APO-MIRTAZAPINE mirtazapine 15 mg tablet bottle

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

mirtazapine, Quantity: 15 mg

Dostupné s:

Arrotex Pharmaceuticals Pty Ltd

INN (Mezinárodní Name):

Mirtazapine

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: hypromellose; hyprolose; croscarmellose sodium; titanium dioxide; lactose monohydrate; macrogol 8000; iron oxide yellow; microcrystalline cellulose; magnesium stearate

Podání:

Oral

Jednotky v balení:

30 tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Treatment of major depression including relapse prevention

Přehled produktů:

Visual Identification: Pale yellow, oval shaped, scored, film coated tablets, imprinted "APO" on one side and "MI" bisect "15" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizace:

Registered

Datum autorizace:

2007-08-14

Charakteristika produktu

1
AUSTRALIAN PRODUCT INFORMATION
APO-MIRTAZAPINE (MIRTAZAPINE) TABLETS
NAME OF THE MEDICINE
Mirtazapine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15, 30 or 45 mg mirtazapine (as mirtazapine
hemihydrate).
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
APO-MIRTAZAPINE 15 MG TABLETS
Pale Yellow, oval shaped, scored, film coated tablets, imprinted
“APO” on one side and “MI”
bisect “15” on the other side.
APO-MIRTAZAPINE 30 MG TABLETS
Light pink, oval shaped, scored, film coated tablets, imprinted
“APO” on one side and “MI”
bisect “30” on the other side.
APO-MIRTAZAPINE 45 MG TABLETS
White to off-white, oval shaped, unscored, film coated tablets,
imprinted “APO” on one side
and “MI-45” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression including relapse prevention.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Mirtazapine Tablets are intended for oral administration.
Mirtazapine should be taken orally, if necessary with fluid, and
swallowed without chewing.
DOSAGE
ADULTS – Treatment should begin with 15 mg daily. The dosage
generally needs to be
increased to obtain an optimal clinical response. The effective daily
dose is usually between
30 and 45 mg but responses have been observed at 60 mg per day.
ELDERLY – The recommended dose is the same as that for adults. In
elderly patients an increase
in dosing should be done under close supervision to elicit a
satisfactory and safe response.
The clearance of mirtazapine may be decreased in patients with renal
or hepatic insufficiency.
This should be taken into account when prescribing mirtazapine to this
category of patients
(see section 5.2 PHARMACOKINETIC PROPERTIES).
Mirtazapine has a half-life of 20–40 hours and therefore mirtazapine
is suitable for once-a-day
administration. It should be taken preferably as a single night-time
dose before going to bed.
Mirtazapine may also be gi