Duro-Tuss Dry Cough Lozenges

Duro-Tuss Dry Cough Lozenges

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Pholcodine, cetylpyridinium chloride.
Description
Each lozenge contains pholcodine 5.5 mg and cetylpyridinium chloride 1.33 mg. It also contains isomalt and saccharin sodium as inactive ingredients.
Action
Pholcodine: Pholcodine is an opioid chemically related to morphine. It is a cough suppressant and has a mild sedative effect which relieves local irritation of the respiratory tract.
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.
Isomalt: Isomalt is a sugar substitute. It is a disaccharide alcohol and is an approximately equimolar mixture of glucose-mannitol and glucose-sorbitol. Isomalt produces no measurable changes in blood glucose levels.
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
Suppression of unproductive coughs and soothe sore throats. To reduce bacteria responsible for coughs and sore throats.
Dosage/Direction for Use
Adults and Children >12 years: Slowly dissolve 2 lozenges in the mouth (1 at a time). Then dissolve 1 or 2 lozenges in the mouth as required during each 3-hr period. Do not take >12 lozenges/day.
Children 5-12 years: Slowly dissolve 1 lozenge in the mouth as required every 3 hrs. Do not take >6 lozenges/day.
Overdosage
Symptoms include drowsiness, restlessness, excitement, ataxia and respiratory depression. Excess consumption of products containing isomalt may have a laxative effect.
Contraindications
Intolerance or hypersensitivity to pholcodine or cetylpyridinium chloride or any other component of Duro-Tuss Dry Cough Lozenges.
Special Precautions
Excess consumption of products containing isomalt may have a laxative effect.
Use in pregnancy: Pholcodine and cetylpyridinium chloride have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Use in lactation: Safety for use in nursing mothers has not been established. Therefore, the potential benefits to the mother should be weighed against the possible risks to the infant.
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: 3 years.
ATC Classification
R05DA08 - pholcodine ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
Presentation/Packing
Lozenge (sugar-free, orange flavour) 24's.
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