- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The study by Antwi et al. (2017) shows that the Tmax and AUC0-8 of pyrazinamide are significantly lower in a co-infection with HIV while the clearance is significantly higher in these children.
The following kinetic parameters have been observed [Arya et al., Gupta et al., McIlleron et al., Roy et al., Thee et al. and Zhu et al.]:
| Cmax (one-time 30 mg/kg) | 37.7-43.4 µg/ml |
|---|---|
| t½ | 3.5-10.9 hours |
| Tmax | 0.75-3 hours |
| Cl | 0.06-0.13 l/kg/hour |
| Vd | 0.67-0.9 l/kg |
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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
| Tuberculosis (combined with other tuberculosis medication) |
|---|
| Latent tuberculosis infection |
|---|
|
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Adjustment not necessaryGFR 30-50 ml/min/1.73 m2
Adjustment not necessaryGFR 10-30 ml/min/1.73 m2
Adjustment not necessaryGFR < 10 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 48 uurA second drug has not been selected yet.
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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
Hepatotoxicity and an increase of the transaminase values, increased uric acid concentration, anorexia, nausea, vomiting, skin abnormalities, arthralgia, fever and anaemia.
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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
Caution is needed in patients with renal function disorders. Regular checks of the hepatic function and uric acid levels are recommended
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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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| Antibiotics | ||
|---|---|---|
| J04AB02 | ||
| Hydrazides | ||
|---|---|---|
| J04AC01 | ||
| Other drugs for treatment of tuberculosis | ||
|---|---|---|
| J04AK05 | ||
| J04AK06 | ||
| J04AK02 | ||
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References
- Blumberg HM, et al, American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis, Am J Respir Crit Care Med, 2003;, 167, 603-662
- Gupta P, et al, Pyrazinamide blood concentrations in children suffering from tuberculosis: a comparative study at two doses, Br J Clin Pharmacol, 2008, 65, 423-7
- Roy V, et al, Pharmacokinetics of pyrazinamide in children suffering from pulmonary tuberculosis, Int J Tuberc Lung Dis, 1999, 3, 133-7
- Sánchez-Albisua I, et al, Tolerance of pyrazinamide in short course chemotherapy for pulmonary tuberculosis in children, Pediatr Infect Dis J, 1997, 16, 760-3
- Starke JR, et al, Management of mycobacterial infection and disease in children, Pediatr Infect Dis J., 1995, 14, 455-69
- Zhu M, et al, Population pharmacokinetic modeling of pyrazinamide in children and adults with tuberculosis, Pharmacotherapy, 2002, 22, 686-95
- Bayhan GI et al. , Pulmonary tuberculosis in infants less than one year old: implications for early diagnosis., Tuberk Toraks., 2011, 59(1), 36-42
- Thee S et al. , Pharmacokinetics of isoniazid, rifampin, and pyrazinamide in children younger than two years of age with tuberculosis: evidence for implementation of revised World Health Organization recommendations., Antimicrob Agents Chemother., 2011 , Dec;55(12), 5560-7
- Mukherjee A et al. , Pharmacokinetics of isoniazid, rifampicin, pyrazinamide and ethambutol in Indian children., BMC Infect Dis. , 2015, Mar 14;15, 126
- Nahid P et al. , Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. , Clin Infect Dis. , 2016 , Oct 1;63(7), e147-95
- Donald PR et al. , Pyrazinamide pharmacokinetics and efficacy in adults and children. , Tuberculosis (Edinb). , 2012 , Jan;92(1), 1-8
- Roy V et al. , Blood levels of pyrazinamide in children at doses administered under the Revised National Tuberculosis Control Program. , Indian Pediatr. , 2012, Sep;49(9), 721-5
- Arya DS et al. , Pharmacokinetics of pyrazinamide in children with primary progressive disease of lungs. , Indian J Med Res. , 2008 , Nov;128(5), 611-5
- McIlleron H et al. , Plasma concentrations of pyrazinamide in young children with tuberculosis. , Pediatr Infect Dis , 2011, 30, 262e5
- Thee S et al. , Pyrazinamide serum levels in childhood tuberculosis. , Int J Tuberc Lung Dis, 2008, 12, 1099e101
- WHO. , Guidance for national tuberculosis programmes on the management of tuberculosis in children. 2nd edition. , www.who.int, 2014
- KNCV Tuberculosefonds. , Richtlijn Behandeling Latente Tuberculose Infectie (LTBI)., www.nvalt.nl, Juni 2006.
- Antwi S et al., Pharmacokinetics of the First-Line Antituberculosis Drugs in Ghanaian Children with Tuberculosis with or without HIV Coinfection, Antimicrob Agents Chemother., 2017, Jan 24;61(2)
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Changes
Changes
