Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Lurasidone Hydrochloride
SUMITOMO PHARMA MALAYSIA SDN. BHD.
Lurasidone Hydrochloride
30 Tablets
Bushu Pharmaceuticals Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LATUDA FILM-COATED TABLETS Lurasidone hydrochloride (20mg, 40mg & 80mg) 1 What is in this leaflet 1. What Latuda is used for 2. How Latuda works 3. Before you use Latuda 4. How to use Latuda 5. While you are using Latuda 6. Side effects 7. Storage and Disposal of Latuda 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT LATUDA IS USED FOR LATUDA is a prescription medicine used: • To treat adult and adolescent patients 13 to 17 years of age and older with schizophrenia. • Alone to treat adult and adolescent patients 13 to 17 years of age and older with major depressive episodes associated with Bipolar I Disorder (bipolar depression). • With the medicine lithium or valproate to treat adults with major depressive episodes associated with Bipolar I Disorder (bipolar depression). HOW LATUDA WORKS LATUDA works by adjusting the levels of certain chemical messengers, called neurotransmitters, in the brain. BEFORE YOU USE LATUDA _- When you must not use it _ Do not take Latuda if you are: • allergic to lurasidone hydrochloride or any of the ingredients in LATUDA. See the end of this Medication Guide for a complete list of ingredients in LATUDA. • taking certain other medicines called CYP3A4 inhibitors or inducers including ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, rifampin, avasimibe, St. John’s wort, phenytoin, or carbamazepine. Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines. _Children and adolescents _ It is not known if LATUDA is safe and effective in children: • less than 13 years of age with schizophrenia. • less than 13 years of age with bipolar depression. • for the treatment of irritability associated with autistic disorder. - _Before you start to use it _ Tell your doctor or pharmacist about all of your medical conditions, including if you: • have or have had heart problems or stroke • have or have had low or h read_full_document
1 PRODUCT NAME LATUDA 20MG FILM-COATED TABLETS LATUDA 40MG FILM-COATED TABLETS LATUDA 80MG FILM-COATED TABLETS NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) LURASIDONE HYDROCHLORIDE 20MG LURASIDONE HYDROCHLORIDE 40MG LURASIDONE HYDROCHLORIDE 80MG PRODUCT DESCRIPTION LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a _R_ ,4 _S_ ,7 _R_ ,7a _S_ )-2-{(1 _R_ ,2 _R_ )-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 _H_ -isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S·HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. LATUDA film-coated tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, or 80 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry ® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 2 Aluminum Lake. PHARMACOLOGY MECHANISM OF ACTION The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D 2 and serotonin Type 2 (5HT 2A ) receptor antagonism. PHARMACODYNAMIC Lurasidone is an antagonist with high affinity binding at the dopamine D 2 receptors (Ki of 1 nM) and the serotonin 5-HT 2A (Ki of 0.5 nM) and 5-HT 7 (Ki of 0.5 nM) receptors. It also binds with moderate affinity to the human α 2C adrenergic receptors (Ki of 11 nM), is a partial agonist at serotonin 5-HT 1A (Ki of 6.4 2 nM) receptors, and is an antagonist at the read_full_document