ROBITUSSIN COUGH AND CHEST CONGESTION Oral solution Ref.[50683] Active ingredients: Demorphan Guaifenesin

Robitussin Cough & Chest Congestion

a) should be used with caution in patients with:

• porphyria, as guaifenesin is possibly porphyrogenic
• in patients with a history of asthma

b) should not be used in patients with:

• a chronic persistent cough accompanying a disease state or for cough associated with excessive secretions
• or at risk of developing respiratory failure, e.g. asthma, chronic obstructive pulmonary disease (COPD), emphysema or smoker’s cough or pneumonia.

Serotonin Syndrome

Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRls), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOls)) and CYP 2D6 inhibitors.

Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/ or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Robitussin Cough & Chest Congestion should be discontinued.

Cases of dextromethorphan abuse and dependence have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.

This product should be kept out of reach of children.

The recommended dosage should not be exceeded.

Use in children

Serious adverse events may occur in children in case of overdose including neurological disorders. Caregivers should be advised not to exceed the recommended dose.

There are no reported interactions with other medicines and guaifenesin.

The following interactions with dextromethorphan have been noted:

Dextromethorphan should not be used in patients taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson’s disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription medication contains one of these drugs, ask a doctor or pharmacist before taking this product.

The use of dextromethorphan with, or within two weeks of taking MAOIs, may increase the risk of serious side effects such as hypertensive crisis, hyperpyrexia and convulsions.

Dextromethorphan when used with SSRI’s (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine) may result in a “serotonin syndrome” with changes in mental status, hypertension, restlessness, myoclonus, hyperreflexia, diaphoresis, shivering and tremor.

Serum levels of dextromethorphan may be increased by the concomitant use of inhibitors of cytochrome P450 2D6, such as the antiarrhythmics quinidine and amiodarone, antidepressants such as fluoxetine and paroxetine, or other drugs which inhibit cytochrome P450 2D6 such as haloperidol and thioridazine.

Concomitant use of dextromethorphan and other CNS depressants (e.g. alcohol, narcotic analgesics and tranquillizers) may increase the CNS depressant effects of these drugs.

Pregnancy

Category A: The active ingredients in Robitussin Cough & Chest Congestion have been taken by large number of pregnant women or women of childbearing age, without any proven increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Breast-feeding

It is not known whether dextromethorphan or guaifenesin are excreted in breast milk or whether they have a harmful effect on the breastfeeding infant. Robitussin Cough & Chest Congestion is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

It is recommended to consult a healthcare professional before using Robitussin Cough & Chest Congestion if pregnant, trying to become pregnant or breastfeeding.

Fertility

Not available.

Risk of impairment is increased when dextromethorphan is taken concurrently with alcohol or medicines that can impair reaction times.

Immune system disorders: Hypersensitivity

Nervous system disorders: Drowsiness, fatigue, dizziness, headache

Gastrointestinal disorders: Nausea or vomiting, stomach discomfort, constipation, diarrhoea and stomach pain

Skin disorders: Rash

Other disorders: Dystonia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/

Not available.