Duro-Tuss Expectorant

Duro-Tuss Expectorant

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Bromhexine hydrochloride, pholcodine.
Description
Each 15mL contains pholcodine 15mg, bromhexine hydrochloride 12mg, sugar free, contains methyl hydroxybenzoate 0.1% w/v and propyl hydroxybenzoate 0.02% w/v as preservatives.
Sugar free.
Action
Pharmacology: Cough suppressant and mucolytic giving relief over 8 to 10 hours.
Pholcodine: 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. 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.
Bromhexine hydrochloride: Bromhexine is an effective oral mucolytic agent with a low level of associated toxicity. Bromhexine is not an expectorant but it has been demonstrated to aid expectoration. Bromhexine alters the structure of bronchial secretions. It has been shown to reduce the viscosity and increase the volume of sputum (or mucus) secretion in chronic chest disease. Bromhexine acts on the mucus at the formative stages in the glands, within the mucus-secreting cells. It has been demonstrated that bromhexine alters the structure of acid mucopolysaccharide fibres (AMPS) which are found in mucoid sputum. It is these fibres which are thought to be responsible for the viscosity of such secretions. By fragmenting the acid mucopolysaccharide fibres bromhexine produces a less viscous mucus, which is thinner, watery, more mobile and hence much easier to expectorant.
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. Bromhexine is well absorbed from the gastrointestinal tract. Most of the dose is excreted in urine mainly as metabolised; only a small amount is excreted in the faeces.
Indications/Uses
To avoid excessive coughing while enabling more effective expectoration when coughing occurs in bronchitis and other respiratory conditions that result in the production of tenacious mucoid sputum which is difficult to expectorate.
Dosage/Direction for Use
Dose: Up to 3 times a day;
Adults: 10 - 15 mL.
Children: 6 to 12 years: 5 to 10 mL; 2 to 5 years: 2.5 - 5 mL.
Under 2 years: consult a doctor.
Overdosage
Symptoms include restlessness, drowsiness, excitement and ataxia.
Treatment should be asymptomatic. Ventilation may be required.
Contraindications
Intolerance or hypersensitivity to either pholcodine or bromhexine or any other component.
Special Precautions
Bromhexine should be given cautiously to patients with gastric ulceration.
Duro-Tuss Expectorant contains methyl hydroxybenzoate and propyl hydroxybenzoate as preservatives.
They have been known to cause sensitization.
Hypersensitivity reactions due to the product or any of its components may occur in susceptible individuals.
Very rare cases of chronically associated severe skin impairments such as Stevens Johnson Syndrome, Toxic Epidermal Necrosis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported. In most cases, these could be explained by the severity of the underlying disease or concomitant administration of another drug. In the early stages of such severe skin reactions, initially only nonspecific flu-like symptoms appear, e.g. fever, arthralgia, runny rose, cough, and sore throat. If skin or mucous membrane damage occurs, seek medical advice immediately and discontinue treatment as a precaution.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Duro-Tuss Expectorant 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 Expectorant 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 Expectorant with serotonergic drugs (See Interactions). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status change (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 Expectorant 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: Safety for use in pregnancy has not been established, therefore the potential benefits to the mother should be weighed against the possible risks to the child. Pholcodine and bromhexine have been taken by a large number of pregnant women and women of child-bearing 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: 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 infants.
Adverse Reactions
Pholcodine may occasionally cause nausea and vomiting. After large doses, restlessness, drowsiness, excitement and ataxia may occur. Gastrointestinal side effects such as nausea, diarrhoea, indigestion and abdominal fullness may occasionally occur with bromhexine. Instances of headache, vertigo, perspiration, skin rash, respiratory depression and a transient rise in serum aminotransferase values have been reported.
Immune System Disorders: Frequency not known: Anaphylactic reactions including anaphylactic shock.
Skin and Subcutaneous Skin Disorders: Frequency not known: Severe skin reactions (including Stevens Johnson syndrome, Toxic epidermal necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP).
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 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 for whom alternative treatment options are inadequate (see Precautions). Limit dosage and duration of concomitant use of benzodiazepines and opioids, and 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 Expectorant 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.
ATC Classification
R05FA01 - opium derivatives and mucolytics ; Belongs to the class of combinations of opium derivatives cough suppressants and expectorants. Used in the treatment of cough.
Presentation/Packing
Oral soln (clear green, slightly viscous liquid; grenadine flavoured) 90 mL.
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