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Introduction About RIBOREA CAPSULE
RIBOREA CAPSULE contains Hydroxyurea, which belongs to a group of medicines called Antimetabolites. It is used to manage resistant chronic myeloid leukaemia and locally advanced squamous cell cancer of the head and neck (excluding the lip) and cervical cancer.
RIBOREA CAPSULE is not recommended for use in patients with a history of any blood problems or severe anaemia. RIBOREA CAPSULE should be used with caution in patients with liver, lung or kidney disease and myelosuppression (leukopenia, thrombocytopenia, anaemia).
RIBOREA CAPSULE is not recommended for use during pregnancy. RIBOREA CAPSULE is not recommended for use by breastfeeding women. RIBOREA CAPSULE is also not recommended for use in children as its safety and effectiveness are not established. RIBOREA CAPSULE should be used with caution in the elderly aged 65 years or above.
The most common side effects of taking RIBOREA 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 RIBOREA CAPSULE
- Manage resistant chronic myeloid leukaemia
- Manage locally advanced squamous cell carcinomas of the head and neck, (excluding lip)
- Manage cervical cancer
How RIBOREA CAPSULE Works
RIBOREA 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.
How to use RIBOREA CAPSULE
Take RIBOREA 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 RIBOREA 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 RIBOREA 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 RIBOREA 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 manage 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
RIBOREA 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 RIBOREA CAPSULE. Contact your doctor before taking RIBOREA CAPSULE.
Breastfeeding
RIBOREA 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 RIBOREA CAPSULE.
Driving and Using Machines
Do not drive or operate any machines if you feel drowsy after taking RIBOREA CAPSULE.
Alcohol
Avoid consuming alcohol while taking this medicine, as it may lead to unwanted effects.
Kidney
RIBOREA CAPSULE should be used with caution in patients with kidney disease. Contact your doctor before taking RIBOREA CAPSULE.
Liver
RIBOREA CAPSULE should be used with caution in patients with liver disease. Contact your doctor before taking RIBOREA CAPSULE.
Allergy
Do not take RIBOREA CAPSULE if you are allergic to Hydroxyurea or lactose or some sugars or other ingredients in this medicine.
Lungs
RIBOREA CAPSULE should be used with caution in patients with pulmonary fibrosis, lung infiltration, pneumonitis and alveolitis or allergic alveolitis. Contact your doctor before taking RIBOREA CAPSULE.
Others
RIBOREA CAPSULE is not recommended for use if you have:
- history of blood disorders
- severe anaemia
Before taking RIBOREA 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:
RIBOREA CAPSULE is not recommended for use in children as safety and effectiveness are not established. Contact your doctor before taking RIBOREA CAPSULE.
Use in geriatrics:
RIBOREA CAPSULE should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking RIBOREA CAPSULE.
Interactions
A. Drug-Drug interactions:
Before taking RIBOREA CAPSULE, inform your doctor if you are taking any of the following medicine:
- antiretroviral medicines (medicines used to manage 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 manage infections)
Overdosage:
If you or anyone else accidentally take too much of RIBOREA 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 RIBOREA CAPSULE out of the sight and reach from children
- Store RIBOREA CAPSULE below 25°C
FAQs About RIBOREA CAPSULE
How does RIBOREA CAPSULE work?
RIBOREA 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 RIBOREA CAPSULEbe used to manage cancer in the neck?
RIBOREA CAPSULE is used to manage 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 RIBOREA CAPSULE.
What are the possible side effects of taking RIBOREA CAPSULE?
The most common side effects of taking RIBOREA 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 RIBOREA CAPSULE cause liver damage?
Yes. RIBOREA 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 RIBOREA CAPSULE cause cancer?
Yes. Avoid prolonged exposure to sunlight and wear protective clothing, sunglasses, and sunscreen while using RIBOREA CAPSULE. Contact your doctor before taking RIBOREA CAPSULE.
References
1. K D Tripathi. Anticancer Drugs. Essentials of medical pharmacology. 7th edition. 2013. Page – 868.
2. Rohit Kumar Agrawal, Rakesh Kantilal Patel, Varsha shah, Lalit Nainiwal, Bhadra Trivedi. Mechanism of Hydroxyurea. National Institute of Health. NLM. National Centre for Biotechnology Information. Pubmed.gov, June 2014. [Accessed on 16th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4022916/#:~:text=Mechanism%20of%20Action&text=Hydroxyurea%20is%20a%20potent%20RR,synthesis%20and%20eventual%20cellular%20cytotoxicity.
3. Corden Pharma Latina S.P.A. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 16th June 2022] https://www.medicines.org.uk/emc/files/pil.271.pdf
4. Bristol-Myers Squibb Company. U.S. Food & Drug Administration. [Revised in July 2019] [Accessed on 16th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf
5. Bristol-Myers Squibb Company. Hydroxyurea. [Revised in July 2021] [Accessed on 16th June 2022] https://packageinserts.bms.com/pi/pi_hydrea.pdf
6. Par Formulations Private Limited. Hydroxyurea. [Revised in June 2021] [Accessed on 16th June 2022] https://www.parpharm.com/pdfs/catalog/generic/Hydroxyurea_PI_20220113.pdf
Useful Diagnostic Tests
- Complete blood count
- Kidney function test
- Liver function test
- Biopsy
- Computerised Tomography (CT) scan
- Magnetic Resonance Imaging (MRI) scan
- Positron emission tomography (PET) scan
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