국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride, Quantity: 33.68 mg
Lupin Australia Pty Limited
Duloxetine hydrochloride
Capsule, enteric
Excipient Ingredients: hypromellose phthalate; triethyl citrate; lactose monohydrate; croscarmellose sodium; dichloromethane; polysorbate 80; hypromellose; pregelatinised maize starch; magnesium stearate; methanol; purified talc; isopropyl alcohol; titanium dioxide; propylene glycol; butan-1-ol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide; ethanol; strong ammonia solution; iron oxide black; indigo carmine; Gelatin; acetic acid; silicon dioxide; sodium lauryl sulfate; citric acid
Oral
28 Capsules (4 x 7 Capsules), 14 Capsules (2 x 7 Capsules), 7 Capsules (1 x 7 Capsules)
(S4) Prescription Only Medicine
Duloxetine Hydrochloride is indicated for the following:,-Treatment of major depressive disorder (MDD). ,-Treatment of generalised anxiety disorder (GAD).
Visual Identification: Size '3' Capsules with dark blue cap & white body, imprinted with "DU" in white ink on cap & "30" in black ink on body,containing six mini tablets.; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-04-29
1 DULOXETINE DR –LUPIN CAPSULES _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Duloxetine DR-Lupin Capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. Always follow the instructions that your doctor and pharmacist give you about the medicine. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. The updated leaflet may contain important information about Duloxetine DR-Lupin Capsules and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Duloxetine-DR Lupin Capsules against the benefits they expect it will have for you. ALWAYS FOLLOW THE INSTRUCTIONS THAT YOUR DOCTOR AND PHARMACIST GIVE YOU ABOUT DULOXETINE DR– LUPIN CAPSULES. IF YOU HAVE ANY CONCERNS, OR ARE UNSURE ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. DO NOT THROW THIS LEAFLET AWAY. You may need to read it again. WHAT DULOXETINE DR–LUPIN CAPSULES ARE USED FOR Duloxetine DR-Lupin Capsules is used to treat major depressive disorder (depression), Generalised Anxiety Disorder (excessive worry) Duloxetine DR-Lupin Capsules belongs to a group of medicines called Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs). SNRIs are believed to work by their action on serotonin and noradrenaline in the brain. Serotonin and noradrenaline are the chemical messengers responsible for controlling the psychological and painful physical symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU . This medicine is available only with a doctor's prescription Duloxetine DR-Lupin Capsules is not recommended for use in children and adolescents un 전체 문서 읽기
PRODUCT INFORMATION Duloxetine DR Lupin Capsule-PI_v4.0 Page 1 of 32 DULOXETINE DR-LUPIN CAPSULE (LUPIN AUSTRALIA PTY.LTD) NAME OF THE MEDICINE Duloxetine (as hydrochloride) Duloxetine Hydrochloride is a selective serotonin and noradrenaline reuptake inhibitor (SNRI) for oral administration. Chemical Formula: C 18 H 19 NOS.HCl Molecular Weight: 333.9 CAS No: 136434-34-9 Chemical Structure: DESCRIPTION DULOXETINE HYDROCHLORIDE It is chemically unrelated to tricyclics, alpha adrenergic receptor agonists or antimuscarinics. Its chemical designation is (+)-(_S_)-_N_-methyl- γ -(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride. It is a white to cream coloured powder, which is sparingly soluble in water, freely soluble in methanol and practically insoluble in hexane. Duloxetine DR Lupin Capsule is a delayed release capsule for oral administration. Each capsule contains enteric-coated mini tablets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine that are designed to prevent degradation of the drug in the acidic environment of the stomach. EXCIPIENTS Inactive ingredients include Lactose, Croscarmellose Sodium, Pregelatinised maize starch, Polysorbate 80, Magnesium stearate, Hypromellose, Hypromellose phthalate, Purified talc, Triethyl citrate. Duloxetine DR Lupin Capsule-PI_v4.0 Page 2 of 32 Empty Hard Gelatin Capsule: The 30 mg capsule is a Size 3 hard gelatin capsule (ARTG No. 108081) with a dark blue cap and a white body and contains Indigo carmine CI73015, Gelatin, Titanium dioxide and Sodium lauryl sulphate. The 60 mg capsule is a Size 1 hard gelatin capsule (ARTG No. 108080) with a dark blue cap and a green body and contains Indigo carmine CI73015, Gelatin, Titanium dioxide, Iron oxide yellow CI77492 and Sodium lauryl sulfate. Both capsule shells are imprinted with TekPrint SW-900B Black Ink, (ARTG No. 2328) and TekPrint SW-0012 White Ink (ARTG No. 13175). PHARMACOLOGY PHARMACODYNAMIC PROPERTIES AND MECHANISM OF ACTION Duloxetine is a selective serotonin and noradrenaline reuptake inhi 전체 문서 읽기