LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

Cipla Medpro Manufacturing (Pty) Ltd

Dosis:

See ingredients

formulario farmacéutico:

PELLET

Composición:

EACH CAPSULE CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg

Estado de Autorización:

Canceled

Fecha de autorización:

2021-02-06

Información para el usuario

Cipla Medpro (Pty) Ltd
Lopinavir 40 and Ritonavir 10 mg
1.3.2 (Clean PIL)
(Oral pellets)
Version 4
Page 1 of 16
PATIENT INFORMATION LEAFLET FOR
LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS
SCHEDULING STATUS:
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS
(Lopinavir 40 mg and Ritonavir 10 mg)
ORAL PELLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING LOPINAVIR
AND
RITONAVIR CIPLA 40/10 ORAL PELLETS:
•
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
•
IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR PHARMACIST.
•
LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS HAS BEEN
PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD NOT SHARE YOUR MEDICINE
WITH OTHER
PEOPLE. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS
YOURS.
WHAT LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS CONTAIN:
Each capsule of oral pellets contains lopinavir 40 mg and ritonavir 10
mg as active ingredients.
The other ingredients are colloidal silicon dioxide, copovidone,
gelatin capsule, hydroxyl propyl
methylcellulose, PEG-6000, sodium stearyl fumarate, sorbitan
monolaurate and talc.
Capsule ingredients: ammonia solution, black iron oxide, gelatin, iron
oxide yellow, potassium
hydroxide, propylene glycol, purified, shellac, sodium dodecyl sulfate
and titanium dioxide.
Cipla Medpro (Pty) Ltd
Lopinavir 40 and Ritonavir 10 mg
1.3.2 (Clean PIL)
(Oral pellets)
Version 4
Page 2 of 16
Sugar free.
WHAT LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS ARE USED FOR:
LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS are indicated in
combination with
other antiretroviral agents for the treatment of HIV infection.
BEFORE YOU TAKE LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS:
DO NOT TAKE LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS IF:
You are allergic to lopinavir, ritonavir or to any of the other
ingredients of LOPINAVIR AND
RITONAVIR CIPLA 40/10 ORAL PELLETS.
You have severe liver disease.
You are currently taking any of the following medicines:
•
Sedatives s

Ficha técnica

Cipla Medpro (Pty) Ltd
Lopinavir 40 mg and Ritonavir 10 mg
1.3.1.1 (Clean PI)
(Oral pellets)
Version 4
Page 1 of 41
PROPOSED PROFESSIONAL INFORMATION FOR
LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
LOPINAVIR AND RITONAVIR CIPLA 40/10 ORAL PELLETS
(Lopinavir 40 mg and Ritonavir 10 mg)
ORAL PELLETS
COMPOSITION:
Each capsule of oral pellets contains lopinavir 40 mg and ritonavir 10
mg as active ingredients.
List of excipients: colloidal silicon dioxide, copovidone, gelatin
capsule, hydroxyl propyl
methylcellulose, PEG-6000, sodium stearyl fumarate, sorbitan
monolaurate and talc.
Capsule ingredients: ammonia solution, black iron oxide, gelatin, iron
oxide yellow, potassium
hydroxide, propylene glycol, Shellac, sodium dodecyl sulfate and
titanium dioxide.
Sugar free.
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 Anti-viral agents
PHARMACOLOGICAL ACTION:
Cipla Medpro (Pty) Ltd
Lopinavir 40 mg and Ritonavir 10 mg
1.3.1.1 (Clean PI)
(Oral pellets)
Version 4
Page 2 of 41
PHARMACODYNAMIC PROPERTIES:
Lopinavir/ritonavir oral pellets is a co-formulation of lopinavir and
ritonavir. Lopinavir is an
inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in these
oral pellets, ritonavir
inhibits the CYP3A4-mediated metabolism of lopinavir, thereby
resulting in increased plasma
levels of lopinavir.
Inhibition
of
HIV
protease
prevents
cleavage
of
the
_gag-pol_
polyprotein
resulting
in
the
production of immature, non-infectious virus. HIV-1 isolates with
reduced susceptibility to
lopinavir have been selected _in vitro. _The presence of ritonavir
does not appear to influence the
selection of lopinavir resistant viruses _in vitro. _Reduced viral
susceptibility to lopinavir has been
observed in clinical studies.
_Cross-resistance: _
Data obtained from four patients previously treated with one or more
protease inhibitors who
developed increased lopinavir phenotypic resistance during therapy
with lopinavir/ritonavir,
indicated
that
patients
either
remained
cross-resistant
or