ATC kod: N02AJ06, N02AJ13, N02BE01, N02BE51
Huvudindikationen för paracetamol är behandling av olika former av smärta samt feber.
Det finns ingen information om skillnader i effekt av paracetamol mellan kvinnor och män. Kvinnor kan ha en något högre exponering för paracetamol vid samma dos. Samtidig användning av orala kombinerade p-piller kan dock minska exponeringen för paracetamol. Den kliniska effekten av detta är oklar.
Paracetamol is also known as acetaminophenin English literature.
In a pharmacokinetic study, female volunteers were given paracetamol in follicular and luteal phase and pharmacokinetics was compared to male volunteers (8 men, 8 women). Compared to men, the mean AUC was increased in women by 39% and 51% and the Cmax increased by 48% and 66% in the follicular and luteal phase, respectively [1].
In a study in healthy volunteers (8 men, 8 women), paracetamol clearance was 22% greater in men compared to women not using oral contraceptives. However, half-life did not differ [2]. Also a British study (43 men, 71 women) described a 12% lower clearance in women than in men [3]. However, another study in healthy volunteers (16 men, 16 women, age 23-78 years) found that total clearance was lower in women than in men when uncorrected for weight (208 and 327 ml/min, respectively), but when the analysis included correction for weight, no significant difference remained [4].
In another study, data were pooled from 49 women at delivery, 8 women not using oral contraceptives, and 14 women using oral contraceptives. Of the 49 women, 8 were observed 10-15 weeks post-partum and 7 also 1 year after delivery. A higher median paracetamol clearance was found in women at delivery compared to postpartum or non-pregnant women (11.9 vs. 6.4 and 8.4 l/h•m2). There was an association between paracetamol clearance and estradiol. However, in non-pregnant women there was no effect on paracetamol clearance of exposure to oral contraceptives [5].
No studies with a clinically relevant sex analysis regarding the effect of paracetamol have been found.
No studies with a clinically relevant sex analysis regarding the adverse effects of paracetamol have been found.
Paracetamol is metabolized to a large extent by glucoronidation and sulphation and concomitant use of oral contraceptive steroids can therefore increase its metabolism. A study compared paracetamol pharmacokinetics in women, 7 with and 7 without combined oral contraceptives. Cmax of paracetamol were similar and occurred at the same time whereas clearance of paracetamol was 64% higher and half-life was reduced in patients on oral contraceptives [6]. Another study found paracetamol clearance increased by 49% and half-life reduced in users of combined oral contraceptives [4]. In both studies, the effects were considered to be due to enhanced glucoronidation [2, 6].In another study, ethinylestradiol 50 µg and levonorgestrel 250 µg were given orally to 6 women who had been on combined oral contraceptives for at least 3 months. At approximately the same time in the subsequent cycle this was repeated and 1g paracetamol was added. Mean AUC for ethinylestradiol was increased 22% by concomitant paracetamol. A decrease in AUC of ethinylestradiol sulphate was seen in association to this whereas levonorgestrel concentrations were not affected [7, 8].Thus, concomitant medication of oral contraceptives and paracetamol results in a lower concentration of paracetamol whereas minor effects on the concentrations of oral contraceptives are found. Regarding drug-drug interactions aspects, please consult Janusmed Interactions (in Swedish, Janusmed interaktioner).
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
In a study of hospital admissions for poisoning in five Oslo hospitals during 2008 paracetamol was utilized by 16% of females and 6% of males [9]. In another cross sectional multicenter study on acute poisonings from Oslo conducted in 2003 paracetamol was utilized by 18% of women and 5% of men [9]. In an English study of self-harm in six hospitals conducted in 2000, more women (41,4%) than men (37,8%) used paracetamol [10].
Fler kvinnor än män hämtade ut läkemedel innehållande paracetamol (ATC-kod N02BE01) på recept i Sverige år 2015, totalt 728 874 kvinnor och 434 309 män. Det motsvarar 150 respektive 89 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var läkemedel innehållande paracetamol 1,6 gånger vanligare hos kvinnor [11]. Paracetamol kan även köpas receptfritt och då saknas information om användarens kön. Totalt köps dock 75 % av all paracetamol på recept [12].
Uppdaterat: 2019-10-10
Litteratursökningsdatum: 2014-06-16
Faktagranskat av: Mia von Euler
Godkänt av: Karin Schenck-Gustafsson