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INTRODUCTION
LUPORAL CAPSULE is a combination of Tegafur and Uracil which belongs to the group of medicines called Thymidylate synthase inhibitors. It is used with calcium folinate to treat metastatic colorectal cancer which is a type of cancer that begins in the colon or rectum and spreads to other parts of the body and characterized by symptoms such as rectal bleeding, narrow stools, persistent abdominal pain and unexplained weight loss.
Along with this treatment, your doctor might advise you for a liver function test to assess the function of your liver. LUPORAL CAPSULE is not recommended for use in patients with severe hepatic impairment, bone marrow suppression from previous radiotherapy or dihydropyrimidine dehydrogenase deficiency disease (a severe neurological disease marked by seizures).
Before taking LUPORAL CAPSULE, inform your doctor if you have heart, kidney or liver disease. LUPORAL CAPSULE is not recommended for use in pregnant and breastfeeding women and it is also not recommended for use in children and adolescents (aged below 18 years).
This medicine should be used with caution in elderly patients (aged 75 years or above) with age-related impaired kidney, liver or heart function and other concomitant medications or diseases.
The most common side effects of taking LUPORAL CAPSULE are nausea, diarrhea, constipation, stomach pain, headache, dizziness and dry skin. Consult your doctor if any of the side effects get worse.
USES OF LUPORAL CAPSULE
- Treats metastatic colorectal cancer (in combination with calcium folinate)
HOW LUPORAL CAPSULE WORKS
LUPORAL CAPSULE helps in preventing the spread of colorectal cancer cells, where tegafur works by converting into fluorouracil or 5-FU in the liver which causes destruction of cancer cells and uracil works by preventing the degradation of 5-FU which results in the prolongation of its stay in the cancer cells thus resulting in the destruction of colorectal cancer cells and preventing its spread to other parts of the body.
DIRECTIONS FOR USE
Always take this medicine as directed by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose for you depending upon your age and disease condition.
SIDE EFFECTS OF LUPORAL CAPSULE
COMMON
- sore or inflammation inside of the mouth or throat
- dehydration, weakness
- anorexia (eating disorder)
- cachexia (wasting syndrome that leads to loss of skeletal muscle and fat)
- insomnia, confusion
- altered taste, taste loss
- dizziness, headache, sleepiness
- tingling or numbness sensation
- shedding tears, conjunctivitis
- breathlessness, increased coughing
- diarrhoea, abdominal pain
- nausea, vomiting
- constipation, flatulence
- indigestion, burping
- dry mouth
- hair loss, dry skin, nail disorder
- rash, itching, skin discoloration
- joint, muscle or back pain
- peripheral oedema, general discomfort
- fever, chills, pain
- weight loss
UNCOMMON
- irregular heartbeat
- heart attack or arrest
- inflammation of the lining of the stomach, intestine or ileum
- jaundice (yellowing of skin or white of the eyes)
- urinary retention, blood in urine
- impotence
- chest pain
RARE
- loss or distorted sense of smell
- interstitial pneumonia
- fatigue
HOW TO MANAGE SIDE EFFECTS
Diarrhea:
Drink lot of fluids such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.
Constipation:
Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate treatments for constipation.
Nausea and vomiting :
Try to take LUPORAL CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich, fried or spicy food. Consult your doctor if the symptom gets worse.
Abdominal pain:
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
LUPORAL CAPSULE is not recommended for use in pregnant women or those who are attempting to become pregnant. Consult your doctor before taking LUPORAL CAPSULE.
BREASTFEEDING
LUPORAL CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking LUPORAL CAPSULE.
DRIVING AND USING MACHINES
LUPORAL CAPSULE should be used with caution while driving or operating machines since it might cause confusion. Consult your doctor before taking LUPORAL CAPSULE.
ALCOHOL
Avoid or limit consumption of alcohol while taking LUPORAL CAPSULE.
KIDNEY
LUPORAL CAPSULE should be used with caution in patients with impaired renal function. Consult your doctor before taking LUPORAL CAPSULE.
LIVER
LUPORAL CAPSULE is not recommended for use in patients with severe hepatic impairment and deficiency of hepatic gene called CYP2A6 (gene responsible for drug metabolism). It should be used with caution in patients with mild to moderate liver dysfunction. Consult your doctor before taking LUPORAL CAPSULE.
ALLERGY
LUPORAL CAPSULE is not recommended for use if you are allergic to 5-FU (flouroracil), tegafur, uracil or any other ingredients of this medicine.
HEART DISEASE
LUPORAL CAPSULE should be used with caution in patients with heart disease such as myocardial ischaemia (low blood flow to heart), angina (chest pain) or myocardial infarction (heart attack). Consult your doctor before taking LUPORAL CAPSULE.
