INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BRUNAZINE ELIXER
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BRUNAZINE ELIXER

COMPOSITION
Each 5 mL contains:
Promethazine hydrochloride         5,0 mg
Ethyl alcohol         5,0% v/v
Preservatives:
Methyl hydroxybenzoate         0,1% m/v
Propyl hydroxybenzoate         0,02% m/v

PHARMACOLOGICAL CLASSIFICATION
A/ 5.7.1/Antihistaminics

PHARMACOLOGICAL ACTION
Promethazine acts as a competitive antagonist to histamine. Promethazine hydrochloride blocks most of the actions of injected or endogenously released histamine.

INDICATIONS
Brunazine Syrup is indicated in those disorders which are known to respond to antihistamine therapy. It is effective in motion sickness, nausea and vomiting. It is used for treatment of allergic reactions.

CONTRA-INDICATIONS
• Hypersensitivity to promethazine hydrochloride.
• Promethazine should be used cautiously in patients with hepatic disease.
• Promethazine hydrochloride is contra-indicated in epileptics and in pregnancy.
• Brunazine should not be administered to children under the age of one year.

WARNINGS
Patients should be warned not to operate vehicles or dangerous machinery or to perform dangerous tasks where loss of concentration could lead to accidents. This may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.

DOSAGE AND DIRECTIONS FOR USE
Adults:                20 mg to 50 mg (four to ten 5 mL medicine measures) daily in divided dosages.
Children:                 
1 to 3 years:        1 and a half medicine measures (1,5 x 5 mL) twice daily.
3 to 7 years: Two 5 mL medicine measures, twice daily
7 to 10 years: 2 and a half medicine measures (2,5 X 5 mL), twice daily
10 to 12 years: Three 5 mL medicine measures, twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sedation is the most common side-effect of promethazine hyrochloride. It may vary from slight drowsiness to deep sleep, and include fatigue, dizziness, and incoordination. These sedative effects may diminish after a few days of treatment.
Gastro-intestinal disturbances may occur, including nausea, vomiting, diarrhoea and epigastric pain.
Extrapyramidal symptoms, such as twitching and jerking of limbs at night and ataxia, may develop.
Paradoxical central nervous system (CNS) stimulation have been reported, especially in children, with insomnia, nervousness, euphoria, irritability, tremors, and rarely nightmares, hallucinations and convulsions. In high doses CNS stimulation may be attributed to antimuscarinic activity.
Antimuscarinic effects which may be experienced, include dry mouth, thickened respiratory-tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, a reduction in tone and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux. In high doses, transient bradycardia, followed by tachycardia, with palpitations, arrhythmias and CNS stimulation, may be experienced.
Hypersensitivity reactions may occur, particularly of the skin, and cross-sensitivity to related drugs may occur. Jaundice, observed rarely, may also be a hypersensitivity reaction.
Photosensitivity reactions have been reported.
Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia, though rare, have been reported; these may have an immune basis.
Other adverse effects that have been reported rarely with promethazine hydrochloride include hypotension, tinnitus, headache and paraesthesia.

Special precautions:
Because of the antimuscarinic properties promethazine hydrochloride should be used with care in patients with conditions such as closed-angle glaucoma, urinary retention, static hyperplasia or pyloroduodenal obstruction. Caution should be exercised in patients with epilepsy, severe cardiovascular disorders, with liver disorders, or with asthma.
Use with caution in the elderly, as they are more susceptible to the central nervous system effects of the antihistamines.
Use with care, especially in acutely ill or dehydrated children.
Ambulant patients should be cautioned against driving or operating dangerous machinery or performing other tasks where loss of mental alertness may lead to accidents.
Interactions:
Promethazine hydrochloride may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, sedatives and tranquillisers, causing increased somnolence and impaired concentration.
Patients should avoid alcoholic drinks while taking this medicine.
Influence on laboratory tests:
False negative or false positive results have been reported with some pregnancy tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdose may be fatal, especially in infants and children. Overdosage is associated with antimuscarinic, extrapyramidal, gastro-intestinal and CNS effects.
In infants and children CNS stimulation predominates over CNS depression, causing ataxia, excitement, tremors, psychoses, hallucinations and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow.
In adults, CNS depression is more common, with symptoms of drowsiness, coma and convulsions, progressing to respiratory failure or possible cardiovascular collapse.
Acute poisoning: Symptoms include unconsciousness, occasionally associated with convulsions and hyperpyrexia.
Treatment: An emetic, or vomiting induced mechanically, is the immediate first aid measure to the conscious patient. Unabsorbed medicine should be removed by gastric lavage. There is no specific treatment for promethazine hydrochloride poisoning, and treatment is along general symptomatic and supportive lines. Should breathing fail, the mechanical support of lung ventilation is suggested.

IDENTIFICATION
A clear, colourless, citrus flavoured elixer.

PRESENTATION
100 mL, 200 mL and 500 mL amber glass bottles with screw caps.

STORAGE INSTRUCTIONS
Store in a cool place, below 25°C out of direct sunlight.
Keep out of reach of children.

REGISTRATION NUMBER
M/5.7.1/153

NAME AND BUSINESS ADDRESS OT THE APPLICANT
Brunel Laboratoria (Pty.) Ltd • 1 van Tonder Street • Sunderland Ridge • Centurion

DATE OF PUBLICATION OF THIS PACKAGE INSERT
11 June 1998

Updated on this site: November 1999

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