Phenyltoloxamine Citrate/Propiomazine 589 2. Kahn A, Blum D. Phenothiazines and sudden infant death syn- Promethazine hydrochloride is used for the sympto- injection or injected into the tubing of a freely running drome. Pediatrics 1982; 70: 75–8. 3. Kahn A, et al. Phenothiazine-induced sleep apneas in normal in- matic relief of allergic conditions including urticaria infusion in a concentration of not more than fants. Pediatrics 1985; 75: 844–7. and angioedema (p.565), rhinitis (p.565) and conjunc- 25 mg/mL, although it is usually diluted to 2.5 mg/mL. 4. Cockfield. Phenergan, Theralene, Algotropyl—drugs responsi- ble for the death of new-born babies. Off J EC 1986; 29: tivitis (p.564), and in pruritic skin disorders (p.565). It The rate of infusion should not exceed 25 mg/minute. C130/25–6. may be given intravenously as an adjunct in the emer- The usual parenteral dose for all indications apart from 5. Stanton AN. Sudden infant death syndrome and phenothiazines. gency treatment of anaphylactic shock (p.563). nausea and vomiting is 25 to 50 mg; a dose of 100 mg Pediatrics 1983; 71: 986–7. Promethazine hydrochloride and promethazine teo- should not be exceeded. Doses of 12.5 to 25 mg, re- Precautions clate are used for their antiemetic action in the preven- peated at intervals of not less than 4 hours, may be giv- As for the sedating antihistamines in general, p.562. tion and treatment of nausea and vomiting in condi- en for the treatment of nausea and vomiting, although Intravenous injections of promethazine hydrochloride tions such as motion sickness, drug-induced vomiting, not more than 100 mg is usually given in 24 hours. must be given slowly and extreme care must be taken and postoperative vomiting (p.564). They are also used Children aged 5 to 10 years may be given 6.25 to to avoid extravasation or inadvertent intra-arterial in- for the symptomatic treatment of nausea and vertigo 12.5 mg of promethazine hydrochloride by deep intra- jection, because of the risk of severe irritation. Intra- caused by Ménière’s disease and other vestibular disor- muscular injection. muscular injection may be painful, and it should not be ders (see Vertigo, p.565). Promethazine hydrochloride Promethazine has been used topically to provide relief given by subcutaneous injection. is also employed pre- and postoperatively in surgery in hypersensitivity disorders of the skin and for burns False negative and positive results have been reported and obstetrics for its sedative effects and for the relief but, as with other antihistamines, it may produce skin with some pregnancy tests. of apprehension (see Anaesthesia, p.563); it is often sensitisation. given with pethidine hydrochloride. Promethazine hy- Anaesthesia. In 8 healthy subjects promethazine 25 mg intra- Sedation. For reference to the use of lytic cocktails of chlorpro- venously decreased lower oesophageal sphincter pressure and drochloride may be used for night-time sedation (see mazine, promethazine, and pethidine, and the view that alterna- increased the incidence of gastro-oesophageal reflux.1 It might, Insomnia, p.564). tives should be considered in children, see under Pethidine, therefore, increase the risk of regurgitation and aspiration of gas- Promethazine hydrochloride is a common ingredient p.115. tric contents during induction of and recovery from anaesthesia. of compound preparations for the symptomatic treat- Preparations The effect was attributed to the antimuscarinic properties of pro- methazine. ment of coughs and the common cold (p.564). BP 2008: Promethazine Hydrochloride Tablets; Promethazine Injection; Promethazine Oral Solution; Promethazine Teoclate Tablets; 1. Brock-Utne JG, et al. The action of commonly used antiemetics The following doses have been given orally. USP 31: Promethazine Hydrochloride Injection; Promethazine Hydrochlo- on the lower oesophageal sphincter. Br J Anaesth 1978; 50: ride Suppositories; Promethazine Hydrochloride Syrup; Promethazine Hy- 295–8. • For the treatment of allergic conditions promethaz- ine hydrochloride is usually given in a dose of 25 mg drochloride Tablets. Children. A possible association between phenothiazine seda- Proprietary Preparations (details are given in Part 3) tives and sudden infant death syndrome has been suggested, but at night increased to 25 mg twice daily if necessary; Arg.: Fenergan; Austral.: Avomine; Gold Cross Antihistamine Elixir†; In- has not been confirmed (see under Adverse Effects, above). The owing to its pronounced sedative effect it is prefera- somn-Eze†; Nyal Plus+ Allergy Relief†; Phenergan; Belg.: Phenergan; Braz.: Alergiderm; Alergosan†; Fenergan; Pamergan; Profergan; Prometa- current view in the UK and USA is that promethazine should not bly given at night but an alternative dose