Heradrea 500 Herabiopharm medicine treats chronic medulla leukemia (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Hydroxyurea

Ingredient

Composition information	Content
Hydroxyurea	500mg

Uses

indications

Heradrea 500 is indicated in the following cases:

Treatment of chronic medullary leukemia.

Cervical cancer treatment combined with radiation.

ATC code: L01xx05.

Hydroxyurea is an effective oral anti -cancer drug. Although the mechanism of action has not been clearly defined Hydroxyurea seems to work by interfering with DNA synthesis.

Dynamic pharmacokinetics

After drinking, hydroxyurea absorbs easily through the digestive tract. The peak concentration of plasma is achieved in 2 hours, the serum concentration is almost zero after 24 hours.

About 80% of oral or intravenous dose 7 to 30 mg/kg can be restored in urine within 12 hours.

Hydroxyurea crosses the bloody barrier. Hydroxyurea well distributed throughout the body.

Before taking Heradrea 500 Herabiopharm medicine treats chronic medulla leukemia (10 blisters x 10 tablets)

How to use

Take oral use.

Note: If the patient cannot drink whole tablets, it is possible to put the nuggets in the tablet in a glass of water and drink immediately.

Do not inhale or directly expose the powder to the skin or mucosa. If the dough is scattered, it must be cleaned immediately.

Dosage

adults

Treatment regimen can be continuous or interrupted. The continuous regimen is especially suitable for chronic medulla leukemia, while the disruption regimen, has a gradual impact on the bone marrow, more suitable for controlling cervical cancer.

Should start hydroxyurea 7 days before radiation therapy simultaneously.

If using hydroxyurea in combination with radiation, often not needed to adjust the dose therapy.

The full testing time to determine the anti -cancer effect of hydroxyurea is 6 weeks. In case of a significant clinical response, therapy may be continued indefinitely, provided that the patient is fully monitored and has no abnormal or serious reaction. Treatment should be interrupted if the number of white blood cells decreases below 2.5 x 10/l or the number of platelets below 100 x 10/l.

In these cases, the number of should be re -evaluated after 3 days and continue treatment when the number of returns is acceptable.

Hematoma is usually fast. If the recovery quickly does not occur during treatment with hydroxyurea combined with radiation therapy, can interrupt radiotherapy. Anemia, even severe, can be controlled without interrupting Hydroxyurea treatment.

Severe stomach pain, such as nausea, vomiting and anorexia, due to combining treatment can often be controlled by interrupting Hydroxyurea treatment.

Pain or discomfort due to mucositis at the irradiation (mucositis) is usually controlled by measures such as local anesthetic and oral pain relief. If the reaction is severe, it may temporarily interrupt the treatment of hydroxyurea; If extremely serious, can temporarily delay the dose of radiation therapy.

Continuous treatment

Should use 20 - 30 mg/kg Hydroxyurea daily with a single dose. Dosage should be based on the actual or ideal weight of the patient, depending on which value is lower. Treatment should be monitored by counting repetitive blood formula.

Disregard treatment

Should use 80 mg/kg hydroxyurea at a single dose every 3 days. When using interruption therapy, the ability to inhibit leukocytes will decrease, but if the number of white blood cells produces is low, one or more doses of hydroxyurea should be removed.

Use a combination of hydroxyurea with other bone marrow inhibitors may need to adjust the dose.

Children

Because the disease is rare in children, the dose has not been set.

Elderly

Elderly people may be more sensitive to the effect of hydroxyurea and may need lower doses.

kidney failure

Because elimination through the kidneys is a discharge path of the drug, it is advisable to consider reducing the dose in these people.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? In the long run, it is essential to carefully monitor the hematopoietic system, and should blood transfusion if necessary.

Acute mucosa has been reported in patients using hydroxyurea at a much larger dosage than recommended. Observed aches, purple red, edema in the palms and soles of the feet, then the scales of the arms and legs, increased the severe skin pigmentation and serious acute stomatitis.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

When using Heradrea 500 you may experience unwanted effects (ADR):

Bone marrow inhibitor is the main harmful effect of hydroxyurea.

Skin vasculitis toxicity includes vascular ulcer and gangrene that occurred in patients with bone marrow hyperthemis during hydroxyurea treatment. The risk of vascular toxicity increases in patients previously treated or in combination with interferon.

