Cureaml Capsules (Hard Gelatin)
Hydroxyurea (Hydroxycarbamide)
500mg
Hikma Pharmaceuticals
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | ALPHAMED DRUG STORE |
| Retail Price | 49.00 AED |
Indications
Cureaml Capsules (Hard Gelatin) is used for:
Chronic myeloid leukaemia, Psoriasis, Myeloproliferative disorders, Sickle-cell disease, Essential thrombocythemia, AIDS
Adult Dose
Solid Tumors
Intermittent Therapy: 80 mg/kg PO q3day, OR
Continuous Therapy: 20-30 mg/kg PO qDay
Head & Neck Tumors
Concomitant therapy with irradiation
80 mg/kg PO q3days
Begin 7 days prior to initiation of irradiation
Chronic Myelocytic Leukemia, Resistant
Continuous Therapy: 20-30 mg/kg PO qDay
Sickle Cell Disease
Start: 15 mg/kg/day as single dose; monitor patient’s blood count every two weeks
Titrate by 5 mg/kg/day q12wk
Dose is not increased if blood counts are between acceptable range and toxic
Not to exceed 35 mg/kg/day
Discontinue therapy until hematologic recovery if blood counts are considered toxic; may resume treatment after reducing dose by 2.5 mg/kg/day from dose associated with hematological toxicity
Thrombocythemia, Essential
15 mg/kg PO qDay
Titrate to control platelets & maintain WBC count
Child Dose
Oral
Sickle-cell disease
Child: 1-18 yr: 10-20 mg/kg/day, increased by 5 mg/kg/day every 12 wk according to response and blood counts.
Renal Dose
Renal impairment: Dose reduction may be needed.
Administration
Contra Indications
Severe bone-marrow suppression, severe anaemia, WBC <3000/mm3 or platelet count <100,000/mm3. Pregnancy and lactation. Hypersensitivity.
Precautions
Regular monitoring of uric acid concentrations, blood counts, renal and hepatic function is recommended. Prior irradiation therapy. Elderly. Avoid use of live vaccines.
Lactation: excreted in breast milk, do not nurse
Pregnancy-Lactation
Pregnancy
No data are available with the use of hydroxyurea in pregnant women Limited available data on hydroxyurea use during pregnancy are insufficient to inform drug-associated risks
In case of an exposure to hydroxyurea of pregnant female patients or pregnant partners of male patients, treated by hydroxyurea, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered
Based on findings in animals and humans, male fertility may be compromised by treatment; azoospermia or oligospermia has been observed in men; before initiating therapy, inform male patients about the possibility of sperm conservation
Advise pregnant women of the potential risk to a fetus; verify the pregnancy status of females of reproductive potential prior to initiating therapy
Advise females of reproductive potential to use effective contraception during and after treatment for at least 6 months after therapy; advise males of reproductive potential to use effective contraception during and after treatment for at least 1 year after therapy
Animal data
In animal reproduction studies, hydroxyurea administration to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m² basis In rats and rabbits, fetal malformations were observed with partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae
Lactation
Unknown whether hydroxyurea is excreted in human milk, the effects of hydroxyurea on the breastfed child, or the effects of hydroxyurea on milk production
Because of the potential for serious adverse reactions in a breastfed child from hydroxyurea, including carcinogenicity, advise patients not to breastfeed during treatment
Interactions
Impairs immune response to vaccines; possible infection with live vaccines, zidovudine, zalcitabine. May alter action of oral anticoagulants and phenytoin.
Potentially Fatal: Fluorouracil may increase potential for neurotoxicity. Modulates metabolism and cytotoxicity of cytarabine. May precipitate didanosine- or stavudine-induced pancreatitis, hepatotoxicity or neuropathy.
Adverse Effects
Side effects of Hydroxyurea (Hydroxycarbamide) :
GI disturbances, Nausea, Vomiting, Constipation, Diarrhea, Hyperuricemia, Renal failure, Rash, Hyperpigmentation. Pulmonary oedema, dermatological reactions, headache, dizziness. Disorientation, drowsiness, hallucinations, convulsions, alopecia.
Potentially Fatal: Bone marrow suppression.
Mechanism of Action
Hydroxycarbamide causes inhibition of DNA synthesis during the S-phase of cell division by acting as a ribonucleotide reductase inhibitor resulting to cell death. It is S-phase specific.
Note
Cureaml 500mg Capsules (Hard Gelatin) manufactured by Hikma Pharmaceuticals. Its generic name is Hydroxyurea (Hydroxycarbamide). Cureaml is availble in United Arab Emirates.
Farmaco UAE drug index information on Cureaml Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.