Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
zolpidem tartrate
Amneal Pharma Australia Pty Ltd
zolpidem tartrate
Page 1 of 4 ZOLPIDEM-GA _Zolpidem tartrate _ _ _ CONSUMER MEDICINE INFORMATION WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH UNUSUAL AND POTENTIALLY DANGEROUS BEHAVIOURS WHILST APPARENTLY ASLEEP. THESE HAVE INCLUDED SLEEP WALKING, DRIVING MOTOR VEHICLES AND OTHER BIZARRE BEHAVIOURS. SOME MEDICINES MAY INTERACT WITH ZOLPIDEM AND PARTICULAR CAUTION IS NEEDED WITH OTHER DRUGS THAT MAY ALSO ACT ON THE BRAIN; BEFORE YOU TAKE ZOLPIDEM REFER TO THE "TAKING OTHER MEDICINES" SECTION BELOW OR ASK YOUR DOCTOR OR PHARMACIST. YOU MUST NOT DRINK ALCOHOL WHEN YOU TAKE ZOLPIDEM. DO NOT TAKE ZOLPIDEM FOR MORE THAN 4 WEEKS. IF YOUR SLEEP PROBLEMS CONTINUE, CONSULT YOUR DOCTOR. WHAT IS IN THIS LEAFLET? This leaflet answers common questions about ZOLPIDEM- GA. 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 risk of taking ZOLPIDEM-GA against the benefits it 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 want to read it again. WHAT IS ZOLPIDEM-GA USED FOR? ZOLPIDEM-GA is a prescription medicine that your doctor has prescribed for you. Do not share it with anyone. ZOLPIDEM-GA is the brand name of a medicine called Zolpidem tartrate. ZOLPIDEM-GA is used to initiate sleep in those with sleeping difficulties, also called insomnia. The cause of sleeping problems should be known, if possible. The causes should be treated before ZOLPIDEM-GA, or any hypnotic is prescribed. IT SHOULD NOT BE USED FOR MORE THAN 4 WEEKS AT A TIME. Continuous long term use is not recommended unless advised by your doctor. THE USE OF ZOLPIDEM-GA MAY LEAD TO DEPENDENCE ON THE MEDICINE. ZOLPIDEM-GA has a different chemical structure to any other sleeping tablet that is currently available in Australia. ZOLPIDEM-GA works by binding to special sites in the brain which produce sleep. Your doctor will have explained why you are be Lesen Sie das vollständige Dokument
Zolpidem-GA PI v2 101006 marketed Page 1 of 13 PRODUCT INFORMATION (MARKETED) ZOLPIDEM-GA TABLETS WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH POTENTIALLY DANGEROUS COMPLEX SLEEP- RELATED BEHAVIOURS WHICH MAY INCLUDE SLEEP WALKING, SLEEP DRIVING AND OTHER BIZARRE BEHAVIOURS. ZOLPIDEM IS NOT TO BE TAKEN WITH ALCOHOL. CAUTION IS NEEDED WITH OTHER CNS DEPRESSANT DRUGS. LIMIT USE TO FOUR WEEKS MAXIMUM UNDER CLOSE MEDICAL SUPERVISION. NAME OF THE MEDICINE ZOLPIDEM-GA Name of the active ingredient: zolpidem tartrate Its chemical name is 2-(4-methylphenyl)-N,N,6-trimethylimidazo [1,2,a] pyridine-3-acetamide hemitartrate. Its molecular formula is C 42 H 48 N 6 O 8 . MW is 764.9. CAS numbers are 99294-93-6 (zolpidem tartrate) and 82626-48-0 (zolpidem free base). DESCRIPTION Zolpidem tartrate is a white to off white colourless, crystalline powder, sparingly soluble in water. Each tablet contains zolpidem tartrate 10 mg with lactose, microcrystalline cellulose, hypromellose, sodium starch glycollate and magnesium stearate. The coating on the tablets consists of hypromellose, titanium dioxide and macrogol 400. PHARMACOLOGY PHARMACODYNAMICS Zolpidem tartrate belongs to the imidazopyridine group of compounds and is structurally unrelated to other hypnotic agents. Zolpidem tartrate selectively binds the omega-1 receptor subtype (also known as the benzodiazepine-1 subtype) which is the alpha unit of the GABA- A receptor complex. Whereas benzodiazepines non-selectively bind all three omega receptor subtypes, zolpidem tartrate preferentially binds the omega-1 subtype. The modulation of the chloride anion channel via this receptor leads to the specific sedative Zolpidem-GA PI v2 101006 marketed Page 2 of 13 effects demonstrated by zolpidem tartrate i.e. the preservation of deep sleep (stage 3 and 4 slow wave sleep). These effects are reversed by the benzodiazepine antagonist flumazenil. In animals: The selective binding of zolpidem tartrate to omega-1 receptors may explain the virtual absence at hypnotic doses of myorelaxant and anti-c Lesen Sie das vollständige Dokument