Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
LORIEN CAPSULES LORIEN TABLETS SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): LORIEN CAPSULES LORIEN TABLETS COMPOSITION: LORIEN CAPSULES: Contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine per capsule. LORIEN TABLETS: Contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine per tablet. PHARMACOLOGICAL CLASSIFICATION: A 1.2 Psychoanaleptics (antidepressants) PHARMACOLOGICAL ACTION: Fluoxetine inhibits the neuronal uptake of serotonin in the central nervous system. Pharmacokinetics: Fluoxetine has a long elimination half-life of 2-3 days and 7 to 9 days for the active metabolite. These long half-lives must be taken into account when doses are titrated or when treatment is stopped. INDICATIONS: Major depressive episodes, i.e. single episode and recurrent depression with associated anxiety. Bulimia nervosa: Fluoxetine has been shown to significantly decrease binge-eating and purging activity. Obsessive compulsive disorder: Fluoxetine is indicated for the treatment of obsessive-compulsive disorder. The obsessions or compulsions must be experienced as intrusive, markedly distressing, time-consuming or interfering significantly with the person's social or occupational functioning. CONTRA-INDICATIONS: Hypersensitivity to fluoxetine. Severe renal failure (glomerular filtration rate <10 mL per minute). Safety in pregnancy and lactation has not been established. Safety in children has not been established. Monoamine oxidase inhibitors: There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations in vital signs and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving fluoxetine in combination with a monoamine oxidase inhibitor (MAOI Read the complete document