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Dimetapp Infant Drops
Each 1 mL contains:
Brompheniramine Maleate 0.8mg
Phenylephrine Hydrochloride 1.0 mg
Dimetapp Infant Drops is a clear, purple-coloured liquid with grape odour and flavour; free from suspended matter and haze.
Dimetapp Infant Drops combines the decongestant action of phenylephrine with the antihistaminic action of brompheniramine.
Brompheniramine maleate appears to be well absorbed from the gastro-intestinal tract with peak plasma concentrations being achieved within about 5 hours. An elimination half-life of about 25 hours has been reported. It undergoes metabolism, with unchanged brompheniramine and metabolites being excreted primarily in the urine.
Phenylephrine has a low oral bioavailability owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver. The metabolites and their route and rate of excretion have not been identified.
Dimetapp Infant Drops temporarily relieves some of the symptomsof the common cold and allergies like hay fever.
Indicated for the temporary symptomatic relief of nasal and sinus congestion and runny nose associated with common colds and also for itchy, watery eyes and sneezing associated with allergies like hay fever.
Administer by mouth 0.15 mL per kilogram of body weight per dose every 6 to 8 hours. For a 5 kg infant this is 0.75 mL (the first mark on the dropper).
For infants between 1 and 6 months the dosage shown below should be used in consultation with a doctor:
1-3 months: 0.75 to 1.0 mL 6-8 hourly.
3-6 months: 1.0 to 1.25 mL 6-8 hourly.
For older children of average weight recommended dosage is:
6-12 months: 1.25 to 1.5 mL 6-8 hourly.
1 to 2 years: 1.5 to 2.0 mL 6-8 hourly.
2 to 4 years: 2.0 to 2.5 mL 6-8 hourly.
4 to 6 years: 2.5 to 3.0 mL 6-8 hourly.
DO NOT ADMINISTER TO CHILDREN UNDER 2 YEARS OF AGE WITHOUT MEDICAL ADVICE. DO NOT EXCEED RECOMMENDED DOSAGE.
Rinse the dropper well with hot water before returning it to the container, if it has come into contact with either milk or saliva.
This product should not be taken by patients with hypertension, heart disease, diabetes, thyroid disease, asthma, glaucoma or difficulty in urination due to enlargement of the prostate gland, except under the advice and supervision of a doctor. Patients are advised not to take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
A persistent cough may be a sign of a serious condition. If symptoms do not improve within 7 days (or within 48 hours in the case of children), tend to recur, or are accompanied by fever, rash, or persistent headache, patients should consult a doctor.
Due to the antihistamine content of Dimetapp Infant Drops, mild drowsiness may occur (less than 20 per cent of the population is affected). Therefore until the response has been determined the patient should be cautioned against engaging in operations requiring alertness, such as driving, or operating machinery. Alcohol, sedatives and tranquillisers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquillisers without first consulting their doctor. Patients should be warned about the additive effects with alcohol and other CNS depressants.
This product is not recommended for children under 12 months of age. This product should not be given to children under 2 years of age without medical advice.
Doses in excess of the recommended dosage may cause nervousness, dizziness or sleeplessness.
Safety in pregnancy has not been established, therefore Dimetapp Infant Drops should not be used in pregnant women, or those likely to become pregnant, unless under the advice of their doctor.
Use in Lactation: It is not known whether Dimetapp Infant Drops is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore Dimetapp Infant Drops is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.
Use in Children: Dimetapp Infant Drops should not be used in premature infants and those less than twelve months old. Do not administer Dimetapp Infant Drops to infants under 2 years of age without the advice of a doctor or pharmacist. In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions or death. As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.
Use in the Elderly (approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
As with other antihistamines, brompheniramine has an atropine-like action and therefore, should be used with caution in patients with: history of bronchial asthma; increased intraocular pressure; hyperthyroidism; cardiovascular disease; hypertension, narrow angle glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction.
Hypersensitivity reactions including skin rashes, urticaria, hypotension and thrombocytopenia have been reported on rare occasions. Severe hypertension too has been reported. As with other antihistamine preparations, drowsiness, lassitude, nausea, giddiness, dryness of the mouth, mydriasis, increased irritability or excitement may be encountered.
Sympathomimetics: Concomitant administration of phenylephrine with other sympathomimetic agents may cause a rise in blood pressure, as well as produce additive effects and increased toxicity.
Monoamine oxidase inhibitors: May produce a hypertensive crisis.
Anti-hypertensive agents: Use with certain antihypertensive agents may diminish their antihypertensive effect.
CNS Depressants: (Including alcohol, tricyclic antidepressants) - potentiation of the sedative effect.
In all cases of suspected overdose, immediately call the Poisons Information Centre.
Symptoms that may be associated with an overdose include: nervousness, dizziness, sleeplessness, ataxia, hallucinations and convulsions.
In the event of overdose, discontinue medication and seek medical help immediately.
Store below 25°C
Keep out of reach of children
Prescription Medicine
50mL bottle (with plastic dropper)
Dimetapp Infant Drops is pleasant tasting, grape flavoured and Sugar Free.
Contains Sodium Benzoate as preservative, Ethanol (Alcohol) 19 mg/mL (2.3% v/v), Citric Acid Anhydrous, dyes (Brilliant Blue FCF and Amaranth) and flavour (Grape flavour). Sugar Free (Contains Sorbitol). Gluten free.
Pharmacy Retailing (NZ) Limited
Trading as Healthcare logistics
58 Richard Pearce Drive
Airport Oaks
Auckland
For all enquiries please contact:
Wyeth Australia Pty Limited
17-19 Solent Circuit
Baulkham Hills NSW 2153
AUSTRALIA
Toll free telephone number: 0800 447 400 or email medinfo@wyeth.com
17 March 2008