Country: Јужноафричка Република
Језик: Енглески
Извор: South African Health Products Regulatory Authority (SAHPRA)
Lennon
AREM®-5 TABLETS SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): AREM ® -5 TABLETS COMPOSITION: Each tablet contains 5 mg of Nitrazepam PHARMACOLOGICAL CLASSIFICATION: A 2.2 Sedatives, hypnotics. PHARMACOLOGICAL ACTION: The major molecular targets of the benzodiazepines are inhibitory neurotransmitter receptors directly activated by the amino-acid, gamma-aminobutyric acid (GABA). The half-life is 26 hours +/-3 and are increased in the elderly and obese patients. INDICATIONS: Relief of insomnia. Nitrazepam is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress. CONTRA-INDICATIONS: - Psychotic patients. - Chronic obstructive lung disease states. - Patients with a known hypersensitivity towards nitrazepam or other benzodiazepines. - Pregnancy (given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking). - Lactating mothers. - Patients suffering from depression and suicidal tendencies. - Acute porphyria Nitrazepam should not be used in patients with pre-existing central nervous system depression or coma, acute pulmonary insufficiency, or sleep apnoea. WARNING: This medicine particularly at the initiation of therapy may lead to drowsiness or impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not drive, climb dangerous heights or operate dangerous machinery where loss of attention might be hazardous. KEEP OUT OF REACH OF CHILDREN DOSAGE AND DIRECTIONS FOR USE: Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. The usual dose is one tablet (5 mg) at night, although two tablets (10 mg) may Прочитајте комплетан документ