INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DIOTROXIN® Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DIOTROXIN^® Tablets

COMPOSITION:
Each tablet contains thyroxine sodium 90 micrograms and liothyronine sodium 10 micrograms.

PHARMACOLOGICAL CLASSIFICATION:
A. 21.3 Thyroid preparation.

PHARMACOLOGICAL ACTION:
Thyroxine and liothyronine have qualitatively similar biological actions, but liothyronine (L-triiodothyronine) acts more promptly with a more intense but shorter lasting effect. The thyroid gland secretes both hormones and both are probably involved in maintaining the normal euthyroid state.
Administration of thyroxine and liothyronine provides a more natural replacement therapy than is given by one hormone alone. The soluble sodium salts are more efficiently and consistently absorbed than the free substances.

INDICATIONS:
Myxoedema and other forms of hypothyroidism.

CONTRA-INDICATIONS:
Thyrotoxicosis.
Hypersensitivity to any component of the tablet.

DOSAGE AND DIRECTIONS FOR USE:
Requirements vary with the individual. Usually two or three DIOTROXIN tablets daily are effective but doses can vary from one to five tablets a day.
Uncomplicated hypothyroidism of short duration: Initially one or two tablets daily, dosage being increased if necessary.
Myxoedema of long standing: Initially half to one tablet may be given increasing at weekly intervals until optimal responses are attained.
Continued maintenance therapy: Dosage must be determined to suit the individual.
Each tablet of DIOTROXIN is roughly equivalent to 60 mg Thyroid B.P.
As the daily dosage is cumulative, the full effect may not be seen for two or three weeks or longer.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Thyroid may enhance the action of anticoagulants and upset the stability of patients receiving antidiabetic agents. The effect of thyroid preparations may be enhanced by phenytoin taken concomitantly; aspirin has been stated to have a similar effect. At the beginning of treatment, ordinary therapeutic doses may cause anginal pain, palpitations and cramps in the skeletal muscle.
Patients with panhypopituitarism or other causes predisposing to adrenal insufficiency may react unfavourably to DIOTROXIN treatment and it is advisable to initiate corticosteroid therapy before giving DIOTROXIN in these cases. Special care is needed when there are symptoms of myocardial insufficiency or ECG evidence of myocardial infarction.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The following effects are indicative of excessive dosage, and usually disappear on reduction of dosage or withdrawal of treatment for a few days: anginal pain, cardiac arrhythmias, palpitations and cramps in skeletal muscle; also tachycardia, diarrhoea, restlessness, excitability, headache, flushing, sweating, excessive loss of mass and muscular weakness. Gastric lavage or emesis is required if the patient is seen within several hours of taking the dose. The appearance of clinical hyperthyroidism may be delayed for up to five days. Treatment is symptomatic, and tachycardia has been controlled in an adult by 40 mg doses of propranolol given every six hours.

IDENTIFICATION:
White biconvex and bisected tablets.

PRESENTATION:
Containers of 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C, and protect from light.
Keep out of reach of children.

REFERENCE NUMBER:
G3083 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Ltd
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12th December 1974

        A128/10/03
        Pinetown Printers

Updated on this site: December 2004
Source: Community Pharmacy
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