Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
aciclovir, Quantity: 400 mg
Amneal Pharma Australia Pty Ltd
Aciclovir
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica
Oral
56 tablets, 100 tablets
(S4) Prescription Only Medicine
Aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advanced symptomatic HIV disease (CD4 + counts < 150 x 10(6)/L). In accordance with details specified in the "Indications" and the "Dosage and Administration" sections of the approved product information provided as Attachment 1.
Visual Identification: White to off-white, capsule shaped, biconvex tablets, with 'ACV' embossed on one side and '400' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-08-09
_Aciclovir AN tablets – Consumer Medicine Information _ _Doc ID: 36.AN.M.1.0 _ _ _ _ _ _Page 1 _ ACICLOVIR AN TABLETS _Aciclovir _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ACICLOVIR AN (aciclovir). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT ACICLOVIR AN IS USED FOR ACICLOVIR AN contains aciclovir, a compound that belongs to a group of medicines called antivirals. ACICLOVIR AN is used for the treatment of shingles (herpes zoster), impaired immunity and genital herpes. In the case of shingles, ACICLOVIR AN works by stopping the multiplication of the virus which causes shingles. It can reduce the length and severity of an outbreak of shingles but it will not get rid of the virus from your body. Aciclovir at high strength is used as part of the management program in people who have human immunodeficiency virus disease (HIV). It acts by preventing further damage to the immune system. In these people, ACICLOVIR AN also guards against the herpes virus disease. Aciclovir does not get rid of the virus from your body. Your doctor may have prescribed ACICLOVIR AN for another purpose. ACICLOVIR AN is not recommended for use in children as there have been no studies of its effects in children. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ACICLOVIR AN HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE ACICLOVIR AN _WHEN YOU MUST NOT TAKE _ _ACICLOVIR AN _ DO NOT TAKE ACICLOVIR AN IF YOU ARE ALLERGIC TO MEDICINES CONTAINING ACICLOVIR OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of a Read the complete document
_Aciclovir AN tablets Product Information _ _ _ _ Scentia Pharmaceuticals Pty Ltd _ Doc ID: 36.AN.P.1.0 Page 1 ACICLOVIR AN _ _ _(ACICLOVIR TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of the medicine is aciclovir CHEMICAL NAME: 9-((2-hydroxyethoxy) methyl) guanine MOLECULAR FORMULA: C 8 H 11 N 5 O 3 MOLECULAR WEIGHT: 225.2 CAS NO:_ [59277-89-3]_ DESCRIPTION Synthetic acyclic purine nucleoside analogue. It is a white crystalline powder. _Excipients _ – magnesium stearate, microcrystalline cellulose, sodium starch glycollate, pregelatinised maize starch, colloidal anhydrous silica. PHARMACOLOGY ACTIONS – Antiviral agent. MICROBIOLOGY Aciclovir is an antiviral agent which is active in vitro against _ Herpes simples _ virus (HSV) types I and II and _ Varicella zoster _ virus (VZV), the latter being considerably less sensitive. The relationship between the level of in vitro sensitivity of herpes viruses to aciclovir and clinical response to therapy has not been adequately established. Development of resistance by HSV to aciclovir has been documented. Aciclovir needs to be phosphorylated to the active compound, aciclovir triphosphate, in order to become active against the virus. Such conversion is very limited in normal cells and, in addition, cellular DNA polymerase is not very sensitive to the active compound. However in infected cells, HSV or VZV coded thymidine kinase facilitates the conversion of aciclovir to aciclovir monophosphate, which is then converted to aciclovir triphosphate by cellular enzymes. Aciclovir triphosphate acts as an _Aciclovir AN tablets Product Information _ _ _ _ Scentia Pharmaceuticals Pty Ltd _ Doc ID: 36.AN.P.1.1 Page 2 inhibitor of and substrate for the herpes specified DNA polymerase, preventing furtherviral DNA synthesis. Pharmacokinetics Aciclovir is only partially and variably absorbed from the gut. Estimated bioavailability following a dose of 200mg is about 20% and decreases to about half of this with an 800mg dose. Mean steady state peak and trough concent Read the complete document