Drugs List

Therapeutic Indications

Uses

Influenza - treatment of symptoms
Symptomatic relief of nasal congestion
Symptoms of common cold

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Galactosaemia
Severe hypertension
Severe ischaemic heart disease

Precautions and Warnings

Benign prostatic hyperplasia
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Glaucoma
Glucose-galactose malabsorption syndrome
Hypertension
Hyperthyroidism
Lactose intolerance
Pregnancy
Severe hepatic impairment
Severe renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Contains lactose
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 pseudoephedrine 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.

Pregnancy and Lactation

Pregnancy

Pseudoephedrine with triprolidine should be used with caution in pregnancy.

The manufacturer notes that pseudoephedrine and triprolidine have been used during pregnancy for many years with no adverse reactions being reported. However there have been no specific studies of their use during pregnancy.

Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

Pseudoephedrine is known to slow uterine blood flow, but the effect has not been sufficiently studied in relation to human reproduction. Studies have shown the possibility of ventricular septal defects due to vasoconstrictive effects, as well as possible increased risk of gastroschisis, small intestinal atresia and hemifacial microsomia, primarily from exposure in the first trimester, and probably only when it is used in combination with other products. It should therefore be avoided in the first trimester, and is not recommended for use in pregnancy. Inadvertent use is not an indication for the termination of pregnancy (Schaefer et al 2007).

Systemic administration of triprolidine in rats and rabbits up to 75 times the human dose did not produce teratogenic effects.

Human pregnancy experience with triprolidine suggests low risk. It is not known if triprolidine crosses the human placenta. The molecular weight (about 279 for the non-hydrated free base) suggests that exposure of the embryo-foetus should be expected.

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

Pseudoephedrine with triprolidine should be used with caution in breastfeeding.

The manufacturer notes that pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breastfed infants is not known. It has been estimated that approximately 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.

Medications and Mothers' Milk has stated that the relative infant dose is less than 1.8% of the weight-normalized maternal dose. This dose is far too low to be clinically relevant.

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

CNS depression
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Excitability
Hallucinations
Rash
Skin irritation
Sleep disturbances
Tachycardia
Urinary retention

Presentation

Tablets containing pseudoephedrine hydrochloride and triprolidine hydrochloride

Drugs List

Therapeutic Indications

Uses

Influenza - treatment of symptoms
Symptomatic relief of nasal congestion
Symptoms of common cold

Dosage

Adults

Elderly

Children

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Galactosaemia
Severe hypertension
Severe ischaemic heart disease

Precautions and Warnings

Benign prostatic hyperplasia
Breastfeeding
Cardiovascular disorder
Diabetes mellitus
Glaucoma
Glucose-galactose malabsorption syndrome
Hypertension
Hyperthyroidism
Lactose intolerance
Pregnancy
Severe hepatic impairment
Severe renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Contains lactose
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 pseudoephedrine 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.

Pregnancy and Lactation

Pregnancy

Pseudoephedrine with triprolidine should be used with caution in pregnancy.

The manufacturer notes that pseudoephedrine and triprolidine have been used during pregnancy for many years with no adverse reactions being reported. However there have been no specific studies of their use during pregnancy.

Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

Pseudoephedrine is known to slow uterine blood flow, but the effect has not been sufficiently studied in relation to human reproduction. Studies have shown the possibility of ventricular septal defects due to vasoconstrictive effects, as well as possible increased risk of gastroschisis, small intestinal atresia and hemifacial microsomia, primarily from exposure in the first trimester, and probably only when it is used in combination with other products. It should therefore be avoided in the first trimester, and is not recommended for use in pregnancy. Inadvertent use is not an indication for the termination of pregnancy (Schaefer et al 2007).

Systemic administration of triprolidine in rats and rabbits up to 75 times the human dose did not produce teratogenic effects.

Human pregnancy experience with triprolidine suggests low risk. It is not known if triprolidine crosses the human placenta. The molecular weight (about 279 for the non-hydrated free base) suggests that exposure of the embryo-foetus should be expected.

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

Pseudoephedrine with triprolidine should be used with caution in breastfeeding.

The manufacturer notes that pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breastfed infants is not known. It has been estimated that approximately 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.

Medications and Mothers' Milk has stated that the relative infant dose is less than 1.8% of the weight-normalized maternal dose. This dose is far too low to be clinically relevant.

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

CNS depression
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Excitability
Hallucinations
Rash
Skin irritation
Sleep disturbances
Tachycardia
Urinary retention

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: January 2015.

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.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 22 January 2015.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 22 January 2014.

Summary of Product Characteristics: Multi-Action Actifed tablets. McNeil Products Limited. revised October 2009.

Reference:
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: 22 January 2015.