CLINT TABLET 100MG

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

ALLOPURINOL

MAH:

KOMEDIC SDN BHD

INN:

ALLOPURINOL

units_in_package:

1000 Tablets

manufactured_by:

MEDOCHEMIE LTD

PIL

------NOT APPLICABLE-----

SPC

1
PACKAGE INSERT – CLINT® 100MG TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
CLINT 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Allopurinol.
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet for oral administration. White, flat, round, scored tablet with
diameter 9.5mm
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the reduction of urate levels in the body whether of idiopathic
nature or in association with other conditions
(neoplastic conditions Lesch-Nyhan syndrome, renal failure, renal
calculus formation, diuretic therapy, psoriasis).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: The initial dose is 100-200mg once daily. The maintenance dose
is 200-600mg/daily. Maximum single dose
is 300 mg. It has rarely been found necessary to exceed 900mg/day.
Should the daily dosage exceed 300mg and
gastrointestinal intolerance be manifested, a divided doses regimen
may be appropriate. The dose should be
adjusted by monitoring serum uric acid and/or urinary uric acid levels
at appropriate intervals until the desired
effect is attained, which may take one to three weeks.
Children under 15 years: 10 to 20 mg/kg body weight/day up to a
maximum of 400mg daily. Use in children is
rarely indicated, except in malignant conditions (especially leukemia)
and certain enzyme disorders such as
Lesch-Nyhan syndrome.
Initiation of therapy: in the early stages of treatment with
Allopurinol, as with the uricosuric agents, an acute
attack of gouty arthritis may be precipitated. Therefore it is
advisable to give a prophylactic dose of a suitable anti-
inflammatory agent or colchicines (0.5mg three times a day) for at
least one month.
Use with uricocurics: As Allopurinol does not interfere with the
action of uricosuric agents, they may be given
concurrently.
When
changing
from
uricosuric
therapy
to
Allopurinol, 1-3
weeks
overlap of
treatments
is
recommended to ensure a continu
ous hypouricaemic effect.
Use