Each ml contains:
Dexamethasone 0,05 mg
is a synthetic glucocorticoid, which is
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 -
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
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.
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.
► Gastric and
► Systemic fungal infections.
► Certain viral infections, e.g. varicella and
herpes genitalis infections.
► 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:
any of the following conditions should be
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
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:
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
of glucocorticoids with any of the following
drugs or substances may lead to the
occurrence of clinically relevant
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
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
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
The following adverse reactions have been
associated with prolonged systemic
Endocrine and metabolic disturbances:
Cushing-like syndrome, hirsutism, menstrual
irregularities, premature epiphyseal
closure, secondary adrenocortical and
pituitary unresponsiveness, decreased
glucose tolerance, negative nitrogen and
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
Gastro-intestinal effects: gastric
and duodenal ulceration, perforation and
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
Ophthalmic effects: glaucoma,
increased intraocular pressure, posterior
Immunosuppressive effects: increased
susceptibility to infections, decreased
responsiveness to vaccination and skin
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
The pleasant taste of Oradexon Organon makes
it imperative to keep the bottle out of
reach of children.
Keep away from
Keep at a temperature not exceeding
Keep out of reach of children.
Bottle of 120 ml.