Aprepitant 80mg capsules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Aprepitant

Dostupno od:

A A H Pharmaceuticals Ltd

ATC koda:

A04AD12

INN (International ime):

Aprepitant

Doziranje:

80mg

Farmaceutski oblik:

Oral capsule

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04060000

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aprepitant Zentiva 80mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80 mg capsule contains 80mg of aprepitant.
Excipient with known effect
Each 80mg capsule contains 80 mg of sucrose and 0.00022 mmol (0.005
mg)
of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule (capsule)
The 80mg hard capsules are presented as opaque hard gelatin capsules
of size No 2,
with a white cap and white body, imprinted in black ink with
“80mg” on the body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of nausea and vomiting associated with highly and
moderately emetogenic
cancer chemotherapy in adults and adolescents from the age of 12.
Aprepitant 125mg/80 mg is given as part of combination therapy (see
section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Aprepitant is given for 3 days as part of a regimen that includes a
corticosteroid and a
5-HT3 antagonist.
The recommended dose is 125mg orally once daily one hour before start
of
chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in
the morning.
The following regimens are recommended in adults for the prevention of
nausea and
vomiting associated with emetogenic cancer chemotherapy:
_Highly Emetogenic Chemotherapy Regimen _
Day 1
Day 2
Day 3
Day 4
Aprepitant
125mg
orally
80mg
orally
80mg
orally
none
Dexamethasone
12mg orally
8mg orally
8mg orally
8mg orally
5-HT
3
antagonists
Standard
dose of
5-HT
3
antagonists.
See the
product
information
for selected
5-HT
3
antagonist
for
appropriate
dosing
information
None
None
None
Dexamethasone should be administered 30 minutes prior to chemotherapy
treatment
on Day 1 and in the morning on Day 2 to 4. The dose of dexamethasone
accounts for
active substance interactions.
_Moderately Emetogenic Chemotherapy Regimen _
Day 1
Day 2
Day 3
Aprepitant
125mg orally
80mg orally
80mg orally
Dexamethasone
12mg orally
None
None
5-HT
3
antagonists
Standard dose of
5-HT
3
antagon