CIPLA-ZIDOVUDINE CAPSULES

देश: दक्षिण अफ़्रीका

भाषा: अंग्रेज़ी

स्रोत: South African Health Products Regulatory Authority (SAHPRA)

थमां उपलब्ध:

Cipla Medpro (Pty) Ltd

डोज़:

See ingredients

फार्मास्यूटिकल फॉर्म:

CAPSULES

रचना:

EACH CAPSULE CONTAINS ZIDOVUDINE 100,0 mg

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2003-01-11

सूचना पत्रक

Page 1 of 15
REGISTERED PATIENT INFORMATION FOR CIPLA-ZIDOVUDINE:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine 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.
SCHEDULING STATUS:
S4
PROPRIETARY NAME (AND DOSAGE FORM):
CIPLA-ZIDOVUDINE (Capsules)
COMPOSITION OF THE MEDICINE, THAT IS, WHAT THIS MEDICINE
CONTAINS:
The active substance is zidovudine 100 mg per capsule.
CIPLA-ZIDOVUDINE (Capsules) _contain_:
Preservative: Bronopol 0.011 % m/m. The other ingredients are
microcrystalline cellulose, sodium starch glycollate, magnesium
stearate,
maize starch, magnesium stearate, colloidal silicon dioxide, purified
talc,
gelatin, povidone, sodium lauryl sulphate and titanium dioxide.
Page 2 of 15
APPROVED INDICATION AND USE, THAT IS, WHAT IS THIS MEDICINE
USED FOR:
CIPLA-ZIDOVUDINE (Capsules) are used in combination with other
antiretroviral agents for the treatment of human immunodeficiency
virus (HIV)
infection in adults, children and mothers who are not breast-feeding
and for
the prophylaxis of maternal-foetal HIV transmission in HIV positive
pregnant
women of over 14 week gestation and their own newborn infants.
INSTRUCTIONS BEFORE YOU TAKE CIPLA-ZIDOVUDINE (CAPSULES):
Tell your doctor if you have ever had any unusual or allergic reaction
to
zidovudine. Also tell your health care professional if you are
allergic to any
other substances, such as foods, preservatives, or dyes.
CIPLA-ZIDOVUDINE (Capsules) can cause serious side-effects in any
patient. Therefore, it is especially important that you discuss with
your child's
doctor the good that this medicine may do as well as the risk of using
it. Your
child must be carefully followed, and frequently seen, by the doctor
while he or
she is taking zidovudine.
DO NOT TAKE CIPLA-ZIDOVUDINE (C

उत्पाद विशेषताएं

Page 1 of 17
REGISTERED PACKAGE INSERT FOR CIPLA-ZIDOVUDINE:
SCHEDULING STATUS:
S4
PROPRIETARY NAME (AND DOSAGE FORM):
CIPLA-ZIDOVUDINE (Capsules)
COMPOSITION:
Each capsule contains zidovudine 100 mg.
Preservative: Bronopol 0.011 % m/m.
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 Antiviral agents.
PHARMACOLOGICAL ACTION:
Zidovudine, a thymidine nucleoside analogue, is an antiviral medicine
with _in_
_vitro_ activity against retroviruses, such as the human
immunodeficiency virus
(HIV) and the Human T lymphotropic virus (HTLV)-I. Following diffusion
into
both infected and uninfected host cells, zidovudine is phosphorylated
to the
monophosphate derivative by cellular thymidine kinase. The
phosphorylation
of zidovudine-monophosphate to the diphosphate derivative and to the
zidovudine-triphosphate is in turn catalysed by cellular thymidylate
kinase and
unspecific kinases, respectively.
Page 2 of 17
Zidovudine-triphosphate is a competitive inhibitor of, and a substrate
for,
reverse transcriptase with respect to the thymidine triphosphate (TTP)
nucleotide. The incorporation of zidovudine-triphosphate into the
proviral DNA
chain blocks further chain formation and results in chain termination.
Zidovudine-triphosphate has greater affinity (approximately 100-fold)
for HIV
reverse transcriptase than for human DNA polymerase alpha.
Combination therapy with lamivudine:
Zidovudine monotherapy leads to development of _in vitro_ and _in
vivo_
resistance to zidovudine.
Zidovudine has been shown to act additively or synergistically with
other anti-
HIV agents, inhibiting the replication of HIV in cell culture.
Additive or synergistic activity in cell culture has been demonstrated
in
medicine combination studies of zidovudine with indinavir,
zalcitabine,
didanosine, delaviridine, lamivudine, saquinavir, ritonavir,
nevirapine, and
interferon-alpha.
_In vitro_ studies indicate that zidovudine-resistant virus isolates
can become
zidovudine-sensitive when they acquire resistance to lamivudine.
PHARMACOKINETICS:
Zidovudine is well absorbed