Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Atomoxetine Hydrochloride eqv Atomoxetine
DKSH SINGAPORE PTE. LTD.
40 mg
CAPSULE
Atomoxetine Hydrochloride eqv Atomoxetine 40 mg
ORAL
Prescription Only
LILLY DEL CARIBE, INC.
ACTIVE
2005-04-04
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 Przeczytaj cały dokument
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 Przeczytaj cały dokument