NEVIRAPINE RBX nevirapine 200 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nevirapine, Quantity: 200 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Nevirapine

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; povidone; colloidal anhydrous silica; sodium starch glycollate type A; lactose monohydrate; microcrystalline cellulose

Administration route:

Oral

Units in package:

14, 60, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Nevirapine in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and adolescents over the age of 16 years.,Resistant virus emerges rapidly when Nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Product summary:

Visual Identification: White to off-white, oval-shaped, uncoated tablets with a break line on both sides and debossed with 'RX921' on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-11-07

Summary of Product characteristics

NEVIRAPINE RBX PI V9 Sep 2013
Page 1 of 33
PRODUCT INFORMATION
NEVIRAPINE RBX
Nevirapine 200 mg Tablets
NAME OF THE MEDICINE
Nevirapine
Structural formula:
Molecular Formula:
C
15
H
14
N
4
O
Chemical Name:
11-Cyclopropyl-4-methyl-5,11-dihydro-6H-dipyrido[3,2-b:2’,3’-
e][1,4]diazepin-6-one
Molecular Weight: 266.3
CAS Number: 129618-40-2
DESCRIPTION
Nevirapine is a non-nucleoside reverse transcriptase inhibitor with
activity against Human
Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is a white to almost
white powder with
a pKa of 2.8. It is practically insoluble in water, sparingly soluble
or slightly soluble in
methylene chloride, and slightly soluble in methanol.
NEVIRAPINE RBX immediate-release tablets contain 200 mg of nevirapine
and the inactive
ingredients lactose, microcrystalline cellulose, povidone, sodium
starch glycollate type A,
colloidal anhydrous silica and magnesium stearate.
PHARMACOLOGY
MECHANISM OF ACTION
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of HIV-1. Nevirapine
binds directly to reverse transcriptase (RT) and blocks the
RNA-dependent and DNA-
NEVIRAPINE RBX PI V9 Sep 2013
Page 2 of 33
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 RT and eukaryotic DNA polymerases (such as human DNA polymerases

or

) are
not inhibited by nevirapine.
In clinical studies, nevirapine has been associated with an increase
in HDL-cholesterol and an
overall improvement in the total to HDL-cholesterol ratio. However, in
the absence of
specific studies with nevirapine on modifying the cardiovascular risk
in HIV infected
patients, the clinical impact of these findings is not known. The
selection of antiretroviral
drugs must be guided primarily by their antiviral efficacy.
MICROBIOLOGY
_IN VITRO _HIV SUSCEPTIBILITY
The _in vitro _antiviral activity of nevirapine has been measured in a
variety of cell lines
includin