Drugs List

Therapeutic Indications

Uses

Hayfever
Rhinitis - allergic
Rhinitis - perennial
Urticaria

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Hypertension
Myocardial infarction
Pregnancy
Severe hepatic impairment
Thyrotoxicosis

Precautions and Warnings

Elderly
Asthma
Benign prostatic hyperplasia
Diabetes mellitus
Epileptic disorder
Hyperthyroidism
Ischaemic heart disease
Narrow angle glaucoma
Pyloroduodenal obstruction
Renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient to avoid alcohol during treatment

Pregnancy and Lactation

Pregnancy

The manufacturer notes that this medication is contraindicated in pregnancy.

Chlorphenamine
The safety of chlorphenamine in pregnancy has not been established. Use during the third trimester may result in reactions in the newborn or premature neonates.

Briggs categorises the use of chlorphenamine in pregnancy as having a low risk of harm to the foetus. But notes than an association between exposure during the last 2 weeks of pregnancy to antihistamines in general and retrolental fibroplasia in premature infants has been reported.

Ephedrine Hydrochloride
Ephedrine-like drugs are teratogenic in some animal species, but human teratogenicity has not been established.

Significant increases in fetal heart rate and beat-to-beat variability may occur, but these effects may be the result of normal reflexes following hypotension-associated bradycardia. The presence of ephedrine in the fetal circulation is probably a major cause of the fetal heart rate changes.

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

The manufacturer notes that this medication is contraindicated in breastfeeding.

Chlorphenamine
Small amounts of antihistamines may be excreted in breast milk and may inhibit lactation.

Medications and Mothers' Milk note that although no data is available on chlorphenamine and its excretion into breast milk, it has not been reported to produce side effects. Sedation is the only likely side effect.

Drug and Lactation Database (LacMed) suggests that small (2 to 4 mg), occasional doses of chlorphenamine are acceptable during breastfeeding. Larger doses or more prolonged use might cause effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Single bedtime doses after the last feeding of the day may be adequate for many women and will minimize any effects of the drug. The nonsedating antihistamines are preferred alternatives.

Ephedrine Hydrochloride
Ephedrine hydrochloride is excreted in breast milk. Irritability and sleep disturbances have been reported in the infant.

Ephedrine hydrochloride is not recommended during lactation.

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

Anxiety
Arrhythmias
Cold extremities
Drowsiness
Dry mouth
Exfoliative dermatitis
Giddiness
Insomnia
Muscle weakness
Palpitations
Restlessness
Tinnitus
Tremor

Presentation

Tablets containing ephedrine hydrochloride and chlorphenamine maleate

Drugs List

Therapeutic Indications

Uses

Hayfever
Rhinitis - allergic
Rhinitis - perennial
Urticaria

Dosage

Tablets should be swallowed whole and not sucked or chewed.

Adults

Elderly

Children

Patients with Hepatic Impairment

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Hypertension
Myocardial infarction
Pregnancy
Severe hepatic impairment
Thyrotoxicosis

Precautions and Warnings

Elderly
Asthma
Benign prostatic hyperplasia
Diabetes mellitus
Epileptic disorder
Hyperthyroidism
Ischaemic heart disease
Narrow angle glaucoma
Pyloroduodenal obstruction
Renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient to avoid alcohol during treatment

Pregnancy and Lactation

Pregnancy

The manufacturer notes that this medication is contraindicated in pregnancy.

Chlorphenamine
The safety of chlorphenamine in pregnancy has not been established. Use during the third trimester may result in reactions in the newborn or premature neonates.

Briggs categorises the use of chlorphenamine in pregnancy as having a low risk of harm to the foetus. But notes than an association between exposure during the last 2 weeks of pregnancy to antihistamines in general and retrolental fibroplasia in premature infants has been reported.

Ephedrine Hydrochloride
Ephedrine-like drugs are teratogenic in some animal species, but human teratogenicity has not been established.

Significant increases in fetal heart rate and beat-to-beat variability may occur, but these effects may be the result of normal reflexes following hypotension-associated bradycardia. The presence of ephedrine in the fetal circulation is probably a major cause of the fetal heart rate changes.

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

The manufacturer notes that this medication is contraindicated in breastfeeding.

Chlorphenamine
Small amounts of antihistamines may be excreted in breast milk and may inhibit lactation.

Medications and Mothers' Milk note that although no data is available on chlorphenamine and its excretion into breast milk, it has not been reported to produce side effects. Sedation is the only likely side effect.

Drug and Lactation Database (LacMed) suggests that small (2 to 4 mg), occasional doses of chlorphenamine are acceptable during breastfeeding. Larger doses or more prolonged use might cause effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Single bedtime doses after the last feeding of the day may be adequate for many women and will minimize any effects of the drug. The nonsedating antihistamines are preferred alternatives.

Ephedrine Hydrochloride
Ephedrine hydrochloride is excreted in breast milk. Irritability and sleep disturbances have been reported in the infant.

Ephedrine hydrochloride is not recommended during lactation.

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

Anxiety
Arrhythmias
Cold extremities
Drowsiness
Dry mouth
Exfoliative dermatitis
Giddiness
Insomnia
Muscle weakness
Palpitations
Restlessness
Tinnitus
Tremor

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 (https://www.toxbase.org/).

Further Information

Last Full Review Date: November 2013

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. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013.

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

Summary of Product Characteristics: Haymine tablets. Chemidex Pharma Limited. Revised March 2008.

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
Last revised:
Last accessed: