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INTRODUCTION
AMAZEO 300MG TABLET contains Amisulpride which belongs to the group of medicines called Antipsychotics. It is used to treat schizophrenia (serious mental disorder) in affected individuals.
AMAZEO 300MG TABLET is not recommended for use in patients with breast cancer or prolactin dependent tumor, phaeochromocytoma (type of adrenal gland tumor), and/or pituitary tumor. It is also not recommended for use in patients allergic to amisulpride.
Before taking AMAZEO 300MG TABLET, inform your doctor if you have diabetes, Parkinson’s disease (type of brain disorder), fits, signs of low potassium levels in your blood (such as constipation, fatigue, muscle damage), stroke, kidney problems, and/or liver problems (such as hepatic impairment).
AMAZEO 300MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy. It is also not recommended for use in breast feeding women.
AMAZEO 300MG TABLET is not recommended for use in children and adolescents (below 18 years of age) which should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking the medicine.
The most common side effects of taking AMAZEO 300MG TABLET are feeling anxious, drowsy or agitated, constipation, nausea, vomiting, and/or blurred vision. Consult your doctor if any of these symptoms worsens.
USES OF AMAZEO 300MG TABLET
- treats schizophrenia
HOW AMAZEO 300MG TABLET WORKS
AMAZEO 300MG TABLET works by blocking dopamine D2 receptors (proteins responsible for synthesis and release of dopamine) in brain which results in reduced synthesis of dopamine thus improving thoughts, feelings and behaviour and thereby treating symptoms of schizophrenia in affected individuals.
DIRECTIONS FOR USE
Tablet:
Take AMAZEO 300MG TABLET 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 upon your age, body weight and disease condition.
Orally Disintegrating Tablet:
Take AMAZEO 300MG TABLET as advised by your physician. Place AMAZEO 300MG TABLET inside your mouth and allow it to dissolve completely. Do not swallow or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF AMAZEO 300MG TABLET
COMMON
- difficulty sleeping, feeling anxious, agitated
- feeling drowsy/sleepy
- constipation, nausea, vomiting, dry mouth
- putting on weight
- unusual production of breast milk in women and men, breast pain
- absence of menstrual period
- breast enlargement in men
- difficulty in getting/maintaining an erection, and/or ejaculating
- dizziness (due to low blood pressure)
- blurred vision
UNCOMMON
- high blood sugar
- slow heartbeat
- feeling confused
- nasal congestion
- osteoporosis (condition marked by weak and brittle bones)
- lung infection (due to accidental inhalation of food)
- increase in blood pressure
- difficulty passing urine
- signs of liver tissue damage such as skin and eyes appear yellow (jaundice), abdominal pain and swelling, itchy skin, nausea and vomiting
RARE
- noncancerous benign tumour
- signs of antidiuretic hormone secretion (condition marked by increased secretion of antidiuretic hormone) such as feeling confused/weak, loss of appetite, feeling irritable
- signs of low sodium level (in blood) such as tiredness, weakness, confusion, and/or aching muscles
Stop taking AMAZEO 300MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- signs of an allergic reaction symptoms such as difficulty in swallowing/breathing (due to swelling of the hands, feet, ankles, face, lips or throat), itchy, lumpy rash, and/or nettle rash
- fits
- more prone get infected due to agranulocytosis (blood disorder) or leukopenia/neutropenia (condition marked by low white blood cells count)
- signs of heart attack/life threatening heart disorder such as very fast/unusual heart rate and/or chest pain.
- signs of neuroleptic malignant syndrome (life threatening antipsychotic drug reaction) such as high temperature, sweating, stiff muscles, fast heartbeat, fast breathing, feel confused, drowsy, and/or agitated.
- signs of blood clots in the veins (especially in the legs) such as swelling, pain, and/or redness in the leg which may travel through blood vessels to lungs causing chest pain and difficulty in breathing.
- trembling, muscle stiffness/spasm, slow movement, producing excess saliva than usual, feeling restless
- uncontrolled movements mainly associated with your arms and legs
- uncontrolled movements associated with your face or tongue
- signs of severe live problems such as fatigue, loss of appetite, nausea, vomiting, abdominal pain and/or yellow discolouration of the eyes or skin
HOW TO MANAGE SIDE EFFECTS
Constipation:
Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Involve in regular exercise (going for a daily walk or run) and if this does not help, consult and inform your doctor for receiving alternate treatments for constipation.
Nausea and vomiting:
Try to take AMAZEO 300MG TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom gets worse.
