Hydroxyurea
هیدروکسیاوره
🎗️ Antineoplastic And Immunomodulating AgentsAntimetabolite
Market / country: 🇺🇸 USA
Siklos (US)
🧮 Dose calculator
Sickle cell anaemia · Regimen source: FDA Siklos · 2.1, Table 1
- • Use actual or ideal weight, whichever is less. Blood count every 2 weeks; increase 5 mg/kg every 8 weeks up to 35 mg/kg. CrCl <60: half dose. FDA Siklos · 2.1, Table 1FDA Siklos · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to hydroxyurea. FDA Siklos · 4
Warnings
- • Boxed warning: myelosuppression and malignancies; frequent blood counts and sun protection. FDA Siklos · Boxed Warning
Formulations
- 100 mg tablet (scored) — tablet 🇺🇸 USA FDA Siklos · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Siklos · 8.1
“Risk Summary SIKLOS can cause fetal harm based on findings from animal studies and the drug's mechanism of action [see Clinical Pharmacology (12.1) ] .”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Siklos · 8.2
“Because of the potential for serious adverse reactions in a breastfed child from SIKLOS, including carcinogenicity, advise patients not to breastfeed during treatment with SIKLOS.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Siklos · 8.4
“The safety and effectiveness of SIKLOS have been established in pediatric patients aged 2-18 years with sickle cell anemia with recurrent moderate to severe painful crises.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Siklos · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during and after treatment with SIKLOS for at least 6 months after therapy.”
🔗 Reference links
- FDA (approval record)NDA208843
- DailyMed (FDA label)FDA Siklos
- MedlinePlus (NIH)Hydroxyurea
- WHO ATC/DDDL01XX05
- Darooyab (Iran)Hydroxyurea
🇮🇷 Registered in Iran Darooyab · G-1012/Hydroxyurea
Dosage forms with Iranian generic codes, per Darooyab.
- 16887 · HYDROXYCARBAMIDE 500MG CAP · کپسول هیدروکسیکاربامید ۵۰۰ میلیگرم
- 00648 · HYDROXYUREA 500MG CAP · کپسول هیدروکسیاوره ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Siklos · 3FDA Siklos · 2.1, Table 1FDA Siklos · 2.2FDA Siklos · 4FDA Siklos · Boxed WarningFDA Siklos · 8.1FDA Siklos · 8.2FDA Siklos · 8.4FDA Siklos · 8.3FDA Siklos · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1012/Hydroxyurea
- Clinical review⚠ Unverified