Nevirapine Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nevirapine 200mg (based on 100% assay and nil water content);  

Available from:

Viatris Limited

INN (International Name):

Nevirapine 200 mg (based on 100% assay and nil water content)

Dosage:

200 mg

Pharmaceutical form:

Tablet

Composition:

Active: Nevirapine 200mg (based on 100% assay and nil water content)   Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium starch glycolate

Units in package:

Blister pack, PVC/Alu, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Resistant virus emerges rapidly and uniformly when nevirapine is administered as monotherapy. Therefore, it should always be administered in combination with at least two additional antiretroviral agents.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Alu - 60 tablets - 48 months from date of manufacture stored at or below 25°C. Store in orginal packaging - Bottle, plastic, HDPE - 60 tablets - 48 months from date of manufacture stored at or below 25°C. Store in orginal container

Authorization date:

2009-12-21

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
NEVIRAPINE VIATRIS
_NEVIRAPINE TABLETS 200 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nevirapine Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Nevirapine
Viatris against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT NEVIRAPINE
VIATRIS IS USED FOR
Nevirapine Viatris is used in
combination with other antiretroviral
medicines to slow down the
progression of Human
Immunodeficiency Virus (HIV)
infection. HIV can lead to Acquired
Immunodeficiency Syndrome
(AIDS) and other related illnesses.
Nevirapine Viatris contains the
active ingredient Nevirapine. It
belongs to a group of antiretroviral
medicines called non-nucleoside
reverse transcriptase inhibitors
(NNRTIs). Nevirapine works by
inhibiting or interrupting the enzyme
reverse transcriptase that the HIV
virus uses to multiply.
Nevirapine Viatris does not cure or
prevent HIV infection or AIDS, but it
does hinder the growth of HIV. In
this way it stops ongoing damage to
the body’s immune system, which
fights infection.
Nevirapine Viatris is prescribed in
combination with other antiretroviral
medicines which hinder the growth
of HIV in other ways. When these
medicines are taken with Nevirapine
Viatris, the growth of HIV is
hindered more effectively.
Nevirapine Viatris does not prevent
or reduce your risk of passing HIV
infection to others. You will still be
able to pass on the HIV virus by
sexual activity or by passing on
blood or bodily secretions which
carry the HIV virus. You should
continue to take all appropriate
precautions.
While taking Nevirapine Viatris and
any other therapy for HIV, you may
continue to develop other infections
and other complications

Summary of Product characteristics

Page 1 of 31
NEW ZEALAND DATA SHEET
NEVIRAPINE VIATRIS
1. PRODUCT NAME
Nevirapine Viatris 200 mg tablet, uncoated.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of nevirapine.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nevirapine Viatris 200 mg tablets are white to off-white, oval shaped,
biconvex uncoated tablets,
debossed with “NE 200” with a single bisect separating the
“NE” and “200” on one side and debossed
with “M” with a single bisect separating the “M” on the other
side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Nevirapine Viatris is indicated for use in combination with other
antiretroviral agents for the treatment
of HIV-1 infection in adults.
Resistant virus emerges rapidly and uniformly when nevirapine is
administered as monotherapy.
Therefore, Nevirapine Viatris should always be administered in
combination with at least two
additional antiretroviral agents.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS 16 YEARS AND OLDER_
The recommended dose for Nevirapine Viatris is one 200 mg tablet daily
for the first 14 days (this
lead-in period should be used because it has been found to lessen the
frequency of rash), followed
by one 200 mg tablet twice daily, in combination with at least two
additional antiretroviral agents. For
concomitantly administered nucleoside therapy, the manufacturer's
recommended dosage and
monitoring should be followed.
Patients should be advised of the need to take Nevirapine Viatris
every day as prescribed. If a dose
is missed the patient should not double the next dose but should take
the next dose as soon as
possible.
Page 2 of 31
_MONITORING OF PATIENTS_
Clinical chemistry tests, which include liver function tests, should
be performed prior to initiating
nevirapine therapy and at appropriate intervals during therapy. It is
strongly recommended to monitor
liver function every two to three weeks in the