Drugs List

Therapeutic Indications

Uses

Labyrinthine disorders
Motion sickness: Prevention
Motion sickness: Treatment
Nausea and vomiting
Post operative nausea and vomiting
Vertigo

Contraindications

Children under 5 years
Within 2 weeks of discontinuing MAOIs
Central nervous system depression
Coma
Galactosaemia

Precautions and Warnings

Asthma
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Bronchiectasis
Bronchitis
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Narrow angle glaucoma
Pregnancy
Pyloroduodenal obstruction
Renal impairment
Reye's syndrome or Reye-like symptoms in children or adolescents
Severe ischaemic heart disease
Urinary retention

May mask ototoxicity caused by ototoxic drugs e.g. salicylates
Suppressed vomiting may mask diagnosis of raised ICP or GI obstruction
Advise patient CNS effects may affect ability to drive or operate machinery
Contains lactose
Elderly: may be more susceptible to antimuscarinic side effects
Discontinue 72 hours before skin tests involving allergies
Immunological pregnancy tests may produce false results during treatment
Maximum duration of treatment is 7 days unless on specialist advice
Advise patient to avoid alcohol during treatment
Advise patient that photosensitivity possible

Pregnancy and Lactation

Pregnancy

Use promethazine teoclate with caution in pregnancy.

Promethazine is sometimes used as an anti-emetic during pregnancy and as an adjunct to opioid analgesics during labour. In general, use during pregnancy appears to be low risk, however the manufacturers advise not to use in pregnancy unless considered essential. Use is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

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 promethazine teoclate tablets with caution in breastfeeding.

There is limited data and experience on the use of promethazine during breastfeeding.

Evidence suggests that the amount excreted in milk is insignificant, however, there are risks of neonate irritability and excitement.

Short-term use for the treatment of nausea and vomiting poses little risk to the breast fed infant. Promethazine can lower basal prolactin secretion, so it may interfere with the establishment of lactation if given in the early postpartum period. An antiemetic without a potent histamine blocking action is preferred.

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

Anaphylaxis
Anorexia
Anticholinergic effects
Arrhythmias
Blood dyscrasias
Blurred vision
Bronchospasm
Confusion
Disorientation
Dizziness
Drowsiness
Dry mouth
Excitement (paradoxical)
Extrapyramidal effects
Gastric irritation
Haemolytic anaemia
Headache
Hypotension
Jaundice
Muscle spasm
Nightmares
Palpitations
Restlessness
Skin photosensitivity
Tics
Tiredness
Urinary retention

Presentation

Oral formulation of promethazine teoclate.

Drugs List

Therapeutic Indications

Uses

Labyrinthine disorders
Motion sickness: Prevention
Motion sickness: Treatment
Nausea and vomiting
Post operative nausea and vomiting
Vertigo

Dosage

Adults

Children

Contraindications

Children under 5 years
Within 2 weeks of discontinuing MAOIs
Central nervous system depression
Coma
Galactosaemia

Precautions and Warnings

Asthma
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Bronchiectasis
Bronchitis
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Narrow angle glaucoma
Pregnancy
Pyloroduodenal obstruction
Renal impairment
Reye's syndrome or Reye-like symptoms in children or adolescents
Severe ischaemic heart disease
Urinary retention

May mask ototoxicity caused by ototoxic drugs e.g. salicylates
Suppressed vomiting may mask diagnosis of raised ICP or GI obstruction
Advise patient CNS effects may affect ability to drive or operate machinery
Contains lactose
Elderly: may be more susceptible to antimuscarinic side effects
Discontinue 72 hours before skin tests involving allergies
Immunological pregnancy tests may produce false results during treatment
Maximum duration of treatment is 7 days unless on specialist advice
Advise patient to avoid alcohol during treatment
Advise patient that photosensitivity possible

Pregnancy and Lactation

Pregnancy

Use promethazine teoclate with caution in pregnancy.

Promethazine is sometimes used as an anti-emetic during pregnancy and as an adjunct to opioid analgesics during labour. In general, use during pregnancy appears to be low risk, however the manufacturers advise not to use in pregnancy unless considered essential. Use is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

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 promethazine teoclate tablets with caution in breastfeeding.

There is limited data and experience on the use of promethazine during breastfeeding.

Evidence suggests that the amount excreted in milk is insignificant, however, there are risks of neonate irritability and excitement.

Short-term use for the treatment of nausea and vomiting poses little risk to the breast fed infant. Promethazine can lower basal prolactin secretion, so it may interfere with the establishment of lactation if given in the early postpartum period. An antiemetic without a potent histamine blocking action is preferred.

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

Anaphylaxis
Anorexia
Anticholinergic effects
Arrhythmias
Blood dyscrasias
Blurred vision
Bronchospasm
Confusion
Disorientation
Dizziness
Drowsiness
Dry mouth
Excitement (paradoxical)
Extrapyramidal effects
Gastric irritation
Haemolytic anaemia
Headache
Hypotension
Jaundice
Muscle spasm
Nightmares
Palpitations
Restlessness
Skin photosensitivity
Tics
Tiredness
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: September 2018

Reference Sources

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

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.

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

Summary of Product Characteristics: Avomine 25mg Tablets. Manx Pharma Limited. Revised February 2018.

Summary of Product Characteristics: Vertigon 25mg Tablets. Manx Pharma Limited. Revised October 2014.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 September 2018

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
Promethazine Last revised: 10 March, 2015
Last accessed: 20 September 2018