STRATTERA 18 mg HARD CAPSULE

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

Atomoxetine Hydrochloride eqv Atomoxetine

Dostupné s:

DKSH SINGAPORE PTE. LTD.

Dávkování:

18 mg

Léková forma:

CAPSULE

Složení:

Atomoxetine Hydrochloride eqv Atomoxetine 18 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

LILLY DEL CARIBE, INC.

Stav Autorizace:

ACTIVE

Datum autorizace:

2005-04-04

Informace pro uživatele

NAME OF THE MEDICINE 
STRATTERA (atomoxetine hydrochloride) 

The active ingredient in Strattera hard
capsules is atomoxetine hydrochloride.  
Chemically, Strattera is (_R_)-(-)-N-Methyl-gamma-(2-methylphenoxy)-
benzenepropanamine hydrochloride.  The empirical formula is C
17
H
21
NO
•HCl which 
corresponds to a molecular weight of 291.82 daltons.
 The chemical structure is: 

O
C
H
3
N
H
CH
3
• HCl

The CAS number for atomoxetine hydrochloride is 82248-59-7. 

DESCRIPTION 
Strattera is a white to practically white solid which has a solubility of 27.8 mg/mL in 
water. 

Strattera is available as hard capsules for oral administration. Each hard capsule contains 
10, 18, 25, 40 or 60 mg of atomoxetine (as hydrochloride).
 The hard capsules also 
contain pregelatinised maize starch, dimethicone 350, gelatin,
sodium lauryl sulfate, 
titanium dioxide, edible black ink (TekPrint SW-9008 or SW-9010),
indigo carmine 
CI73015 (25 mg, 40 mg and 60 mg only), yellow iron
oxide CI77492 (18 mg and 60 mg 
only). 

PHARMACOLOGY 
PHARMACODYNAMICS 
Strattera is a treatment
for Attention-Deficit/Hyperactivity Disorder (ADHD).  ADHD 
was formerly known as Attention Deficit Disorder (ADD) with
or without hyperactivity.  
Strattera is a relatively potent inhibitor of the presynaptic noradrenaline transporter (K
i

4.5 nM), a moderate inhibitor of 5HT uptake (K
i
 152 nM) and a weak inhibitor of 
dopamine uptake (K
i
 658 nM), with minimal affinity for the other noradrenergic 
receptors.  Strattera has moderate affinity for 5HT
2
 and GABA
A
 receptors but poor 
affinity for most other receptors. 
The main hydroxyatomoxetine metabolite is equipotent 
to the parent compound at the noradrenaline transporter (K
i
 3.0 nM), and a more potent 
inhibitor of the 5HT transporter (K
i
 43 nM) than the parent compound. 

A thoro

Charakteristika produktu

NAME OF THE MEDICINE
Strattera 10mg, 18mg, 25mg, 40mg or 60mg Hard Capsule
The active ingredient in Strattera hard capsules is atomoxetine
hydrochloride. Chemically, Strattera is
(_R_)-(-)-N-Methyl-gamma-(2-methylphenoxy)-
benzenepropanamine hydrochloride. The empirical formula is C
17
H
21
NO•HCl which corresponds to a molecular weight of 291.82 daltons.
The chemical structure is:
O
N
H
H
3
C
CH
3
• HCl
The CAS number for atomoxetine hydrochloride is 82248-59-7.
DESCRIPTION
Atomoxetine hydrochloride is a white to practically white solid which
has a solubility of 27.8 mg/mL in water.
Strattera is available as hard capsules for oral administration. Each
hard capsule contains 10, 18, 25, 40 or 60mg of atomoxetine (as
hydrochloride).
The hard capsules also contain pregelatinised maize starch,
dimethicone 350, gelatin, sodium lauryl sulfate, titanium dioxide,
edible black ink
(TekPrint SW-9008 or SW-9010), indigo carmine CI73015 (25mg, 40mg and
60mg only), yellow iron oxide CI77492 (18mg and 60mg only).
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Psychoanaleptics, centrally acting
sympathomimetics
ATC code: N06BA09
Strattera is a treatment for Attention-Deficit/Hyperactivity Disorder
(ADHD). ADHD was formerly known as Attention Deficit Disorder (ADD)
with
or without hyperactivity. Atomoxetine is a relatively potent inhibitor
of the presynaptic noradrenaline transporter (K
i
4.5nM), a moderate inhibitor of
5HT uptake (K
i
152nM) and a weak inhibitor of dopamine uptake (K
i
658nM), with minimal affinity for the other noradrenergic receptors.
Atomoxetine
has moderate affinity for 5HT
2
and GABA
A
receptors but poor affinity for most other receptors. The main
hydroxyatomoxetine metabolite is
equipotent to the parent compound at the noradrenaline transporter (K
i
3.0nM), and a more potent inhibitor of the 5HT transporter (K
i
43nM) than
the parent compound.
A thorough QT/QTc study, conducted in healthy adult CYP2D6 poor
metaboliser (PM) subjects dosed up to 60mg of atomoxetine twice daily,
demonstrated
th