Drug reference

Promethazine hydrochloride

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 323, 324

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Symptomatic relief of allergy such as hay fever and urticaria | Insomnia associated with urticaria and pruritus ▶BY MOUTH ▶Child 2–4 years: 5 mg twice daily, alternatively 5–15 mg once daily, dose to be taken at night ▶Child 5–9 years: 5–10 mg twice daily, alternatively 10–25 mg once daily, dose to be taken at night ▶Child 10–17 years: 10–20 mg 2–3 times a day, alternatively 25 mg once daily, dose to be taken at night, increased if necessary to 25 mg twice daily ▶Adult: 10–20 mg 2–3 times a day ▶BY DEEP INTRAMUSCULAR INJECTION ▶Adult: 25–50 mg (max. per dose 100 mg) Emergency treatment of anaphylactic reactions ▶BY SLOW INTRAVENOUS INJECTION ▶Adult: 25–50 mg, to be administered as a solution containing 2.5 mg/mL in water for injections; maximum 100 mg per course Sedation (short-term use) ▶BY MOUTH ▶Child 2–4 years: 15–20 mg ▶Child 5–9 years: 20–25 mg ▶Child 10–17 years: 25–50 mg ▶Adult: 25–50 mg ▶BY DEEP INTRAMUSCULAR INJECTION ▶Adult: 25–50 mg Nausea | Vomiting | Vertigo | Labyrinthine disorders | Motion sickness ▶BY MOUTH ▶Child 2–4 years: 5 mg, to be taken at bedtime on night before travel, repeat following morning if necessary ▶Child 5–9 years: 10 mg, to be taken at bedtime on night before travel, repeat following morning if necessary ▶Child 10–17 years: 20–25 mg, to be taken at bedtime on night before travel, repeat following morning if necessary ▶Adult: 20–25 mg, to be taken at bedtime on night before travel, repeat following morning if necessary

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Cautions

GENERAL CAUTIONS Epilepsy. prostatic hypertrophy (in adults). pyloroduodenal obstruction. severe coronary artery disease. susceptibility to angle-closure glaucoma. urinary retention Respiratory system SPECIFIC CAUTIONS ▶With intravenous use Avoid extravasation with intravenous injection

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Exceptions To Legal Category

Prescription only medicine restriction does not apply to promethazine hydrochloride injection where administration is for saving life in emergency.

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Safety

Important Safety Information

MHRA/CHM ADVICE: OVER-THE-COUNTER COUGH AND COLD MEDICINES FOR CHILDREN (APRIL 2009) Children under 6 years should not be given over-the- counter cough and cold medicines containing promethazine.

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Interactions

→Appendix 1: antihistamines, sedating

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Side Effects

GENERAL SIDE-EFFECTS Arrhythmia. blood disorder. confusion. dizziness. drowsiness. dry mouth. headache. hypotension. jaundice. movement disorders. palpitations . photosensitivity reaction. urinary retention. vision blurred SPECIFIC SIDE-EFFECTS ▶With oral use Agranulocytosis. angle closure glaucoma. anticholinergic syndrome. anxiety. insomnia. leucopenia . nasal congestion. nausea. rash. seizure. thrombocytopenia. tinnitus. tremor. vomiting ▶With parenteral use Appetite decreased. epigastric discomfort. fatigue. haemolytic anaemia. hypersensitivity . muscle spasms. nightmare. restlessness. skin reactions SIDE-EFFECTS, FURTHER INFORMATION Elderly patients are more susceptible to anticholinergic side-effects.

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Pregnancy

Most manufacturers of antihistamines advise avoiding their use during pregnancy; however, there is no evidence of teratogenicity. Use in the latter part of the third trimester may cause adverse effects in neonates such as irritability, paradoxical excitability, and tremor.

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Breast Feeding

Most antihistamines are present in breast milk in varying amounts; although not known to be harmful, most manufacturers advise avoiding their use in mothers who are breast-feeding.

PDF page 323

Hepatic Impairment

Manufacturer advises caution.

PDF page 323

Renal Impairment

Use with caution.

