Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Akromed
SPARINE* INJECTION SPARINE* SYRUP SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): SPARINE* INJECTION SPARINE* SYRUP COMPOSITION: SPARINE INJECTION: Each mL of parenteral SPARINE contains 50 mg promazine hydrochloride in water for injection with 3,6 mg sodium citrate, 0,75 mg citric acid and 1,0 mg sodium formaldehyde sulphoxylate (0,1 % ) as preservative. SPARINE SYRUP: Each 5 mL contains 10 mg promazine hydrochloride in a flavoured syrup base with 0,25 % sodium benzoate and 0,25 % sodium propionate as preservatives. Contains TARTRAZINE. PHARMACOLOGICAL CLASSIFICATION: Category A, 2.6.1. Phenothiazines and derivatives. PHARMACOLOGICAL ACTION: SPARINE (promazine) has actions at all levels of the central nervous system as well as on multiple organ systems. Its main actions are central sedation, potentiation of analgesics, anaesthetics, hypnotics and sedatives. It is also a potent antipsychotic and anti-emetic agent. The mechanism whereby its therapeutic action takes place is not known. INDICATIONS: 1. Psychotic conditions: It controls excitement, agitation and other psychomotor disturbances in schizophrenic patients and reduces the manic phase of manic depressive conditions. It is used to control hyperkinetic states and aggression and is sometimes given in other psychiatric conditions for the control of anxiety and tension. 2. SPARINE (promazine) is anti-emetic and is used to control the nausea and vomiting of a variety of diseases and that caused by various drugs. 3. For sedation in labour and as premedication for surgical or diagnostic procedures. 4. Alcoholic hallucinosis. 5. Alleviation of intractable hiccup. CONTRA-INDICATIONS: Promazine should not be used in comatose states due to central nervous system depressants (alcohol, barbiturates, opiates, etc.). In patients with Read the complete document