XEPASONE TABLET (WHITE) 5MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PREDNISOLONE

Available from:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (International Name):

PREDNISOLONE

Units in package:

1000Tablet Tablets

Manufactured by:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Summary of Product characteristics

Important Information. Please read carefully.
Xepasone
Tablets
COMPOSITION
Each tablet contains Prednisolone 5 mg
PHARMACODYNAMICS
Prednisolone is a synthetic glucocorticoid that is about four
times more potent than hydrocortisone in glucocorticoid and
anti-inflammatory
activity,
but
with
considerably
less
pronounced mineralocorticoid activity.
PHARMACOKINETICS
Prednisolone is readily absorbed via gastrointestinal tract.
Peak plasma concentration is obtained 1 or 2 hours after oral
dose; and has a usual plasma half-life of 2 to 4 hours.
Prednisolone is extensively bound to plasma proteins. It is
largely
inactivated
as
it
crosses
the
placenta
and
small
amounts are excreted in breast milk. Most prednisolone are
metabolised
and
excreted
in
the
urine
as
conjugated
metabolite and some excreted unchanged.
INDICATIONS
Suppression of inflammatory and allergic disorders including
asthma,
serum
sickness,
drug
sensitisation,
rheumatoid
arthritis and urticaria.
DOSAGE AND ADMINISTRATION
For oral use only.
Dosage requirements vary and must be adjusted according to
individual response and the basis of the disease.
As a guide, the initial dosage range from 5 to 60 mg daily, in
divided doses. After a favourable initial response is observed,
the proper maintenance dosage should be determined by
decreasing the initial dosage by small amounts to the lowest
dosage that maintains an adequate clinical response. If the
drug is to be stopped after more than a few days of treatment,
it
should
be
withdrawn
gradually.
In
long-term
therapy
dosage should be maintained at not more than 7 mg daily
whenever possible, as side effects occur with higher dosage.
CONTRAINDICATIONS
XEPASONE is similar to hydrocortisone and is contraindicated
in
patients
with
peptic
ulcer,
osteoporosis,
psychoses
or
severe
psychoneuroses,
epilepsy,
diabetes
mellitus,
tuberculosis, acute bacterial infection, herpes zoster, herpes
simplex
and
other
viral
infections.
Vaccination
with
live
vaccine is contraindicated during therapy with XEPASONE. It
should
be
used
with
gre