Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOTHIEPIN HCL
DUOPHARMA (M) SDN. BHD.
DOTHIEPIN HCL
100 Tablets
DUOPHARMA (M) SDN. BHD.
_Patient Information Leaflet (PIL) _ 1 DEPROPIN TABLET Dothiepin hydrochloride 25mg WHAT IS IN THE LEAFLET? 1. What DEPROPIN is used for 2. How DEPROPIN works 3. Before you use DEPROPIN 4. How to use DEPROPIN 5. While you are using it 6. Side effects 7. Storage and Disposal of DEPROPIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DEPROPIN IS USED FOR DEPROPIN is used to treat depression. Your doctor may have prescribed DEPROPIN for another reason. Ask your doctor if you have any questions about why DEPROPIN has been prescribed for you. HOW DEPROPIN WORKS DEPROPIN contains dothiepin hydrochloride. It belongs to a group of medicines known as tricyclic antidepressants (TCAs). DEPROPIN corrects the chemical imbalance and may help relieve the symptoms of depression. BEFORE YOU USE DEPROPIN - _When you must not take it _ _ _ Do not use DEPROPIN if you have liver failure. Do not use DEPROPIN if you have fits. DEPROPIN is not recommended for use in children under 16 years. Do not take this medicine if you are allergic to • dothiepin hydrochloride • any of the ingredients listed at the end of this leaflet • any other tricyclic antidepressants such as : ▪ amitriptyline ▪ clomipramine ▪ desipramine ▪ doxepin ▪ imipramine ▪ nortriptyline ▪ protriptyline ▪ trimipramine Do not take DEPROPIN if you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) such as isocarboxazid, nialamide, phenelzine, hydracarbazine. Ask your doctor or pharmacist if you are unsure as to whether or not you are taking a MAOI. Do not take DEPROPIN if you are recovering from a recent heart attack. It may make your condition worse. Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start using this medicine, talk to your doctor. - _Before you start to use it _ _ _ Baca dokumen lengkap
DESCRIPTION: DEPROPIN TABLET 25MG: A 7 mm diameter round shaped tablet, apple green in colour with “DUOMA/DUOMA” and “DUO 861” markings. COMPOSITION: Each tablet contains Dothiepin Hydrochloride 25 mg. PHARMACODYNAMICS: ACTIONS: Tricyclic antidepressant PHARMACOLOGY: Dothiepin is a thionalogue of amitriptyline. In anti-reserpine activity, it is generally equivalent to amitriptyline but less potent than imipramine. SITE AND MODE OF ACTION: The site of action is thought to be in the CNS, but the mechanism by which this drug and all tricyclic antidepressants produce an antidepressant effect is unknown. Dothiepin possesses anticholinergic, antihistamine and central sedative properties. It is postulated that the aetiology of depression is associated with a functional abnormality of one or more of the biogenic amines, particularly the cathecolamines, in the brain. The tricyclics inhibit uptake of noradrenaline and 5-hydroxytryptamine from the nerve endings thus increasing their availability at central noradrenergic synapses. PHARMACOKINETICS: _ABSORPTION: _Well absorbed. Animal studies show dothiepin is absorbed from the small intestine. After a single 50 mg oral dose in one patient, a peak level of 20 nanogram / mL was achieved after 3 hours, falling to 10 nanograms / mL at 6 hours. There are substantial inter-individual variations in steady state concentra- tions. In 10 patients takin 100 mg / day for two weeks, the serum concentration ranged from 18-84 nanogram / mL (mean 41 ± 7 nanogram / mL). After increasing the dose to 175 mg / day for a further two weeks the concentration ranged from 43 to 196 nanogram / mL (mean 96 ± 15 nanogram / mL). Steady state concentrations appear to be reached after 10 to 14 days. _DISTRIBUTION:_ Dothiepin is present in low concentrations in breast milk. It crosses the placental and blood brain barriers in animals. Animal studies in the dog or cat show maximal concentration after 24 hours in liver, uveal tract of the eye, lung, kidney, pituitary and thyroid in descending order Baca dokumen lengkap