Drugs List

Therapeutic Indications

Uses

Rhinitis - allergic

Contraindications

Children under 12 years
Elderly
Within 2 weeks of discontinuing MAOIs
First trimester of pregnancy
Galactosaemia
Severe cardiac disorder
Severe hypertension
Severe renal impairment

Precautions and Warnings

Benign prostatic hyperplasia
Breastfeeding
Cardiac disorder
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hypertension
Hyperthyroidism
Lactose intolerance
Moderate renal impairment
Raised intra-ocular pressure
Second trimester of pregnancy
Third trimester of pregnancy

Advise impaired alertness may affect ability to drive or operate machinery
Contains lactose
May potentiate effect of CNS depressants
Advise patient to avoid alcohol during treatment

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 acrivastine is contraindicated in the first trimester of pregnancy.

Use pseudoephedrine with acrivastine with caution in the second and third trimesters of pregnancy.

The manufacturer has noted that there is no information available on the effects of administration of this product during human pregnancy and it should not, therefore, be used during pregnancy unless the potential benefit of treatment to the mother outweighs any possible risk to the developing foetus.

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 in combination with other products. It should, therefore, be avoided in the first trimester and is generally not recommended for use in pregnancy. Inadvertent use is not an indication for termination (Schaefer et al 2007).

There is no information on the use of acrivastine in human pregnancy. Animal studies did not produce embryotoxic or teratogenic effects and did not show altered fertility.

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 pseudoephedrine with acrivastine with caution in breastfeeding.

The majority of coughs and colds will get better on their own, and medicines may not help. Consider measures such as rest and increased fluid intake in preference to medicine whilst breastfeeding. The active ingredients in this product are discussed below.

Pseudoephedrine is excreted in breast milk in amounts small enough to be considered safe in occasional doses. It is unlikely that it will harm the infant but may cause occasional irritability, restlessness or mild sedation. Some data suggests that it may inhibit milk production significantly and repeated use may interfere with lactation. It is, therefore, not recommended for use in cases where lactation is not yet well established or where mothers are having difficulties producing sufficient milk.

There is no information on the use of acrivastine in human breast feeding or the degree, if any, to which acrivastine is excreted in human 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

Drowsiness
Hallucinations
Rash
Sleep disturbances
Urinary retention

Presentation

Oral formulation of pseudoephedrine with acrivastine

Drugs List

Therapeutic Indications

Uses

Rhinitis - allergic

Dosage

Adults

Children

Contraindications

Children under 12 years
Elderly
Within 2 weeks of discontinuing MAOIs
First trimester of pregnancy
Galactosaemia
Severe cardiac disorder
Severe hypertension
Severe renal impairment

Precautions and Warnings

Benign prostatic hyperplasia
Breastfeeding
Cardiac disorder
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hypertension
Hyperthyroidism
Lactose intolerance
Moderate renal impairment
Raised intra-ocular pressure
Second trimester of pregnancy
Third trimester of pregnancy

Advise impaired alertness may affect ability to drive or operate machinery
Contains lactose
May potentiate effect of CNS depressants
Advise patient to avoid alcohol during treatment

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 acrivastine is contraindicated in the first trimester of pregnancy.

Use pseudoephedrine with acrivastine with caution in the second and third trimesters of pregnancy.

The manufacturer has noted that there is no information available on the effects of administration of this product during human pregnancy and it should not, therefore, be used during pregnancy unless the potential benefit of treatment to the mother outweighs any possible risk to the developing foetus.

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 in combination with other products. It should, therefore, be avoided in the first trimester and is generally not recommended for use in pregnancy. Inadvertent use is not an indication for termination (Schaefer et al 2007).

There is no information on the use of acrivastine in human pregnancy. Animal studies did not produce embryotoxic or teratogenic effects and did not show altered fertility.

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 pseudoephedrine with acrivastine with caution in breastfeeding.

The majority of coughs and colds will get better on their own, and medicines may not help. Consider measures such as rest and increased fluid intake in preference to medicine whilst breastfeeding. The active ingredients in this product are discussed below.

Pseudoephedrine is excreted in breast milk in amounts small enough to be considered safe in occasional doses. It is unlikely that it will harm the infant but may cause occasional irritability, restlessness or mild sedation. Some data suggests that it may inhibit milk production significantly and repeated use may interfere with lactation. It is, therefore, not recommended for use in cases where lactation is not yet well established or where mothers are having difficulties producing sufficient milk.

There is no information on the use of acrivastine in human breast feeding or the degree, if any, to which acrivastine is excreted in human 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

Drowsiness
Hallucinations
Rash
Sleep disturbances
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: October 2015

Reference Sources

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

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.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 20 October 2015.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Benadryl Allergy Relief Plus Decongestant Capsules. McNeil Products Limited. Revised May 2015.