INTRODUCTION
ATRANZA 10MG CAPSULE contains Tretinoin, which belongs to the group of medicines called Retinoids. It is used to treat acute promyelocytic leukaemia (APL). Acute Promyelocytic Leukemia is a form of acute myeloid leukaemia (bone marrow cancer), in which the immature blood-forming cells (RBC, WBC and platelets) called promyelocytes accumulates in the bone marrow and blood, leading to a shortage of normal white and red blood cells and platelets in the body. Shortage of blood-forming cells in the blood leads to symptoms such as abnormal bleeding and bruising, blood clots, excessive tiredness, pale skin, pain in affected areas, loss of appetite and weight loss.
Do not take ATRANZA 10MG CAPSULE if you are pregnant or if you are trying to become pregnant, because it may cause harm to your unborn baby. Your doctor will suggest a suitable method for contraception. Also, you should not get pregnant during or within 1 month after stopping treatment with ATRANZA 10MG CAPSULE. ATRANZA 10MG CAPSULE is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking it.
ATRANZA 10MG CAPSULE should be used with caution in children. Consult your doctor before taking it. ATRANZA 10MG CAPSULE should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking it. The most common side effects of using ATRANZA 10MG CAPSULE are hair loss, irregular heartbeat, altered eyesight or hearing, bone, joint, chest or abdominal pain, skin problems, dry skin, swollen, dry or cracked lips, breathing difficulties, headache, etc. Contact your doctor if any of the side effects worsen.
USES OF ATRANZA 10MG CAPSULE
- Treats acute promyelocytic leukemia
HOW ATRANZA 10MG CAPSULE WORKS
ATRANZA 10MG CAPSULE works by slowing the growth of certain types of diseased blood cells and promotes the growth of normal, mature cells in the bone marrow and blood, thereby helping treat blood cancer (acute promyelocytic leukemia).
DIRECTIONS FOR USE
Take ATRANZA 10MG CAPSULE as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.
SIDE EFFECTS OF ATRANZA 10MG CAPSULE
COMMON
- hair loss
- irregular heartbeat
- altered eyesight or hearing
- bone, joint, chest and stomach pain
- skin itching, redness, rash, peeling or inflammation
- dry skin, mouth or nose, swollen, dry or cracked lips
- breathing problems like asthma, which may worsen
- eye infection and inflammation, dry eyes (problematic if you wear contact lenses)
- trouble sleeping
- sweating too much
- headache, dizziness
- tiredness, cold or feeling generally unwell
- confusion, worry or depression
- tingling or numbness in arms or feet
- loss of appetite, nausea, vomiting, stomach upset, stomach pain, inflammation of the pancreas or the lips, vomiting, diarrhoea or constipation
- changes in your blood like raised levels of transaminases, creatinine or fat
RARE
Stop taking ATRANZA 10MG CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- fever, along with breathing problems, coughing, dizziness, chest and abdominal pain, dark lumpy markings on the skin of your face and neck
- severe headache with nausea or vomiting, trouble breathing, fever, dizziness, chest or back pain
- pancreatitis (severe stomach pain spreading to your back)
- blood clot (painful swelling in your leg, sudden chest pain or trouble breathing)
- heart attack (pain in your chest spreading to your arm or neck)
- increased pressure in your head (double vision and dizziness, along with nausea or vomiting, ringing in your ears and headache)
- stroke (an unexplained headache or migraine, with or without disturbed vision)
- changes in your mood and behaviour
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Try to take ATRANZA 10MG CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.
Headache:
Drink an ample amount of water. Get adequate rest. Try to be relaxed and stress-free. Ask your doctor before taking any medicine for a headache. If the symptom does not improve, contact your doctor.
Dizziness:
Lie down until the dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. If the symptom does not improve, contact your doctor.
Constipation:
Eat plenty of fiber-rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. If the symptom does not improve, contact your doctor.
Diarrhea:
Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. If the symptom does not improve, contact your doctor.
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heating pad on your stomach. If the symptom does not improve, contact your doctor.
Loss of appetite:
Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. If the symptom does not improve, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
Do not take ATRANZA 10MG CAPSULE if you are pregnant or if you are trying to become pregnant, because it may cause harm to your unborn baby. Your doctor will suggest a suitable method for contraception. Also, you should not get pregnant during or within 1 month after stopping treatment with ATRANZA 10MG CAPSULE.
BREASTFEEDING
ATRANZA 10MG CAPSULE is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness or severe headache after taking ATRANZA 10MG CAPSULE.
