NEVIREX (Nevirapine Oral suspension 50mg5ml)

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

NEVIRAPINE HEMIHYDRATE

Dostępny od:

UNIMED SDN BHD

INN (International Nazwa):

NEVIRAPINE HEMIHYDRATE

Sztuk w opakowaniu:

240 ml; 100 ml

Wyprodukowano przez:

Aurobindo Pharma Limited (Unit III),

Charakterystyka produktu

(For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory)
NEVIREX (NEVIRAPINE ORAL SUSPENSION 50MG/5ML)
(Nevirapine 50mg/5ml)
COMPOSITION:
Each 5 ml contains: Nevirapine USP as Nevirapine hemihydrate 50mg/5ml
Methyl paraben as preservative 9 mg
Propylparaben as preservative 1.2 mg
DOSAGE FORM:
Powder for oral suspension
DESCRIPTION:
White to off white homogenous suspension.
PHARMACODYNAMICS & PHARMACOKINETICS:
PHARMACODYNAMICS:
PHARMACOTHERAPEUTIC GROUP:
antiviral agent, ATC code J05A G01.
_MECHANISM OF ACTION _
Nevirapine is a NNRTI of HIV-1. Nevirapine binds directly to reverse
transcriptase and blocks the RNA-dependent
and DNA-dependent DNA polymerase activities by causing a disruption of
the enzyme's catalytic site. The activity
of nevirapine does not compete with template or nucleoside
triphosphates. HIV-2 reverse transcriptase and
eukaryotic DNA polymerases (such as human DNA polymerases α, β, γ,
or δ) are not inhibited by nevirapine.
RESISTANCE
HIV isolates with reduced susceptibility (100 to 250-fold) to
nevirapine emerge in vitro. Phenotypic and genotypic
changes occur in HIV isolates from patients treated with Nevirapine or
Nevirapine + zidovudine over one to 12
weeks. By week 8 of Nevirapine monotherapy, 100 % of the patients
tested had HIV isolates with a >100-fold
decrease in susceptibility to nevirapine, regardless of dose.
Nevirapine + zidovudine combination therapy did not
alter the emergence rate of nevirapine-resistant virus. Genotypic and
phenotypic resistance was examined for
patients receiving Nevirapine in triple and double therapy drug
combination therapy, and in the non- Nevirapine
comparative group from the INCAS study. Antiretroviral naive subjects
with CD4 cells counts of 200-600/mm3
were treated with either Nevirapine + zidovudine (n = 46), zidovudine
+ didanosine (n = 51) or Nevirapine +
zidovudine + didanosine (n = 51) and followed for 52 weeks or longer
on therapy. Virologic evaluations were
performed at baseline, six months and 12 months. The phenoty