Acyclovir cream 5 g
Acyclovir cream 5 g
Qualitative and quantitative composition
The drug substance , 1 g of cream contains 50 mg of Aciclovir
3 . Formulation
4 . Clinical properties
Treatment of primary and recurrent labial and genital herpes.
4.2 . Dosage and method of administration
A thin layer of cream on the affected skin areas twice daily 5 4 chasa.Izpolzva cotton swab is to be taken as a cream, as necessary zapokrivane of the infected skin area. When applying Acyclovir STADA International, make sure that you not only cover the area with visible manifestations of herpes infection ( blistering, swelling , redness) , but also the neighboring areas. If Spread Acyclovir STADA International hand , surely wash your hands before and after application of the cream to prevent overgrowth of the injured area of skin ( bacteria , etc. . ) And / or of transmitting the virus to others , still intact mucosal or skin areas. Treatment usually lasts 5 days, but treatment should be individualized and continue to strengthen bubbles or until complete healing . However , it shall not exceed 10 days.
4.3 . Contraindications
Hypersensitivity to aciclovir or any of the excipients .
4.4 . Special warnings and special precautions for use
Acyclovir STADA should not be used for eyes . Should be . taken to avoid accidental contamination of the product in the eye. Acyclovir STADA should be administered within the mouth and vagina .
Concurrent use of Acyclovir STADA in the genital and anal area with latex condoms , the resistance of the latter may be reduced by paraffin and petroleum jelly contained in the cream , which jeopardizes their credibility .
It is very important in recurrent herpes infection to begin treatment during the prodromal period or when lesions first appear .
4.5 . Interactions
None known so far.
4.6 . Pregnancy and lactation
No action. It can be taken during pregnancy only if the expected results of treatment outweigh the possible risks to ploda.Ogranichenite test data in humans have shown that drug passes into breast milk only after systemic administration .
4.7 . Effects on ability to drive and use machines
4.8 . Undesirable effects
Implementation of Acyclovir STADA can cause rapid passage burning, itching or stinging of the treated skin areas .
In rare cases, it may be observed redness, dryness and flaking of the treated with Acyclovir STADA skin.
There have been rare reports of contact dermatitis after using Acyclovir STADA . In most cases, when performed allergy testing, it was found that more pharmaceutical excipients of the cream base than the active ingredient aciclovir cause skin reactions. Contact dermatitis occurs through the aforementioned side effects in a more pronounced form , as a cover and adjacent skin areas of those treated with krema.Mnogo infrequently with topical application of aciclovir were reported hypersensitivity reactions , including angioedema .
4.9 . overdose
Not for external use
5 . Pharmacological properties
5.1. Pharmacodynamic properties
Acyclovir is a pharmacologically -active substance, which is transformed into the active antiviral drug only after penetration into cells infected with the herpes simplex virus (HSV) or a varicella - zoster virus (VZV). This activation of acyclovir is catalyzed by thymidine kinase , an enzyme essential for the reproduction of HSV and VZY- In other words , the virus synthesized their own antiviral drug . This process is carried out as follows:
1. After application , acyclovir penetrates more and more infected with herpes cells in the body.
2 . Virus thymidine kinase present in the cells , phosphorylation of acyclovir to acyclovir monophosphate .
3 . Cellular enzymes convert acyclovir monophosphate in protnvovirusno - active acyclovir triphosphate .
4 . Affinity of acyclovir - triphosphate into the viral DNA polymerase is 10-30 times greater than its affinity for the cellular DNA polymerase . Therefore acyclovir - triphosphate selectively inhibits the viral enzyme activity.
5 . Furthermore , the viral DNA polymerase incorporates acyclovir into the viral DNA , causing the breakage of the chain synthesis , J. The combination of these steps very effectively reduced viral replication .
When tested for the reduction of plaque inhibitory effect can be achieved with acyclovir 0.1 mmol / 1 in the infected with HSV Vero cells ( a culture of renal parenchymal cells of African green monkey ) compared to acyclovir 300 mmol / 1 for non-infected Vero cells .
The therapeutic index , determined in cell culture , therefore, it was 3000 . Spectrum of activity in vitro very sensitive :
Herpes simplex virus types 1 and 2 , varicella - zoster virus .
Na virus Epstein-Barr.
Partially sensitive to resistant :
Cytomegalovirus virus .
RNA - viruses
5.2 . Pharmacokinetics and preclinical safety data
The overall absorption of external applications acyclovir minimal and the resulting blood levels are below the limit in which can be detected . Therefore, it is impossible to determine the kinetics and bioavailability of acyclovir , topical administration . Toxic effects are not typical for him, because the drug does not reach the blood circulation in the body.
Local tolerance of Acyclovir STADA has been determined in two comparative studies involving 605 patients. 10/114 or 10/219 patients experienced erythema and slight worsening of skin rash : two patients showed allergic reactions. 104/114 or 217/219 patients otsenyavat.ponosimostta to Acyclovir STADA as good or satisfactory .
6 . Pharmaceutical particulars
6.1. List of excipients
Dimethicone, PEG- 5 glycerol-stearate, cetyl alcohol, liquid paraffin, propylene glycol, white vaseline, purified water.
6.2 . Fnznko Incompatibilities
So far there are no known
6.3. Expiration date
Do not use after expiry date .
6.4 . Special precautions for storage
Do not store above 25 ° C.
6.5. Packaging Data
Original package with 5 g cream
Original package with 20 g cream
6.6. Recommendations for use
For better results , treatment with Acyclovir STADA International should begin as soon as possible before, i.e. as soon as the patient noticed the first signs of herpes (burning , itching, discomfort, redness) . Protpvovirusnoto treatment with Acyclovir STADA is meaningless if the affected areas have begun to catch crust .