Each tablet contains: Prednisolone 5 mg
Round, white, flat, plain tablet with "S.W." debossed on one side only.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which
also have salt-retaining properties, are used as replacement therapy in
adrenocortical deficiency states. Their synthetic analogs such as
Prednisolone are primarily used for their potent anti-inflammatory effects
in disorders of many organ systems.
In addition, Prednisolone causes profound and varied metabolic effects. The
pharmacologic effects include action on the electrolyte balance,
gluconeogenesis, lipolysis, protein catabolism, the action on tissue repair
and healing, and the secretion of corticotrophin by the anterior lobe of the
pituitary gland, glucose utilization and anti-insulin activity.
Prednisolone is effective when given by mouth and is absorbed from the
gastrointestinal tract. Prednisolone is 70 - 90% protein bound in the plasma
and it is eliminated from the plasma with a half-life of 2 - 4 hours.
It is indicated for primary or secondary adrenocortical insufficiency,
rheumatic disorders, collagen diseases (systemic lupus erythematosus),
dermatologic diseases (pemphigus, severe psoriasis, severe seborrheic
dermatitis), bronchial asthma, ophthalmic diseases (eye inflammation, herpes
zoster ophthalmicus, allergic conjunctivitis), hematologic disorders,
neoplastic diseases (leukemia), edematous states and gastrointestinal
diseases (ulcerative colitis).
Adverse reactions include fluid and electrolyte disturbance, muscle
weakness, osteoporosis, acute pancreatitis, cushingoid state, growth
retardation, menstrual irregularities, increased intraocular pressure,
visual disturbances, manifestation of latent diabetes mellitus, peptic ulcer
with possible perforation and hemorrhage, impaired wound healing, convulsion
and increased intracranial pressure with papilloedema.
It is contraindicated in systemic fungal infection and hypersensitivity to
any component of the product.
It should be used with caution in congestive heart failure, diabetes
mellitus, chronic renal failure, hypertension, recent intestinal anastomoses,
infectious diseases, elderly persons, pregnancy, myasthenia gravis and
ocular herpes simplex.
Patients with quiescent tuberculosis should be observed closely and should
receive chemoprophylaxis if corticosteroid therapy is prolonged.
Growth and development of infants and children on prolonged corticosteroids
therapy should be carefully observed.
Prolonged use of corticosteroids may produce posterior subcapsular
cataracts, glaucoma with possible damage to the optic nerves and may enhance
the establishment of secondary ocular infections due to fungi or viruses.
Use in Pregnancy and Lactation
Since adequate human reproduction studies have not been done with
corticosteroids, use of these drugs in pregnancy or in women of childbearing
potential requires that the anticipated benefits be weighed against the
possible hazards to the mother and embryo or fetus. Infants born of mothers
who have received substantial doses of corticosteroids during pregnancy
should be carefully observed for signs of hypoadrenalism. Corticosteroids
appear in breast milk and could suppress growth, interfere with endogenous
corticosteroids production, or cause other unwanted effects. Mothers taking
pharmacologic doses of corticosteroids should be advised not to nurse.
It is usually given in a dose range of 5 to 60mg daily, in divided doses or
as a single daily dose at 8am or as a double dose on alternate days.
In long term therapy, dosage should be maintained at not more than about 7
mg daily whenever possible as side effects inevitably occur with higher
Phenytoin, phenobarbital, ephedrine and rifampicin may enhance the
metabolism of corticosteroids resulting in decreased blood levels and
lessened physiologic activity, thus requiring adjustment in corticosteroid
dosage. Drugs such as barbiturates which induce hepatic microsomal drug
metabolizing enzyme activity may enhance metabolism of Prednisolone and
require the dosage of Deltasolone to be adjusted.
Symptoms and Treatment for overdosage and antidote(s)
Symptoms are as mentioned in 'Side effects'. The effects of accidental
ingestion of large quantities of Prednisolone over a very short period of
time have not been reported. Elevation of blood pressure and increased
potassium excretion may be controlled with dietary salt restriction and
potassium supplementation. Treatment of acute overdosage is by immediate
gastric lavage or emesis. For chronic overdosage in the face of severe
disease requiring continuous steroid therapy the dosage of Prednisolone may
be reduced only temporarily, or alternate day treatment may be introduced.
Blister pack: A box of 10 x 10, 50 x 10 and 100 x 10 tablets per strip.
Store at temperature 25°C.