INFORMATION FOR HEALTH PROFESSIONALS
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DIMETAPP DM COLD & COUGH PAEDIATRIC DROPS:
Each 1 mL contains:
Brompheniramine Maleate 0.4mg
Phenylephrine Hydrochloride 1.0 mg
Dextromethorphan Hydrobromide 2.0 mg
Dimetapp DM Cold & Cough Paediatric Drops is a clear, red liquid with grape odour and flavour, free from suspended matter and haze.
Dimetapp DM Cold & Cough Paediatric Drops combines the decongestant action of phenylephrine with the antitussive action of the non-narcotic, centrally acting cough suppressant dextromethorphan and 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 3 to 5 hours. An elimination half-life of about 12 hours has been reported in children. It undergoes metabolism, with unchanged brompheniramine and metabolites being excreted primarily in the urine.
Dextromethorphan is rapidly absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites, one of which is active (dextrorphan). Peak plasma levels are achieved in approximately 2 to 2.5 hours, with a reported half-life of 1.4 to 2.9 hours.
Phenylephrine has a low oral bioavailability owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver. It undergoes metabolism, with unchanged phenylephrine and metabolites being excreted primarily in the urine. The reported elimination half-life is about 2 to 3 hours.
Dimetapp DM Cold & Cough Paediatric Drops suppresses coughs and temporarily relieves cold symptoms including nasal congestion, runny nose, itchy watery eyes, coughing and sneezing.
Indicated for the temporary symptomatic relief of allergic manifestations of upper respiratory tract illnesses, such as the common cold, seasonal allergies, sinusitis, rhinitis, conjunctivitis and otitis. It reduces inflammatory oedema, nasal congestion, and excessive upper respiratory tract secretions, thereby affording relief from nasal stuffiness and post nasal drip.
Infants up to 12 months: NOT RECOMMENDED
Dosage every 4 hours:
1 to 2 years: 1.6 to 2.0 mL (ONLY ON MEDICAL
ADVICE).
2 to 6 years: 2.5 mL
DO NOT EXCEED 6 DOSES IN 24 HOURS
Rinse the dropper well with hot water before returning it to the container, if it has come into contact with either milk or saliva.
i) Hypersensitivity to any of the ingredients.
ii) Hypertension or heart disease.
iii) Diabetes, thyroid disease or glaucoma.
iv) Patients who are taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI medication.
This product should not be taken by patients with hypertension, heart disease, diabetes, thyroid disease, 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 DM Cold & Cough Paediatric 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 DM Cold & Cough Paediatric Drops should not be used in pregnant women, or those likely to become pregnant, unless under the advice of their doctor.
It is not known wether this product is excreted in breast milk nor wether it has a harmful effect on the newborn. Therefore this product is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.
Dimetapp DM Cold & Cough Paediatric Drops should not be used in premature infants and those less than twelve months old. For children under 2 years of age, use only under medical advice. 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.
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. Hypertension, vomiting, increased heart rate, agitation, and abdominal pain has also been reported. As with other antihistamine preparations, dizziness, 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. Serious toxicity may result if this product is used with monoamine oxidase inhibitors.
Anti-hypertensive agents: Use with certain antihypertensive agents may diminish their antihypertensive effect.
CNS Depressants: (Including alcohol, tricyclic antidepressants) - May potentiate sedative effects.
In all cases of suspected overdose, immediately call the Poisons Information Centre.
Symptoms that may be associated with an overdose include: hypertension, nausea, vomiting, 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
50 mL bottle
Dimetapp DM Cold & Cough Paediatric Drops is pleasant tasting, grape flavoured and sugar free.
Dimetapp DM Cold & Cough Paediatric Drops also contain inactive ingredients such as Ethanol 96%, Citric acid, Dye Allura Red AC and Dye Brilliant Blue FCF, Glycerol, Grape Flavour Artificial 5-8994, Grape Flavour Artificial 11540, Propylene Glycol, Saccharin Sodium, Sodium Benzoate (as preservative), Sorbitol Solution 70% Crystallising and Water - Purified. 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 Consumer Healthcare Pty Limited
17-19 Solent Circuit
Baulkham Hills NSW 2153
AUSTRALIA
Toll free telephone number: 0800 447 400 or visit: www.dimetapp.co.nz
17 March 2008