亞眠靚長效錠

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

MELATONIN

可用日期:

法諾亞生技藥品股份有限公司 臺北市大安區延吉街253巷2弄6號 (54665812)

ATC代码:

N05CH01

药物剂型:

長效錠

组成:

主成分 (每錠含：) ; MELATONIN (6839000100) MG

每包单位数:

PVC-PVDC/aluminium鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

OMAN PHARMACEUTICAL PRODUCTS CO., LLC PLOT NO. 101, RAYSUT INDUSTRIAL ESTATE, P.O. BOX:2240, POSTAL CODE-211, SALALAH, OMAN OM

治疗领域:

melatonin

疗效迹象:

單獨使用於55歲以上睡眠品質差的原發性失眠病人的短期治療。

產品總結:

有效日期: 2025/02/24; 英文品名: Somn Well XR Tablets

授权日期:

2020-02-24

资料单张

027800
SOMN WELL XR TABLET
(MELATONIN 2MG PROLONGED RELEASE TABLETS)
Melatonin
N-[2-(5-Methoxy-1H-indol-3-y)ethyl]acetamide
Melatonin
C
13
H
16
N
2
O
2
232.27
Melatonin 2 mg prolonged release tablets
melatonin
Lactose Monohydrate
Calcium hydrogen phosphate dehydrate
Methyl alcohol
Ammonio methacrylate copolymer
Purified Talc
Colloidal anhydrous silicaMagnesium Stearate
Melatonin Receptor AATC code
N05CH01
2-4
Melatonin
MT1MT2
MT1
MT2
55
15
50%
2-8
15
85%2.6
T
max
Melatonin 2
T
max
1.62.6AUC
60%
1-
P450CYP1A1
CYP1A2
CYP2C19
6-6-S-MT
12
3.5-489
6-2
C
max
3-4
C
max
AUC
C
max
18-45C
max
500 pg/mLC
max
1200 pg/mL
55-65AUC3000 pg*h/mL
AUC6000 pg*h/mL
1
3
23:002
411.4 ± 56.5432.00 ± 83.2 pg/mL
6-sulfatoxymelatonin
55
N
H
H
H
H
H
O
H
3
C
CH
2
CH
2
NHCOCH
3
LSEQ
10
LSEQGTSQOS
AFSBFW
PSG40
2
3
3
9
10
1121
20
Neurim VII17082
88
3
2
QOS
47
27
6mm9mm
334
1691652
3
3
26
15
24.3
12.9
55600400
6
3
7.8p=0.014
13
PSQI<6
10%(WHO-5)
3
16.7%10.6%
p=0.044
1325.8%15.7%
p=0.006
3
26
96
12
55
2 mg
1-2
13
18
LAPP–
900
900
System Organ
Class
900
250
18
AUC
700
CYP3A
CYP1ACYP1A
CYP1A
CYP1A
CYP1A2
Carbamazepine and rifampicin - CYP1A2
Carbamazepine
rifampicin
FluvoxamineFluvoxamine
P 4 5 0
CYPCYP1A2
CYP2C19AUC
17C
max
12
5-8-5- or 8-methoxypsoralen
5-
8-5
8-MOP
CimetidineCimetidine
Cimetidine
1.7
CimetidineCYP2D
Cimetidine
CYP1A2
CYP1A1
CYP1A2
/
/
zalepon
zolpidem zopiclone
zolpidem
1
zolpidemzolpidem
Thioridazine and imipramine
thioridazine
imipramine
i m i p r a m i n e
imipramine
tothioridazine
tothioridazine“”
19311642
48.8
37.8100
5.743
vs.
3.013
MedDRA
722.9
624.0
≥1
9.57.4
≥1/10
≥1/100
<1/10
≥
1/1,000 <
1/100>
1/10,000 <
1/1,000
<
1/10,000
1
5mg
12
300
12
30
25°C
Oman Pharmaceutical Products Co. LLC
Plot No. 101, Raysut Industrial Estate,
P.O. Box: 2240, Postal Code -211, Salalah, Oman.
25326
(N=1931)
(N=1642)
1.1
1.0
1.2
3.1
1.8
1.5
0.7
1.2
0.9
1.8
1.7
0.9
1.9
1.2
1.5
1.9
4.0
1.9
2.9
2.1
0.9
1.2
3.0
1.2
1.2
0.7
3.5
3.8
1.1
1.1
1.6
1.8
1.5
0.6
0.6
1.1
1.6
5.7
1.1
1.2
6.2
1.2
1.0
1.2
2.2
1.5
1.1
1.3
0.9
0.9
(N=1931)
(N