GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Hydroxyurea scored tablets - SIKLOS

SIKLOS

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Cautions / source differences (1)

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The same 50% renal reduction starts from different adult and pediatric doses

SIKLOS provides separate pediatric and adult starting doses. The DROXIA extract is adult capsule guidance. Applying the adult starting amount to a child would change the regimen even if the percentage reduction were correct.

Before applying: Use the exact age/product starting dose, prescribed weight method, measured CrCl instruction and hematology monitoring plan. Related hydroxyurea products remain separate.

Also check: The same 50% renal reduction starts from different adult and pediatric doses

Official source

Hydroxyurea scored tablets - SIKLOS

Product / population
SIKLOS hydroxyurea 100-mg and 1000-mg scored tablets; sickle cell anemia, age >=2 years
Renal measure
CrCl, mL/min, obtained using a 24-hour urine collection

Renal dosing, restrictions and evidence limits

At CrCl >=60 mL/min, the initial daily dose is 20 mg/kg in pediatric patients and 15 mg/kg in adults. Below 60 or in ESRD, reduce by 50%: 10 mg/kg/day in children and 7.5 mg/kg/day in adults. Obtain CrCl using a 24-hour urine collection. On hemodialysis days, administer after dialysis.

For starting-dose weight, use actual or ideal body weight, whichever is less. Monitor blood counts every two weeks and follow the full escalation, toxicity interruption and recovery instructions. These scored tablets are labeled for sickle cell anemia in adults and children at least two years old; do not substitute the adult DROXIA capsule starting dose for the pediatric SIKLOS dose.

Source revision: November 2023 | Retrieved: 2026-09-07. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76957c0d-0f98-4376-bb06-eee651adc09d

Scope: Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph. GlobalRPh v6.6.

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Official product label

Hydroxyurea scored tablets - SIKLOS

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

SIKLOS hydroxyurea 100-mg and 1000-mg scored tablets; sickle cell anemia, age >=2 years

Renal method: CrCl, mL/min, obtained using a 24-hour urine collection
Retrieved: 2026-09-07

Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

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population and formulation

The same 50% renal reduction starts from different adult and pediatric doses

SIKLOS provides separate pediatric and adult starting doses. The DROXIA extract is adult capsule guidance. Applying the adult starting amount to a child would change the regimen even if the percentage reduction were correct.

How to use this: Use the exact age/product starting dose, prescribed weight method, measured CrCl instruction and hematology monitoring plan. Related hydroxyurea products remain separate.

Source-specific interpretation; independent clinician adjudication pending.

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Renal dosing and precautions

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Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76957c0d-0f98-4376-bb06-eee651adc09d

Exact product and population

SIKLOS hydroxyurea 100-mg and 1000-mg scored tablets; sickle cell anemia, age >=2 years

RDM38-SCOPE-hydroxyurea-siklos · Source section: Selected source product scopeRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Hydroxyurea scored tablets - SIKLOS

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DailyMed / Medunik USA · SIKLOS hydroxyurea 100-mg and 1000-mg scored tablets; sickle cell anemia, age >=2 years

Renal method: CrCl, mL/min, obtained using a 24-hour urine collection
Source date: November 2023
Retrieved: 2026-09-07

Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

At CrCl >=60 mL/min, the initial daily dose is 20 mg/kg in pediatric patients and 15 mg/kg in adults. Below 60 or in ESRD, reduce by 50%: 10 mg/kg/day in children and 7.5 mg/kg/day in adults. Obtain CrCl using a 24-hour urine collection. On hemodialysis days, administer after dialysis.

For starting-dose weight, use actual or ideal body weight, whichever is less. Monitor blood counts every two weeks and follow the full escalation, toxicity interruption and recovery instructions. These scored tablets are labeled for sickle cell anemia in adults and children at least two years old; do not substitute the adult DROXIA capsule starting dose for the pediatric SIKLOS dose.

RDM38-official-hydroxyurea-siklos-20ae06ae5f-C1 · Source locator: Sections 1, 2.1, 2.2 renal table and 5.1

Source identity and provenance
Source family
product_label
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76957c0d-0f98-4376-bb06-eee651adc09d
Retrieved
2026-09-07
Exact label title
Hydroxyurea scored tablets - SIKLOS
DailyMed Set ID
76957c0d-0f98-4376-bb06-eee651adc09d
Labeler
Medunik USA
Label revision
November 2023
Renal-function method
CrCl, mL/min, obtained using a 24-hour urine collection
Source date/version
November 2023
Hash meaning
SHA-256 of local authored summary only; not original HTML, PDF or SPL bytes.
Local summary SHA-256
316f07d515ddc354bd2a13c4156f70103171a19b458af4c48453f08a6a1c0c23

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76957c0d-0f98-4376-bb06-eee651adc09d
Source retrieval
2026-09-07. This is not the source publication or label revision date.
Original source type
source summary
Local text SHA-256
588702d3487b1a354f582210bbbc0297096e5239129e46771cdc64422dd5a6db
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

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