ALENDRONATE PLUS D3
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
27-11-2017
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Active ingredient:
alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg); colecalciferol, Quantity: 0.07 mg
Available from:
Dr Reddys Laboratories Australia Pty Ltd
INN (International Name):
alendronate sodium,colecalciferol
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: Gelatin; povidone; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; medium chain triglycerides; butylated hydroxytoluene; magnesium stearate; sucrose
Administration route:
Oral
Units in package:
4 Tablets, 1 Tablet
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
TRADENAMES are indicated for the treatment of: ? Osteoporosis* in select patients where vitamin D supplementation is recommended,* Prior to treatment, osteoporosis must be confirmed by: - the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by - the presence of osteoporotic fracture
Product summary:
Visual Identification: White to off-white, modified capsule-shaped uncoated tablet, debossed with ADC on one side and 28 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-12-16
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
ALENDRONATE PLUS D3-DRLA 70 MG/70 MCG
(ALENDRONATE SODIUM AND COLECALCIFEROL)
ALENDRONATE PLUS D3-DRLA 70 MG/140 MCG
(ALENDRONATE SODIUM AND COLECALCIFEROL)
1
NAME OF THE MEDICINE
Alendronate sodium and colecalciferol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Alendronate Plus D3-DRLA 70 mg/70 mcg contains 91.37 mg
of alendronate
sodium, which is the molar equivalent to 70 mg of alendronic acid, and
70 microgram of
colecalciferol equivalent to 2800 IU vitamin D.
Each tablet of Alendronate Plus D3-DRLA 70 mg/140 mcg contains 91.37
mg of alendronate
sodium, which is the molar equivalent to 70 mg of alendronic acid, and
140 microgram of
colecalciferol equivalent to 5600 IU vitamin D.
EXCIPIENTS WITH KNOWN EFFECT
Sucrose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Alendronate Plus D3-DRLA 70 mg/ 70 mcg once weekly tablet is a white
to off-white, modified
capsule- shaped uncoated tablet, debossed with 'ADC' on one side and
'28' on the other side.
Alendronate Plus D3-DRLA 70 mg/ 140 mcg once weekly tablet is a white
to off-white, modified
capsule- shaped uncoated tablet, debossed with 'ADC' on one side and
'56' on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronate Plus D3-DRLA 70 mg/70 mcg and Alendronate Plus D3-DRLA 70
mg/140 mcg
are indicated for the treatment of:
•
Osteoporosis in select patients where vitamin D supplementation is
recommended
Prior to treatment, osteoporosis must be confirmed by:
•
the finding of low bone mass of at least 2 standard deviations below
the gender
specific mean for young adults or by
•
the presence of osteoporotic fracture
4.2
DOSE AND METHOD OF ADMINISTRATION
Alendronate Plus D3-DRLA (70 mg/70 mcg or 70 mg/140 mcg)
Treatment of osteoporosis in patients where vitamin D
3
supplementation is recommended
1
The recommended dose is one tablet of Alendronate Plus D3 (70 mg/70
mcg or 70 mg/140
mcg) once weekly.
The optimal duration of use has not been determined. All pa
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