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Hydroxycarbamide, also known as hydroxyurea, is a chemotherapy drug usually given to treat chronic myeloid leukaemia(CML), cervical cancer and some pre-cancerous conditions.

 
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Hydroxyurea  500mg Capsules 


Generics Name Hydroxyurea 500mg Capsules / Brand Tharolax®


 

Composition

 Packing

Expiry

  Hydroxyurea 500mg Capsules, USP 10

3 Yrs

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).


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What is hydroxyurea (Tharolax)?
Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells. Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck). Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia. Hydroxyurea may also be used for purposes not listed in this medication guide

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Tharolax® (hydroxyurea capsules, USP)
500 mg per capsule
Rx only
hydroxyurea capsules, is a chemotherapy drug

Hydroxycarbamide (Tharolax®)

Hydroxycarbamide, also known as hydroxyurea, is a chemotherapy drug usually given to treat chronic myeloid leukaemia(CML), cervical cancer and some pre-cancerous conditions.

What is hydroxyurea (Tharolax)?

Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells.

Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck).

Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.

Hydroxyurea may also be used for purposes not listed in this medication guide.

What are the possible side effects of hydroxyurea (Tharolax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.hydroxyurea capsules india

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • skin redness, skin ulcers, or open sores;

  • painful or difficult urination;

  • confusion, hallucinations, seizure; or

  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • hair loss;

  • skin peeling or discoloration, mild rash;

  • upset stomach, constipation, diarrhea;

  • headache, dizziness; or

  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Tharolax (hydroxyurea capsules) Side Effects Center for a complete guide to possible side effects.

hydroxyurea capsules, USP

What is the most important information I should know about hydroxyurea (Tharolax)?

You should not use hydroxyurea if you are allergic to it, or if you have severe bone marrow suppression, severe anemia, or low levels of platelets in your blood.

Before using hydroxyurea, tell your doctor if you have bone marrow suppression, HIV or AIDS, liver or kidney disease, or if you are receiving chemotherapy or radiation.

Wash your hands before and after you handle a hydroxyurea capsule or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills.

Do not open the hydroxyurea capsule. Do not use a pill that has been accidentally opened or broken. The medicine from an open capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.hydroxyurea capsules

If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

WARNING

Treatment of patients with THAROLAX may be complicated by severe, sometimes lifethreatening, adverse effects. THAROLAX should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumedHydroxyurea 500MG Capsules USP transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient's underlying disease. The physician and patient must very carefully consider the potential benefits of THAROLAX relative to the undefined risk of developing secondary malignancies.

Tharolax is used to treat chronic myeloid leukaemia or cervical cancer.

Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered.

How well you feel and how you are likely to cope with treatment is also important.

Your cancer treatment will usually consist of a treatment session with Tharolax followed by a break of a number of days before the next treatment session with Tharolax. This cycle may be repeated many times as part of your cancer treatment.

Tharolax works by damaging cancer cells in the body. Tharolax also affects healthy cells and treatment with Tharolax may damage your immune system. Your medical team may arrange for you to have some blood tests to check how well your immune system is working.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

WARNING: Along with its benefits, hydroxyurea treatment may cause severe, sometimes fatal side effects (see also Side Effects section). Your doctor will follow you closely while you are taking this medication. Keep all medical and laboratory appointments.

Cancers have been reported with the use of this medication but it is not known if these cancers are due to the drug or the disease being treated. Consult your doctor for more details.

USES: This medication is used in people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. It ishydroxyurea capsules_usp also used to treat several types of cancer (such as melanoma, chronic myelogenous leukemia, squamous cell carcinomas).OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to treat polycythemia vera and thrombocythemia.

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Generic Manufacturer – Taj Pharmaceuticals

Our number one priority at Generic Manufacturing is to build innovative and useful packaging, quality and manufacturing drugs according to the customer's specifications. We can customize one batch of Generic Medicine or an entire set of products.

Taj Pharmaceuticals Ltd. is a Pharmaceutical Generic manufacturer of Hydroxyurea and manufacturer of various pharmaceutical formulations in India. Taj Pharmaceuticals Ltd. provide different pharmaceutical brands and Generic Medicines

The generic manufacturing strategies of New Drug (Hydroxyurea) and the product-process of Taj Pharmaceuticals Ltd. are compared and collaborated using data from global Pharmaceuticals manufacturing plants in the UK(Newcastle), US, Korea, Italy, Germany and Japan.

We are an eminent manufacturer, supplier and exporter of Hydroxyurea and various pharmaceuticals generics medicines in Tablets, capsules, Vial (injections), ampule, Strips and schedule packs etc.

Hydroxyurea and different pharma Tablet & Capsule formulations are also available in different drug delivery forms. We also have large volume manufacturing facilities for these Products.

