- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No kinetic studies are known to have been carried out 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
| Chronic hepatitis C |
|---|
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
No adjustment necessary.GFR 30-50 ml/min/1.73 m2
25 percentage of single dose and dosing interval : 24 uurThe first 2 doses given are 100% of the normal single dose each time (2 times 7.5 mg/kg with a dosing interval of 12 hours).
GFR 10-30 ml/min/1.73 m2
16 percentage of single dose and dosing interval : 24 uurThe first 2 doses given are 100% of the normal single dose each time (2 times 7.5 mg/kg with a dosing interval of 12 hours).
GFR < 10 ml/min/1.73 m2
16 percentage of single dose and dosing interval : 24 uurThe first 2 doses given are 100% of the normal single dose each time (2 times 7.5 mg/kg with a dosing interval of 12 hours).
Clinical consequences
Dose-related side effects, including anemia (iron independent). Therefore, treatment with ribavirin should be done under close monitoring of the hemoglobin concentration; monitoring of the ribavirin level can be considered.
Patients on dialysis
In case of intermittent hemodialysis, continuous venovenous hemodialysis and hemo (dia) filtration, peritoneal dialysis: avoid use. If this is not possible: loading dose of 15 mg/kg in 2 doses (dosing interval 12 hours), followed by 16.7% of the normal single dose and interval between two doses: 24 hours.
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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
Oral: In general, the side effects in children and adolescents are similar. However, growth inhibition is observed in about 21% of the children that can also last years after stopping the therapy (> 5 years); the risk of growth inhibition is the greatest in prepubescent children. In combination with interferon α-2b, the following are also seen relatively often in this age category: fever, anorexia, vomiting, emotional lability, suicidal thoughts or attempts (about 2%), elevation of TSH.
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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 in children
Oral: Children and adolescents:
- existing severe psychological conditions, in particular severe depression, suicidal thoughts/attempts or in medical history
- autoimmune hepatitis or autoimmune disease in medical history
- GFR <50 ml/min/1.73m²
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
Monitor the growth and development, thyroid function (elevated TSH), HCV/HIV co-infection and problems with the teeth and gums. Monitor for anaemia in cases of renal impairment. Carefully monitor whether significantly deviating hepatic function abnormalities develop during the therapy.
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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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| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB11 | ||
| J05AB14 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE10 | ||
| J05AE03 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF10 | ||
| J05AF05 | ||
| J05AF01 | ||
| Non-nucleoside reverse transcriptase inhibitors | ||
|---|---|---|
| J05AG01 | ||
| Neuraminidase inhibitors | ||
|---|---|---|
| J05AH02 | ||
| Antivirals for treatment of HIV infections, combinations | ||
|---|---|---|
| J05AR02 | ||
| J05AR10 | ||
| Other antivirals | ||
|---|---|---|
| J05AX12 | ||
| J05AX08 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| J05AR10 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP57 | ||
| J05AP08 | ||
| J05AP55 | ||
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References
- Schwarz KB, et al, The Combination of Ribavirin and Peginterferon Is Superior to Peginterferon and Placebo for Children and Adolescents Chronic Hepatitis C, Gastroenterology, 2010, Oct 28
- Wirth S, et al, Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C, Hepatology, 2005, May;41(5), 1013-8
- Wirth S, et al, Recombinant alfa-interferon plus ribavirin therapy in children and adolescents with chronic hepatitis C, Hepatology, 2002, Nov;36(5), 1280-4
- Fried MW, et al, Hepatitis C in adults and adolescents with hemophilia: a randomized, controlled trial of interferon alfa-2b and ribavirin, Hepatology, 2002, Oct;36(4 Pt 1), 967-72
- Hu J, et al, Treatment of hepatitis C in children: a systematic review, PLoS One, 2010, 5(7), e11542
- Wheeler JG, et al, Historical cohort evaluation of ribavirin efficacy in respiratory syncytial virus infection, Pediatr Infect Dis J, 1993, Mar;12(3), 209-13
- Van Woensel J, et al, Therapy for respiratory tract infections caused by respiratory syncytial virus, Eur J Pediatr, 2000, Jun;159(6), 391-8
- Ventre K, et al, Ribavirin for respiratory syncytial virus infection of the lower respiratory tract in infants and young children, Cochrane Database Syst Rev, 2007, (1), CD000181
- Long CE, et al, Long term follow-up of children hospitalized with respiratory syncytial virus lower respiratory tract infection and randomly treated with ribavirin or placebo, Pediatr Infect Dis J, 1997, Nov;16(11), 1023-8
- MSD SHARP & DOHME GMBH, SmPC Rebetol 200mg Hartkapseln (EU/1/99/107/001), 10/2015
- ratiopharm, SmPC Ribavirin 200mg/400mg Filmtabletten (82714.00.00), 11/2016
- MSD SHARP & DOHME GMBH, SmPC Rebetol 40mg/ml Lösung zum Einnehmen (EU/1/99/107/004), 10/2015
- Roche, SmPC Copegus 200mg/400mg Filmtabletten (54828.00.00), 01/2015
- Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed May 25, 2018
- Aurobindo, SmPC Ribavirin 200mg Hartkapseln (84747.00.00), 02/2016
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Changes
Changes
