Pharmacokinetics in children

Children and adolescents [SmPC]

Single dose study: After a single dose of 500 mg metformin hydrochloride, pediatric patients showed the same pharmacokinetic profile as healthy adults.
Multi-dose study: Data are limited to one study. After repeated doses of 500 mg metformin hydrochloride twice daily for 7 days, maximum plasma concentration (Cmax) and systemic uptake (AUC0-t) were reduced by approximately 33 and 40%, respectively, compared to adult diabetics receiving repeated doses of 500 mg twice daily for 14 days. However, since the dose must be individually adjusted depending on blood glucose control, this is of limited clinical relevance.

Controlled one-year clinical trials in a limited number of patients aged between 10 and 16 years showed a similar effect on blood glucose control as in adults.

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

Type 2 diabetes mellitus
Oral 10 years up to 18 years [1] 500 - 850 mg/day in 1 dose. Max: 2 g/day. Administer the maximum dose in 2-3 doses. Adjust the dose after 10-15 days according to blood glucose determinations. Increasing the dose gradually can improve the gastrointestinal tolerance.

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Adjustment not necessary.

GFR 30-50 ml/min/1.73 m2

Start with 50% of normal dose each time and do not adjust the interval between two doses. Then gradually raise the dose to the maximum tolerated maintenance dose

GFR 10-30 ml/min/1.73 m2

No generalized recommendations are given. The recommendation for an adult is 500 mg per day.

GFR < 10 ml/min/1.73 m2

Contraindicated

Clinical consequences

Note: Do not increase further in the event of an increased risk of dehydration or other reason risking sudden deterioration of renal function.

Accumulation of metformin can occur in patients with renal impairment.

Lactic acidosis can occur in rare cases. The reported cases of lactate acidosis in patients treated with metformin were primarily identified in diabetes patients with significant renal failure, although other risk factors may also play a role.

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

The side effects reported in children aged 10-16 years are the same in both nature and severity as in adult patients.

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 effects on growth and puberty in children, as long-term data on their effects are lacking.

Interactions

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

• ALIMENTARY TRACT AND METABOLISM
• DRUGS USED IN DIABETES

BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

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. Pharmachemie BV, SPC Metformine RVG 10500, www.cbg-meb.nl, http://db.cbg-meb.nl/IB-teksten/h10500.pdf
2. ratiopharm, SmPC Metformin-ratiopharm® 500 mg, 850 mg, 1000 mg Filmtabletten (35104.00.00), 12/2016
3. Infectopharm, SmPC MetfoLiquid GeriaSan® 1000 mg/5 ml Lösung zum Einnehmen (95448.00.00), 02/2018
4. Merck Serono, SmPC Glucophage 500 mg, 850 mg, 1000 mg Filmtabletten (6207899.00.00), 04/2017
5. Winthrop, SmPC Metformin Lich 850 mg (35234.00.00), 09/2017
6. Winthrop, SmPC Metformin Lich 500 mg (35233.00.00), 04/2017
7. Winthrop, SmPC Metformin Lich 1000 mg (56819.00.00), 04/2017
8. Infectopharm, MetfoLiquid GeriaSan 500 mg/5 ml Lösung zum Einnehmen (76459.00.00), 10/2013
9. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed May 14

Changes

Therapeutic Drug Monitoring

Overdose