KALETRA TABLETS lopinavir 100 mg and ritonavir 25 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lopinavir, Quantity: 100 mg; ritonavir, Quantity: 25 mg

Available from:

Abbvie Pty Ltd

INN (International Name):

Lopinavir,Ritonavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; polyvinyl alcohol; macrogol 3350; purified talc; colloidal anhydrous silica; iron oxide yellow; copovidone; sorbitan monolaurate; sodium stearylfumarate

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KALETRA is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. This indication is based on the analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled clinical studies (see clinical trials).

Product summary:

Visual Identification: Pale yellow, ovaloid, film-coated tablet debossed with Abbott logo and 'KC' on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-02-21

Patient Information leaflet

KALETRA
®
K
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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 KALETRA?
Kaletra contains the active ingredients lopinavir and ritonavir.
Kaletra is used to treat HIV (Human Immunodeficiency Virus) infection.
For more information, see Section 1. Why am I taking Kaletra? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE KALETRA?
Check the list of ingredients at the end of the CMI. Do not take
Kaletra 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
Kaletra? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Kaletra and affect how it works, or
Kaletra 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 KALETRA?
•
Tablets for patients 35 kg and over: Take two (200 mg/50 mg) tablets
together in the morning and two tablets together in the
evening every day, unless your doctor advises otherwise.
•
Oral Solution for patients 35 kg and over: Take 5 mL in the morning
and in the evening every day, unless your doctor advises
otherwise.
•
Oral Solution for Children less than 35 kg: The dose is calculated
based on weight. Your doctor will advise the appropriate dose.
More instructions can be found in Section 4. How do I take Kaletra? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING KALETRA?
THINGS YOU
SHOULD DO
•
Call your doctor straightaway if you become pregnant while taking
Kaletra
•
If you have diabetes, monitor your sugar levels regularly
•
Remind any doctor, dentist or pharmacist you visit that you are ta

Summary of Product characteristics

Kaletra PI
Version 33
7 July 2020
Page 1 of 59
AUSTRALIAN PRODUCT INFORMATION – KALETRA
®
(LOPINAVIR / RITONAVIR) TABLETS AND ORAL SOLUTION
1
NAME OF THE MEDICINE
Lopinavir / Ritonavir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kaletra is a co-formulation of lopinavir and ritonavir.
TABLETS
Kaletra tablets are available for oral administration in a strength of
200 mg of lopinavir and 50
mg of ritonavir with the following inactive ingredients: copovidone,
sorbitan monolaurate,
colloidal anhydrous silica, and sodium stearylfumarate and the
following inactive ingredients
in the film coating: hypromellose, titanium dioxide, macrogol 400,
hyprolose, talc, colloidal
anhydrous silica, macrogol 3350, iron oxide yellow CI 77492, and
polysorbate 80.
Kaletra tablets are also available in a strength of 100 mg of
lopinavir and 25 mg of ritonavir
with the following inactive ingredients: copovidone, sorbitan
monolaurate, colloidal anhydrous
silica, and sodium stearylfumarate and the following inactive
ingredients in the film coating:
polyvinyl alcohol, titanium dioxide, talc, macrogol 3350, iron oxide
yellow CI 77492.
ORAL SOLUTION
Kaletra Oral Solution is available for oral administration as 80 mg
lopinavir and 20 mg ritonavir
per millilitre with the following ingredients: PEG-40 hydrogenated
castor oil, purified water,
sodium chloride, sodium citrate, saccharin sodium, acesulfame
potassium, citric acid, absolute
ethanol, propylene glycol, menthol, povidone, glycerol, high fructose
maize syrup, peppermint
oil, water, Magnasweet Flavour (2x) (ARTG No. 4333), Vanilla natural &
artificial flavour
(Yarnilla) 33869 (ARTG No. 4338) and Artificial cotton candy flavour
(ARTG No. 4381).
Kaletra Oral Solution contains 42.4% alcohol (v/v) and 15.3% propylene
glycol (w/v).
Kaletra PI
Version 33
7 July 2020
Page 2 of 59
3
PHARMACEUTICAL FORM
Kaletra is available as 200 mg lopinavir/50 mg ritonavir tablets and
100 mg lopinavir/25 mg
ritonavir tablets. Kaletra 200/50 mg tablets are yellow, ovaloid,
film-coated tablets debossed
with the Ab