1/21/2025

Janusmed kön och genus

Janusmed kön och genus – Pilokarpin Minims

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Tillbaka till index
B B
B B

Pilokarpin – lokalt

Pilokarpin – lokalt

Klass : B

Produkter

Fotil, Fotil forte, Isopto-Pilokarpin, Minims Pilocarpinenitraat, Pilo......

Fotil, Fotil forte, Isopto-Pilokarpin, Minims Pilocarpinenitraat, Pilocarpina Farmigea, Pilocarpine, Pilokarpin APL, Pilokarpin Karo Pharma, Pilokarpin Minims
ATC-koder

S01EB01, S01ED51

S01EB01, S01ED51
Substanser

pilokarpin, pilokarpinhydroklorid, pilokarpinnitrat

pilokarpin, pilokarpinhydroklorid, pilokarpinnitrat
Sammanfattning

Det saknas kontrollerade studier om skillnader mellan könen avseende effekt, säkerhet och farmakokinetik för pilokarpin ögondroppar.

Det saknas kontrollerade studier om skillnader mellan könen avseende effekt, säkerhet och farmakokinetik för pilokarpin ögondroppar.
Background

The dominating type of glaucoma, primary open-angle glaucoma (POAC), is more common in men [1, 2]. Angle-closure glaucoma (ACG) is more common in women, due to anatomic factors. Endogenous estrogen may have a protective role in glaucoma, since a longer reproductive period is associated with decreased risk of OAG [1, 3]. Globally, men have higher glaucoma burden than women [4]. Sex-stratified data on efficacy and adverse events for ophthalmic drugs are scarce in clinical trials [5].

Pharmacokinetics and dosing
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of pilocarpine eye-drops have been found. According to the manufacturer’s documentation to FDA, the systemic exposure following topical administration of pilocarpine is low and the pharmacokinetics has not been thoroughly studied in men and women separately prior to registration [6].

Effects
No studies with a clinically relevant sex analysis regarding the effects pilocarpine eyedrops have been found.

Adverse effects
No studies with a clinically relevant sex analysis regarding the ad......

The dominating type of glaucoma, primary open-angle glaucoma (POAC), is more common in men [1, 2]. Angle-closure glaucoma (ACG) is more common in women, due to anatomic factors. Endogenous estrogen may have a protective role in glaucoma, since a longer reproductive period is associated with decreased risk of OAG [1, 3]. Globally, men have higher glaucoma burden than women [4]. Sex-stratified data on efficacy and adverse events for ophthalmic drugs are scarce in clinical trials [5]. # Pharmacokinetics and dosing No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of pilocarpine eye-drops have been found. According to the manufacturer’s documentation to FDA, the systemic exposure following topical administration of pilocarpine is low and the pharmacokinetics has not been thoroughly studied in men and women separately prior to registration [6]. # Effects No studies with a clinically relevant sex analysis regarding the effects pilocarpine eyedrops have been found. # Adverse effects No studies with a clinically relevant sex analysis regarding the adverse effects of pilocarpine eyedrops have been found. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information A retrospective nonrandomized comparative study of patients (15 men, 19 women) visiting an eye clinic due to unilateral idiopathic tonic pupil showed that women had a more dilated pupil (anisocoria) at arrival and a greater ratio of pupil decrease after pilocarpine instillation than men. According to the authors, the degree of pupillo-accommodative dysfunction could be greater in female patients. In a subgroup of patients who had a symptom onset > 2 months before arrival, women had a larger pupil size at first examination and a longer near-point of accommodation after instillation of pilocarpine than men [7].
Försäljning på recept

Fler kvinnor än män hämtade ut ögondroppar innehållande pilokarpin (ATC-kod S01EB01) på recept i Sverige år 2023, totalt 3 429 kvinnor och 2 600 män. Det motsvarar 0,7 respektive 0,5 patienter mer tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. Totalt sett var ögondroppar innehållande pilokarpin 1,3 gånger vanligare hos kvinnor [8].
Referenser
  1. Zetterberg M. Age-related eye disease and gender. Maturitas. 2016;83:19-26.
  2. Rudnicka AR, Mt-Isa S, Owen CG, Cook DG, Ashby D. Variations in primary open-angle glaucoma prevalence by age, gender, and race: a Bayesian meta-analysis. Invest Ophthalmol Vis Sci. 2006;47(10):4254-61.
  3. Douglass A, Dattilo M, Feola AJ. Evidence for Menopause as a Sex-Specific Risk Factor for Glaucoma. Cell Mol Neurobiol. 2023;43(1):79-97.
  4. Ye X, She X, Shen L. Association of sex with the global burden of glaucoma: an analysis from the global burden of disease study 2017. Acta Ophthalmol. 2020;98(5):e593-e598.
  5. Xie JS, Kaur H, Tao B, Lee J, Solish D, Kohly R et al. Sex or Gender Reporting in Ophthalmology Clinical Trials Among US Food and Drug Administration Approvals, 1995 to 2022. JAMA Ophthalmol. 2024;142(2):123-130.
  6. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - ISOPTO CARPINE (pilocarpine hydrochloride) [updated 2010-05-21].
  7. Koh KM, Kim US. Characteristics of pupillo-accommodative functions according to time of onset, gender and age in tonic pupil. Int J Ophthalmol. 2013;6:659-61.
  8. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2023 [cited 2024-03-06.]
Uppdaterat

Litteratursökningsdatum: 2/6/2024

Litteratursökningsdatum: 2/6/2024