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Dexfen Syrup
DESCRIPTION
Orange coloured syrup having fruity flavour.
COMPOSITION
Each 5 ml contains dextromethorphan hydrobromide 15 mg.
ACTION AND PHARMACOLOGY
Dextromethorphan is an established antitussive agent which acts to relieve
and suppress coughing.
Pharmacodynamics:
Dextromethorphan is a non-opioid antitussive drug. It exerts its antitussive
activity by acting on the cough centre in the medulla oblongata, raising the
threshold for the cough reflex.
Pharmacokinetics:
Following oral administration, dextromethorphan is well absorbed from the
gut. Pharmacokinetic values are highly variable due to individual
differences in the metabolism of dextromethorphan.
Dextromethorphan undergoes rapid
and extensive first-pass metabolism in the liver after oral administration.
Unmetabolised dextromethorphan, together with the three demethylated
morphinan metabolites dextrophan (also known as 3-hydroxy- methylmorphinan)
3-hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated
products in the urine. Dextrorphan is the main metabolite which has
antitussive action.
INDICATIONS
Indicated as an antitussive, for the control of non-productive cough or
relief of persistent, dry, irritating cough.
CONTRAINDICATIONS
Dexfen syrup is contraindicated in patients with allergy/ hypersensitivity
to any of the ingredients of Dexfen syrup. It is also contraindicated in
individuals who are taking, or have taken, monoamine oxidase inhibitors
within the preceding two weeks. The concomitant use of a dextromethorphan-containing
product and monoamine oxidase inhibitors, can occasionally result in
symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.
SIDE EFFECTS
Generally minimal side effects at recommended dosage. Occasionally,
drowsiness, dizziness, excitation, mental confusion and gastrointestinal
disturbance.
WARNING
Not suitable to be used in children below 2 years.
For children between 2 to 6 years old - use with caution and follow the
advice given by the doctor or pharmacist.
PRECAUTIONS
Patients with high fever, skin rash (allergy), headache, nausea or vomiting
should consult a physician. It should be used with caution in patients with
liver disease. Do not take Dexfen syrup for chronic cough or chronic cough
due to heavy smoking, emphysema, asthma or if cough is accompanied by
excessive phlegm (mucus).
PREGNANCY & LACTATION
Although dextromethorphan has been in widespread use for many years without
apparent ill consequence, there is insufficient information on the effects
of administration during human pregnancy. It is not known whether
dextromethorphan or its metabolites are excreted in breast milk. Therefore,
it should only be used when the potential benefit of the treatment to the
mother exceeds any possible hazards to the developing foetus or suckling
infant.
DRUG INTERACTION
Dextromethorphan hydrobromide may interact with MAOIs. The concomitant use
of a dextromethorphan-containing product and monoamine oxidase inhibitors
can occasionally result in symptoms such as hyperpyrexia, hallucinations,
gross excitation or coma.
DOSAGE AND ADMINISTRATION
Adults and children over 12 years:
30 mg (or 10ml) every 6 to 8 hours, to a usual maximum of 120 mg (or 40ml)
in 24 hours.
Children aged 6 to 12 years:
15 mg (or 5ml) every 6 to 8 hours to a maximum of 60 mg (or 20ml) in 24
hours.
OVERDOSAGE AND TREATMENT
Overdosage may lead to drowsiness, excitation, confusion, lethargy,
nystagmus, ataxia, respiratory depression, nausea, vomiting, and
hyperactivity. There is no specific antidote for an overdose, therefore,
treatment of the patients consist of symptomatic and supportive therapy.
PRESENTATION
Bottle of 120 ml and 60 ml.
STORAGE
Store in a dry place below 25°C. Keep container tightly closed. Protect from
light. Keep out of reach of children.
SHELF-LIFE
3 years. |
