NORVIR ritonavir 100 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ritonavir, Quantity: 100 mg

Available from:

Abbvie Pty Ltd

INN (International Name):

Ritonavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 3350; macrogol 400; sodium stearylfumarate; titanium dioxide; calcium hydrogen phosphate; sorbitan monolaurate; copovidone; hyprolose; purified talc; polysorbate 80; hypromellose; colloidal anhydrous silica

Administration route:

Oral

Units in package:

60, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Norvir (ritonavir) is indicated for use in combination with appropriate antiretriviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of HIV-1 infection in adults and children aged 12 years and older. For persons with advanced HIV disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and AIDS defining clinical events for patients who received ritonavir. Median duration of follow-up in this study was 6 months. The clinical benefit from ritonavir for longer periods of treatment is unknown. For persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks in duration ( see CLINICAL TRIALS).

Product summary:

Visual Identification: White to off-white film coated ovaloid tablets debossed with NK on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-11-30

Patient Information leaflet

NORVIR
®
N
O
R
V
I
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING NORVIR?
Norvir contains the active ingredient ritonavir. Norvir is used to
treat HIV (Human Immunodeficiency Virus) infection.
For more information, see Section 1. Why am I taking Norvir? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE NORVIR?
Check the list of ingredients at the end of the CMI. Do not take
Norvir if you have ever had an allergic reaction to any of them.
TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS NOT
AWARE THAT 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
Norvir? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Norvir and affect how it works, or
Norvir may interfere with other medicines and affect how they
work.
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 NORVIR?
•
Take six tablets, all together, in the morning and six tablets, all
together, in evening every day
•
Take Norvir during a meal or immediately after a meal.
More instructions can be found in Section 4. How do I take Norvir? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING NORVIR?
THINGS YOU
SHOULD DO
•
If you have diabetes, monitor your sugar levels regularly
•
Remind any doctor, dentist, or pharmacist you visit that you are
taking Norvir.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine, or change the dose unless your
doctor tells you to.
•
Do not give this medicine to a child younger than 12 years of age.
DRIVING
OR USING
MACHINES
•
There is no specific information on the effect of Norvir on your
ability to drive or use machines.
DRINKING
ALCOHOL
•
There is no information on the effects of taking Norvir

Summary of Product characteristics

Norvir PI
Version 36
7
July
2020
Page 1 of 47
AUSTRALIAN PRODUCT INFORMATION – NORVIR
®
RITONAVIR
1
NAME OF THE MEDICINE
Ritonavir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Norvir film coated tablets are available for oral administration in a
strength of 100mg ritonavir with
the following inactive ingredients: copovidone, calcium hydrogen
phosphate, sorbitan monolaurate,
colloidal anhydrous silica, and sodium stearylfumarate. The following
are the ingredients in the film
coating:
hypromellose,
titanium
dioxide,
macrogol
400,
hydroxypropylcellulose,
purified
talc,
macrogol 3350, colloidal anhydrous silica, and polysorbate 80.
3
PHARMACEUTICAL FORM
Norvir tablets are white film-coated oval tablets debossed with the
corporate Abbott
logo and the
Abbott-Code “NK” providing 100 mg ritonavir.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Norvir is indicated for use in combination with appropriate
antiretroviral agents or as monotherapy if
combination therapy is inappropriate, for the treatment of HIV-1
infection in adults and children aged
12 years and older.
For persons with advanced HIV disease, the indication for ritonavir is
based on the results for one
study that showed a reduction in both mortality and AIDS defining
clinical events for patients who
received ritonavir. Median duration of follow-up in this study was 6
months. The clinical benefit from
ritonavir for longer periods of treatment is unknown. For persons with
less advanced disease, the
indication is based on changes in surrogate markers in controlled
trials of up to 16 weeks duration
(see 5.1 PHARMACODYNAMIC PROPERTIES).
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL DOSING GUIDELINES
Prescribers should consult the full product information and clinical
study information of protease
inhibitors (PIs) if they are co-administered with a reduced dose of
ritonavir.
Norvir PI
Version 36
7
July
2020
Page 2 of 47
The recommended dose of Norvir tablets is 600 mg (six tablets) twice
daily by mouth and should be
given with food.
Norvir tablets should be