APREPITANT ARX aprepitant 80 mg & 125 mg tri-pack capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aprepitant, Quantity: 80 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule

Composition:

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

Administration route:

Oral

Units in package:

2x 80 mg & 1x 125 mg

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 white cap and white body, printed with 80 mg 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:

2019-06-11

Patient Information leaflet

APREPITANT APOTEX
_aprepitant_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
_CHEMOTHERAPY INDUCED_
_NAUSEA AND VOMITING_
Aprepitant, in combination with
other medicines, is used to prevent
nausea (feeling sick) and vomiting
associated with cancer
chemotherapy.
_POST-OPERATIVE NAUSEA AND_
_VOMITING_
Aprepitant is used to prevent nausea
(feeling sick) and vomiting which
can occur after surgery.
Aprepitant 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
aprepitant.
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING:
•
cisapride, used to treat stomach
ref

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APREPITANT APOTEX
CAPSULES (APREPITANT)
1
NAME OF THE MEDICINE
Aprepitant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aprepitant is a substance P neurokinin 1 (NK1) receptor antagonist.
Aprepitant is a white to off-white crystalline solid. It is
practically insoluble in water. Aprepitant is
sparingly soluble in ethanol and isopropyl acetate and slightly
soluble in acetonitrile.
Each capsule of APREPITANT APOTEX for oral administration contains 40
mg, 80 mg, 125 mg
or 165 mg of aprepitant.
Excipient with known effect:
Each 40 mg capsule contains 40 mg of sucrose.
Each 80 mg capsule contains 80 mg of sucrose.
Each 125 mg capsule contains 125 mg of sucrose.
Each 165 mg capsule contains 165 mg of sucrose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APREPITANT APOTEX is available in a 165 mg, 125 mg, 80 mg and 40 mg
capsule.
The 165 mg capsules are
presented as opaque hard gelatin capsules with a blue cap and white
body, printed with “165mg” on the body.
The 125 mg capsules are
presented as opaque hard gelatin capsules with a pink cap and white
body, printed with “125mg” on the body.
The 80 mg capsules are
presented as opaque hard gelatin capsules with a white cap and white
body, printed with “80mg” on the body
.
The 40 mg capsules are
presented as opaque hard gelatin capsules with a yellow cap and
white body, printed with “40mg” on the body
.
4
CLINICAL PARTICULARS
4.1 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.
2
4.2 DOSE AND METHOD OF ADMINISTRATION
_PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV) _
Aprepitant is given for 1 day or 3 days as part of a regimen that
includes a corticos