Generic Droxia (Hydroxyurea)

Droxia
Generic Droxia
Generic Droxia (Hydroxyurea) is an antitumor agent of alkylating action. It is supposed that the mechanism of action aimed at DNA synthesis inhibition. It is a highly effective medication prescribed for the treatment of chronic myeloid leukemia and cancer of the cervix in conjunction with radiotherapy, as well as against some other types of cancer.
Active Ingredient: Hydroxyurea
Dosage Form: Tablet
Dosage: 200 mg; 500 mg
Minimum Market Price: 1.02

General information

Droxia (Hydroxyurea) is a highly effective medication prescribed for the treatment of chronic myeloid leukemia and cancer of the cervix in conjunction with radiotherapy; sickle cell anemia; polycythemia vera; essential thrombocythemia; acute leukemia; acute erythremia and erythroleukemia; osteomyelofibrosis; melanoma; head and neck tumors (with radiation therapy); cancer of the ovary, placenta, breast (in conjunction with radiation therapy); neoplasms of the colon, rectum, rectosigmoid compound; melanoma of the skin.

Droxia contains Hydroxyurea, the active component, which is a phase-specific cytostatic drug (an antimetabolite, according to some data is an alkylating action), acting in the S phase of the cell cycle. Blocks the growth of cells in the Gl-S interphase, which is essential for simultaneous radiation therapy, since the synergistic sensitivity of tumor cells in the G1 phase to irradiation appears. Strengthening the action of the RNA reductase inhibitor — ribonucleoside diphosphate reductase causes suppression of DNA synthesis. The drug does not affect the synthesis of RNA and protein.

Precautions

  • Hypersensitivity to hydroxyurea or any other excipient, which is part of the drug.
  • Leukopenia is below 2500/l, thrombocytopenia is below 100000/l.
  • Pregnancy and breastfeeding period.
  • With caution — with hepatic and/or renal failure, anemia (needs corrections before starting treatment).

The drug has a cytotoxic effect, so care should be taken when opening the capsules and avoid contact of the powder capsules with the skin, tunica mucosa or inhalation of the medication. If the inside of the capsule are accidentally scattered, immediately collect the powder with a napkin in a plastic bag, tie it up and throw it away.

How long does it take for this medicine to take effect?

The onset of action for hydroxyurea can vary depending on the condition being treated and the individual patient's response to the medication. In the treatment of cancer, some patients may see a response within several weeks, but it can take longer for the full effects to be observed. For sickle cell anemia, improvements in symptoms may be noticed within a few weeks of consistent use.

How long do the effects of this medicine last?

The duration of effects of hydroxyurea also varies. Its half-life is approximately 3 to 4 hours, but the biological effect on cells can last much longer. Continuous daily administration is typically required to maintain its therapeutic effects, and treatment duration depends on the condition being treated, patient response, and tolerance of the medication.

Is it safe to consume alcohol while taking this medicine?

There is no direct contraindication for consuming alcohol while taking hydroxyurea, but alcohol may exacerbate some side effects of hydroxyurea, such as liver toxicity or lowering the blood's ability to clot. Patients should discuss alcohol use with their healthcare provider, who may advise moderation or avoidance based on individual health factors and treatment goals.

Is this a habit forming medicine?

Hydroxyurea is not considered habit-forming and does not have the potential for abuse or psychological dependence. It is used for its pharmacological effects in treating specific medical conditions.

Can this medicine be taken during pregnancy?

Hydroxyurea is classified as FDA Pregnancy Category D, indicating there is positive evidence of human fetal risk based on adverse reaction data, but potential benefits may warrant use in pregnant women despite potential risks. Hydroxyurea can cause harm to the fetus when administered to a pregnant woman, including birth defects and miscarriage. Use during pregnancy is generally contraindicated unless no other suitable treatment options are available.

Can this medicine be taken while breast-feeding?

It is not known whether hydroxyurea is excreted in human breast milk. However, due to the potential for serious adverse reactions in nursing infants from hydroxyurea, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of the medication to the mother's health.

Dosage

  • When choosing a regimen and doses in each individual case, you should be guided by the data of special literature.
  • The drug is taken orally.
  • If swallowing is difficult, the capsule can be opened, the contents dissolved in a glass of water, and drunk whole. However, some water-insoluble auxiliary substances may remain on the surface of the solution.
  • During treatment, the drug should take a sufficiently large amount of fluid.

Solid tumors

  • 80 mg/kg once a day every three days (6-7 doses).
  • 20-30 mg / kg daily for 3 weeks.

Head and Neck Cancer, Cervical Cancer

  • 80 mg/kg once a day, every third day in combination with radiation therapy.

Drug treatment begins no less than 7 days before the start of radiation therapy and continues during radiation therapy. After radiation therapy, the drug continues to be taken for an unlimited time with strict observation of the patient and in the absence of unusual or severe toxicity reactions.

Resistant chronic myeloid leukemia

  • Continuous therapy. 20 to 30 mg/kg daily once a day.

Evaluation of the effectiveness of the drug is carried out after 6 weeks of treatment. In severe clinical remission, treatment can continue indefinitely. Treatment should be suspended if the white blood cell count is less than 2500 / l, and the platelet count is less than 100000 / l. After 3 days, the blood test is repeated. Treatment is proceeded when the content of white blood cells and red blood cells begins to increase markedly.

True polycythemia

Treatment begins with a daily dose of 15-20 mg/kg. The dose is set individually, seeking to maintain the hematocrit at a level below 45%, and the number of platelets — below 400000 / l. In most patients, it is possible to achieve these indicators by constantly applying hydroxycarbamide at a daily dose of 500 to 1000 mg.

