APREPITANT LUPIN aprepitant 40 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aprepitant, Quantity: 40 mg

Available from:

Southern Cross Pharma Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: iron oxide yellow; hypromellose; poloxamer; sucrose; Gelatin; sodium lauryl sulfate; titanium dioxide; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aprepitant in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy.,? moderately emetogenic cancer chemotherapy,Aprepitant is indicated for the prevention of postoperative nausea and vomiting.

Product summary:

Visual Identification: opaque hard gelatin capsules with a yellow cap and white body, printed with 40mg on the body; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-03

Patient Information leaflet

APREPITANT SCP/102018/CMI-00
1
APREPITANT SCP
_contains the active ingredient aprepitant _
_ _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about APREPITANT SCP.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking APREPITANT SCP
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What APREPITANT SCP is
used for
CHEMOTHERAPY INDUCED
NAUSEA AND VOMITING
APREPITANT SCP, in combination
with other medicines, is used to
prevent nausea (feeling sick) and
vomiting associated with cancer
chemotherapy.
POST-OPERATIVE NAUSEA AND
VOMITING
APREPITANT SCP is used to prevent
nausea (feeling sick) and vomiting
which can occur after surgery.
APREPITANT SCP belongs to a group
of medicines called neurokinin 1
(NK1) receptor antagonists. It
works by blocking the actions of
substances in your brain, called
substance P neurokinins, that
cause nausea and vomiting.
APREPITANT SCP is available only
with a doctor's prescription.
Your doctor may have prescribed
APREPITANT SCP for another
reason.
Ask your doctor if you have any
questions about why APREPITANT
SCP has been prescribed for you.
The safety and effectiveness of
APREPITANT SCP in children and
teenagers under the age of 18
years have not been established.
APREPITANT SCP is not addictive.
Before you take
APREPITANT SCP
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE APREPITANT SCP IF
YOU HAVE AN ALLERGY TO
APREPITANT SCP OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THE LEAFLET.
DO NOT TAKE APREPITANT SCP IF
YOU ARE TAKING:
•
cisapride, used to treat stomach
reflux
•
pimozide, used to treat psychotic
•
conditions
•
terfenadine (Teldane*) and
astemizole (Hismanal*),
antihistamines used for allergic
conditions, inclu

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
APREPITANT SCP, (APREPITANT) CAPSULES
_ _
1. NAME OF THE MEDICINE
Aprepitant
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule of APREPITANT SCP for oral administration contains 40 mg,
80 mg, 125 mg or 165 mg of
aprepitant.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
APREPITANT SCP is available in a 40mg, 80mg, 125mg and 165mg capsule.
The APREPITANT SCP 40 mg capsules are opaque hard gelatin capsules
with a yellow cap and white body,
printed with “40mg” on the body.
The APREPITANT SCP 80 mg capsules are opaque hard gelatin capsules
with a white cap and white body,
printed with “80mg” on the body.
The APREPITANT SCP 125 mg capsules are opaque hard gelatin capsules
with a pink cap and white body,
printed with “125mg” on the body.
The APREPITANT SCP 165 mg capsules are opaque hard gelatin capsules
with a blue cap and white body,
printed with “165mg” on the body.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
APREPITANT SCP, in combination with other antiemetic agents, is
indicated for the prevention of acute and
delayed nausea and vomiting associated with initial and repeat courses
of:
•
highly emetogenic cancer chemotherapy.
•
moderately emetogenic cancer chemotherapy
APREPITANT SCP is indicated for the prevention of postoperative nausea
and vomiting.
4.2. DOSE AND METHOD OF ADMINISTRATION
GENERAL INFORMATION
APREPITANT SCP may be taken with or without food. It is recommended
that APREPITANT SCP 165 mg be
taken with or without a light (low fat) meal, as administration with a
high fat meal results in a 47% increase in
systemic exposure of aprepitant see Section 5.2 PHARMACOKINETICS
PROPERTIES.
No dosage adjustment is necessary based on age, gender or race.
No
dosage
adjustment
is
necessary
for
patients
with
severe
renal
insufficiency
(creatinine
clearance
<30 mL/min) or for patients with end stage renal disease undergoing
haemodialysis.
APREPITANT SCP – AUSTRALIAN PRODUCT INFORMATION
2
No dosage adjustm