Isoniazid

Generic name
Isoniazid
Brand name
ATC Code
J04AC01
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

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

Tuberculosis, actual or suspected tuberculous meningitis/miliary TBC/joint or bone TBC
  • Oral
    • 1 month up to 18 years
      [2] [3]
      • 10 - 15 mg/kg/day in 1 dose. Max: 300 mg/day.
      • Duration of treatment:

        Tuberculosis: 6 months
        Actual or suspected tuberculous meningitis/miliary TBC/joint or bone TBC: 9-12 months

      • Start prophylactic treatment immediately in children aged < 5 years who have been in direct contact with a patient with an open and (as yet) negative tuberculin skin test. If the tuberculin skin test is still negative after two months, then prophylaxis can then be stopped.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Hepatotoxicity and neuropathies.

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

Regular checks of the hepatic function are recommended. Adding 20 mg pyridoxine once daily to the isoniazid for preventing neuropathy is only needed in children who are being breast-fed and in adolescents and children with an insufficient diet. Watch out for convulsions.

TDM (plasma) is feasible in patients with polyneuropathies and/or heptic impairment:
T=0: <0,5 mg/l

Interactions

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

DRUGS FOR TREATMENT OF TUBERCULOSIS

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

Antibiotics
J04AB02
Other drugs for treatment of tuberculosis
J04AK05
J04AK06
J04AK02
J04AK01

References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiële therapie, 2005
  2. NVALT, Richtlijn Medicamenteuze behandeling van tuberculose, www.nvalt.nl, 2014
  3. Pharmachemie BV, SPC Isoniazide (RVG 52072), www.cbg-meb.nl, Geraadpleegd 14 juli 2010, http://db.cbg-meb.nl/IB-teksten/h52072.pdf
  4. RIEMSER, SmPC ISOZID® 200 mg, Tabletten (6192548.02.00), 10/2015
  5. RIEMSER, SmPC ISOZID® 100 mg, Tabletten (6192548.01.00), 10/2015
  6. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed June 4, 2018
  7. RIEMSER, SmPC ISOZID 0,5 N, Pulver zur Herstellung einer Infusionslösung (6192577.00.00), 10/2018
  8. RIEMSER, SmPC ISOZID® 50 mg, Tabletten (6192548.00.00), 10/2015

Changes

Therapeutic Drug Monitoring


Overdose