OTHERS
LUPORAL CAPSULE is not recommended for use if you:
- have bone marrow suppression (a condition of low blood cells) from previous radiotherapy (a cancer therapy that uses radiation to shrink tumors and kill cancer cells)
- have dihydropyrimidine dehydrogenase deficiency disease (a severe neurological disease marked by seizures
Before taking LUPORAL CAPSULE, inform your doctor if you:
- signs and symptoms of bowel obstruction
Use in Pediatrics:
LUPORAL CAPSULE is not recommended for use in children and adolescents (aged below 18 years). Consult your child’s doctor for advice.
Use in Geriatrics:
LUPORAL CAPSULE should be used with caution in elderly patients (aged 75 years or above) with age-related impaired kidney, liver or heart function and other concomitant medications or diseases. Consult your doctor before taking LUPORAL CAPSULE.
INTERACTIONS
A. Drug-Drug Interactions:
Before taking LUPORAL CAPSULE, inform your doctor, if you are taking any of the following medicines:
- medicines that inhibit dihydropyrimidine dehydrogenase (an enzyme responsible for breaking down thymine and uracil which forms a structure of gene) Ex. brivudine
- cytotoxic agents such as cyclophosphamide, busulfan and bleomycin (used to treat cancer)
- warfarin (used to prevent blood clotting)
- phenytoin (used to control certain type of seizures during or after surgery)
- coumarin (used in the treatment of prostate cancer, kidney cancer)
- methoxypsoralen (medicine used to treat psoriasis and vitiligo)
- medicines used to treat fungal infections Ex. clotrimazole, ketoconazole and miconazole
Overdosage:
If you or anyone else accidentally takes too much of LUPORAL CAPSULE, consult your doctor immediately or visit the nearby hospital. Overdose symptoms of LUPORAL CAPSULE are nausea, vomiting, diarrhea, stomach ulcers, bleeding and bone marrow suppression (a condition of low blood cells).
SYNOPSIS
| Drug | : | Tegafur, Uracil |
| Pharmacological Category | : | Thymidylate synthase inhibitors |
| Therapeutic Indication | : | Metastatic colorectal cancer |
| Dosage Forms | : | Capsule |
MORE INFORMATION
- Keep the medicine out of reach of children
- Store LUPORAL CAPSULE at room temperature
FAQs ABOUT LUPORAL CAPSULE
What is LUPORAL CAPSULE used for?
LUPORAL CAPSULE is used with calcium folinate to treat metastatic colorectal cancer which is a type of cancer that begins in the colon or rectum and spreads to other parts of the body and characterized by symptoms such as rectal bleeding, narrow stools, persistent abdominal pain and unexplained weight loss.
What happens if you take more LUPORAL CAPSULE than your required dose?
If you or anyone else accidentally takes too much of LUPORAL CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, diarrhea, stomach ulcers, bleeding and bone marrow suppression (a condition of low blood cells).
Who should avoid taking LUPORAL CAPSULE?
LUPORAL CAPSULE is not recommended for use in patients with severe liver impairment, bone marrow suppression (a condition of low blood cells) from previous radiotherapy (a cancer therapy that uses radiation to shrink tumors and kill cancer cells) and dihydropyrimidine dehydrogenase deficiency disease (a severe neurological disease marked by seizures).
Is LUPORAL CAPSULE safe to use in children?
No, LUPORAL CAPSULE is not recommended for use in children and adolescents (below 18 years of age). If LUPORAL CAPSULE is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.
Can LUPORAL CAPSULE be used in patients with liver problems?
LUPORAL CAPSULE is not recommended for use in patients with severe hepatic impairment and deficiency of hepatic gene called CYP2A6 (gene responsible for drug metabolism). It should be used with caution in patients with mild to moderate liver dysfunction. Consult your doctor before taking LUPORAL CAPSULE.
REFERENCES
1. KD. Tripathi. Anticancer Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 864
2. Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Tegafur-Uracil or Observation in Treating Patients with Stage II Colorectal Cancer That Has Been Completely Removed by Surgery. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in September 2016] [Accessed on 16th May 2022] https://clinicaltrials.gov/ct2/show/NCT00392899
3. Alejandro Recio-Boiles; Burt Cagir. Colon Cancer. NIH National Library of Medicine, National center for biotechnology information. January 2022 [Accessed on 16th May 2022] https://www.ncbi.nlm.nih.gov/books/NBK470380/
4. Bristol-Myers Squibb (Pty) Ltd. UFT Capsules. [Revised in July 2001] [Accessed on 16th May 2022] https://hemonc.org/docs/packageinsert/uraciltegafur.pdf
5. Merck Serono Limited. Health Products Regulatory Authority (HPRA). [Revised in August 2010] [Accessed on 16th May 2022] https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA0654-017-001_09082010151841.pdf
USEFUL DIAGNOSTIC TESTS
- Colonoscopy
- Biomarker testing of the tumor
PRODUCT DETAILS
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