Drugs List

Therapeutic Indications

Uses

Symptomatic relief of dry irritating coughs

Contraindications

Children under 12 years
Predisposition to respiratory failure
Productive cough
Within 2 weeks of discontinuing MAOIs
Acute asthma
Breastfeeding
Hereditary fructose intolerance
Respiratory failure
Severe hepatic impairment

Precautions and Warnings

Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
Pregnancy

Advise patient ability to drive or operate machinery may be impaired
Advise patient dizziness may affect ability to drive or operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Contains alcohol
Preparation contains sucrose
Advise patient not to exceed stated dose
Advise patient to consult a doctor if symptoms persist despite treatment

MHRA/CHM advice (February 2009)
Cough and cold remedies containing dextromethorphan should no longer be used in children under 6 as the balance of benefits and risk has not been shown to be favourable.
Medicines to treat cough and colds in older children (6 to 12) can be considered after basic principles of best care have been tried.
Products for children from 6 to 12 will continue to be available in pharmacies where advice can be given.

MHRA/CHM advice (March 2008)
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.

Pregnancy and Lactation

Pregnancy

Available human data on the reproductive effects of dextromethorphan do not demonstrate a major teratogenic risk. However, safety during pregnancy has not been established. The constituents of this product have been widely used for many years without any apparent adverse effects.

Use with caution only if essential.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Dextromethorphan with menthol administration should be avoided during breastfeeding.

It is not known of dextromethorphan or its metabolites are excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Constipation
Dizziness
Drowsiness
Gastro-intestinal discomfort
Nausea
Vomiting

Presentation

Oral formulation of dextromethorphan and menthol

Drugs List

Therapeutic Indications

Uses

Symptomatic relief of dry irritating coughs

Dosage

Adults

Elderly

Children

Contraindications

Children under 12 years
Predisposition to respiratory failure
Productive cough
Within 2 weeks of discontinuing MAOIs
Acute asthma
Breastfeeding
Hereditary fructose intolerance
Respiratory failure
Severe hepatic impairment

Precautions and Warnings

Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
Pregnancy

Advise patient ability to drive or operate machinery may be impaired
Advise patient dizziness may affect ability to drive or operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Contains alcohol
Preparation contains sucrose
Advise patient not to exceed stated dose
Advise patient to consult a doctor if symptoms persist despite treatment

MHRA/CHM advice (February 2009)
Cough and cold remedies containing dextromethorphan should no longer be used in children under 6 as the balance of benefits and risk has not been shown to be favourable.
Medicines to treat cough and colds in older children (6 to 12) can be considered after basic principles of best care have been tried.
Products for children from 6 to 12 will continue to be available in pharmacies where advice can be given.

MHRA/CHM advice (March 2008)
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.

Pregnancy and Lactation

Pregnancy

Available human data on the reproductive effects of dextromethorphan do not demonstrate a major teratogenic risk. However, safety during pregnancy has not been established. The constituents of this product have been widely used for many years without any apparent adverse effects.

Use with caution only if essential.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Dextromethorphan with menthol administration should be avoided during breastfeeding.

It is not known of dextromethorphan or its metabolites are excreted in breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.

Side Effects

Constipation
Dizziness
Drowsiness
Gastro-intestinal discomfort
Nausea
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: March 2013

Reference Sources

Summary of Product Characteristics: Covonia Bronchial Balsam. Thornton and Ross Ltd. Revised April 2012

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Updated advice - Over-the-counter cough and cold medicines for young children. Medicines and Healthcare products Regulatory Agency. 27th March 2008.
Available at: https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014446
Last accessed: March 27, 2013

Better medicines for children's coughs and colds. Medicines and Healthcare products Regulatory Agency. 28th February 2009.
Available at: https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014446
Last accessed: March 22, 2013

Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015