Lopimune Tablets 20050 mg (Lopinavir and Ritonavir Tablets 20050 mg)

Land: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

RITONAVIR; LOPINAVIR

Fáanlegur frá:

CIPLA MALAYSIA SDN BHD

INN (Alþjóðlegt nafn):

RITONAVIR; LOPINAVIR

Einingar í pakka:

Container containing 120 tablet each Tablets

Framleitt af:

CIPLA LTD

Upplýsingar fylgiseðill

24 March 2021
MY-CIPLA/RA/0321(13)
National Pharmaceutical Regulatory Agency
Lot 36, Jalan Universiti,
46200 Petaling Jaya,
Selangor.
Dear Sir / Madam,
LETTER OF COMMITMENT – SUBMISSION OF PIL / RIMUP
LOPIMUNE TABLETS 200/50 MG (LOPINAVIR AND RITONAVIR 200/50 MG)
MAL12020021AZ
We commit to submit PIL / RiMUP for above mentioned product to
Pharmacovigilance Section, Centre
of Compliance and Quality Control (PKKK) for approval.
Sincerely,
GIAM WEI LI
DEPUTY MANAGER – REGULATORY AFFAIRS
[e-mail]

Vara einkenni

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for Specialist _
_Use only_
_ _
_ _
LOPIMUNE TABLETS 200/50MG
Lopinavir and Ritonavir Tablets 200/50 mg
COMPOSITION
Each film coated tablet contains:
Lopinavir USP… .................... 200 mg
Ritonavir USP… ............... 50 mg
DESCRIPTION
Yellow coloured, capsule shaped, film coated tablets debossed with
“LRT” on one side and plain on
other side.
DOSAGE FORM
Film coated Tablets
PHARMACOLOGY
_PHARMACODYNAMICS _
Pharmaco-therapeutic group: antivirals for systemic use, antivirals
for treatment of HIV infections,
combinations, ATC code: J05AR10
Mechanism of action
Lopinavir provides the antiviral activity of lopinavir/ritonavir
tablets. Lopinavir is an inhibitor of the
HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents
cleavage of the
_gag-pol _
polyprotein
resulting in the production of immature, non-infectious virus.
Effects on the electrocardiogram
QTcF interval was evaluated in a randomised, placebo and active
(moxifloxacin 400 mg once daily)
controlled crossover study in 39 healthy adults, with 10 measurements
over 12 hours on Day 3. The
maximum mean (95% upper confidence bound) differences in QTcF from
placebo were 3.6 (6.3) and
13.1(15.8)
for
400/100
mg
twice
daily
and
supratherapeutic
800/200
mg
twice
daily
LPV/r,
respectively.
The
induced
QRS
interval
prolongation
from
6
ms
to
9.5
ms
with
high
dose
lopinavir/ritonavir (800/200 mg twice daily) contributes to QT
prolongation. The two regimens
resulted in exposures on Day 3 which were approximately 1.5 and 3-fold
higher than those observed
with recommended once-daily or twice-daily LPV/r doses at steady
state. No subject experienced an
increase in QTcF of ≥ 60 ms from baseline or a QTcF interval
exceeding the potentially clinically
relevant threshold of 500 ms.
Modest prolongation of the PR interval was also noted in subjects
receiving lopinavir/ritonavir in the
same study on Day 3. The mean changes from baseline in PR interval
ranged from 11.6 ms to