Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
gabapentin, Quantity: 600 mg
MedTAS Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; hyprolose; purified talc
Oral
10, 20, 30, 45, 50, 60, 84, 90 or 100 tablets.
(S4) Prescription Only Medicine
GABAPENTIN B&B is indicated for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children age 3 years and above who have not achieved adequate control with standard anti-epileptic drugs.,GABAPENTIN B&B is indicated for the treatment of neuropathic pain.
Visual Identification: White to off white, oval, biconvex, film coated tablets approx.18.00 mm long and 9.20 mm wide, engraved with '600' on one face and plain on the other; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2017-12-05
WP GABAPENTIN 1 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I USING WP GABAPENTIN? 2. WHAT SHOULD I KNOW BEFORE I USE WP GABAPENTIN? 3. WHAT IF I AM TAKING OTHER MEDICINES? 4. HOW DO I USE WP GABAPENTIN ? 5. WHAT SHOULD I KNOW WHILE USING WP GABAPENTIN ? WP GABAPENTIN The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WP Gabapentin contains the active ingredient gabapentin. WP Gabapentin is used to control epilepsy. For more information, see Section 1. Why am I using WP Gabapentin? in the full CMI. Do not use if you have ever had an allergic reaction to WP Gabapentin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use WP Gabapentin? in the full CMI. Some medicines may interfere with WP Gabapentin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. • Your doctor will decide what dose of WP Gabapentin you will receive. The dosage will depend on your condition. More instructions can be found in Section 4. How do I use WP Gabapentin? in the full CMI. THINGS YOU SHOULD DO • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking WP Gabapentin. WP GABAPENTIN 2 THINGS YOU SHOULD NOT DO • Do not take WP Gabapentin to treat any other complaints unless your doctor tells you to. • Do not give WP Gabapentin to anyone else, even if their symptoms seem similar to yours or they have the same condition as you. • Do not stop taking WP Gabapentin or lower the dose without checking with your doctor. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how WP Gabapentin affects you. DRINKING ALCOHOL • Be careful when drinking alcohol while you are taking WP Gab Przeczytaj cały dokument
PRODUCT INFORMATION GABAPENTIN B&B 600 MG /800 MG TABLETS NAME OF THE MEDICINE Gabapentin B&B (gabapentin) 600 mg and 800 mg Tablets Gabapentin B&B contains the active ingredient gabapentin. The structural formula of gabapentin is shown below: Chemical name : 1-(aminomethyl) cyclohexaneacetic acid Molecular formu1a : C 9 H 17 NO 2 Molecular weight : 171.24 CAS Registry Number : 60142-96-3 DESCRIPTION Gabapentin is a white to off-white crystalline powder. It is freely soluble in water and both basic and acidic aqueous solutions. It has values for LogP of -1.10, and values for pKa of 3.68 and 10.70. Gabapentin B&B tablets also contain the following inactive ingredients: hyprolose, magnesium stearate and Opadry white YS-1-18111 (ARPING No. 3289). PHARMACOLOGY PHARMACODYNAMICS The mechanism by which gabapentin exerts its anticonvulsant action is unknown. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but its mechanism of action is different from that of several other drugs that interact with GABA synapses including valproate, barbiturates, benzodiazepines, GABA transaminase inhibitors, GABA uptake inhibitors, GABA agonists, and GABA prodrugs. _In vitro _ studies with radiolabelled gabapentin have characterised a novel peptide binding site in rat brain tissues including neocortex and hippocampus that may relate to anticonvulsant activity of gabapentin and its structural derivatives. However, the identification and function of the gabapentin binding site remains to be elucidated. Gabapentin at relevant clinical concentrations does not bind to other common drug or neurotransmitter receptors of the brain including GABA A , GABA B , benzodiazepine, glutamate, glycine or _N_ -methyl-d-aspartate receptors. Gabapentin does not interact with sodium channels _in vitro_ and so differs from phenytoin and carbamazepine. Several test systems ordinarily used to assess activity at the NMDA receptor complex have been examined. Results are contradictory. Accordingly no general statement about Przeczytaj cały dokument