국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
alendronate sodium monohydrate, Quantity: 46.42 mg (Equivalent: alendronic acid, Qty 40 mg)
Arrotex Pharmaceuticals Pty Ltd
alendronate sodium monohydrate
Tablet, uncoated
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; magnesium stearate
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of osteoporosis, including glucocorticoid induced osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults or by the presence of history of osteoporotic fracture. Paget's disease of bone.
Visual Identification: white to off-white triangular tablet marked 'AN' over '40' on one side and the Arrow logo on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2005-05-27
1 AUSTRALIAN PRODUCT INFORMATION – ALENDRO (ALENDRONIC ACID) TABLETS 1 NAME OF THE MEDICINE Alendronic acid (as alendronate sodium monohydrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alendro tablets come in three strengths and contain 10 mg, 40 mg or 70 mg of alendronic acid as alendronate sodium monohydrate. Alendro tablets contains lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Alendro 10 White to off-white capsule-shaped tablet embossed with “AN 10” on one side and the Arrow logo on the other. Alendro 40 White to off-white triangle shaped tablet embossed with “AN” over “40” on one side and the Arrow logo on the other. Alendro Once Weekly White to off-white oval-shaped tablet embossed with “AN 70” on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS (See SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION) Treatment of osteoporosis, including glucocorticoid induced osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults, or by the presence of osteoporotic fracture. Paget's disease of bone. 2 4.2 D OSE AND METHOD OF ADMINISTRATION Alendronate must be taken at least 30 minutes before the first food, beverage or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of alendronate (see SECTION 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). To facilitate delivery to the stomach and thus reduce the potential for oesophageal irritation, alendronate should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of oesophageal adverse expe 전체 문서 읽기