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Oradexon Organon
 for children 0.05 mg/ml

Composition:
Each ml contains: Dexamethasone 0,05 mg

Properties:
Dexamethasone is a synthetic glucocorticoid, which is easily
absorbed from the gastro - intestinal tract. It has 7 times the anti-
inflammatory potency of prednisolone.
Like other glucocorticoids, Dexamethasone also has anti -allergic, anti-toxic, anti-shock, anti-pyretic and immunosuppressive properties. Dexamethasone has practically no water and salt - retaining properties.
Because of the long biological half-life (36 - 54 hours),
Dexamethasone is especially indicated in conditions where a continuous glucocorticoid action is desired.
Oradexon Organon is a pleasant-tasting liquid.
Moreover the active ingredient can be accurately dosed. This makes the product especially suitable for pediatric use, e.g. in the treatment of adrenogenital syndromes.

Indications:
Oradexon Organon has the same indications as the other glucocorticoids, though chiefly in the pediatric field, including: Congenital and acquired adrenalcortical, insufficiency and adrenogenital syndrome (only if supplemented with mineralocorticoid therapy), in serious cases of rheumatoid arthritis (Still's disease), acute rheumatic carditis, nephrotic-syndrome with minimal change lesions, hypersensitivity reactions to drugs or chemicals, insect stings and bites, severe hay-fever, Stevens-Johnson syndrome, prevention of scars and sympathetic ophthalmia caused by eye surgery and eye injuries, oesophagitis corrosiva, thrombocytopenic purpura, auto-immune haemolytic anaemia, acute lymphocytic
leukaemia, Hodgkin's disease, aplastic anaemia, in selected cases of myasthenia gravis, in tuberculous meningitis to prevent obstruction of the flow of cerebrospinal fluid, severe hypervitaminosis-D, idiopathic infantile hypercalcaemia, persistent hypoglycaemia of the newborn.

Contraindications:
Gastric and duodenal ulcers.
Systemic fungal infections.
Certain viral infections, e.g. varicella and herpes genitalis infections.
Glaucoma.
Hypersensitivity to glucocorticoids. In general no contraindications apply in conditions where the use of glucocorticoids may be life-saving.

Use during pregnancy and breast - feeding:
This drug is not intended for use in women of fertile age.

Warning and Precautions:
Patients with any of the following conditions should be monitored:
Latent or overt cardiac failure, renal dysfunction, hypertension or migraine, since glucocorticoids may induce fluid retention.
Osteoporosis,since glucocorticoids have a negative effect on the calcium balance.
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 to infections. Appropriate antimicrobial therapy should accompany glucocorticoid therapy when necessary, e.g. in tuberculosis, and viral and fungal infections of the eye.
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 adrenocortical insufficiency. The use of corticosteroids may influence the results of certain laboratory tests.

Dosage & route of administration & duration:
The following dosages are given as a guide for children up to 5 years of age. In certain conditions (e.g. nephrotic syndrome) a much higher dosage may be needed.
Oradexon Organon should be taken orally.
Inside the small measuring beaker on this bottle of Oradexon Organon is a plastic collar which enables the contents to be poured without spilling. The beaker is marked at 2, 2.5, 3, 4, 5, 8, 10,12 & 15 prescribed doses. When the bottle is first opened attach the pouring collar inside the neck of the bottle. After measuring out the required quantity close the bottle by replacing the screw cap leaving the pouring collar in position. Unless the attending physician prescribes otherwise, one should - according to the daily rhythm of the adrenal cortex - preferably give the total daily dosage once, between 8 and 10 o'clock in the morning.

Drug interaction:
Concomitant use of glucocorticoids with any of the following drugs or substances may lead to the occurrence of clinically relevant interactions:
Diuretics and/or cardiac glucosides (potassium loss may be enhanced which is a particular risk in patients using cardiac glycosides, since hypokalaemia increases the toxicity of these drugs).
Antidiabetics (glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs).
Non-steroidal anti-inflammatory drugs (the incidence and / or severity of gastrointestinal ulceration may increase).
Oral anticoagulants (glucocorticoids may alter the need for these drugs).
Active vaccines (glucocorticoids may suppress the immune response of the body; extra caution should be exercised with live vaccines).
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.

Adverse effects:
Adverse reactions, associated with prolonged systemic glucocorticoid therapy, are unlikely when high doses are administered over a short period of time. Nevertheless, gastric and duodenal ulceration, with possible perforation and haemorrhage, may occasionally occur.
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, and hypokalaemic alkalosis.
Musculo - skeletal effects: myopathy, abdominal distention, osteoporosis, and aseptic necrosis of femoral and humeral heads.
Gastro-intestinal effects: gastric and duodenal ulceration, perforation and haemorrhage.
Dermatologic effects: impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising ,facial erythema, increased sweating, acne.
C.N.S. 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.

Overdosage:
In animal experiments the acute toxicity of dexamethasone has been shown to be rather low. Symptoms of acute overdosage that can occur are nausea and vomiting. If vomiting has not yet occurred this can be provoked. For the rest a symptomatic treatment is probably sufficient.
Note:
The pleasant taste of Oradexon Organon makes it imperative to keep the bottle out of reach of children.

Storage:
Keep away from light .
Keep at a temperature not exceeding 25° C.
Keep out of reach of children.

Presentation:
Bottle of 120 ml.

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