Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
LETHYL® -15, -30, -60 TABLETS SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): LETHYL ® -15, -30, -60 TABLETS COMPOSITION: Each tablet contains: 15 mg, 30 mg or 60 mg Phenobarbitone . PHARMACOLOGICAL CLASSIFICATION: A 2.3 - Barbiturates PHARMACOLOGICAL ACTION: Phenobarbitone is a long acting barbiturate acting by depression of the central nervous system. It is readily absorbed from the gastro-intestinal tract and the onset of action is approximately 1 hour. Excretion is mainly in the unchanged form in the urine. It is 40% to 60% bound to plasma proteins and bound to a similar extent in tissues including the brain. The plasma half-life is about 100 hours in adults, it is somewhat longer in neonates, while it is shorter and more variable in children. INDICATIONS: It is used as a sedative and hypnotic in nervous insomnia and anxiety states and for the relief of migraine. CONTRA-INDICATIONS: Hypersensitivity to phenobarbitone or the barbiturates. It is contra-indicated in cases of severe impairment of hepatic, renal or respiratory function and in patients with acute porphyria. DOSAGE AND DIRECTIONS FOR USE: Adults: 30-120 mg three times a day Children: 2-5 years 15-30 mg three times a day 6-12 years 15-120 mg three times a day SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The most frequent side-effect is sedation, but this often becomes less marked with continued administration. Phenobarbitone may produce subtle mood changes and impairment of cognition and memory which may not be apparent without testing. Mental depression may occur. Prolonged administration may occasionally result in folate deficiency or hypocalcaemia; less frequently, megaloblastic anaemic or osteomalacia have been reported. At high doses nystagmus and ataxia may occur and the typical barbi Read the complete document