ACICLOVIR Each uncoated tablets contains Aciclovir 400mg Available CompositionVICOVIR-400 PHARMACOLOGICAL CLASSIFICATION AntiviralMECHANISM OF ACTION Acyclovir (9-[2-hydroxymethyl]guanine) is a nucleoside analog which selectively inhibits the replication of HSV (types 1 and 2) and VZV. It is converted to acyclovir monophosphate by virally-encoded thymidine kinase; this step does not occur to any significant degree in uninfected cells and thereby lends specificity to the drugs activity. The monophosphate derivative is subsequently converted to acyclovir triphosphate by cellular enzymes.Acyclovir triphosphate, acting as an analog to deoxyguanosine triphosphate (dGTP), competitively inhibits viral DNA polymerase; incorporation of acyclovir triphosphate into DNA results in chain termination because the absence of a 3 hydroxyl group prevents the attachment of additional nucleosides. Acyclovir triphosphate has a much higher affinity for viral DNA polymerase than for the cellular homolog, yielding a high therapeutic ratio which makes the inhibition of native DNA polymerase clinically unimportant.In sum, aciclovir can be considered a prodrug: it is administered in an inactive (or less active form) and is metabolised into a more active species after administration. PHARMACOKINETICSAcylovir is poorly water soluble and has poor oral bioavailability (10–20%), hence intravenous administration is necessary if high concentrations are required. When orally administered, peak plasma concentration occurs after 1–2 hours. Acylovir has a high distribution rate, only 30% is protein-bound in plasma. The elimination half-life of aciclovir is approximately 3 hours. It is renally excreted, partly by glomerular filtration and partly by tubular secretion. INDICATIONSVICOVIR-400 is indicated for the treatment of HSV and VZV infections, including: Patient information: BEFORE YOU TAKE VICOVIR-400 Make sure you have told your doctor if you:- have ever had an allergic reaction to Aciclovir Tablets, VICOVIR-400 or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. - are pregnant, plan to become pregnant or are breast feeding. - Have any kidney disease.- Are taking Probenecid or any other medicines for gout.- Have liver problems- Have nerve disease- Have blood conditions. HOW TO TAKE VICOVIR-400 You must take your medicine as the doctor tells you. It is important to take VICOVIR-400 Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. The usual doses for adults are one 400 mg tablet every six hours (taken 4 times a day) or two 400 mg tablets every 4 hours (taken 5 times a day leaving out the night time dose). But this may be changed by your doctor. You should take the tablets as soon as you notice the symptoms.You should take VICOVIR-400 Tablets after food. Dissolve the tablet in a quarter of a glass of water and stir before drinking. If preferred, the tablet can be swallowed whole with a drink of water. IF YOU MISS A DOSE If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally. Do not take a double dose to make up for the dose that you missed. If you miss more than one dose, or you are not sure what to do, ask your doctor or pharmacist. WHAT TO DO IF AN OVERDOSE IS TAKENIn that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. TAKING OTHER MEDICINEAre taking other medicines such as ciclosporin (used following organ transplants and also for eczema, psoriasis, rheumatic disease and ulcerative colitis) cimetidine (used to treat stomach ulcers), probenecid (used to treat gout), mycophenolate mofetil (used to prevent rejection of organs following transplants), theophylline (used to treat severe asthma), zidovudine (used to treat HIV infection), and including any that you can buy without a prescription. VICOVIR-400 may make you feel drowsy. Make sure you are not affected before you drive or operate machinery. | SIDE EFFECTS Like all medicines, VICOVIR-400 can sometimes cause unwanted side effects.If the following happens, stop taking VICOVIR-400 and tell your doctor immediately. An allergic reaction: swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. A severe rash involving reddening, peeling and swelling of skin which looks like severe burns. These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.Known side effects with estimated likelihood of occurring are:Common: Feeling or being sick, diarrhoea, stomach pains, skin rashes which might be itchy and/or red, itching, headache, dizziness and fatigue.Uncommon: Oversensitivity of the skin to sunlight and fever.Rare: Feeling sleepy, confusion, imagining things (hallucinations), convulsions (fits), coma and generally feeling unwell. These effects usually occur in those patients receiving high doses injected into a vein or those with kidney problems. Also, changes in blood tests for the liver, hair loss, poor kidney function and kidney failure (usually reversible).Very rare: Changes in the numbers of certain blood cells, unexpected bruising, nose bleeds or repeated infections such as colds or sore throats); hepatitis (inflammation of the liver) and jaundice (yellowing of the skin or whites of the eyes). |
STORAGE Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets stored below 25°C in a dry place and in the original packaging. Keep them in a secure place where children cannot get at or see them. |
