Drugs List

Therapeutic Indications

Uses

Allergic reaction
Insomnia (short-term treatment)

Contraindications

2 weeks prior to estimated delivery date

Precautions and Warnings

Children under 16 years
Elderly
Within 2 weeks of discontinuing MAOIs
Asthma
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Bronchitis
Central nervous system depression
Chronic obstructive pulmonary disease
Epileptic disorder
Galactosaemia
Glaucoma
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Moderate hepatic impairment
Moderate renal impairment
Myasthenia gravis
Porphyria
Pregnancy
Pyloroduodenal obstruction
Stenosing peptic ulcer
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all indications
Some formulations contain lactose
Some formulations contain sucrose
Tolerance may develop with continued use
Not licensed for all indications in all age groups
Should not be taken with other cough or cold medicine
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

Pregnancy and Lactation

Pregnancy

Use diphenhydramine with caution in pregnancy.

The majority of published human and animal data suggests that diphenhydramine does not cause complications in pregnancy. Some sources, however, have indentified a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.

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 diphenhydramine with caution in breastfeeding.

Small amounts of antihistamines are excreted in breast milk.

Data is limited in humans but expected breast milk concentrations are not thought to be sufficiently high to affect a nursing infant.

The Drug and Lactation Database (LactMed) states that small, occasional doses of diphenhydramine would not be expected to cause any adverse effects in the breastfed infants. Larger doses or more prolonged use may cause effects in the infant or decrease the milk supply. The non-sedating antihistamines are preferred 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

Agranulocytosis
Alopecia
Anaphylaxis
Angioedema
Anorexia
Antimuscarinic effects
Arrhythmias
Attention disturbances
Blood disorders
Blurred vision
Bronchospasm
Confusion
Constipation
Convulsions
Depression
Diarrhoea
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dyspnoea
Epigastric pain
Excitement (paradoxical)
Extrapyramidal effects
Fatigue
Gastro-intestinal symptoms
Gastroesophageal reflux
Haemolytic anaemia
Headache
Hepatic impairment
Hypersensitivity reactions
Hypotension
Inco-ordination
Increased energy
Lassitude
Leucopenia
Muscle twitch
Myalgia
Nausea
Nervousness
Palpitations
Paraesthesia
Photosensitivity
Psychomotor impairment
Rash
Restlessness
Sedation
Sleep disturbances
Sweating
Tachycardia
Thickening of bronchial secretions
Thrombocytopenia
Tinnitus
Tremor
Unsteady gait
Urinary retention
Urticaria
Vomiting
Weight gain

Presentation

Oral formulations of diphenhydramine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Allergic reaction
Insomnia (short-term treatment)

Dosage

Individual brands may vary in their dosage recommendations and maximum daily dosage.

Adults

Elderly

Children

Contraindications

2 weeks prior to estimated delivery date

Precautions and Warnings

Children under 16 years
Elderly
Within 2 weeks of discontinuing MAOIs
Asthma
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Bronchitis
Central nervous system depression
Chronic obstructive pulmonary disease
Epileptic disorder
Galactosaemia
Glaucoma
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Moderate hepatic impairment
Moderate renal impairment
Myasthenia gravis
Porphyria
Pregnancy
Pyloroduodenal obstruction
Stenosing peptic ulcer
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all indications
Some formulations contain lactose
Some formulations contain sucrose
Tolerance may develop with continued use
Not licensed for all indications in all age groups
Should not be taken with other cough or cold medicine
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

Pregnancy and Lactation

Pregnancy

Use diphenhydramine with caution in pregnancy.

The majority of published human and animal data suggests that diphenhydramine does not cause complications in pregnancy. Some sources, however, have indentified a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.

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 diphenhydramine with caution in breastfeeding.

Small amounts of antihistamines are excreted in breast milk.

Data is limited in humans but expected breast milk concentrations are not thought to be sufficiently high to affect a nursing infant.

The Drug and Lactation Database (LactMed) states that small, occasional doses of diphenhydramine would not be expected to cause any adverse effects in the breastfed infants. Larger doses or more prolonged use may cause effects in the infant or decrease the milk supply. The non-sedating antihistamines are preferred 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

Agranulocytosis
Alopecia
Anaphylaxis
Angioedema
Anorexia
Antimuscarinic effects
Arrhythmias
Attention disturbances
Blood disorders
Blurred vision
Bronchospasm
Confusion
Constipation
Convulsions
Depression
Diarrhoea
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dyspnoea
Epigastric pain
Excitement (paradoxical)
Extrapyramidal effects
Fatigue
Gastro-intestinal symptoms
Gastroesophageal reflux
Haemolytic anaemia
Headache
Hepatic impairment
Hypersensitivity reactions
Hypotension
Inco-ordination
Increased energy
Lassitude
Leucopenia
Muscle twitch
Myalgia
Nausea
Nervousness
Palpitations
Paraesthesia
Photosensitivity
Psychomotor impairment
Rash
Restlessness
Sedation
Sleep disturbances
Sweating
Tachycardia
Thickening of bronchial secretions
Thrombocytopenia
Tinnitus
Tremor
Unsteady gait
Urinary retention
Urticaria
Vomiting
Weight gain

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: November 2017.

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Galpharm One a Night Nightcalm. Galpharm International. Revised November 2015.

Summary of Product Characteristics: Histergan/NightAid/Paxidorm/Sleep Aid tablets 25mg. Norma Chemicals Ltd. Revised March 2017.

Summary of Product Characteristics: Lunox Sleep Aid 25mg tablets. Crescent Pharma Limited. Revised April 2016.

Summary of Product Characteristics: Lunox Max Strength Sleep Aid 50mg tablets. Crescent Pharma Limited. Revised June 2016.

Summary of Product Characteristics: Nytol One-A-Night. Omega Pharma Ltd. Revised January 2016.

Summary of Product Characteristics: Nytol Original. Omega Pharma Ltd. Revised January 2016.

Summary of Product Characteristics: Nytol Simply Sleep Hot Chocolate 50mg Powder for Oral Solution. Omega Pharma Ltd. Revised January 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 June 2017

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
Diphenhydramine; Last revised: 7 September 2013
Last accessed: 15 March 2017

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
Last accessed: 15 March 2017