ACUGEST EXPECT SYRUP

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

ACUGEST EXPECT SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUGEST EXPECT SYRUP

COMPOSITION:
Each 5 mL contains:

Triprolidine Hydrochloride	1,25 mg
Pseudoephedrine Hydrochloride	30 mg
Guaiphenesin	100 mg

Preservatives:

Methyl Hydroxybenzoate	0,12% m/v
Propyl Hydroxybenzoate	0,02% m/v
Contains Alcohol	6,7% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants

INDICATIONS:
For the alleviation of cough.

CONTRA-INDICATIONS:
ACUGEST Expect Syrup should not be administered to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, thyrotoxicosis, prostatism, bladder dysfunction and narrow angle glaucoma.
Patient who have previously exhibited intolerance to it or to any of its constituents.
Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment, ephedrine and other sympathomimetic agents as a hypertensive response may result.
Avoid during cyclopropane or halothane anaesthesia (or any other halogenated anaesthetic), phaeochromocytoma.
Do not give during an attack of asthma in asthmatic patients.

WARNINGS:
The safety of ACUGEST Expect Syrup during pregnancy and lactation has not been established.
ACUGEST Expect Syrup may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant. Patients should be warned not to drive vehicles, climb dangerous heights or operate dangerous machinery, as impaired decision making could lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:

Adults and children over 12 years	10 mL
Children 6 to 12 years	5 to 7,5 mL
Children 1 to 5 years	2,5 to 5 mL

May be given three times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Pseudoephedrine may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitation, difficulty with micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur.
Pseudoephedrine should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort.
In patients with prostatic enlargement, it may cause difficulty with micturition.
Fixed drug eruption due to pseudoephedrine, taking the form of erythematous nummular patches has been reported.
Other side-effects of pseudoephedrine include agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrest, confusion, dizziness, dyspnoea, aneurisms, fainting, fear, flushing, disturbances of glucose metabolism, irritability, miosis, dry mouth and psychotic states.
ACUGEST Expect Syrup should be used with caution in patients taking other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, or antihypertensive agents, as this may cause a rise in blood pressure largely because of interaction with pseudoephedrine. The effect of a single dose of ACUGEST Expect Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.
ACUGEST Expect Syrup should be used with caution in patients with diabetes mellitus, and occlusive vascular disorders (arteriosclerosis). It should be use carefully in elderly and debilitated patients. Tolerance may develop when given to asthmatics for its anti-asthmatic effect.
The most common side-effects of triprolidine are sedation varying from slight drowsiness the deep sleep, inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Other side-effects include gastrointestinal distubances such an nausea, vomiting, diarrhoea or constipation and epigastric pain. Headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty with micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands, deepening coma, convulsions, extrapyramidal effects, insomnia, leucopenia, nervousness, photosensitisation of the skin, tachycardia and tremor may occur.
Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects. Should be used with caution in patients with glaucoma, liver impairment, prostatic hypertrophy and urinary retention. The positive results of skin test may be suppressed.
Lichenoid skin eruption due to triprolidine HCl has been reported.
Guaiphenesin may cause gastro-intestinal discomfort and may cause nausea and vomiting. It may interfere with diagnostic measurement of 5-hydroxy-indoleacetic acid and vanillylmandelic acid.
INTERACTIONS:
The antibacterial agent, furazolidine, is known to cause a dose related inhibition of monoamine oxidase. ACUGEST Expect Syrup and furazolidine should not be taken together.
The effects of ACUGEST Expect Syrup due to pseudoephedrine are diminshed by guanethidine, reserpine, methyldopa and may be diminshed by tricyclic antidepressants.
The effects of atropine and tricyclic antidepressants may be enchanced by triprolidine. Triprolidine may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism, of drugs in the liver.
Long term use of anticonvulsants and oral steroid contraceptives cause an increase in the first past metabolism or clearance rate and may prevent attainment of therapeutic levels.
The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. Monoamine oxidase inhibitors may enhance the anticholinergic effects. Reversal of the effects of antihypertensive agents may occur.
Do not give together with cardiac glycosides.
Do not give together with quinidine.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
For symptoms of overdosage see side-effects.
Symptoms of overdosage of triprolidine include ataxia, drowsiness and hypotension. Respiratory collapse, and death from respiratory failure may occur. Overdosage may be fatal, especially in infants and children in whom main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and, hyperpyrexia.
Symtoms of pseudoephedrine overdosage may include paranoid psychosis, delusions and hallucinations.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear orange-yellow syrup with menthol odour and taste.

PRESENTATION:
Amber glass bottles containing 100 mL, 200 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
X/10.1/1

NAME AND BUSINESS ADDRESS OF APPLICANT:
ACUPHARM (Pty) Ltd.
43 Richards Drive
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

Highland Print

ACP 017
94H0994