- 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 |
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Synechiae of the labia minora |
|---|
|
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Renal impaiment in children > 3 months
Dose adjustment is not necessary in renal impairment (all grades).
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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].
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Natural and semisynthetic estrogens, plain | ||
|---|---|---|
| G03CA01 | ||
| G03CA03 | ||
| G03CA57 | ||
| NATURAL AND SEMISYNTHETIC ESTROGENS, PLAIN | ||
|---|---|---|
| G03CA01 | ||
| G03CA03 | ||
| G03CA57 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Capraro VJ., Adhesions of the labia minora. A study of 50 patients, Obstet Gynecol., 1972, 39(1), 65-9
- Soyer T., Topical estrogen therapy in labial adhesions in children: therapeutic or prophylactic?, J Pediatr Adolesc Gynecol., 2007, 20(4), 241-4
- 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
- Aribarg A., Topical oestrogen therapy for labial adhesions in children., Br J Obstet Gynaecol, 1975, 82(5), 424-5
- Muram D., Treatment of prepubertal girls with labial adhesions., J Pediatr Adolesc Gynecol, 1999, 12(2, 67-70
- Leung AK, et al., Treatment of labial fusion with topical estrogen therapy, Clin Pediatr (Phila), 2005, 44(3), 245-7
- Kumetz LM, et al., Estrogen treatment success in recurrent and persistent labial agglutination., J Pediatr Adolesc Gynecol, 2006, 19(6), 381-4
- 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
- Dowlut-McElroy T, et al., Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial. , J Pediatr Adolesc Gynecol., 2019, 32(3), 259-63
- 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
- Dowlut-McElroy T, et al., Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial., J Pediatr Adolesc Gynecol., 2019, 32(3), 259-63
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Changes
Changes
