Duro-Tuss/Duro-Tuss Forte

Duro-Tuss/Duro-Tuss Forte

pholcodine

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Pholcodine.
Description
Duro-Tuss: Each 15 mL of Oral Liquid contains: Pholcodine 15mg (0.1%w/v), Sorbitol 3.7 g, Sodium Benzoate 30mg as Preservative.
Each 15mL contains pholcodine 15mg; sugar free; contains sodium benzoate as preservative.
Sugar Free, Lactose Free, Gluten Free, Alcohol Free.
Duro-Tuss Forte: Each 5 mL of Oral Liquid contains: Pholcodine 15mg (0.3%w/v), Sorbitol 1.2g, Sodium Benzoate 10mg (0.2%w/v) as Preservative.
Each 5mL contains pholcodine 15mg; sugar free; contains sodium benzoate as preservative.
Sugar free, Lactose Free, Gluten Free.
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 to 10 hours. 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 bloodbrain barrier. It is metabolised in the liver and its action may be prolonged in hepatic insufficiency.
Indications/Uses
For relief of unproductive irritating coughs associated with the common cold, sinusitis, influenza and infections of the upper respiratory tract. Suitable for cough treatment for diabetics.
Dosage/Direction for Use
Duro-Tuss: Adults: 10-15mL every 8 to 10 hours.
Children: 5 to 14 years: 5 to 7.5 mL every 8 to 10 hours.
2 to 5 years: 1 mL per year of age every 8 to 10 hours.
Duro-Tuss Forte: Adults: 5mL every 8 to 10 hours.
Not recommended for children under 2 years of age except on the advice of a physician.
Overdosage
Symptoms include 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.
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.
Duro-Tuss/Duro-Tuss Forte contains sodium benzoate as a preservative.
Products containing sorbitol may have a laxative effect or cause diarrhoea.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Duro-Tuss/Duro-Tuss Forte with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe an opioid in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Duro-Tuss/Duro-Tuss Forte is used with benzodiazepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of benzodiazepines (See Interactions).
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concurrent use of Duro-Tuss/Duro-Tuss Forte with serotonergic drugs (See Interactions). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) and can be fatal (See Interactions). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that.
Discontinue Duro-Tuss/Duro-Tuss Forte if serotonin syndrome is suspected.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, decreased appetite, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement dosing of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Sexual Function/Reproduction: Long term use of opioids may be associated with decreased sex hormone levels and symptoms, such as low libido, erectile dysfunction, or infertility (See Postmarketing Experience under Adverse Reactions).
Use In Pregnancy & Lactation
Use in Pregnancy: Pholcodine has been taken by a large number of pregnant women and women of child bearing age without an increase in the frequency 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.
Adverse Reactions
Nausea and vomiting occasionally occur. After large doses, drowsiness, restlessness, excitement, ataxia and respiratory depression may occur.
Postmarketing Experience: Serotonin syndrome: (See Precautions).
Adrenal insufficiency: (See Precautions).
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.
Infertility: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.
Drug Interactions
Pholcodine may enhance the effects of CNS depressants.
Benzodiazepines: Due to additive pharmacologic effect, the concomitant use of opioids with benzodiazepines increases the risk of respiratory depression, profound sedation, coma and death.
The concomitant use of opioids and benzodiazepines increases the risk of respiratory depression because of actions at different respiratory depression because of actions at different receptor sites in the central nervous system that control respiration. Opioids interact primarily at μ-receptors, and benzodiazepines interact at GABAA sites. When opioids and benzodiazepines are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Reserve concomitant prescribing of these drugs for use in patients whom alternative treatment options are inadequate (See Precautions).
Limit dosage and duration of concomitant use of benzodiazepines and opioids, follow patients closely for respiratory depression and sedation.
Serotonergic Drugs: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Duro-Tuss/Duro-Tuss Forte if serotonin syndrome is suspected.
Examples of serotonergic drugs are selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g. mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (See Precautions).
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 oral liqd 0.1% w/v (a colourless, slightly viscous solution with fruity odour) x 90 mL. Duro-Tuss Forte oral liqd 0.3% w/v (a clear, yellow-orange, slightly viscous solution with odour of apricot) x 90 mL.
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