Viramune

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nevirapine 200mg

Available from:

Boehringer Ingelheim (NZ) Ltd

INN (International Name):

Nevirapine 200 mg

Dosage:

200 mg

Pharmaceutical form:

Tablet

Composition:

Active: Nevirapine 200mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium starch glycolate

Units in package:

Blister pack, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim Chemicals Inc.

Therapeutic indications:

Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children over the age of 2 months.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 60 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1996-05-21

Patient Information leaflet

VIRAMUNE CMI0057-17
1
VIRAMUNE
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING VIRAMUNE?
Viramune contains the active ingredient nevirapine. Viramune is used
in the treatment of the infection caused by the Human
Immunodeficiency Virus (HIV-1). For more information, see Section 1.
Why am I taking Viramune? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE VIRAMUNE?
Do not take Viramune if you have ever had an allergic reaction to
nevirapine or any of the ingredients listed at the end of the
CMI. Do not take Viramune if you have rare inherited problems of
galactose or fructose intolerance, severe liver dysfunction or if
you previously experienced serious liver or skin reactions while
taking Viramune.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I take Viramune? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Viramune and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE VIRAMUNE?
Adults 16 years and older:
•
FIRST 14 DAYS: Take one nevirapine 200 mg immediate release tablet or
20 mL Viramune oral suspension once daily.
•
AFTER THE FIRST 14 DAYS: Take one nevirapine 200 mg immediate release
tablet or 20 mL Viramune oral suspension twice daily
(i.e. at regular 12-hour intervals at about the same time each day:
morning and night).
Children (aged 2 months or older) and adolescents to 15 years:
•
Your child's doctor will determine the dose of Viramune based on your
child's age and body weight, or body surface area.
•
FIRST 14 DAYS: Viramune oral suspension is given once daily.
•
AFTER THE FIRST 14 DAYS: Viramune oral suspension is given twice
daily.
More instructions c

Summary of Product characteristics

VIRAMUNE NZ DS v02
1
NEW ZEALAND DATASHEET
1. PRODUCT NAME
VIRAMUNE 50 mg/5 mL oral suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
VIRAMUNE 50 mg/5 mL oral suspension contains 10 mg nevirapine per mL
(in the form of 10.35
mg/mL of nevirapine hemihydrate).
Excipients with known effect:
Each mL of oral suspension contains 150 mg sucrose, 162 mg sorbitol,
1.8 mg of methyl
hydroxybenzoate and 0.24 mg of propyl hydroxybenzoate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension
White to off white homogenous suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VIRAMUNE is indicated for use in combination with other antiretroviral
agents for the treatment of
HIV-1 infection in adults and children over the age of 2 months.
Resistant virus emerges rapidly and uniformly when VIRAMUNE is
administered as monotherapy.
Therefore, VIRAMUNE should always be administered in combination with
at least two additional
antiretroviral agents.
4.2 DOSE AND METHOD OF ADMINISTRATION
Patients 16 years and older
The recommended dose for VIRAMUNE is 20 mL (200 mg) oral suspension
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 20 mL oral suspension twice daily, in combination with at
least two additional
antiretroviral agents. VIRAMUNE can be taken with or without food. For
concomitantly administered
nucleoside therapy, the manufacturer's recommended dosage and
monitoring should be followed.
Paediatric Patients
The total daily dose should not exceed 400 mg of VIRAMUNE. VIRAMUNE
may be dosed in
paediatric patients either by body surface area (BSA) or by body
weight as follows:
By BSA using the Mosteller formula the recommended oral dose for
paediatric patients of all ages
is 150 mg/m
2
once daily for two weeks followed by 150 mg/m
2
twice daily thereafter.
Calculation of the volume of VIRAMUNE oral suspension (50 mg/5 ml)
required for paediatric dosing
on a body surface basis of 150 mg/m
2
:
VIRAMUNE