Oestriol

Generic name
Oestriol
Brand name
ATC Code
G03CA04
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No pharmacokinetic studies have been performed in children.

In adults, the following PK parameters apply [SmPC Synapause]:

Cmax:  100 pg/ml (dose 0.5 mg)
Tmax:  1-2 hours
T1/2: 6-9 hours

 

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Synechiae of the labia minora
  • Vaginal
    • 1 month up to 18 years

      • Apply thinly once or twice daily.

Renal impaiment in children > 3 months

Dose adjustment is not necessary in renal impairment (all grades).

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Labial pigmentation has been mentioned as possible side effect [Bussen 2016].

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Be aware of the possibility of overdosing: systemic absorption! Strictly as prescribed.

Experts say that the Synapause preparation is sometimes experienced by patients as being very painful.  

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OESTROGENEN

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Natural and semisynthetic estrogens, plain
G03CA01
G03CA03
G03CA57
NATURAL AND SEMISYNTHETIC ESTROGENS, PLAIN
G03CA01
G03CA03
G03CA57

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Capraro VJ., Adhesions of the labia minora. A study of 50 patients, Obstet Gynecol., 1972, 39(1), 65-9
  3. Soyer T., Topical estrogen therapy in labial adhesions in children: therapeutic or prophylactic?, J Pediatr Adolesc Gynecol., 2007, 20(4), 241-4
  4. Bussen S. et al, Comparison of Conservative and Surgical Therapy Concepts for Synechia of the Labia in Pre-Pubertal Girls., Geburtshilfe Frauenheilkd, 2016, 76(4), 390-5
  5. Aribarg A., Topical oestrogen therapy for labial adhesions in children., Br J Obstet Gynaecol, 1975, 82(5), 424-5
  6. Muram D., Treatment of prepubertal girls with labial adhesions., J Pediatr Adolesc Gynecol, 1999, 12(2, 67-70
  7. Leung AK, et al., Treatment of labial fusion with topical estrogen therapy, Clin Pediatr (Phila), 2005, 44(3), 245-7
  8. Kumetz LM, et al., Estrogen treatment success in recurrent and persistent labial agglutination., J Pediatr Adolesc Gynecol, 2006, 19(6), 381-4
  9. Kim SW, et al., Effect of topical estrogen cream compared with observation in prepubertal girls with labial adhesions., J Pediatr Urol., 2023, 19(4):403, e1-.e6
  10. Dowlut-McElroy T, et al., Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial. , J Pediatr Adolesc Gynecol., 2019, 32(3), 259-63
  11. Wejde E, et al., Treatment with oestrogen or manual separation for labial adhesions - initial outcome and long-term follow-up., BMC Pediatr, 2018, 18(1), 104
  12. Dowlut-McElroy T, et al., Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial., J Pediatr Adolesc Gynecol., 2019, 32(3), 259-63

Changes

Therapeutic Drug Monitoring


Overdose