Drugs List

Therapeutic Indications

Uses

Nasal congestion (topical treatment)
Rhinitis - allergic
Rhinitis - perennial
Sinusitis

Contraindications

Children under 6 years
Central nervous system surgery
Trans-sphenoidal hypophysectomy

Precautions and Warnings

Children 6 to 12 years
Within 2 weeks of discontinuing MAOIs
Benign prostatic hyperplasia
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Hereditary fructose intolerance
Hypertension
Hyperthyroidism
Narrow angle glaucoma
Phaeochromocytoma
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for use in children under 12 years
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain benzalkonium chloride
Avoid spray in or near eyes
Prolonged use may cause rebound congestion
Maximum treatment 5 days for children under 12 years
Maximum treatment 7 days unless on doctor's advice
Should not be taken with other cough or cold medicine

MHRA/CHM advice (February 2009)

Cough and cold remedies containing xylometazoline 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

Use xylometazoline with caution in pregnancy.

The manufacturers report that there have been no animal studies for the foetal toxicity or fertility effects of xylometazoline. However, as this medicine is a vasoconstrictor, in large doses it has the potential to decrease the blood flow to the foetus. Schaeffer, Peters & Miller (2007) state that if topical nasal decongestants are needed during pregnancy xylometazoline may be used. The dosage and treatment interval should be kept as low as possible. Physiological sodium chloride solution or steam inhalation may be considered as alternatives.

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

Use xylometazoline with caution in breastfeeding.

At the time of writing, there is no published experience concerning the use of xylometazoline hydrochloride during breastfeeding. For this reason caution in use is advised while breastfeeding. Physiological sodium chloride solution or steam inhalation may be considered as alternatives.

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

Allergic reaction
Burning sensation (local)
Cardiovascular effects
CNS effects
Dizziness
Hallucinations
Headache
Insomnia
Irritation (localised)
Itching sensation (local)
Nasal dryness and stinging
Nausea
Palpitations
Rebound congestion
Restlessness
Sleep disturbances
Sneezing
Sore nose
Tolerance with diminished effect
Visual disturbances

Presentation

Nasal formulations containing xylometazoline hydrochloride

Drugs List

Therapeutic Indications

Uses

Nasal congestion (topical treatment)
Rhinitis - allergic
Rhinitis - perennial
Sinusitis

Dosage

Adults

Elderly

Children

Contraindications

Children under 6 years
Central nervous system surgery
Trans-sphenoidal hypophysectomy

Precautions and Warnings

Children 6 to 12 years
Within 2 weeks of discontinuing MAOIs
Benign prostatic hyperplasia
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Hereditary fructose intolerance
Hypertension
Hyperthyroidism
Narrow angle glaucoma
Phaeochromocytoma
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for use in children under 12 years
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain benzalkonium chloride
Avoid spray in or near eyes
Prolonged use may cause rebound congestion
Maximum treatment 5 days for children under 12 years
Maximum treatment 7 days unless on doctor's advice
Should not be taken with other cough or cold medicine

MHRA/CHM advice (February 2009)

Cough and cold remedies containing xylometazoline 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

Use xylometazoline with caution in pregnancy.

The manufacturers report that there have been no animal studies for the foetal toxicity or fertility effects of xylometazoline. However, as this medicine is a vasoconstrictor, in large doses it has the potential to decrease the blood flow to the foetus. Schaeffer, Peters & Miller (2007) state that if topical nasal decongestants are needed during pregnancy xylometazoline may be used. The dosage and treatment interval should be kept as low as possible. Physiological sodium chloride solution or steam inhalation may be considered as alternatives.

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

Use xylometazoline with caution in breastfeeding.

At the time of writing, there is no published experience concerning the use of xylometazoline hydrochloride during breastfeeding. For this reason caution in use is advised while breastfeeding. Physiological sodium chloride solution or steam inhalation may be considered as alternatives.

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

Allergic reaction
Burning sensation (local)
Cardiovascular effects
CNS effects
Dizziness
Hallucinations
Headache
Insomnia
Irritation (localised)
Itching sensation (local)
Nasal dryness and stinging
Nausea
Palpitations
Rebound congestion
Restlessness
Sleep disturbances
Sneezing
Sore nose
Tolerance with diminished effect
Visual disturbances

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 2016

Reference Sources

Drugs during Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd Edition, ed. Schaefer, Peters & Miller, Academic Press, London 2007.

Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.

Paediatric Formulary Committee. BNF for Children 2015-2016. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2015.

Summary of Product Characteristics: Otrivine Allergy Relief 0.1% Nasal Spray. Novartis Consumer Health. Revised May 2013.
Summary of Product Characteristics: Otrivine Adult Measured Dose Sinusitis Spray. Novartis Consumer Health. Revised May 2013.
Summary of Product Characteristics: Otrivine Adult Nasal Drops. Novartis Consumer Health. Revised September 2013.
Summary of Product Characteristics: Otrivine Adult Nasal Spray. Novartis Consumer Health. Revised July 2013.
Summary of Product Characteristics: Otrivine Child Nasal Drops. Novartis Consumer Health. Revised September 2013.
Summary of Product Characteristics: Otrivine Congestion Relief 0.1% Nasal Spray. Novartis Consumer Health. Revised July 2014.
Summary of Product Characteristics: Sudafed Congestion Relief 0.1% Nasal Spray. McNeil Ltd. Revised June 2015.
Summary of Product Characteristics: Sudafed Blocked Nose Nasal Spray. McNeil Ltd. Revised June 2015.
Summary of Product Characteristics: Sudafed Mucus Relief 0.1% Nasal Spray. McNeil Ltd. Revised June 2015.

Dear Healthcare Professional Letter. Medicines and Healthcare products Regulatory Agency. February 28th, 2009.
Available at: https://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON038904&RevisionSelectionMethod=LatestReleased
Last accessed: 9 March 2016

Press Release: Updated advice - Over-the-counter cough and cold medicines for young children. Medicines and Healthcare products Regulatory Agency. March 27th, 2008.
Available at: https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014446
Last accessed: 9 March 2016