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HYDROXYUREA USP
Pediatric Friendly Formulation Scedamin 100mg & 500mg scored.
NOT FOR SALE IN THE USA,
FOR EXPORT ONLY.
Additional Information
SCEDAMIN is an FDA approved prescription medicine for adults and children, 9 months of age and older, diagnosed with sickle cell disease. It helps in reducing need for frequent blood transfusions, and in preventing recurrence of painful crisis.
Oral medication dissolvable in water.
Dosage is titrated according to patient's actual body weight.
How Hydroxyurea works
Red blood cells contain hemoglobin, and this enables the red blood cells carry oxygen from the lungs to other parts of the body. People with normal hemoglobin have higher level of Hemoglobin A (HbA) in their red blood cells. In contrast, people with sickle cell disease have a high level of sickle or Hemoglobin S (HbS) in their red blood cells. HbS is an abnormal type of hemoglobin, as it causes the red blood cells to change from a round shape to a sickle or crescent shape. Also, HbS makes the red blood cells to become rigid and sticky. This leads to obstruction of blood flow to important body organs, muscles, and tissues.
Hydroxyurea treatment helps the red blood cells stay round and flexible, thus enabling the red blood cells travel more easily through tiny blood vessels. This is because hydroxyurea increases the amount of fetal hemoglobin (HbF) in red blood cells. Newborn babies have HbF, and this protects them from sickle cell complications during the first six months of life. With an increased amount of HbF, red blood cells are less likely to change into the sickle or crescent shape. People with sickle cell disease on treatment, and with higher levels of HbF, usually have fewer complications of the disease.
Hydroxyurea does not cure sickle cell disease, but greatly reduces some of the complications associated with the disease.
Hydroxyurea for Children with Sickle Cell Anemia
Daily hydroxyurea treatment is feasible and safe for children with sickle cell anemia in Sub-Saharan Africa.
ABOUT SICKLE CELL DISEASE
Sickle cell disease is an inherited disease of the red blood cells. The red blood cells become stiff and crescent-shaped, causing them to obstruct blood vessels and block blood flow. This can result in severe pain and organ damage, requiring urgent hospitalization.
complications of sickle cell diseasE
Painful crises
Acute chest syndrome
Painful crises
Abnormal red blood cells block blood flow through the blood vessels, causing recurrent pain in the chest, abdomen, joints and bones. Pain can be moderate to severe, and last from a few hours to a few weeks. Severe painful crises may require that your child be hospitalized.
Anemia
Acute chest syndrome
Painful crises
The abnormal red blood cells easily breakdown (hemolyze), resulting in a shortage of red blood cells. This causes a lack of oxygen flow in the body, leading to fatigue, and build up of acid in blood. Your child will also require frequent blood transfusions in order to treat the anemia.
Acute chest syndrome
Acute chest syndrome
Swelling of hands and feet
When a painful crisis affects the lungs, it is called “acute chest syndrome”. Symptoms include chest pain, fever and difficulty breathing. This condition requires immediate medical attention.
Swelling of hands and feet
Swelling of hands and feet
Swelling of hands and feet
Blood flow to hand and feet can become obstructed when abnormal red blood cells stick within the small vessels supplying blood to the hands and feet. This causes painful swelling on the affected limbs.
Frequent infections
Swelling of hands and feet
Frequent infections
Abnormal red blood cells can damage infection-fighting organs, leaving your child more vulnerable to infections. An infection can also trigger a painful crisis or acute chest syndrome. That’s why it’s important to consult a healthcare professional any time your child has a fever or any other sign or symptom of infection.
Delayed growth
Swelling of hands and feet
Frequent infections
Because red blood cells provide the body with the oxygen and nutrients it needs to grow, a shortage of healthy red blood cells can slow your child’s growth and development.
INDICATION AND IMPORTANT SAFETY INFORMATION
Scedamin is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults and children, 9 months of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.
WARNING: LOW BLOOD CELL COUNT and CANCER
See Full Prescribing Information for complete Boxed Warning;
- Low blood cell counts are common with Scedamin, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with Scedamin. Your healthcare provider may change your dose or tell you to stop taking Scedamin if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising.
- Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking Scedamin for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.
WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT SCEDAMIN?
Scedamin can harm your unborn baby.
For females taking Scedamin who can become pregnant;
- You should talk with your healthcare provider about the risks of Scedamin to your unborn baby.
- You should use effective birth control during treatment with Scedamin and for at least 6 months after treatment with Scedamin.
- Your healthcare provider will perform a pregnancy test before you start treatment with Scedamin. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
For males taking Scedamin: Scedamin can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with Scedamin and for at least 6 months after treatment.
Scedamin may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.
WHO SHOULD NOT TAKE SCEDAMIN?
Do not take Scedamin if you are allergic to hydroxyurea or any of the ingredients in Scedamin. See the Medication Guide for a list of the ingredients in Scedamin.
HOW SHOULD I TAKE SCEDAMIN?
Read the Instructions for Use for step-by-step instructions on how to prepare a dose of Scedamin.
- Take Scedamin exactly as your healthcare provider tells you to take it.
- Take Scedamin 1 time a day at the same time each day.
- Swallow the tablets with a glass of water. If you are not able to swallow Scedamin tablets, you can dissolve your prescribed dose in a small amount of water in a teaspoon and swallow right away. Scedamin tablets must be handled with care.
WHAT SHOULD YOU TELL YOUR HEALTH CARE PROVIDER BEFORE TAKING SCEDAMIN?
Tell your healthcare provider about all of your medical conditions, including if you;
- Have kidney problems or are receiving hemodialysis have liver problems
- Have human immunodeficiency virus (HIV) or take HIV medicines. Taking Scedamin with certain HIV medicines can cause serious reactions and may lead to death.
- Have increased levels of uric acid in your blood (hyperuricemia)
- Have a history of receiving interferon therapy or are currently receiving interferon therapy
- Have leg wounds or ulcers plan to receive any vaccinations. You should not receive “live vaccines” during treatment with Scedamin.
- Are pregnant or plan to become pregnant. See “What is the most important information I should know about Scedamin?”
- Are breastfeeding or plan to breastfeed. It is not known if Scedamin can pass into your breast milk. Do not breastfeed during treatment with Scedamin.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SCEDAMIN?
Scedamin may cause serious side effects, including;
- Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take Scedamin. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with Scedamin if you develop any skin ulcers.
- Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take Scedamin and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you.
- Hemolytic Anemia, the fast breakdown of red blood cells, has happened in people who take Scedamin. Tell your healthcare provider I you develop yellowing of your skin (jaundice) or blood in your urine. Your healthcare provider may do blood tests if you have persistent or worsening anemia not related to sickle cell anemia.
The most common side effects of Scedamin in children include: infections and low white blood cells.
The most common side effects of Scedamin in adults include: infections, headache, and dry skin.
These are not all the possible side effects of Scedamin.
You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or 1-800-FDA-1088.
Please read the Full Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use, at www.scedamin.com
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