ALLERGY
Do not take ATRANZA 10MG CAPSULE if you are allergic to Tretinoin or any of the other ingredients of this medicine.
OTHERS
Before taking ATRANZA 10MG CAPSULE inform your doctor if you:
- have any other illness
- have ever had any mental health problems including depression, aggressive tendencies or mood changes
- have an intolerance to some sugars
Use in pediatrics:
ATRANZA 10MG CAPSULE should be used with caution in children. Consult your doctor before taking it.
Use in geriatrics:
ATRANZA 10MG CAPSULE should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ATRANZA 10MG CAPSULE inform your doctor if you are taking any of the following medicine:
- vitamin A or other retinoids such as other retinoid medicines such as isotretinoin, acitretin and tazarotene
- medicines used to treat bacterial infections (rifampicin, clarithromycin, erythromycin and tetracyclines)
- progestogens (used to prevent pregnancy)
- medicines used to treat allergies and inflammation (Ex. prednisolone, dexamethasone)
- phenobarbital (used to treat fits)
- pentobarbital (used to treat lack of sleep)
- medicines used to treat fungal infections (Ex. ketoconazole, fluconazole, itraconazole, posaconazole)
- medicines used to treat HIV infection (Ex. ritonavir, saquinavir)
- cimetidine (used to treat stomach ulcers)
- medicines used to treat heart conditions or high blood pressure (Ex. verapamil and diltiazem)
- ciclosporin (used after organ or bone marrow transplants)
- medicines used to reduce bleeding (Ex. tranexamic acid, aminocaproic acid, aprotinin)
B. Drug-Food interactions:
Do not take peanuts or soya while taking ATRANZA 10MG CAPSULE.
Overdosage:
If you or anyone else accidentally take too much of ATRANZA 10MG CAPSULE, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Tretinoin |
| Pharmacological Category | : | Retinoids |
| Therapeutic Indication | : | Acute promyelocytic leukemia |
| Dosage Forms | : | Capsule, Cream, Gel, Gel (Topical) |
MORE INFORMATION
- Keep ATRANZA 10MG CAPSULE out of reach from children
- Store at room temperature
FAQs ABOUT ATRANZA 10MG CAPSULE
Can ATRANZA 10MG CAPSULE affect my mental health?
Yes. ATRANZA 10MG CAPSULE can affect your mood and behavior. You may not notice these changes, so it is very important that you tell your friends and family if they notice any changes and help you identify any problems that you need to inform your doctor about.
Can ATRANZA 10MG CAPSULE be taken during pregnancy?
ATRANZA 10MG CAPSULE is not recommended for use during pregnancy. You should not become pregnant during and one month after stopping this treatment. If you are pregnant, think you may be pregnant or are planning to get pregnant, consult your doctor before taking ATRANZA 10MG CAPSULE. Discuss contraception with your doctor while taking ATRANZA 10MG CAPSULE.
What if I forget to take a dose of ATRANZA 10MG CAPSULE?
If you forget to take a dose of ATRANZA 10MG CAPSULE, take it as soon as you remember. However, omit the missed dose if it is almost time for the next dose. Do not take ATRANZA 10MG CAPSULE twice to make up for a forgotten dose.
Can ATRANZA 10MG CAPSULE be crushed?
No. Do not break, crush or chew ATRANZA 10MG CAPSULE. Simply swallow it wholly, with a glass of water.
What precautions do I need to follow while taking ATRANZA 10MG CAPSULE?
Patients taking ATRANZA 10MG CAPSULE must inform their doctor about their pre-existing disease conditions like any mental health problems (depression or mood changes) or any other diseases or if they are taking any medicines containing vitamin A, tetracyclines or retinoids. Patients should also inform if they are pregnant, breastfeeding or have any allergies. Contact your doctor immediately if you have any unusual symptoms.
REFERENCES
1. KD Tripathi. Anticancer drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 869.
2. Bruce A. Chabner. General principles of cancer chemotherapy. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1722-1723.
3. Gerald G. Briggs and Roger K. Freeman. I. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3898-3899.
4. Children's Oncology Group. Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on November 2020] [Accessed on 31st May 2022] https://clinicaltrials.gov/ct2/show/NCT02339740
5. Cheplapharm Arzneimittel GmbH. Electronic Medicines Compendium (EMC). [Revised on Jan 2022] [Accessed on 31st May 2022] https://www.medicines.org.uk/emc/files/pil.2535.pdf
USEFUL DIAGNOSTIC TESTS
- Complete blood count
- Bone marrow biopsy
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