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teva pharmaceuticals usa, inc. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules are indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)] . there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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 (see data). advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydroxyurea c

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules, usp is indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see  clinical pharmacology (12.1) ]. there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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/m 2 basis ( see data ). advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydroxyurea capsules. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m 2 basis. hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m 2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m 2 basis) in rabbits. embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. hydroxyurea crosses the placenta. single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m 2 basis) to rats caused growth retardation and impaired learning ability. risk summary hydroxyurea is excreted in human milk. because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during treatment with hydroxyurea capsules. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating hydroxyurea capsules therapy. contraception females hydroxyurea capsules can cause fetal harm when administered to a pregnant woman [ see  use in specific populations (8.1) ]. advise females of reproductive potential to use effective contraception during and after treatment with hydroxyurea capsules for at least 6 months after therapy. advise females to immediately report pregnancy. males hydroxyurea capsules may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and after treatment with hydroxyurea capsules for at least 1 year after therapy [ see  nonclinical toxicology (13.1) ].  infertility males based on findings in animals and humans, male fertility may be compromised by treatment with hydroxyurea capsules. azoospermia or oligospermia, sometimes reversible, has been observed in men. inform male patients about the possibility of sperm conservation before the start of therapy [ see  adverse reactions (6) and  nonclinical toxicology (13.1)]. safety and effectiveness in pediatric patients have not been established. elderly patients may be more sensitive to the effects of hydroxyurea, and may require a lower dose regimen. hydroxyurea is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.3) ] . the exposure to hydroxyurea is higher in patients with creatinine clearance of less than 60 ml/min or in patients with end-stage renal desease (esrd). reduce dosage and closely monitor the hematologic parameters when hydroxyurea capsules is to be administered to these patients [see  dosage and administration (2.3) and  clinical pharmacology (12.3) ]. there are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. close monitoring of hematologic parameters is advised in these patients.

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules are indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)] . there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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 (see data) . advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydroxyurea c

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules, usp is indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1) ]. there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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 (see data ). advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with

United States - English - NLM (National Library of Medicine)

american health packaging - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules are indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)]. there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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/m 2 basis (see data). advise women of the potential risk to a fetus and to avoid becoming pregnant while be

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules, usp is indicated for the treatment of: hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)]. there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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/m 2 basis (see data). advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydroxyurea capsules. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically

United States - English - NLM (National Library of Medicine)

avkare - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules are indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology ( 12.1)] . there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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/m 2 basis (see data). advise women of the potential risk to

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydroxyurea capsules, usp is indicated for the treatment of: - resistant chronic myeloid leukemia. - locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. risk summary hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see  clinical pharmacology (12.1) ]. there are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea 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/m 2 basis ( see data ). advise women of the potential risk to a fetus and to avo

United States - English - NLM (National Library of Medicine)

acella pharmaceuticals - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - urea 35 g in 100 g - indications and usage for enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris, or eschar. topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails. contraindications known hypersensitivity to any of the listed ingredients.

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physicians total care, inc. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - significant tumor response to hydroxyurea capsules usp has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary. hydroxyurea, usp used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip. hydroxyurea is contraindicated in patients with marked bone marrow depression, i.e., leukopenia (< 2500 wbc) or thrombocytopenia (< 100,000), or severe anemia. hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.