Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 750 mg
Arrow Pharma Pty Ltd
Levetiracetam
Tablet, film coated
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; povidone; maize starch; purified talc; titanium dioxide; indigo carmine; hypromellose; sunset yellow FCF; macrogol 4000; iron oxide red
Oral
60, 30
(S4) Prescription Only Medicine
It is indicated for:,? use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME),and,? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).
Visual Identification: Orange oval shaped biconvex film-coated tablets debossed with a deep break line separating 'E' and '12' on one side and plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-12-23
KERRON™ CONSUMER MEDICINE INFORMATION Levetiracetam film-coated tablets and oral solution WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KERRON. 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 KERRON against the benefits they expect it will 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 KERRON IS USED FOR KERRON is used to control epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. This medicine belongs to a group of medicines called antiepileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. KERRON may be used alone, or in combination with other medicines, to treat your condition. Your doctor may have prescribed this medicine in addition to your current therapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that this medicine is addictive. This medicine is available only with a doctor’s prescription. The safety and effectiveness of KERRON has not been established in patients less than 4 years of age. BEFORE YOU TAKE KERRON _ _ _WHEN YOU MUST NOT TAKE IT: _ DO NOT TAKE KERRON IF YOU HAVE AN ALLERGY TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; or rash, itching or hives on the skin. KERRON ORAL SOLUTION CONTAINS MALTITOL. DO NOT USE THIS MEDICINE IF YOU HAVE HEREDITARY PROBLEMS OF FRUCTOSE INTOLERANCE. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE (EXP) PRINTED ON Read the complete document
Page 1 of 23 PRODUCT INFORMATION KERRON (LEVETIRACETAM) FILM-COATED TABLETS AND ORAL SOLUTION NAME OF THE MEDICINE Active ingredient: Levetiracetam Chemical name: (2S)-2-(2-Oxopyrrolidin-1-yl)butanamide CAS number: 102767-28-2 Molecular weight: 170.21 Molecular formula: C 8 H 14 N 2 O 2 Chemical structure: DESCRIPTION Levetiracetam is white or almost white powder. It is very soluble in water, soluble in acetonitrile, practically insoluble in hexane. KERRON is available as film coated tablets containing 250 mg, 500 mg, 750 mg & 1000 mg levetiracetam and oral solution containing 100 mg levetiracetam per mL. KERRON tablets contain the following inactive ingredients: maize starch, colloidal anhydrous silica, povidone, purified talc & magnesium stearate. 250 mg tablet also contains Opadry OY-S-30913 Blue (PI-ARTG No.3804). 500 mg tablet also contains Opadry Complete Film Coating System 05F82840 Yellow (PI-ARTG No.106470). 750 mg tablet also contains Opadry OY-S-33016 Orange (PI-ARTG No.3803). 1000 mg tablet also contains Opadry White Y-1-7000 E171 (PI-ARTG No.2731). KERRON oral solution contains the following inactive ingredients: sodium citrate, citric acid monohydrate, methyl hydroxybenzoate, propyl hydroxybenzoate, propylene glycol, glycerol, maltitol solution, acesulfame potassium, mafco magnasweet 110, grape flavour 50147 C and purified water. PHARMACOLOGY MECHANISM OF ACTION The precise mechanism of action by which levetiracetam induces seizure protection still remains to be fully elucidated, but appears to be unrelated to the mechanisms of current anti-epileptic drugs. _ In vitro_ and _ in vivo_ experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission. Page 2 of 23 _In vitro_ studies show that levetiracetam affects intraneuronal Ca 2+ levels by partial inhibition of N- type Ca 2+ currents and by reducing the release of Ca 2+ from intraneuronal stores. In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β- Read the complete document