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Pseudoephedrine + triprolidine oral


Tablets containing pseudoephedrine hydrochloride and triprolidine hydrochloride

Drugs List

  • pseudoephedrine 60mg and triprolidine 2.5mg tablets
  • Therapeutic Indications


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



    One tablet every 4 to 6 hours up to 4 times daily.


    One tablet every 4 to 6 hours up to 4 times daily.


    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.

    Children over 12 years
    One tablet every 4 to 6 hours up to 4 times daily.


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

    Precautions and Warnings

    Benign prostatic hyperplasia
    Cardiovascular disorder
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    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


    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 ( ) or if this is unavailable at the backup site ( ).


    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

    Side Effects

    CNS depression
    Dry mouth
    Dry throat
    Dryness of nose
    Skin irritation
    Sleep disturbances
    Urinary retention


    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 ( ) or if this is unavailable at the backup site ( ).

    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.

    Dear Healthcare Professional Letter. Medicines and Healthcare products Regulatory Agency. 28th February 2009.
    Last accessed: 22 January 2015.

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