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Droxia (Generic Hydroxyurea)

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WARNING

Your bone marrow’s ability to produce blood cells can suffer significantly if you take hydroxyurea. This could make it more likely that you’ll get major bleeding or infection. Call your doctor right away if you have any of the following symptoms: Fever, chills, extreme tiredness or weakness, body aches, sore throat, shortness of breath, persistent cough, and congestion are all indications of infection. Other symptoms include unusual bleeding or bruising, bloody or black, tarry stools, and vomiting blood or brown material that resembles coffee grounds.

Keep all of your appointments with your physician and the lab. Regular tests will be prescribed by your doctor to monitor your body’s reaction to hydroxyurea and determine whether your blood count has decreased. If your blood count has fallen too low, your doctor may need to adjust your dosage or advise you to temporarily stop taking hydroxyurea so that it can rise again.

The use of hydroxyurea may make it more likely that you’ll get other cancers, such as skin cancer. Have a plan to limit your time spent in the sun and to use sunscreen, sunglasses, and protective clothes. The dangers of using hydroxyurea should be discussed with your doctor.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start hydroxyurea treatment and each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

A certain type of chronic myelogenous leukaemia (CML; a type of cancer of the white blood cells) and specific head and neck cancers are treated with hydroxyurea (Hydrea), either alone or in combination with other drugs or radiation therapy (including cancer of the mouth, cheek, tongue, throat, tonsils, and sinuses). In adults and children with sickle cell anaemia 2 years of age and older, hydroxyurea (Droxia, Siklos) is used to lessen the frequency of excruciating crises and lessen the requirement for blood transfusions (an inherited blood disorder in which the red blood cells are abnormally shaped [shaped like a sickle] and cannot bring enough oxygen to all parts of the body). A group of drugs known as antimetabolites includes hydroxyurea. Cancer is treated with hydroxyurea by reducing or halting the proliferation of cancer cells within the body. By assisting in preventing the development of sickle-shaped red blood cells, hydroxyurea treats sickle cell anaemia.

How should this medicine be used?

Hydroxyurea is available as a pill and capsule for oral consumption. It is typically taken with a glass of water once per day. Some cancers can be treated with hydroxyurea by taking it once every third day. Take hydroxyurea every day at around the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the hydroxyurea directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Depending on how you respond to treatment and any adverse effects you may have, your doctor may need to postpone your treatment or change the dosage of hydroxyurea. Discuss your feelings regarding your treatment with your doctor. Without consulting your doctor, do not stop taking hydroxyurea.

To lessen some of this medication’s negative effects, your doctor will likely advise you to take folic acid, a vitamin. Follow the directions on the prescription exactly.

Do not break, chew, or crush the capsules; instead, swallow them whole.

The Siklos hydroxyurea 1,000 mg tablets are scored to make it simple to cut them into quarters or halves for lesser doses. The 100 mg hydroxyurea pills should not be broken into smaller pieces. How to break the tablets and how many tablets or parts of a tablet you should take will be specified by your doctor.

You can dissolve your dose of hydroxyurea tablets in water if you are unable to swallow whole tablets or portions of tablets. Your dose should be placed in a teaspoon along with a tiny amount of water. The tablet(s) should be given about a minute to dissolve before being swallowed.

When handling the capsules or pills, you should wear rubber or latex gloves to prevent medication contact with your skin. Before and after touching the bottle or medication, wash your hands with soap and water. If you accidentally get hydroxyurea in your eyes, immediately rinse them out with water for at least 15 minutes. If a tablet or capsule’s powder falls, clean it up right away using a damp paper towel. After that, put the towel in a closed container, like a plastic bag, and dispose of it in a trashcan that is out of kids’ and dogs’ reach. Using a detergent solution and then clean water, clean the spill area.

Other uses for this medicine

Polycythemia vera can also occasionally be treated with hydroxyurea (a blood disease in which your body makes too many red blood cells). The dangers of using this drug for your illness should be discussed with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking hydroxyurea,

  • If you have any allergies, including to hydroxyurea, other drugs, or any of the inactive components in hydroxyurea capsules or tablets, notify your doctor right away. Get a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention any of the following: interferon, certain HIV (human immunodeficiency virus) drugs including didanosine (Videx), stavudine (Zerit), and (Actimmune, Avonex, Betaseron, Infergen, Intron A, others). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you have AIDS, HIV, high blood uric acid levels, leg ulcers, cancer chemotherapy, radiation therapy, hemodialysis, renal or liver illness, or if you have previously had any of these conditions. You should also mention if you have ever had any of these conditions.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. While taking hydroxyurea, it is not recommended that you get pregnant or breastfeed. Before starting hydroxyurea therapy, a pregnancy test will be required. Use reliable birth control if you’re a female while taking hydroxyurea and for at least six months after quitting the medication. If you are a man, you should use effective birth control while taking hydroxyurea and for at least 6 months (Siklos) or at least 1 year (Droxia, Hydrea) after finishing therapy. This also applies whether you are taking Siklos or Droxia. During and after your treatment, ask your doctor about birth control options you can use, as well as how long you should keep using them. Call your doctor as soon as possible if you find out you’re pregnant while taking hydroxyurea. The foetus could be harmed by hydroxyurea.
  • You should be aware that this drug may reduce male fertility. The dangers of using hydroxyurea should be discussed with your doctor.
  • Avoid getting any shots without first consulting your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from hydroxyurea. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Diarrhea
  • Reduced appetite
  • Gaining weight
  • Mouth- and throat-related sores
  • Constipation
  • Rash
  • Light skin
  • Dizziness
  • Headache
  • Hair fall
  • Alterations to skin and nails

Certain adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT CAUTION section:

  • Rapid heart rate
  • Chronic stomach ache that occasionally radiates to the back
  • Leg ulcers or sores
  • Blisters, redness, swelling, stinging, or pain on the skin
  • Stomach ache in the top right corner
  • Urine with blood in it
  • Eyes or skin that have a yellow tint
  • Tingling, numbness, or burning in the hands or feet
  • Shortness of breath, cough, and other breathing issues

Further negative effects of hydroxyurea are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this prescription tightly wrapped in the container it came in, out from the reach of children and animals. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). The bottle must be used within three months of receiving broken 1,000 mg tablets.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Mouth- and throat-related sores
  • Hands and feet may experience discomfort, redness, edoema, and scaling.
  • Lowering of skin tone

What other information should I know?

Inform the lab staff and your doctor that you are taking hydroxyurea prior to any laboratory test.

No one else should take your medication. The drug or the bottle containing the medication should not be touched by anyone who is not taking hydroxyurea.

Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Droxia®
  • Hydrea®
  • Siklos®
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