Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Empagliflozine + metformine

Generic name
Empagliflozine + metformine
Brand name
ATC Code
A10BD20

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Type 2 diabetes mellitus
  • Oral
    • ≥ 10 years
      • Empagliflozin/metforminhydrochloride: depending on the daily dose of metformin already in use: 10 mg/1700 mg per day in 2 doses or 10 mg/2000 mg in 2 doses.
        If this dosage is tolerated and stricter blood glucose regulation is needed, the dose of empagliflozin can be increased to 25 mg/day.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Hypoglycemia was the most common side effect in the empagliflozin group in children in the study.

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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

Carefully monitor the possible effects of metformin on children's growth and puberty, as long-term data on this is lacking. No effect on growth and puberty has been observed in clinical trials lasting one year.

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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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Biguanides
A10BA02
Sulfonylureas
A10BB01
Glucagon-like peptide-1 (GLP-1) analogues
A10BJ05
A10BJ01
A10BJ02
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10BK01
A10BK03

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Reference

  1. Boehringer Ingelheim International GmbH, SmPC Synjardy (EU/1/15/1003/001) 15-01-2025, Rev 28, www.ema.europa.eu

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Changes

Changes