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Prometazin

Klassificering: A

Preparat: Lergigan®, Lergigan® forte, Lergigan® mite, Phenergan, Phénergan, Phenergan 2,5 %, Phenergan Sanofi, Prometazin Actavis

ATC kod: R06AD02

Substanser: prometazin, prometazinhydroklorid

Sammanfattning

Det saknas publicerade studier med kliniskt relevant analys av könsskillnader vad gäller effekt eller säkerhet av prometazin.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

Pharmacokinetics and dosing

The pharmacokinetics of promethazine was evaluated in an open-label study with crossover design. Healthy subjects (18 men, 18 women) were randomized to two 12.5 mg suppositories, one 25 mg suppository, one 50 mg suppository, or 50 mg oral syrup. Promethazine pharmacokinetics was reported to be similar in men and women [1].

Effects

Promethazine and morphine as surgical premedication was evaluated in a double-blind study (96 men, 174 women). Patients were randomized to receive injections with either morphine 5 or 10 mg alone or in combination with promethazine 6.25 mg, 12.5 mg, or 25 mg. Promethazine 25 mg alone was also studied. The sedation level was assessed by a nurse at 15 and 30 minutes after injection and by the patient at 24h after surgery.  The authors report that men in the study had lower mean sedation scores than women, however, this effect could be explained by weight as the men were heavier than the women [2].

The antiemetic efficacy of promethazine was evaluated based on medical records for 369 patients undergoing radiofrequency catheter ablation performed during 4 years. Women had increased risk of nausea. Patients who received larger doses of promethazine had a lower incidence of vomiting [3].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of promethazine have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

A study of case series of promethazine overdose explored the relationship between possible predictors and delirium. Women and men had similar probability to have delirium (26% vs. 29%) [4].

Promethazine is a potentially inappropriate medication for use in elderly [5]. In a large American study of 19.5 million emergency department visits, promethazine was among the five most common potentially inappropriate medications used. Female sex was associated with more potentially inappropriate medications than men, odds ratio 1.39 [6].

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande prometazin (ATC-kod R06AD02) på recept i Sverige år 2015, totalt 48 671 kvinnor och 23 039 män. Det motsvarar 9,9 respektive 4,7 personer per tusen invånare. I genomsnitt var läkemedel innehållande prometazin 2,0 gånger vanligare hos kvinnor [7].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2016-12-13

Referenser

  1. Strenkoski-Nix LC, Ermer J, DeCleene S, Cevallos W, Mayer PR. Pharmacokinetics of promethazine hydrochloride after administration of rectal suppositories and oral syrup to healthy subjects. Am J Health Syst Pharm. 2000;57:1499-505. PubMed
  2. Conner JT, Bellville JW, Wender R, Wapner S, Dorey FJ, Katz RL. Morphine and promethazine as intravenous premedicants. Anesth Analg. 1977;56:801-7. PubMed
  3. Tyndall A, Nyström KV, Funk M. Nausea and vomiting in patients undergoing radiofrequency catheter ablation. Am J Crit Care. 1997;6:437-44. PubMed
  4. Page CB, Duffull SB, Whyte IM, Isbister GK. Promethazine overdose: clinical effects, predicting delirium and the effect of charcoal. QJM. 2009;102:123-31. PubMed
  5. Socialstyrelsen. Olämpliga läkemedel för äldre. Äldre och läkemedel [www]. [cited 2016-12-19]. länk
  6. Meurer WJ, Potti TA, Kerber KA, Sasson C, Macy ML, West BT et al. Potentially inappropriate medication utilization in the emergency department visits by older adults: analysis from a nationally representative sample. Acad Emerg Med. 2010;17:231-7. PubMed
  7. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-12-19.] Socialstyrelsens statistikdatabas

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson