Thông tin thuốc gốc
Chỉ định và Liều dùng
Short-term management of insomnia
Adult: ≥55 years As prolonged-release tab: 2 mg once daily, taken 1-2 hours before bedtime. Recommended Max treatment duration: 13 weeks.

Short-term management of jet lag
Adult: As immediate-release tab: 1-5 mg, taken on arrival at the destination at the habitual bedtime. As oral solution: 3 mg once daily, may be increased to 6 mg once daily if necessary; 1st dose is taken after arrival at destination at the habitual bedtime. Max duration: 5 days. Doses must not be taken before 8:00 P.M. or after 4:00 A.M. at destination. Max of 16 treatment courses per year.
Suy gan
Not recommended.
Chống chỉ định
Concomitant use with fluvoxamine or alcohol.
Thận trọng
Patient with autoimmune disease, epilepsy. Cigarette smokers. Not recommended in patients with hepatic impairment. Renal impairment. Elderly. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: CNS depression, exacerbation of autoimmune disease; may increase seizure frequency.
Gastrointestinal disorders: Abdominal pain, constipation, diarrhoea, nausea, vomiting.
General disorders and administration site conditions: Asthenia.
Infections and infestations: Influenza.
Musculoskeletal and connective tissue disorders: Arthralgia, back or neck pain, muscle cramp, pain in extremity.
Nervous system disorders: Headache, somnolence, dizziness, migraine.
Psychiatric disorders: Nervousness, anxiety, restlessness.
Respiratory, thoracic and mediastinal disorders: Respiratory tract infection, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, cough, rhinitis.
Thông tin tư vấn bệnh nhân
This drug may cause CNS depression (e.g. drowsiness), if affected, do not drive or operate machinery.
Tương tác
Increased plasma concentrations with CYP1A2 inhibitors (e.g. ciprofloxacin, norfloxacin, verapamil, contraceptives or hormone replacement therapy), 5- or 8-methoxypsoralen (5- or 8-MOP), cimetidine, and caffeine. Decreased plasma concentrations with CYP1A2 inducers (e.g. carbamazepine, phenytoin, rifampicin, omeprazole). May reduce the hypotensive effect of Ca channel antagonists (e.g. nifedipine). May enhance the sedative effects of benzodiazepines and non-benzodiazepine hypnotics (e.g. zolpidem, zopiclone, zaleplon). Concomitant use with vitamin K antagonists (e.g. warfarin) may lead to increased or decreased prothrombin levels.
Potentially Fatal: Fluvoxamine significantly increases melatonin levels.
Tương tác với thức ăn
Alcohol reduces the effect of melatonin; avoid concomitant use.
Tác dụng
Description: Melatonin is a hormone secreted by the pineal gland. Its agonist activity at the MT1, MT2 and MT3 receptors is believed to contribute to its sleep-promoting properties, as these receptors (primarily MT1 and MT2) are involved in the control of circadian rhythms and sleep regulation.
Absorption: Completely absorbed. Food delays rate of absorption (prolonged-release tab). Bioavailability: 15%. Time to peak plasma concentration: Prolonged-release tab: 2.6-3 hours (fed state); 0.75-1.6 hours (fasting state).
Distribution: Crosses the placenta; may enter breastmilk. Plasma protein binding: Approx 60% (mainly to albumin, α1-acid glycoprotein and high-density lipoprotein).
Metabolism: Metabolised in the liver by CYP1A1, CYP1A2 and possibly CYP2C19 isoenzymes to 6-sulphatoxy-melatonin (inactive metabolite).
Excretion: Via urine (89% as inactive metabolite, 2% as unchanged drug). Elimination half-life: 3.5-4 hours.
Đặc tính

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 896, Melatonin. Accessed Sept. 24, 2021.

Bảo quản
Store below 25°C. Protect from light.
Phân loại MIMS
Các liệu pháp bổ trợ & Thực phẩm chức năng
Phân loại ATC
N05CH01 - melatonin ; Belongs to the class of melatonin receptor agonists. Used as hypnotics and sedatives.
Tài liệu tham khảo
Anon. Melatonin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 10/08/2021.

Buckingham R (ed). Melatonin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 10/08/2021.

Circadin 2 mg Prolonged Release Tablets (DKSH Singapore Pte Ltd.). MIMS Singapore. Accessed 20/08/2021.

Joint Formulary Committee. Melatonin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 10/08/2021.

Melatonin 1 mg/mL Oral Solution (Colonis Pharma Ltd). MHRA. Accessed 12/08/2021.

Melatonin AGB 3 mg Tablets (AGB-Pharma AB). MHRA. Accessed 10/08/2021.

Melatonin Teva XL 2 mg Prolonged-Release Tablets (Teva UK Limited). MHRA. Accessed 10/08/2021.

Pharmacy Retailing t/a Healthcare Logistics. Circadin 2 mg Prolonged Release Tablets data sheet 10 December 2020. Medsafe. Accessed 10/08/2021.

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