With over two decades of experience, we, Taj Pharmaceuticals Ltd., are one of the leading generic pharmaceutical companies. We believe that access to quality healthcare is a right, and not a privilege. Therefore, we endeavor to ensure the availability of world class, quality medicines at affordable prices across the globe.

We are committed to work towards a healthier and happier world. The company is an integrated, research based international pharmaceutical company, producing a wide range of quality, affordable generic (Hydroxyurea) medicines, trusted by health-care professionals and patients across geographies.

We offer you the highest quality new Generic medicines ie. Hydroxyurea, drugs and also with innovative packing at the lowest prices shipped to you from India. Browse our latest Pharmaceuticals and Generics possibilities and other pharmaceuticals possibilities…more.

Note: This site contains medical information that is intended for doctors or medical practitioner only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Privacy Policy and Terms of Use. © Copyright 2014 Taj Pharmaceuticals Limited (India),. All Rights Reserved.

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hydroxyurea capsules, USP


Tharolax® (hydroxyurea capsules, USP)
500 mg per capsule
Rx only

 

hydroxyurea capsules, USP
hydroxyurea capsules, USP 500mg Capsules
hydroxyurea treatment
 
Note: This site contains medical information that is intended for doctors or medical practitioner only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Privacy Policy and Terms of Use. © Copyright 2014 Taj Pharmaceuticals Limited (India),. All Rights Reserved.

WARNING hydroxyurea capsules, USP
 
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hydroxyurea capsules, USP India

Hydroxycarbamide can cause a rash, which may be itchy. Your doctor can prescribe medicine to help with this. You may also develop leg sores or ulcers. Let your doctor know if you develop a leg ulcer, as your treatment may need to be adjusted. Areas of skin that have previously been treated with radiotherapy may become red and sore. Let your doctor know if this happens. Rarely, your skin may darken. If it does, it usually returns to normal a few months after the treatment has finished.
Fever and chills

These may occur from the time your treatment is given, but they don’t usually last long. Your doctor may prescribe medicines to reduce these effects.

It’s important to let your doctor know straight away if you feel unwell or have any severe side effects, even if they’re not mentioned above.
Additional information
Conditions other than cancer

Hydroxycarbamide may be prescribed for conditions other than cancer. The drug dosage will be much lower and so the side effects mentioned in this fact sheet will probably not occur. You should discuss the treatment and any possible side effects with your relevant specialist.
Risk of developing a blood clot

Cancer can increase the risk of developing a blood clot (thrombosis), and chemotherapy may increase this risk further.

A blood clot may cause symptoms such as pain, redness and swelling in a leg, or breathlessness and chest pain. Blood clots can be very serious, so it’s important to tell your doctor straight away if you notice any of these symptoms. Most clots can be treated with drugs that thin the blood. The doctor or nurse can give you more information.
Other medicines

Some medicines, including those you can buy in a shop or chemist, can be harmful to take when you are having chemotherapy. Tell your doctor about any medicines you are taking, including over-the-counter drugs, complementary therapies and herbal drugs.
Fertility

Your ability to become pregnant or father a child may be affected by having this treatment. It's important to discuss fertility with your doctor before starting treatment.
Contraception

It's not advisable to become pregnant or father a child while having hydroxycarbamide, as it may harm the developing baby. It’s important to use effective contraception while having this drug and for at least a few months afterwards. You can discuss this with your doctor.

It’s not known whether chemotherapy drugs can be present in semen or vaginal fluids. To protect your partner, it’s safest to either avoid sex or use a barrier form of contraception for about 48 hours after chemotherapy.
Breastfeeding

There's a potential risk that chemotherapy drugs may be present in breast milk. Women are advised not to breastfeed during chemotherapy and for a few months afterwards.
Non-cancer admission

If you’re admitted to hospital for a reason not related to the cancer, it’s important to tell the doctors and nurses looking after you that you're having chemotherapy treatment. You should tell them the name of your cancer specialist so that they can ask for advice.
Emergency contacts

It’s a good idea to know who you should contact if you have any problems or troublesome side effects when you’re at home. Your chemotherapy nurse or doctor will give you details of who to contact for advice. This should include ‘out-of hours’ contact details if you need to call someone at evenings, overnight or at the weekend.

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WARNING

Treatment of patients with THAROLAX may be complicated by severe, sometimes lifethreatening, adverse effects. THAROLAX should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient's underlying disease. The physician and patient must very carefully consider the potential benefits of THAROLAX relative to the undefined risk of developing secondary malignancies.

Tharolax is used to treat chronic myeloid leukaemia or cervical cancer.

Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered.

How well you feel and how you are likely to cope with treatment is also important.