In some patients, hyperpigmentation, nail color change, skin atrophy and nails, scales, purple nodules and hair loss have been observed after a few years of long -term maintenance for Hydroxyurea.

Cases of fatal and non -fatal pancreatitis, serious peripheral liver and peripheral neuropidia have been recorded in HIV -infected patients when taking hydroxyurea in combination with retrovirus anti -Retrovirus drugs, especially the Didanosine along with Stavudine. Patients treated with hydroxyurea combined with Didanosine, Stavudine and Indinavir shows an average CD4 cell decline of about 100/mm³.

The adverse reactions are observed when combining hydroxyurea and radiation therapy similar to reports when using Hydroxyurea alone, mainly bone marrow failure (leukopenia and anemia) and stomach irritation. Almost all patients treated with hydroxyurea combined with adequate radiation will be leukemia. The number of platelets decreases (

Hydroxyurea may have the potential to cause some adverse reactions commonly seen when radiotherapy, such as stomach pain and mucous inflammation.

hypersensitivity

Drug fever

High fever (> 39 ° C) needs to be hospitalized in some cases that have been reported simultaneously with manifestations of the digestive tract, lungs, musculoskeletal, liver, dermatology or cardiovascular. The onset usually occurs within 6 weeks from the beginning and resolution quickly after stopping using hydroxyurea.

After reuse, the fever recurs within 24 hours.

Unwanted effects are evaluated on the organ systems based on the following frequency: Very common (ADR> 1/10), common (1/100

Very common

Blood and lymphatic system: Bone marrow failure, reduced lymphocytes CD4, leukopenia, platelet reduction, reduced number of platelets, anemia. Under the skin: Vascular inflammation in the skin, atopic dermatitis, hair loss, lumpy rash, papules, skin peeling, skin atrophy, skin ulcers, erythema, skin hyperpigmentation, nail disorders. tolerance.

benign and malignant tumors (including cysts and polyps): Skin cancer.

Mental: illusion, disorientation.

Liver: Hepatic poisoning*, increased liver enzyme, cholestasis, hepatitis.

Rare

Infection and parasitic infection: Mail.

Skin and subcutaneous organization: Nail color change.

Instructions on how to handle ADR:

Notify the physician the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Heradrea 500 is contraindicated in the following cases:

Hydroxyurea is contraindicated in patients with hypersensitivity to the active ingredient or any ingredient of the drug.

clearly leukopenia (

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

depending on the bone

A full condition of blood, including bone marrow test, if indicated, as well as kidney function and liver function, should be determined in advance and repeated during treatment. If the bone marrow function is impaired, do not start treating with hydroxyurea. It is advisable to determine the concentration of hemoglobin, the total number of white blood cells and the number of platelets at least once a week during the treatment with hydroxyurea.

If leukocytes drop below 2.5 x 10/l or the number of platelets down

Hydroxyurea can cause bone marrow inhibitor, leukopenia is generally the first and most common manifestation of it. Platelets and anemia are less likely to occur and rarely have previous leukopenia. Bone marrow failure is more likely to be encountered in patients who have used radiation or use cytotoxic chemotherapy, which should be used with caution hydroxyurea in these patients. Bone marrow recovers quickly when interrupting Hydroxyurea treatment.

Anemia

severe anemia must be adjusted by changing the entire blood before starting Hydroxyurea therapy. If anemia occurs during treatment, adjust without interrupting hydroxyurea therapy. Abnormal red blood cells, huge limited red blood cells are often seen early during treatment with hydroxyurea. The morphological change is similar to malignant anemia, but not related to vitamin B12 deficiency or folic acid deficiency. Mahoydum may hide the random development of folic acid deficiency, so regular testing of folic acid. Hydroxyurea can also delay the iron clearance in plasma and reduce the rate of erythrocytes' erythrocytes but the drug does not seem to change the life time of red blood cells.

Radiotherapy

Patients who have been radiotherapy may be worse after radiation therapy when taking hydroxyurea.

kidney

Should use caution in patients with significant kidney dysfunction.

HIV

Hydroxyurea is not allowed to be used in combination with HIV treatment drugs and the drug can cause treatment and toxic failures (in some cases of death) in HIV patients.

