APO-CALCITRIOL calcitriol 0.25 microgram capsule bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

calcitriol

Disponible depuis:

Apotex Pty Ltd

DCI (Dénomination commune internationale):

Calcitriol

Statut de autorisation:

Registered

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
APO-CALCITRIOL (CALCITRIOL) CAPSULES
1
NAME OF THE MEDICINE
Calcitriol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each APO-Calcitriol capsule contains 0.25 μg of calcitriol as active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Red coloured, oval soft gelatin capsules containing a clear oily
liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Calcitriol is indicated for the:
•
treatment
of
established
osteoporosis
diagnosed
by
objective
measuring
techniques, such as densitometry, or by radiographic evidence of a
traumatic
fracture
•
prevention of corticosteroid-induced osteoporosis in patients
commencing oral
steroid therapy in a dose and regimen expected to result in a
significant bone loss
•
treatment
of
hypocalcaemia
in
patients
with
uraemic
osteodystrophy,
hypoparathyroidism and in hypophosphataemic rickets.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Calcitriol capsules are intended for oral administration.
DOSAGE
GENERAL
The optimal daily dose of calcitriol must be carefully determined for
each patient and indication.
Dosage
optimisation
should
be
accompanied
by
regular
monitoring
of
serum
calcium
concentration.
When the optimal dosage of calcitriol has been determined, the serum
calcium levels should
be checked regularly. As soon as serum calcium nears hypercalcaemic
levels (1 mg per
100 mL [0.25 mmol/L] above normal 9-11 mg per 100 mL [2.25-2.75
mmol/L] on average), the
dosage of calcitriol should be substantially reduced or treatment
stopped altogether until
normocalcaemia
ensues.
If
hypercalcaemia
occurs,
the
drug
should
be
immediately
discontinued until normocalcaemia ensues. Withdrawal of additional
doses of calcium can also
be
of
benefit
in
bringing
about
rapid
normalisation
of
serum
calcium
levels.
Careful
consideration should also be given to lowering the dietary calcium
intake.
Should hypercalcaemia occur, calcitriol should be suspended
immediately and se