AT 10

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DIHYDROTACHYSTEROL

Available from:

Intrapharm Laboratories Limited

ATC code:

A11CC02

INN (International Name):

DIHYDROTACHYSTEROL

Dosage:

250 Microgram/ML

Pharmaceutical form:

Oral Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

dihydrotachysterol

Authorization status:

Not marketed

Authorization date:

1986-03-26

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AT 10 250 micrograms/ml Oral Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of liquid contains 250 micrograms of dihydrotachysterol in
arachis oil (peanut oil).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
A clear, deep straw- coloured liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AT10 is recommended in the treatment of hypocalcaemic tetany due to
hypoparathyroidism.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
In acute cases 3 to 5ml (0.75 to 1.25mg) may be given on each of the
first three days of treatment, followed 2 to 3 days
later by blood and urinary calcium estimations. The maintenance dose
is within the range of 1 to 7ml (0.25 to 1.75mg)
each week, the precise amount depending on the results of serum and
urinary calcium determinations.
In chronic cases, an initial dose of 2ml (0.5mg) daily or on alternate
days, may be sufficient to maintain
normocalcaemia in moderate cases.
AT10 is for oral administration only.
4.3 CONTRAINDICATIONS
Hypersensitivity to dihydrotachysterol and other ingredients of the
preparation.
Hypercalcaemia.
Hypervitaminosis D.
Allergy to nuts (including peanuts).
Do not use with calcium supplements.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Uncontrolled prolonged administration can result in hypercalcaemia
which may lead to nephrocalcinosis. Accurate
blood calcium determinations must be made at initiation of treatment
and periodically during maintenance. The serum
calcium level should be kept between 2.25-2.5mmol/litre.
Serum phosphate, magnesium and alkaline phosphatase should also be
measured periodically to monitor progress.
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