Cancer

In long -term patients with hydroxyurea for bone marrow hyperthemis such as red blood cells, secondary leukemia have been reported. It is unclear whether leukemia is a secondary effect of hydroxyurea or related to the patient's potential disease. Skin cancer has been reported in patients using long -term hydroxyurea. It is recommended that patients protect the skin from sun exposure. In addition, patients should conduct self -examination during treatment and after stopping hydroxyurea treatment and screening secondary malignant diseases in regular re -examination.

vasculitis toxicity

Skin vascular toxicity including vascular ulcer and gangrene has occurred in patients with bone marrow hypertrophy disorders when treated with hydroxyurea. The risk of vascular poisoning increases in patients treated with interferon before or in combination. Blood vessel ulcer scattered in the fingers, toes and clinical manifestations of the peripheral vascular failure leading to anemia in the fingers, toes or indignation differently different from typical skin ulcers that often describe to Hydroxyurea. Due to the serious clinical results for blood vessel ulcers reported in patients with bone marrow hyperpathy, hydroxyurea should be stopped if blood vessel ulcer develops and should start using replacement drugs to reduce cells.

uric acid

The ability to increase serum uric acid, leading to gout or worst, kidney disease caused by uric acid, should be noted for patients treated with hydroxyurea, especially when used for other cytotoxic agents. Therefore, it is important to monitor the concentration of uric acid regularly and maintain plenty of water during treatment.

vaccinated

Use a combination of hydroxyurea with a live virus vaccine that can increase the multiplication of the vaccine virus and/or may increase some adverse reactions of the vaccine virus because the normal defense mechanism may be inhibited Hydroxyurea. Vaccinations live in patients using hydroxyurea can lead to severe infections. The patient's antibody reaction to the vaccine may decrease. The vaccine should be avoided during treatment and for at least 6 months after the end of treatment and advice from the doctor.

excipients

This product contains parabens, which can cause allergic reactions (which can occur slowly).

The effect of the drug on the ability to drive and operate machinery

hydroxyurea can cause drowsiness. Patients who use hydroxyurea should not drive or operate machines unless the drug is shown not to affect physical or mental capacity.

Use drugs for women during pregnancy and lactation

drugs that affect DNA synthesis, such as hydroxyurea, can be a strong mutant cause. The doctor should carefully consider this ability before taking hydroxyurea for male or female patients who may intend to get pregnant. Because hydroxyurea is a cytotoxic agent, the drug has caused teratogen in some animals.

In mice and dogs, high doses of hydroxyurea reduces sperm production.

hydroxyurea excreted through breast milk. Due to the ability to cause serious adverse custody reactions to breastfeeding Hydroxyurea, it is advisable to make a decision to stop breastfeeding or stop using hydroxyurea, taking into account the importance of the drug for the mother.

Hydroxyurea can be harmful to the fetus when used for pregnant women. Hydroxyurea should often not be used for pregnant patients, or for nursing mothers, unless the potential benefits are far beyond possible dangers.

Women's patients have the ability to reproduce should be advised on the use of effective contraception during treatment and at least 6 months after treatment.

There is no sperm or sperm reduction, sometimes recovered, observed in men. It is advisable to notify male patients, so the ability to preserve sperm before starting treatment. Hydroxyurea can be toxic to gene.

Men are treating should use effective contraception in and at least 1 year after treatment.

Drug interaction

Bone marrow inhibitor activity may be enhanced with radiation therapy or previous cellular toxicity or combination. Pancreatitis is deadly and non -fatal, which occurred in HIV -infected patients while treatment with hydroxyurea and leftine, with or without stavudine. Hepatic poisoning and liver failure leads to deaths that have been reported during medication monitoring after circulation in HIV -infected patients treated with hydroxyurea and other antiviral drugs. The deadly liver events are reported most often in patients with treatment combined with hydroxyurea, didanosine and stavudine. This combination should be avoided. Peripheral and serious neuropathy in some cases, have been reported in HIV -infected patients using hydroxyurea combined with antacids, including didanosine, with or without stavudine.

Studies have shown that hydroxyurea influence analysis of enzymes (urease, uricase and lactic dehydrogenase) used to determine urea, uric acid and lactic acid, offering major misleading results in patients treated with hydroxyurea.

vaccination

Increased risk of severe or fatal infections when used simultaneously with live vaccines. It is not recommended to use vaccines in patients with immunosuppressive.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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