Your cancer treatment will usually consist of a treatment session with Tharolax followed by a break of a number of days before the next treatment session with Tharolax. This cycle may be repeated many times as part of your cancer treatment.

 

`  

How it is given
Your doctor will tell you how many capsules to take and when to take them. You'll need to make sure you are taking the right dose.

You should swallow the capsules whole with plenty of water. If you have trouble swallowing them, you can empty the contents of the capsules into a glass of water and drink it straight away. You should avoid touching the contents of the capsules and make sure you finish the whole drink.The glass and spoon should be washed and kept separate from your other crockery and cooking utensils.

Chemotherapy is usually given as a course of several sessions (cycles) of treatment over a few months. The length of your treatment and the number of cycles you have will depend on the type of cancer you are being treated for. Your nurse or doctor will discuss your treatment plan with you.

Before you begin your treatment your doctor will arrange for you to have blood tests. You will usually be given anti-sickness drugs before and/or during your treatment.

Possible side effects
Each person’s reaction to chemotherapy is different. Some people have very few side effects while others may experience more. The side effects described here won't affect everyone who has hydroxycarbamide and may be different if you are having more than one type of chemotherapy drug.

We have outlined the most common side effects but haven't included those that are rare and unlikely to affect you. If you notice any effects that aren't listed here, discuss them with your doctor, chemotherapy nurse or pharmacist.
Risk of infection

Hydroxycarbamide can reduce the number of white blood cells, which help fight infection. White blood cells are produced by the bone marrow. If the number of your white blood cells is low you'll be more prone to infections. A low white blood cell count is called neutropenia.

Neutropenia begins seven days after treatment, and your resistance to infection is usually at its lowest 10–14 days after chemotherapy. The number of your white blood cells will then increase steadily and usually return to normal before your next cycle of chemotherapy is due.
Contact your doctor or the hospital straight away if:

your temperature goes above 38ºC (100.4ºF)
you suddenly feel unwell even with a normal temperature.

You'll have a blood test before having more chemotherapy to check the number of white blood cells. Occasionally, your treatment may need to be delayed if the number of your blood cells (blood count) is still low.
Bruising and bleeding

Hydroxycarbamide can reduce the production of platelets, which help the blood to clot. Tell your doctor if you have any unexplained bruising or bleeding, such as nosebleeds, bleeding gums, blood spots or rashes on the skin. You may need to have a platelet transfusion if your platelet count is low.
Anaemia

Hydroxycarbamide can reduce the number of red blood cells, which carry oxygen around the body. A low red blood cell count is called anaemia. This may make you feel tired and breathless. Tell your doctor or nurse if you have these symptoms. You may need to have a blood transfusion if the number of red blood cells becomes too low.
Raised levels of uric acid in the blood

This is more likely to happen when you first start taking hydroxycarbamide. Too much uric acid can affect the kidneys and result in a condition called gout, which causes inflammation of the joints. To prevent these effects, you may be given a drug called allopurinol (Zyloric®), and you may be asked to drink plenty of fluids. While you're having hydroxycarbamide your uric acid levels will be checked regularly with blood tests.

Less common side effects
Feeling sick (nausea) or being sick (vomiting)

Your doctor can prescribe very effective anti-sickness (anti-emetic) drugs to prevent or greatly reduce nausea and vomiting. If the sickness isn't controlled, or if it continues, tell your doctor they can prescribe other anti-sickness drugs that may be more effective.

Some anti-sickness drugs can cause constipation. Let your doctor or nurse know if this is a problem.
Sore mouth

Your mouth may become sore or dry, or you may notice small ulcers during this treatment. Drinking plenty of fluids, and cleaning your teeth regularly and gently with a soft toothbrush, can help reduce the risk of this happening. Some people may find sucking on ice soothing. Tell your nurse or doctor if you have any of these problems, as they can prescribe mouthwashes and medicine to prevent or clear mouth infections.
Taste changes

You may notice that food tastes different. Normal taste usually comes back after treatment finishes. A dietitian or specialist nurse at your hospital can give you advice about ways of coping with this side effect.
Tiredness (fatigue)

Feeling tired is a common side effect of chemotherapy, especially towards the end of treatment and for some weeks after it’s over. It’s important to try to pace yourself and get as much rest as you need. Try to balance this with some gentle exercise, such as short walks, which will help. If tiredness is making you feel sleepy, don’t operate or drive machinery.
Diarrhoea

Hydroxycarbamide can cause diarrhoea. This can usually be easily controlled with medicine, but tell your doctor if it is severe or continues. It's important to drink plenty of fluids if you have diarrhoea.
Hair loss

It's very unusual to lose your hair during treatment. Some people notice that their hair becomes a little thinner but not usually enough to be noticeable to other people.
Skin changes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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