Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
valaciclovir hydrochloride, Quantity: 556 mg
Amneal Pharma Australia Pty Ltd
valaciclovir hydrochloride
Tablet, film coated
Excipient Ingredients: magnesium stearate; crospovidone; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake
Oral
30, 100, 500
(S4) Prescription Only Medicine
For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash.,For the treatment of ophthalmic zoster.,For the treatment of recurrent herpes labialis (cold sores),For the treatment of clinical episodes of genital herpes simplex infections.,For the prevention of recurrent genital herpes.,Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Valaciclovir, it is recommended that patients use safer sex practices. ,Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.
Visual Identification: Blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing 'F' on one side and '9' and '3' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-10-25
_Valaciclovir AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 104.AN.CMI.1.0 _ _ _ _Page 1 _ VALACICLOVIR AN TABLETS _valaciclovir (as hydrochloride) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VALACICLOVIR AN tablets. It does not contain all of 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 VALACICLOVIR AN tablets against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VALACICLOVIR AN TABLETS ARE USED FOR _HOW VALACICLOVIR AN _ _TABLETS WORK _ VALACICLOVIR AN tablets belong to a group of medicines called antivirals. VALACICLOVIR AN tablets are used for the treatment of genital herpes infection, shingles (infection zoster), ophthalmic zosters (shingles affecting the eye region), cold sores (herpes labialis) and for the prevention of Cytomegalovirus (CMV) infection in people following an organ transplant. VALACICLOVIR AN tablets work by stopping the multiplication of the virus which causes herpes, shingles and cold sores. They can reduce the length and severity of an outbreak of herpes, shingles and cold sores and the duration of pain and shorten the time to healing of crusts associated with herpes. GENITAL HERPES VALACICLOVIR AN tablets do not eliminate the herpes virus from the body. The herpes virus is also known as the Herpes Simplex Virus, or HSV. VALACICLOVIR AN tablets help the blisters to heal more quickly. If you start taking them as soon as you feel an outbreak starting, you may actually prevent the blisters from developing. VALACICLOVIR AN tablets can also be taken long term to help prevent the HSV infection coming back. VALACICLOVIR AN tablets can also reduce the risk of transmitting the virus that causes genital herpes in patients who Read the complete document
_Valaciclovir_ _AN Product Information_ _Amneal Pharma Australia _ Pty Ltd Valaciclovir AN PI v1.2 Page 1 of 22 VALACICLOVIR AN _(VALACICLOVIR HYDROCHLORIDE TABLETS) _ _ _ _ _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE The name of the medicine is valaciclovir as valaciclovir hydrochloride. CHEMICAL NAME: 2-[(2-amino-1, 6-dihydro-6-oxo-9H-purin-9-yl) methoxy] ethyl-l-valinate hydrochloride MOLECULAR FORMULA: C 13 H 20 N 6 O 4 .HCl MOLECULAR WEIGHT: 360.84 CAS REGISTRY NUMBER: _[_ _124832-27-5_ _]_ DESCRIPTION Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a purine nucleoside analogue. Valaciclovir hydrochloride is a white or almost white powder. It is freely soluble in water, practically insoluble in ethanol and 1-octanol. INACTIVE: Microcrystalline cellulose, crospovidone, povidone, magnesium stearate and opadry Blue 13B50578 (PI-ARTG No. 106487). PHARMACOLOGY MODE OF ACTION Valaciclovir is rapidly and almost completely converted in man to aciclovir probably by the enzyme valaciclovir hydrolase. Aciclovir is a specific inhibitor of the herpes viruses with _in vitro _ activity against herpes simplex viruses (HSV) type 1 and type 2 (IC 50 0.1 – 3.0μM), varicella- zoster virus (VZV) (IC 50 1.6 – 5.1μM) and human cytomegalovirus (HCMV) (IC 50 10 - > 200μM). Aciclovir inhibits herpes virus DNA synthesis once it has been phosphorylated to the active triphosphate form. The first stage of phosphorylation requires the activity of a virus- specific enzyme: thymidine kinase in HSV and VZV infected cells or protein kinase in HCMV infected cells. This requirement for activation of aciclovir by a virus specific enzyme largely explains its unique selectivity. The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular kinases. Aciclovir triphosphate competitively inhibits the virus DNA _Valaciclovir_ _AN Product Information_ _Amneal Pharma Australia _ Pty Ltd Valaciclovir AN PI v1.2 Page 2 of 22 polymerase and incorporation of this nucleoside analogue results in obligate Read the complete document