Duro-Tuss Regular/Duro-Tuss Forte

Duro-Tuss Regular/Duro-Tuss Forte

pholcodine

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Pholcodine.
Description
Duro-Tuss Regular/Duro-Tuss Forte also contains methyl hydroxybenzoate as preservative.
Action
Pharmacology: Pholcodine is an opioid chemically related to morphine. Pholcodine is a cough suppressant and has a mild sedative effect which relieves local irritation of the respiratory tract over 8-10 hrs.
Pholcodine acts primarily on the CNS causing depression of the cough reflex which is due partly to the direct effect on the cough centre in the medulla.
Pholcodine has little or no analgesic action.
Unlike morphine, codeine and dihydrocodeine, therapeutic doses of pholcodine do not cause depression of respiration, CNS excitation, constipation or other side effects associated with narcotics. Pholcodine has a selective effect on the cough centre without affecting the respiratory centre.
Pholcodine is not euphorigenic, therefore, psychological dependence is unlikely to be a problem. There is no evidence of physical dependence after prolonged administration of pholcodine so it is not likely to be habit-forming.
Pharmacokinetics: Pholcodine is readily absorbed from the gastrointestinal tract and does cross the blood-brain barrier. It is metabolised in the liver and its action may be prolonged in hepatic insufficiency.
Indications/Uses
For the relief of nonproductive, irritating coughs associated with the common colds, sinusitis, influenza and infections of the upper respiratory tract. Suitable for cough treatment for diabetics.
Dosage/Direction for Use
Duro-Tuss Regular: Adults: 10-15 mL.
Children 5-14 years: 5-7.5 mL; 2-5 years: 1 mL per year of age.
Duro-Tuss Forte: Adults: 5 mL.
All doses to be taken every 8-10 hrs.
Not recommended for children <2 years except on the advice of a physician.
Overdosage
Symptoms: Drowsiness, restlessness, excitement, ataxia and respiratory depression.
Treatment: Should be symptomatic. Ventilation may be required.
Contraindications
Intolerance or hypersensitivity to pholcodine or any other component of Duro-Tuss Regular/Duro-Tuss Forte.
Special Precautions
Pholcodine should be used with caution in patients who have decreased respiratory reserve.
Pholcodine depresses the respiratory centre to some extent and should be used with caution in asthmatics. Since pholcodine is metabolised in the liver, its action may be prolonged in hepatic insufficiency. The dosage and frequency may need to be reduced in patients with impaired liver function.
Methyl hydroxybenzoate has been known to cause sensitisation. Hypersensitivity reactions due to Duro-Tuss Regular/Duro-Tuss Forte or any of its components may occur in susceptible individuals.
Use in pregnancy: Pholcodine has been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Use in lactation: No information is available as to whether pholcodine is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore, it is not recommended for nursing mothers unless the expected benefit to the mother outweighs any potential risks to the infant.
Use in children: Not recommended for children under 2 years except on physician's advice.
Adverse Reactions
Nausea and vomiting occasionally occur. After large doses, drowsiness, restlessness, excitement, ataxia and respiratory depression may occur.
Drug Interactions
Pholcodine may enhance the effects of CNS depressants.
Storage
Store below 30°C.
Shelf-Life: 2 years.
ATC Classification
R05DA08 - pholcodine ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
Presentation/Packing
Duro-Tuss Regular: Oral soln 0.1% (tropical fruits-flavoured, sugar-free) x 100 mL x 1's.
Duro-Tuss Forte: Oral soln 0.3% (apricot-flavoured, sugar-free) x 100 mL x 1's, 500 mL x 1's.
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