INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ORADEXON-ORGANON Tablets - Discontinued


SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

ORADEXON-ORGANON Tablets - Discontinued

COMPOSITION
Each capsule contains:
0,5 mg
dexamethasone

PHARMACOLOGICAL CLASSIFICATION
A/21.5/Corticosteroids

PHARMACOLOGICAL ACTION
Dexamethasone is a synthetic glucocorticoid with a high anti-inflammatory potency. Dexamethasone also has anti-allergic, antitoxic, antishock, antipyretic and immunosuppressive properties.

INDICATIONS
Nephrotic syndrome attributable to systemic lupus erythematosus.
Collagen diseases: polyarteritis nodosa, mixed connective tissue disease, arteritis temporalis.
Manifestations of allergic disease, that are limited in duration, such as: serum sickness, drug reactions, bee stings, angioneurotic oedema, Stevens-Johnson syndrome; for chronic immunosuppression in transplantation patients.
Rheumatology: selected cases of rheumatoid arthritis, polymyalgia rheumatica, acute rheumatic carditis. Endocrinology: primary or secondary adrenocortical insufficiency.
Dermatology, severe cases of pemphigus.
Ophthalmology: inflammatory processes of the eye other than viral or fungal infections.
Disease of the intestinal tract: to induce a remission of chronic ulcerative colitis in selected patients.
Bronchial asthma: severe bronchial asthma and other inflammatory obstructive lung diseases. Malignancies: acute lymphocytic leukemia and lymphomas.
Cerebral oedema.

CONTRA-INDICATIONS
Gastric and duodenal ulcers.
Systemic and ophthalmic fungal infections.
Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye. Glaucoma.
Hypersensitivity to corticosteroids.
Use during pregnancy and breast-feeding
Safety in pregnancy has not been established.
Glucocorticoids appear in breast milk. Mothers taking high dosages of corticosteroids should be advised not to breast-feed.

DOSAGE AND DIRECTIONS FOR USE
1. In general glucocorticoid dosage depends on the severity of the condition and the response of the patient. Under certain circumstances, for instance in stress and changed clinical picture, extra dosage adjustments may be necessary. It no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.
2. In adult patients, daily oral dosages vary from 1,0 mg to 10 mg and in children from 0,03-0,20 mg/kg body weight, according to the individual response.
3. In some patients higher dosages may be temporarily required, to control the disease. As soon as circumstances permit, dosage should be decreased.
4. For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning. Patients who do not show a decrease in cortisol can be exposed to a longer test: 0,5 mg dexamethasone is given at 6-hour intervals for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17alpha.-hydroxycorticoids.
  Administration:
  ORADEXON-ORGANON TABLETS should be taken orally, preferably with some fluid.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy:
Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.
Fluid and electrolyte disturbances: sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.
Musculo-skeletal effects: myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.
Gastro-intestinal effects: gastric and duodenal ulceration, perforation and haemorrhage.
Dermatological effects: impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.
Central Nervous System effects: psychic disturbances ranging from euphoria to frank psychotic manifestations, convulsions, in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.
Ophthalmic effects: glaucoma, increased intraocular pressure, posterior subcapsular cataracts.
Immunosuppressive effects: increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
Precautions
Patients with the following conditions should be monitored:
latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine, since glucocorticoids may induce fluid retention.
Osteoporosis.
A history of psychotic illness.
Latent tuberculosis, since glucocorticoids may induce reactivation.
Certain parasitic infestations, in particular amoebiasis.
Incomplete statural growth, since glucocorticoids on prolonged administration may accelerate epiphyseal closure.
Glucocorticoid therapy is non-specific, suppresses the symptoms and signs of disease and decreases the resistance of infections: Appropriate antimicrobial therapy should accompany glucocorticoid therapy whenever necessary, e.g. in tuberculosis, and viral and fungal infections of the eye.
If a live vaccine is to be administered it should be borne in mind that glucocorticoids exert an immunosuppressive effect.
Patients on long-term glucocorticoid therapy should be regularly examined for increased intra-ocular pressure and posterior subcapsular cataracts.
Patients on long-term glucocorticoid therapy should be regularly examined with respect to their glucose metabolism.
Before, during and after stressful situations; dosage may need to be increased in patients currently on glucocorticoids or resumed in patients who have undergone prolonged glucocorticoid treatment in the previous year.
Discontinuation of prolonged therapy should be carried out by gradual reduction of dosage and under strict medical supervision; since withdrawal may result in acute exacerbation of the disease and acute adreno-cortical insufficiency.
Patients treated concomitantly with glucocorticoids and one of the following drugs should be monitored:
diuretics and/or cardiac glycosides, since potassium loss may be enhanced. This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
oral anti-coagulants since glucocorticoids may alter the need for these drugs.
Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs, such as rifampicin, ephedrine, barbiturates, phenytoin and primidone:
If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
Antacids; especially those containing magnesium trisilicate, have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage is unlikely, however it will produce those symptoms listed under side-effects.

CONDITIONS OF REGISTRATION
Advertising to the professions only.

IDENTIFICATION
White, round; flat tablets with bevelled edges and code marked “XC4”on one side and “Organon”on the other side.

PRESENTATION
Securitainers containing 100 tablets.

STORAGE INSTRUCTIONS
The tablets should be protected from light and stored below 25°C. Keep in well-dosed containers.
Keep out of reach of children.

REGISTRATION NUMBER
G/21.5/3194

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Donmed Pharmaceuticals (Pty) Ltd
Cambridge Place
cnr. Kirkby and Oxford Roads
Bedfordview

DATE OF PUBLICATION OF THIS PACKAGE INSERT
June 1988.

DONMED
Under license of NV Organon Oss

Britepak                11/93

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