Lemitat 500mcg 500 mcg

Country: Jordan

Language: English

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

Active ingredient:

Roflumilast 500 mcg

Available from:

الشركة المتحدة لصناعة الأدوية - United Pharmaceutical Manufacturing Co. Ltd.

ATC code:

R03DX07

INN (International Name):

Roflumilast 500 mcg

Dosage:

500 mcg

Units in package:

30

Manufactured by:

UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN (الاردن)

Product summary:

39.34 :سعر الجمهور + الضريبة

Patient Information leaflet

THIS MEDICINE IS SUBJECT TO ADDITIONAL MONITORING. THIS
will allow quick identification of new safety information.
You can help by reporting any side effects you may get.
DESCRIPTION:
LEMITAT
®
“Roflumilast” belongs to a group of medicines called
‘phosphodiesterase type 4 (PDE4) inhibitors’. It blocks the action
of
the PDE4 enzyme, which is involved in the inflammation process that
leads to COPD. By blocking the action of PDE4, roflumilast reduces the
inflammation in the lungs, helping to reduce the patient’s symptoms
or
to prevent them from getting worse.
PROPERTIES:
ABSORPTION:
The absolute bioavailability of roflumilast following a 500 micrograms
oral dose is approximately 80%. Maximum plasma concentrations of
roflumilast typically occur approximately one hour after dosing
(ranging
from 0.5 to 2 hours) in the fasted state. Maximum concentrations of
the
N-oxide metabolite are reached after about eight hours (ranging from
4 to 13 hours). Food intake does not affect the total PDE4 inhibitory
activity, but delays time to maximum concentration (tmax) of
roflumilast
by one hour and reduces Cmax by approximately 40%. However, Cmax
and tmax of roflumilast N-oxide are unaffected.
DISTRIBUTION:
Plasma protein binding of roflumilast and its N-oxide metabolite is
approximately 99% and 97%, respectively. Volume of distribution for
single dose of 500 micrograms roflumilast is about 2.9 l/kg. Due to
the
physicochemical properties, roflumilast is readily distributed to
organs
and tissues including fatty tissue of mice, hamster and rat. There is
no
evidence for a specific accumulation or retention of roflumilast or
its
metabolites in organs and fatty tissue.
Metabolism:
Roflumilast is extensively metabolised via Phase I (cytochrome P450)
and Phase II (conjugation) reactions. The N-oxide metabolite is the
major metabolite observed in the plasma of humans.
ELIMINATION:
The plasma clearance after short term intravenous infusion of
roflumilast
is about 9.6 l/h. Following an oral dose, the median plasma effective
half li