HYDREA 500MG CAPSULE contains Hydroxyurea, which belongs to a group of medicines called Antimetabolites. It is used to treat resistant chronic myeloid leukaemia and locally advanced squamous cell cancer of the head and neck (excluding the lip) and cervical cancer.
HYDREA 500MG CAPSULE is not recommended for use in patients with a history of any blood problems or severe anaemia. HYDREA 500MG CAPSULE should be used with caution in patients with liver, lung or kidney disease and myelosuppression (leukopenia, thrombocytopenia, anaemia).
HYDREA 500MG CAPSULE is not recommended for use during pregnancy. HYDREA 500MG CAPSULE is not recommended for use by breastfeeding women. HYDREA 500MG CAPSULE is also not recommended for use in children as its safety and effectiveness are not established. HYDREA 500MG CAPSULE should be used with caution in the elderly aged 65 years or above.
The most common side effects of taking HYDREA 500MG CAPSULE are loss of appetite, weakness, loss of energy, sickness, diarrhoea, constipation, abdominal pain, hair loss, blood disorders (decrease in white blood cells, red blood cells and platelets), low back pain, black tarry stools or blood in the stools, unusual bleeding or bruising, muscle weakness, sores on the lips or mouth etc. Contact your physician if any of the symptoms worsen.
USES OF HYDREA 500MG CAPSULE
- Treats resistant chronic myeloid leukaemia
- Treats locally advanced squamous cell carcinomas of the head and neck, (excluding lip)
- Treats cervical cancer
HOW HYDREA 500MG CAPSULE WORKS
HYDREA 500MG CAPSULE gets converted to free radical nitroxide (NO), which enters the cells, inactivates the ribonucleotide reductase enzyme and causes immediate inhibition of DNA synthesis, leading to cell death.
DIRECTIONS FOR USE
Take HYDREA 500MG CAPSULE as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your physician will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF HYDREA 500MG CAPSULE
COMMON
- Blood disorders (decrease in white blood cells, red blood cells and platelets)
- Low back pain
- Black tarry or blood in stools
- Unusual bleeding or bruising
- Skin changes (dermatomyositis) a scaly, purple, raised rash on the face, hands or other parts of the body with redness, darkening of the skin, peeling of the skin and worsening of redness or skin and mucous membrane discomfort in patients with a history of radiation
- Muscle weakness – symptoms such as muscle tenderness, muscle weakness or tiredness when climbing stairs, walking or rising from a chair etc
- Sores on the lips or mouth
- Difficulty or pain passing urine
- Azoospermia or oligospermia (absence or decreased amount of sperm in the semen)
- Anorexia, weakness, decreased energy
- Sickness, diarrhoea, constipation, abdominal pain
- Hair loss
- Kidney problems
- Unexplained shortness of breath or cough with fever
- Numbness or tingling of hands or feet
- Skin cancer
- Problems with the flow of the bile (cholestasis) causing itchiness, yellowish discolouration of skin or whites of eye, very dark urine, pale stools
- Inflammation of the liver (hepatitis), which causes flu-like symptoms, including tiredness, loss of appetite, fever, pain, nausea, vomiting, pressure or pain below the right ribs and might also include yellowing of the skin or eyes
- Drowsiness, dizziness, fits, confusion or hallucinations
- Headache
RARE
- Skin ulceration with severe infection
- Tumour lysis syndrome
Stop taking HYDREA 500MG CAPSULE and contact your physician immediately if you experience any of the following side effects:
- Allergic reaction such as skin rashes, itching, swelling of the face, lips, tongue or throat causing difficulty breathing
- Unexplained fever, chills, sore throat or cough
- Wasting of muscles
- Peeling of the skin and nails
- High fever with stomach, lung, muscle, liver, skin or heart problems within 6 weeks of taking HYDREA 500MG CAPSULE
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a pain-relieving balm to your forehead if necessary. Contact your doctor if the symptom does not improve.
Nausea and vomiting:
Take the medicine with or just after a meal. Stick to simple meals. Avoid eating oily or spicy foods. Contact your doctor if the symptom does not improve.
Diarrhoea: Drink lots of fluids, such as water or fruit juices, to keep you hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if the symptom does not improve.
Stomach pain:
Try to rest and relax. Eat small meals but take them frequently. Keep a heating pad on your stomach to ease stomach pain. Contact your doctor if the symptom does not improve.
Constipation:
Eat plenty of fiber-rich foods such as fresh fruits, vegetables and cereals. Drink plenty of water and exercise more regularly. Contact your doctor if the symptom does not improve.
Dizziness or drowsiness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any machines if you feel dizzy. Contact your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
HYDREA 500MG CAPSULE is not recommended for use by pregnant women. Inform your doctor if you expect or are planning for pregnancy. Avoid becoming pregnant while taking HYDREA 500MG CAPSULE. Contact your doctor before taking HYDREA 500MG CAPSULE.