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Solution for injection EXCIPIENTS: May contain Sulfites ▶Phenergan (Sanofi) Promethazine hydrochloride 25 mg per 1 ml Phenergan 25mg/1ml solution for injection ampoules | 10 ampoule P £6.74 DT = £6.74 Oral solution CAUTIONARY AND ADVISORY LABELS 2 EXCIPIENTS: May contain Sulfites ELECTROLYTES: May contain Sodium ▶Phenergan (Sanofi) Promethazine hydrochloride 1 mg per 1 ml Phenergan 5mg/5ml elixir sugar-free | 100 ml p £2.85 DT = £2.85 Tablet CAUTIONARY AND ADVISORY LABELS 2 ▶Promethazine hydrochloride (Non-proprietary) Promethazine hydrochloride 10 mg Promethazine hydrochloride 10mg tablets | 56 tablet P £3.67 DT = £3.67 Promethazine hydrochloride 25 mg Promethazine hydrochloride Respiratory system 25mg tablets | 56 tablet p £4.65–£4.91 DT = £4.85 ▶Phenergan (Sanofi) Promethazine hydrochloride 10 mg Phenergan 10mg tablets | 56 tablet p £2.96 DT = £3.67 Promethazine hydrochloride 25 mg Phenergan Nightime 25mg tablets | 14 tablet p £2.79 Phenergan 25mg tablets | 56 tablet p £4.65 DT = £4.85 ▶Sominex (Teva UK Ltd) Promethazine hydrochloride 20 mg Sominex 20mg tablets | 8 tablet p £1.89 DT = £1.89 | 16 tablet p £2.69 DT = £2.69 VACCINES › ALLERGEN-TYPE VACCINES

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Clinical care

Patient And Carer Advice

Driving and skilled tasks Drowsiness may affect the performance of skilled tasks (e.g. cycling or driving); sedating effects enhanced by alcohol. l PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Promethazine Hydrochloride Tablets 10 mg or 25 mg may be prescribed. Promethazine Hydrochloride Oral Solution (elixir) 5 mg/5 mL may be prescribed. l LESS SUITABLE FOR PRESCRIBING Promethazine is less suitable for prescribing for sedation.

PDF page 323

Dose text by age group

Child 2–4 years

5 mg twice daily, alternatively 5–15 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 5–9 years

5–10 mg twice daily, alternatively

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 10–17 years

10–20 mg 2–3 times a day,

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

10–20 mg 2–3 times a day

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg (max. per dose 100 mg)

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg, to be administered as a solution

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 2–4 years

15–20 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 5–9 years

20–25 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 10–17 years

25–50 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 2–4 years

5 mg, to be taken at bedtime on night

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 5–9 years

10 mg, to be taken at bedtime on night

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 10–17 years

20–25 mg, to be taken at bedtime on

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

20–25 mg, to be taken at bedtime on night

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Promethazine hydrochloride

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 323, 324

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 323

Cautions

PDF page 323

Exceptions To Legal Category

Prescription only medicine restriction does not apply to promethazine hydrochloride injection where administration is for saving life in emergency.

PDF page 323

Safety

Important Safety Information

MHRA/CHM ADVICE: OVER-THE-COUNTER COUGH AND COLD MEDICINES FOR CHILDREN (APRIL 2009) Children under 6 years should not be given over-the- counter cough and cold medicines containing promethazine.

PDF page 323

Interactions

→Appendix 1: antihistamines, sedating

PDF page 323

Side Effects

PDF page 323

Pregnancy

PDF page 323

Breast Feeding

Most antihistamines are present in breast milk in varying amounts; although not known to be harmful, most manufacturers advise avoiding their use in mothers who are breast-feeding.

PDF page 323

Hepatic Impairment

Manufacturer advises caution.

PDF page 323

Renal Impairment

Use with caution.

PDF page 323

Dose and formulations

Medicinal Forms

PDF pages 323, 324

Clinical care

Patient And Carer Advice

PDF page 323

Dose text by age group

Child 2–4 years

5 mg twice daily, alternatively 5–15 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 5–9 years

5–10 mg twice daily, alternatively

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 10–17 years

10–20 mg 2–3 times a day,

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

10–20 mg 2–3 times a day

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg (max. per dose 100 mg)

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg, to be administered as a solution

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 2–4 years

15–20 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 5–9 years

20–25 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 10–17 years

25–50 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

25–50 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 2–4 years

5 mg, to be taken at bedtime on night

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 5–9 years

10 mg, to be taken at bedtime on night

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Child 10–17 years

20–25 mg, to be taken at bedtime on

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Adult

20–25 mg, to be taken at bedtime on night

First-line fragment. Read the complete Indications and Dose section above.

PDF page 323

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.