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

Interactions
PK
Renal impairment
References

Risedronic acid

Generic name
Risedronic acid
Brand name
ATC Code
M05BA07

Pharmacokinetics in children

No studies have been carried out into the pharmacokinetic parameters in children.

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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

Osteogenesis imperfecta, bone resorption inhibition
  • Oral
    • < 40 kg
      • Sodiumrisedronate: 15 mg/dose once a week.
      • Directions for administration:

        Take the tablet with sufficient water at least 30 minutes before breakfast sitting upright or standing and do not lie down for 30 minutes after taking it. 

      • Only limited scientific research has been done into the use of risedronic acid in children. Only to be used by a specialist with experience with this drug.

        ...read more
    • ≥ 40 kg
      • Sodiumrisedronate: 30 - 35 mg/dose once a week.
      • Directions for administration:

        Take the tablet with sufficient water at least 30 minutes before breakfast sitting upright or standing and do not lie down for 30 minutes after taking it.

      • Only limited scientific research has been done into the use of risedronic acid in children.  Only to be used by a specialist with experience with this drug.

         

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment not needed
GFR 30-50 ml/min/1.73 m2
Dose adjustment not needed
GFR 10-30 ml/min/1.73 m2
Avoid use due to lack of data
GFR < 10 ml/min/1.73 m2
Avoid use due to lack of data
Clinical consequences

With impaired renal function, the renal clearance of risedronic acid may be reduced. This increases the risk of side effects.

Clinical consequences:
Gastrointestinal disturbances such as nausea, diarrhea, abdominal pain, flatulence and cramps, especially at high doses and at the beginning of treatment.

With substantial overdose, a decrease in serum calcium levels can be expected and symptoms of hypocalcemia could occur.

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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

No information is present at this moment.

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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

No information available on specific warnings and precautions in children.

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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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Bisphosphonates
M05BA04
M05BA03
Other drugs affecting bone structure and mineralization
M05BX05
M05BX04

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References

  1. Bishop N, et al, A randomized, controlled dose-ranging study of risedronate in children with moderate and severe osteogenesis imperfecta, J Bone Miner Res, 2010, Jan;25(1), 32-40
  2. Rauch F, et al, Risedronate in the treatment of mild pediatric osteogenesis imperfecta: a randomized placebo-controlled study, J Bone Miner Res, 2009, Jul;24(7):, 1282-9
  3. Sectie Kinderendocrinologie NVK, Expert opinie, dd 07 april 2011
  4. NKFK Werkgroep nierfunctiestoornissen, Extrapolatie van KNMP risico analyse "Verminderde nierfunctie" voor volwassenen naar kinderen, 20 Dec 2021

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Changes

Changes