País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lorazepam
Arpimed LLC
lorazepam
1mg
tablets
Prescription
SUMMARY PRODUCT CHARACTERISTIC (SPC) LORAZEPAM 1 MG AND 2 MG TABLETS 1.1 BRAND NAME - LORAZEPAM 1.2 INTERNATIONAL NON-PROPERTY NAME - LORAZEPAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lorazepam 1 mg tablet contains: _ACTIVE INGREDIENT: _lorazepam - 1 mg _For a full list of excipients, see section 6.1. _ Each Lorazepam 2 mg tablet contains: _ACTIVE INGREDIENT: _lorazepam - 2 mg _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM _Lorazepam, 1 mg tablets _ White or off white scored cylindrical tablets with a few small darker spots and with a risk on one side and a facet on both sides. _Lorazepam, 2 mg tablets _ White scored cylindrical tablets with a risk on one side and a facet on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lorazepam is indicated for the short term treatment of unacceptable disabling or distressful anxiety states including anxiety associated with psychosomatic, organic and psychotic illness, and the short term treatment of insomnia associated with anxiety. Lorazepam may also be used as premedication before operative dentistry and general surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore, the drug should be discontinued gradually for all patients (see section 4.4). Generally, the duration of treatment varies from a few days to 4 weeks including the tapering off process. Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Increases in the dosage of lorazepam should be made gradually to help avoid adverse effects. The evening dose should be increased before the daytime doses. DOSAGE: ADULTS: Moderate and severe anxiety: Insomnia: Premedication before operative dentistry or general surgery: 1-4 mg daily in divided doses. 1-2 mg before retiring 2- 3 mg th Leer el documento completo