Essential thrombocythemia

Usually, the drug is administered at an initial daily dose of 15 mg/kg; then a dose is selected that maintains the number of platelets below 600000 / l, without leading to a decrease in the number of white blood cells below 4000 / l.

How to take Droxia?

Droxia is taken orally before a meal. If swallowing is difficult, it is possible to open the capsule, dissolve the contents in a glass of water and drink it whole. However, some water-insoluble auxiliary substances may remain on the surface of the solution. After its ingestion, Droxia is rapidly absorbed from the digestive route. The maximum concentration of the medicament in the blood plasma is reached within 1-4 hours after taking it.

A therapeutic regimen can be continuous or intermittent. When used continuously, Droxia 20-30 mg/kg should be given every day once per day. Dosage is determined based on the patient's actual or ideal weight.

When used intermittently, Droxia is taken at 80 mg/kg once every 3 days or daily at 20-30 mg/kg once (doses are given in terms of actual or normal body weight, and the smallest of the indicated values is used). In patients with old age, it is advisable to use smaller doses. Patients should drink enough liquid during treatment with Droxia.

After ingestion Droxia is rapidly absorbed from the digestive tract. Cmax drugs in the blood plasma are achieved within 1-4 hours after administration. Eating does not affect the absorption of drugs.

It is rapidly distributed through the tissues of the body, penetrates the blood-brain barrier. In the cerebrospinal fluid is determined 10-20%, in ascitic fluid — 15-50% of the concentration in the blood plasma.

T1 / 2 — 3-4 hours. Partially metabolized in the liver and kidneys. 80% of hydroxyurea is excreted in the urine within 12 hours, with 50% in unchanged form and in small quantities as urea. The drug is also excreted via the respiratory tract as carbon dioxide. It is not defined in the plasma after 24 hours.

Side-effects

From the side of blood-forming organs: leukopenia, anemia, thrombocytopenia.

On the part of the digestive system: stomatitis, bleeding gums, anorexia, sickness, vomiting, diarrhea or constipation, ulceration of the mucous membrane of the digestive tract. Increased liver enzyme activity.

On the part of the skin and skin appendages: maculopapular eruptions, erythema of the face and peripheral erythema, dermato-mitoznyh skin changes. In some cases, as a result of daily use of the drug for several years, patients had hyperpigmentation, erythema, atrophy of the skin and nails, peeling, purple-colored papules. In rare cases, there is alopecia, skin cancer.

From the nervous system: headache, dizziness, fatigue, drowsiness, disorientation; rarely — hallucinations and convulsions.

On the part of the urinary system: an increase in the content of uric acid, blood urea nitrogen and plasma creatinine, urinary retention, interstitial nephritis. In rare cases, dysuria is noted.

Other: chills, general malaise, increased ESR, skin allergic reactions, fertility disorders (azoospermia, cessation of menstruation). In rare cases, acute pulmonary reactions associated with the use of the drug have been reported: diffuse pulmonary infiltration, fever, and shortness of breath.

Overdose

When using the drug in doses several times higher than recommended, patients develop signs of acute dermatological toxicity: algesthesis, erythema violet, edema followed by peeling of the palms of the hands and feet, intense generalized skin polychromia.

The specific antidote is unknown. Symptomatic treatment.

Interactions

With the simultaneous use of drugs with other myelosuppressive drugs or chemoradiotherapy, the degree of suppression of bone marrow functions, development of allergic reactions or the development of other side effects may increase.

The drug may increase the amount of uric acid in the blood so you may need to adjust the dosage of drugs that increase the excretion of uric acid from the body.

Droxia weakens the body's immune system; therefore, to obtain the desired immune response, vaccine administration is suggested 3-12 months after the end of treatment.

Alcohol interaction

If the dug is used together with antidepressants, sedatives, antihistamines, narcotic drugs, sleeping pills, alcohol, its effectiveness decreases.

Reviews

Jerome Lipski: I usually feel drowsiness, dizziness, hypotension, or headache while taking Droxia. Then I give up driving and do not work with any equipment. You must give up driving if taking a drug makes you drowsy, dizzy, or hypotensive. Doctors recommended me to stop using alcohol with this drug because alcohol significantly increases the side effects and drowsiness. So, be sure to contact your doctor for advice, taking into account the characteristics of your body and general health.

Melany: Never exceed the recommended dose! Once I did: excessive use of the drug does not relieve your condition, and can also cause poisoning and serious side effects. I know this for sure! In addition, if you know of an overdose of Droxia, contact the emergency services or the nearest hospital. Be sure to take with you the packaging, container or name of the drug to facilitate the diagnosis.

Anna: My father was prescribed Droxia when melanoma of the skin was diagnosed in him. He checked the function of the bone marrow, kidneys and liver periodically during treatment with the drug, as the doctor said it is necessary to check. Overall side effects were mild and few.

Downy: I’ve to take Droxia for already three years. My diagnosis is recurrent metastatic melanoma. In 2017 doctors found multiple metastases in lymph nodes, soft tissue, and lung. They refused to operate; there are no chemotherapy drugs left; Droxia was prescribed. Literally, a month later, a CT scan of the lung showed a decrease in metastasis by half. For a year, metastases in the lymph nodes and soft tissues are gone, and metastasis in the lung has resolved in two. I continue to take the drug, I began to endure much more easily, I hardly notice side effects anymore.

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Minimum Market Price
$1.02