Drugs List

Therapeutic Indications

Uses

Cough with viscous sputum
Night time relief of cough

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Hereditary fructose intolerance

Precautions and Warnings

Asthma
Benign prostatic hyperplasia
Breastfeeding
Chronic cough
Excessive bronchial secretions
Glucose-galactose malabsorption syndrome
Hepatic impairment
Narrow angle glaucoma
Porphyria
Pregnancy
Renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Contains glucose
Preparation contains sucrose
May affect results of some laboratory tests
Advise patient to avoid alcohol during treatment
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 guaifenesin, diphenhydramine hydrochloride and levomenthol should no longer be used in children under 6 as the balance of benefits and risk has not been shown to be favourable.

However, the MHRA/CHM also lists a number of combination products which are being phased out from the market for use in children under 12 years. This product is included on this list, therefore, it is not recommended for children up to the age of 12 years.

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.

Use in Porphyria

Guaifenesin is considered to be possibly porphyrinogenic and therefore, it should be used only when no safer alternative is available.

Diphenhydramine
Martindale says diphenhydramine has been associated with acute attacks. NAPOS website has not yet classified the drug and advises, therefore, it is not used. However 'European Porphyria Iniciative' and 'Welsh Medicines Information Porphyria' classifies the drug as safe.

Pregnancy and Lactation

Pregnancy

Guaifenesin with diphenhydramine and levomenthol should be used with caution in pregnancy.

Animal data and most published human experience suggest that diphenhydramine does not cause complications in pregnancy. There is one report of a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.

There is insufficient information available to determine if guaifenesin has teratogenic or mutagenic potential. There is no data to support an association between guaifenesin and congenital defects.

Animal studies show that menthol does not produce statistically significant teratogenic effects in rats, rabbits and mice, and has no mutagenic potential.

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 to 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

Guaifenesin with diphenhydramine and levomenthol should be used with caution in breastfeeding.

Diphenhydramine should not be used during lactation as small amounts of antihistamines are excreted in breast milk. Data is limited in humans but expected breast milk concentrations are not thought to be sufficiently high to affect a nursing infant.

At the time of writing, there is no published experience concerning the use of guaifenesin during breast feeding. Guaifenesin is excreted in breast milk in small amounts with no effects expected on the infant.

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

Angioedema
Blurred vision
Convulsions
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Erythema
Gastro-intestinal symptoms
Hypersensitivity reactions
Nausea
Palpitations
Paraesthesia
Rash
Tremor
Urticaria
Vomiting

Presentation

Oral formulation containing guaifenesin, diphenhydramine hydrochloride and levomenthol

Drugs List

Therapeutic Indications

Uses

Cough with viscous sputum
Night time relief of cough

Dosage

Adults

Children

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Hereditary fructose intolerance

Precautions and Warnings

Asthma
Benign prostatic hyperplasia
Breastfeeding
Chronic cough
Excessive bronchial secretions
Glucose-galactose malabsorption syndrome
Hepatic impairment
Narrow angle glaucoma
Porphyria
Pregnancy
Renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Contains glucose
Preparation contains sucrose
May affect results of some laboratory tests
Advise patient to avoid alcohol during treatment
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 guaifenesin, diphenhydramine hydrochloride and levomenthol should no longer be used in children under 6 as the balance of benefits and risk has not been shown to be favourable.

However, the MHRA/CHM also lists a number of combination products which are being phased out from the market for use in children under 12 years. This product is included on this list, therefore, it is not recommended for children up to the age of 12 years.

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.

Use in Porphyria

Guaifenesin is considered to be possibly porphyrinogenic and therefore, it should be used only when no safer alternative is available.

Diphenhydramine
Martindale says diphenhydramine has been associated with acute attacks. NAPOS website has not yet classified the drug and advises, therefore, it is not used. However 'European Porphyria Iniciative' and 'Welsh Medicines Information Porphyria' classifies the drug as safe.

Pregnancy and Lactation

Pregnancy

Guaifenesin with diphenhydramine and levomenthol should be used with caution in pregnancy.

Animal data and most published human experience suggest that diphenhydramine does not cause complications in pregnancy. There is one report of a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.

There is insufficient information available to determine if guaifenesin has teratogenic or mutagenic potential. There is no data to support an association between guaifenesin and congenital defects.

Animal studies show that menthol does not produce statistically significant teratogenic effects in rats, rabbits and mice, and has no mutagenic potential.

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 to 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

Guaifenesin with diphenhydramine and levomenthol should be used with caution in breastfeeding.

Diphenhydramine should not be used during lactation as small amounts of antihistamines are excreted in breast milk. Data is limited in humans but expected breast milk concentrations are not thought to be sufficiently high to affect a nursing infant.

At the time of writing, there is no published experience concerning the use of guaifenesin during breast feeding. Guaifenesin is excreted in breast milk in small amounts with no effects expected on the infant.

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

Angioedema
Blurred vision
Convulsions
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Erythema
Gastro-intestinal symptoms
Hypersensitivity reactions
Nausea
Palpitations
Paraesthesia
Rash
Tremor
Urticaria
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: May 2016

Reference Sources

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.
Summary of Product Characteristics: Benylin Mucus Cough Night. Revised January 2012.

Dear Healthcare Professional Letter. Medicines and Healthcare products Regulatory Agency. 28th February 2009.
https://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON038904&RevisionSelectionMethod=LatestReleased
Last accessed: 26 May 2016.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Diphenhydramine; Last revised: 7 September 2013
Last accessed: 26 May 2016

The Welsh Medicines Information Centre (WMIC) - Porphyria Information Service.
Available at: https://www.wmic.wales.nhs.uk/porphyria_info.php
Last accessed: 26 May 2016

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
Last accessed: 26 May 2016

European Porphyria Network (EpNet).
Available at: https://www.porphyria-europe.com/03-drugs/warning.asp?strPageRub=selecting-drugs.asp
Last accessed: 26 May 2016

The Drug Database for Acute Porphyria (NAPOS)
Available at: https://www.drugs-porphyria.org
Last accessed: 13 July 2015
Last revised: 23 April 2010