Famotidine

Generic name
Famotidine
Brand name
ATC Code
A02BA03
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Famotidine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

  0-1 month  1-3 month 3-12 month 0-12 month (n=5) 11-15 year(n=8)
Dose 0,5 mg/kg    
AUC0-infinity (ng*hour/ml)       645 ± 249 580 ± 60
Cmax (ng/ml)       79,2 97,3
Tmax (hour)       2 (1-4,1) 2,3 (2,1-2,9)
T½ (hour) 10,5 8,1 4,5 5,82 2,13
Cl (L/hour/kg) 0,13 ± 0,06 0,21 ± 0,06 0,49 ± 0,17    

Source: Product label Famotidine oral suspension FDA

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

Gastro-esophageal reflux disease (GERD)
  • Oral
    • 1 month up to 3 months
      • 0.5 - 1 mg/kg/day in 1 dose
    • 3 months up to 1 year
      • 1 - 2 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.
    • Term neonate
      • 0.5 - 1 mg/kg/day in 1 dose
Peptic Ulcer Disease
  • Oral
    • 1 year up to 18 years
      • 0.5 - 1 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.
    • 1 year up to 18 years
      [1]
      • 0.5 - 1 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.
Symptomatic treatment of hyperacidity in acid regurgitation and heartburn
  • Oral
    • ≥ 12 years
      • 10 - 20 mg/day in 1 - 2 doses.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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

Agitation

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.

Interactions

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

DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

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

H2-receptor antagonists
A02BA01
A02BA02
Proton pump inhibitors
A02BC05
A02BC01
A02BC02
Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
A02BX13
A02BX02

References

  1. Padagis, Product Label Famotidin oral suspension (NDC 0574-0147-04) , https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019527Origs032lbl.pdf
  2. Aurobindo Pharma B.V, SmPC Famotidine Sanias 10 mg (RVG 25579) 21-09-2023, www.geneesmiddelinformatiebank.nl
  3. Padagis, Product Label Famotidin oral suspension (NDC 0574-0147-04), https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019527Origs032lbl.pdf

Changes

Therapeutic Drug Monitoring


Overdose