is 10 to zol; Canad.: Histantil; Phenergan†; Cz.: Prothazin; Denm.: Phenergan; Fr.: be given to children under 2 years of age. 20 mg two or three times daily. Phenergan; Ger.: Atosil; Closin; Eusedon mono†; Promethawern†; Prone- urin; Prothanon; Gr.: Phenergan; Titanox; Hong Kong: Anvomin; Fenazin; Porphyria. Promethazine is considered to be unsafe in patients • Promethazine hydrochloride is given in doses of 20 Synvomin; Hung.: Pipolphen; India: Avomine; Emin; Phenergan; Indon.: with porphyria because it has been shown to be porphyrinogenic Nufapreg; Phenergan; Irl.: Phenergan; Israel: Prothiazine; Ital.: Allerfen†; in animals or in-vitro systems. to 50 mg at night for the short-term management of Fargan; Farganesse; Fenazil; Malaysia: Prothazine†; Norw.: Phenergan; insomnia although its prolonged duration of action NZ: Allersoothe; Avomine; Phenergan; Philipp.: Zinmet; Pol.: Diphergan; Pregnancy. For discussion of the use of antihistamines in preg- Port.: Fenergan; Rus.: Pipolphen (Пипольфен); S.Afr.: Avomine; Bruna- nancy, including studies involving phenothiazines, see p.563. can lead to considerable drowsiness the following zine; Daralix; Lenazine; Phenergan; Prohist; Receptozine; Spain: Fenergan day. Topico; Frinova; Swed.: Lergigan; Thai.: Meta; Phenergan; Titanox†; UAE: Renal impairment. Phenothiazine-induced toxic psychosis Histaloc; UK: Avomine; Phenergan; Sominex; Ziz; USA: Phenadoz; Phener- occurred in a patient with chronic renal failure who had been giv- • For the prevention of motion sickness promethazine gan; Promethegan; Venez.: Diven†; Fenergan†. en promethazine.1 hydrochloride can be given in a dose of 20 or 25 mg Multi-ingredient: Austral.: Painstop; Painstop Night-Time Pain Reliever; 1. McAllister CJ, et al. Toxic psychosis induced by phenothiazine the night before travelling followed by a similar dose Panquil; Phensedyl†; Tixylix Nightime; Braz.: Dorilen; Doriless; Fenergan administration in patients with chronic renal failure. Clin Neph- Expectorante; Lisador; Canad.: Promatussin DM†; Cz.: Coldrex Nite; Fr.: the following morning if necessary. The teoclate is Algotropyl†; Fluisedal; Rhinathiol Promethazine; Transmer†; Tussisedal; rol 1978; 10: 191–5. Ger.: Prothazin; Hong Kong: Dhasedyl; Ephedyl; Fendyl; Marsedyl; Meth- used similarly. For the prevention of motion sickness orsedyl; PEC; Phensedyn; Procodine†; Promethazine Compound Linctus†; Interactions the dose of promethazine teoclate is 25 mg at night Rhinathiol Promethazine; Super Cough†; Tripe P; Hung.: Tar dyl†; India: Tixylix; Indon.: Berlifed; Fludexin; Halmezin; Neo Davenol; Phenadex; As for the sedating antihistamines in general, p.563. or 25 mg one to two hours before travelling. Prome; Promedex; Promethazine Ikapharmindo; Irl.: Night Nurse; Israel: • For nausea and vomiting arising from causes such as Promethazine Expectorants; Prothiazine Expectorant; Ital.: Bronconait†; Nuleron; Tachinotte; Malaysia: Axcel Dextrozine; Dextrodyl; Dex- Pharmacokinetics labyrinthitis a dose of promethazine teoclate 25 mg tromethorphan Compound; Dhasedyl DM; Hosedyl DM; Mucoease Plus; Promethazine is well absorbed after oral or intramus- Phensedyl Dry Cough; Phensedyl†; Promedyl†; Rhinathiol Promethazine; at night is usually adequate; this may be increased to Russedyl Plus; Russedyl†; SCMC Promethazine†; Sedilix DM†; Sedilix†; Tix- cular doses. Peak plasma concentrations have been 50 or 75 mg at night or to 25 mg two or three times ylix†; NZ: Phensedyl Dry Family Cough†; Tixylix; Rus.: Prothiazine Expec- seen 2 to 3 hours after a dose by these routes, although torant (Протиазин Экспекторант); S.Afr.: Acustop; Adco-Kiddipayne; daily if necessary to a maximum of 100 mg daily. Antipyn†; Ban Pain; Brunacod; Colcaps; Dequa-Coff; Fevapar; Go-Pain; there is low systemic bioavailability after oral doses, •For severe vomiting in pregnancy the BNF recom- Goldgesic†; Histodor; Infacet; Infapain Forte; Kid-Eeze; Lenazine Forte; Len- due to high first-pass metabolism in the liver. Promet- togesic; Lesspain†; Medipyn; Megapyn; Mepromol; Painagon; Pedpain; mends a dose of promethazine teoclate 25 mg at Phensedyl; Propain†; Pynmed; Salterpyn; Stilpane; Stopayne; Tenston; Tixy- hazine crosses the blood-brain barrier and the placenta, night, increased if necessary to a maximum of lix; Vacudol; Xeramax†; Singapore: Beacodyl; Cophadyl; Cophadyl-E; and is distributed into breast milk. Values ranging from Dhasedyl; Dhasedyl DM; PCL†; Phensedyl†; Procodin; Promedyl†; Rhinath- 100 mg. iol Promethazine; Sedilix; Sedilix DM; Unisedyl†; Spain: Actithiol Antihist; 76 to 93% have been reported for plasma-protein bind- In children the following oral doses of promethazine Antihemorroidal†; Fenergan Expectorante; Psicosoma Solucion; Swed.: ing. Promethazine undergoes extensive