Neurotop Retard tab 600 mg

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Carbamazepine 600 mg

Available from:

مستودع أدويـة الكردي - Kurdi Drug Store

ATC code:

N03AF01

INN (International Name):

Carbamazepine 600 mg

Dosage:

600 mg

Units in package:

50

Manufactured by:

G.L Pharma GmbH (النمسا)

Product summary:

14.57 :سعر الجمهور + الضريبة

Patient Information leaflet

ACTIVE INGREDIENT: Carbamazepine
REG. NO. (AUSTRIA):
200 mg: 1-17282
300 mg: 1-18147
600 mg: 1-18146
WHAT IS IN NEUROTOP 200 MG TABLETS?
1 tablet contains:
carbamazepine
200 mg
Other
ingredients:
lactose,
corn
starch,
gelatine,
sodium
starch
glycolate,
talc,
magnesium stearate.
WHAT IS IN NEUROTOP RETARD 300 MG TABLETS?
1 prolonged-release tablet contains:
carbamazepine
300 mg
Other
ingredients:
Eudragit
(RS
PM
and
L 30D), colloidal anhydrous silica, magnesium
stearate,
talcum,
sodium
starch
glycolate,
microcrystalline cellulose.
WHAT IS IN NEUROTOP RETARD 600 MG TABLETS?
1 prolonged-release tablet contains:
carbamazepine
600 mg
Other
ingredients:
Eudragit
(RS
PM
and
L 30D), colloidal anhydrous silica, magnesium
stearate,
talcum,
sodium
starch
glycolate,
microcrystalline cellulose.
DOSAGE FORM:
200 mg: Tablets
300 and 600 mg: Prolonged-release Tablets
PACKAGE SIZES: 50 and 100 tablets
HOW DOES NEUROTOP WORK?
Absorption
Carbamazepine
is
absorbed
almost
completely
from
the
tablets
and
relatively
slowly
depending
on
the
dosage
form:
following a single dose, tmax is attained after
12 (tablets) or 24 hours (prolonged-release
tablets).
Bioavailability:
The
bioavailability
of
carba-
mazepine
following
administration
of
the
tablets is almost 100%; with the prolonged-
release tablets it is approximately 15% lower.
Food intake has no effect on bioavailability.
Plasma concentrations: The C
max
of carba-
mazepine following a single dose of 400 mg
(tablets) is approx. 4.5 µg/ml.
With
the
prolonged-release
tablets
there
was
a
statistically
significant
reduction
in
fluctuation index and C
max
at steady state,
and a non·significant reduction in C
min
. The
plasma
concentration
in
the
„therapeutic
range“ at steady state is approx. 4–12 µg/ml,
equivalent to 17–50 µmol/litre carbamazepine;
the
concentration
of
carbamazepine-10,11-
epoxide (pharmacologically active metabolite)
is
approx.
30%
of
the
carbamazepine
concentration.
Steady-state plasma concentrations of carba-
mazepine
are
reached
within
1–2
weeks,
depending