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DROXIA

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Overview

What is DROXIA?

DROXIA (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules).

Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CHNO and it has a molecular weight of 76.05. Its structural formula is:



What does DROXIA look like?



What are the available doses of DROXIA?

Capsules:

What should I talk to my health care provider before I take DROXIA?

How should I use DROXIA?

DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.

Patients should swallow DROXIA capsules whole and not to open, since hydroxurea is a cytotoxic drug. Patients must be able to follow directions regarding drug administration and their monitoring and care.

Fetal hemoglobin (HbF) levels may be used to evaluate the efficacy of DROXIA in clinical use. Obtain HbF levels every three to four months. Monitor for an increase in HbF of at least two-fold over the baseline value.

DROXIA causes macrocytosis, which may mask the incidental development of folic acid deficiency. Prophylactic administration of folic acid is recommended.

DROXIA is a cytotoxic drug. Follow applicable special handling and disposal procedures


What interacts with DROXIA?

Sorry No Records found


What are the warnings of DROXIA?

Sorry No Records found


What are the precautions of DROXIA?

Sorry No Records found


What are the side effects of DROXIA?

Sorry No records found


What should I look out for while using DROXIA?

DROXIA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.


What might happen if I take too much DROXIA?

Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have been observed.


How should I store and handle DROXIA?

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep tightly closed.Isoxsuprine HCl Tablets, USP 10 mg are white, round, biconvex tablets identified as "I10" debossed on one side and bisected on the other.Isoxsuprine HCl Tablets, USP 20 mg are white, round, biconvex tablets identified as "20" debossed on one side and bisected on the other.Isoxsuprine HCl Tablets, USP 10 mg are white, round, biconvex tablets identified as "I10" debossed on one side and bisected on the other.Isoxsuprine HCl Tablets, USP 20 mg are white, round, biconvex tablets identified as "20" debossed on one side and bisected on the other.