Pharmacokinetics in children

There is no specific data known about adolescents.

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

Prevention of endometrial hyperplasia in oestrogen treatment for puberty induction or growth inhibition
Oral ≥ 12 years 5 - 10 mg/day in 1 dose Duration of treatment: During the first 10-14 days of the month

Contraception
Subcutaneous After menarche, ≥ 12 years 104 mg/dose once every 13 weeks. If other contraceptives cannot be considered. Administer in the fornt side of the thigh or in the (lower) abdomen. Intramuscular After menarche, ≥ 12 years 150 mg/dose once every 12 weeks. If other contraceptives cannot be considered. Administer in the buttock muscle or alternatively in the upper arm.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Caution is needed in renal function disorders because medroxyprogesterone can cause poor fluid retention.

GFR 30-50 ml/min/1.73 m2

Caution is needed in renal function disorders because medroxyprogesterone can cause poor fluid retention.

GFR 10-30 ml/min/1.73 m2

Caution is needed in renal function disorders because medroxyprogesterone can cause poor fluid retention.

GFR < 10 ml/min/1.73 m2

generalized recommendations cannot be given. An assessment must be made per patient of the desired effect against the risks of side effects on overdosing and failure of the therapy on underdosing.

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

Side effects

No information is present at this moment.

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

In adolescent females, use is only indicated if other contraceptive methods are considered unsuitable or unacceptable due to the unknown long-term effects on bone density during the critical period of bone growth. [SmPC SAYANA®]

Interactions

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

• GENITO URINARY SYSTEM AND SEX HORMONES
• SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

HORMONALE ANTICONCEPTIVA VOOR SYSTEMISCH GEBRUIK

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

References

1. Pfizer BV, SmPC Sayana (RVG 35305) 01-07-2023, www.cbg-meb.nl
2. Pfizer BV, SPC Depo-Provera (RVG 06602) 26-03-2020, www.geneesmiddeleninformatiebank.nl
3. Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
4. Pfizer, SmPC Depo-Clinovir 150mg Injektionssuspension (2704.00.02), 08/2016
5. Pfizer, SmPC Sayana 104mg/0,65ml Injektionssuspension (69347.00.00), 06/2016
6. Rangaupharm, SmPC Depo-Progevera 150mg Injektionssuspension (97378.00.00), 08/2016

Changes

Therapeutic Drug Monitoring

Overdose