NIMEGEN SOFT CAPSULE

Country: Malaysia

Language: English

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

Active ingredient:

ISOTRETINOIN

Available from:

THE ZYFAS MEDICAL CO.,

INN (International Name):

ISOTRETINOIN

Units in package:

30Capsule Capsules

Manufactured by:

R.P. SCHERER KOREA LTD

Summary of Product characteristics

128x270
NIMEGEN SOFT CAPSULE
(LSOTRETINOIN)
DESCRIPTION
NIMEGEN Capsules are light purple, oval and soft. They come in a white
opaque blister of 10 capsules; 3 such
blisters in a printed box with a package insert.
COMPOSITION
Each capsule contains: lsotretinoin 10mg, Methyl parahydroxybenzoate
0.18mg and Propyl parahydroxybenzoate
0.07mg.
PHARMACOLOGICAL ACTION
lsotretinoin is an orally active retinoic acid derivative for the
treatment of severe refractory nodulocystic acne. The
pharmacological profile of the isotretinoin suggests that it acts
primarily by reducing sebaceous gland size and
sebum production, and as a result alters skin surface lipid
composition. Bacterial skin microflora is reduced,
probably as a result of decreased sebum secretion.
PHARMACOKINETICS
Time-related blood concentrations can be predicted on the basis of
linear pharmacokinetics.
ABSORPTION
Peak plasma concentrations (C max) of approximately 250mg/ml have been
achieved in healthy volunteers and in
patients with cystic acne one to four hours (t max) alter
administration of 80-100mg isotretinoin. Taking isotretinoin
with food increases bioavailability up to two fold relative to fasting
conditions, probably as a result of easier
absorption of this highly lipophilic medication. Furthermore, there
was an overall decrease in fluctuations in
systemic availability when isotretinolin is ingested with food.
DISTRIBUTION
Isotretinoin is extensively bound to plasma proteins (99.9%), with the
results that the free active fraction of the drug
is less than 0.1% of the total over a wide range of therapeutic
concentrations. Albumin appears to be the major
binding protein. The volume of distribution of isotretinoin is not
known in man since it is not available as an
intravenous preparation.
Isotretinoin crosses the placental barrier in amounts that lead to
congenital deformities. Owing to its lipophilicity,
there is a high probability that isotretinoin is excreted into the
breast milk. It is therefore contraindicated in nursing
mothers.
METABOLISM
The maj