BREASTFEEDING
HYDREA 500MG CAPSULE is not recommended for use by breastfeeding women as it may pass through breast milk to the breastfed baby. Contact your doctor before taking HYDREA 500MG CAPSULE.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel drowsy after taking HYDREA 500MG CAPSULE.
ALCOHOL
Avoid consuming alcohol while taking this medicine, as it may lead to unwanted effects.
KIDNEY
HYDREA 500MG CAPSULE should be used with caution in patients with kidney disease. Contact your doctor before taking HYDREA 500MG CAPSULE.
LIVER
HYDREA 500MG CAPSULE should be used with caution in patients with liver disease. Contact your doctor before taking HYDREA 500MG CAPSULE.
ALLERGY
Do not take HYDREA 500MG CAPSULE if you are allergic to Hydroxyurea or lactose or some sugars or other ingredients in this medicine.
LUNGS
HYDREA 500MG CAPSULE should be used with caution in patients with pulmonary fibrosis, lung infiltration, pneumonitis and alveolitis or allergic alveolitis. Contact your doctor before taking HYDREA 500MG CAPSULE.
OTHERS
HYDREA 500MG CAPSULE is not recommended for use if you have:
- History of blood disorders
- Severe anaemia
Before taking HYDREA 500MG CAPSULE, inform your doctor if you have:
- Myelosuppression (leukopenia, thrombocytopenia, anaemia)
- Previously received radiotherapy or chemotherapy
- Myeloproliferative disorders
- Secondary leukaemia
- Skin cancer
- Cutaneous vasculitis ulcers and gangrene
- Gout
- Leg ulcers
- Folic acid deficiency
- HIV infection
- Pancreatitis, hepatotoxicity and peripheral neuropathy
- Live vaccines
- Radiation
- Macrocytosis (enlarged red blood cells)
- Sickle cell anaemia
- Blood test for uric acid, urea or lactic acid
Use in paediatrics:
HYDREA 500MG CAPSULE is not recommended for use in children as safety and effectiveness are not established. Contact your doctor before taking HYDREA 500MG CAPSULE.
Use in geriatrics:
HYDREA 500MG CAPSULE should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking HYDREA 500MG CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking HYDREA 500MG CAPSULE, inform your doctor if you are taking any of the following medicine:
- Antiretroviral medicines (medicines used to treat viral infections such as HIV) Ex. didanosine, stavudine and indinavir
- Medicines which suppress the bone marrow (Ex. chemotherapies and radiation therapy)
- Vaccines (medicines used to prevent infections)
Overdosage:
If you or anyone else accidentally take too much of HYDREA 500MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are acute mucocutaneous toxicity, soreness, violet erythema, swelling of hands and feet, followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin and stomatitis.
SYNOPSIS
| Drug | : | Hydroxyurea |
| Pharmacological Category | : | Antimetabolites |
| Therapeutic Indication | : | resistant chronic myeloid leukaemia, locally advanced squamous cell cancer of the head and neck (excluding lip), cervical cancer |
| Dosage Forms | : | Capsule |
MORE INFORMATION
- Keep HYDREA 500MG CAPSULE out of the sight and reach from children
- Store HYDREA 500MG CAPSULE below 25°C
FAQs ABOUT HYDREA 500MG CAPSULE
How does HYDREA 500MG CAPSULE work?
HYDREA 500MG CAPSULE gets converted to free radical nitroxide (NO), which enters the cells, inactivates the ribonucleotide reductase enzyme and causes immediate inhibition of DNA synthesis, leading to cell death.
Can HYDREA 500MG CAPSULEbe used to treat cancer in the neck?
HYDREA 500MG CAPSULE is used to treat resistant chronic myeloid leukaemia and locally advanced squamous cell carcinomas of the head and neck (excluding the lip) and cervical cancer. Contact your doctor before taking HYDREA 500MG CAPSULE.
What are the possible side effects of taking HYDREA 500MG CAPSULE?
The most common side effects of taking HYDREA 500MG CAPSULE are loss of appetite, weakness, loss of energy, sickness, diarrhoea, constipation, abdominal pain, hair loss, blood disorders (decrease in white blood cells, red blood cells and platelets), low back pain, black tarry stools or blood in the stools, unusual bleeding or bruising, muscle weakness, sores on the lips or mouth etc. Contact your physician if any of the symptoms get worse.
Can HYDREA 500MG CAPSULE cause liver damage?
Yes. HYDREA 500MG CAPSULE can cause liver damage. Contact your doctor if you experience any unusual symptoms like yellowish discolouration of the skin or whites of the eyes, dark urine or pale stools.
Does HYDREA 500MG CAPSULE cause cancer?
Yes. Avoid prolonged exposure to sunlight and wear protective clothing, sunglasses, and sunscreen while using HYDREA 500MG CAPSULE. Contact your doctor before taking HYDREA 500MG CAPSULE.
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