient sharp or burning pain after applying the cream, moderate drying and peeling of the skin, itching, acute generalized exanthematous pustulosis (AGEP).
Rare (≥ 1/10,000; < 1/1,000): erythema, contact dermatitis after applying the cream (sensitivity testing showed that these cases were most often associated with the components of the cream base, and not with acyclovir).
Expiration date
4 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children. Do not freeze.
Packaging
2 g of cream in a tube; 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Salutas Pharma GmbH.
Location of the manufacturer and its business address
Production site in Osterwedingen, Lange Goeren 3, Sulzetal, OT Osterwedingen, Saxony-Anhalt, 39171, Germany.