Dry mouth:
Try to drink plenty of cold water and sip on cold unsweetened drinks and use lip balm if your lips are dry. Brush your teeth twice a day and use mouthwash. Consult and inform your doctor if the symptom gets worse.
Dizziness:
Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.
WARNING & PRECAUTIONS
PREGNANCY
AMAZEO 300MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy. Women of childbearing potential should not the medicine if effective contraception is not practised. Consult your doctor before taking the medicine.
BREASTFEEDING
AMAZEO 300MG TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking the medicine.
DRIVING AND USING MACHINES
Do not drive or operate machines if you feel less alert, drowsy, sleepy and/or have blurred vision after taking AMAZEO 300MG TABLET.
ALCOHOL
Avoid consumption of alcohol while taking AMAZEO 300MG TABLET since it may alter the effect of the medicine.
KIDNEY
AMAZEO 300MG TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking the medicine.
LIVER
AMAZEO 300MG TABLET should be used with caution in patients with liver problems such as hepatic impairment. Consult your doctor before taking the medicine.
ALLERGY
Do not take AMAZEO 300MG TABLET if you are allergic to amisulpride and/or any of the other ingredients of this medicine.
HEART DISEASE
AMAZEO 300MG TABLET should be taken with caution in patients with unusual heart rate. Consult your doctor before taking the medicine.
OTHERS
AMAZEO 300MG TABLET is not recommended for use if you have:
- breast cancer or prolactin dependent tumour
- tumour on your adrenal gland (phaeochromocytoma)
- pituitary tumour
Before taking AMAZEO 300MG TABLET, inform your doctor if you have:
- diabetes
- Parkinson’s disease (type of brain disorder)
- fits
- signs of low potassium levels in your blood such as constipation, fatigue, muscle damage
- stroke
- history of blood clots
- agranulocytosis (condition marked by low number of white blood cells)
- signs of leukopenia (low white blood cell count) such as fever, severe chills, sore throat or mouth ulcers.
Use in Pediatrics:
AMAZEO 300MG TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your doctor before taking the medicine.
Use in Geriatrics:
AMAZEO 300MG TABLET should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking the medicine.
INTERACTIONS
A. Drug-Drug interactions:
Before taking AMAZEO 300MG TABLET, inform your doctor, if you are taking any of the following medicine.
- medicine used to treat Parkinson’s disease (Ex. Levodopa)
- dopamine agonists (Ex. ropinirole and bromocriptine)
- medicines used to control heart rate (Ex. quinidine, disopyramide, sotalol, amiodarone)
- clozapine (used to schizophrenia)
- other antipsychotic drugs used to treat mental health problems (Ex. risperidone, quetiapine, olanzapine)
- medicines used to treat high blood pressure and migraine (Ex. clonidine, diltiazem, verapamil, guanfacine, digitalis)
- mefloquine (used to treat malaria)
- medicines that induce sleep (Ex. barbiturates, benzodiazepines)
- pain killers (medicines used to relieve pain) Ex. tramadol, indomethacin
- anesthetics (medicines used to numb sensation in certain areas of the body or induce sleep) Ex. benzodiazepines, diazepam, lorazepam
- antihistamines (medicines that induce sleep) Ex. promethazine
- medicines that can affect the level of sodium and potassium in blood such as water tablets (Ex. bumetanide, ethacrynic acid, furosemide), some laxatives (Ex. bisacodyl), glucocorticoids (Ex. prednisone, prednisolone, triamcinolone), tetracosactide, amphotericin
Overdosage:
If you or anyone else accidentally take too much of AMAZEO 300MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are feeling restless or shaky, rigid muscles, feeling drowsy and/or sleepy which could lead to a loss of consciousness.
SYNOPSIS
| Drug | : | Amisulpride |
| Pharmacological Category | : | Antipsychotics |
| Therapeutic Indication | : | Schizophrenia |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep AMAZEO 300MG TABLET out of reach of children
- Store the medicine at room temperature
FAQs ABOUT AMAZEO 300MG TABLET
What AMAZEO 300MG TABLET is used for?
[GBNKEWYORD] is used in the treatment of schizophrenia which is a serious mental disorder that affects a person’s ability to think, feel and/or behave clearly. It is generally characterized by symptoms such as delusions, hallucinations, and/or confused thoughts in affected individuals.
How AMAZEO 300MG TABLET is taken?
Take AMAZEO 300MG TABLET 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 upon your age, body weight and disease condition.
Can AMAZEO 300MG TABLET be stopped without consulting the doctor?
No, AMAZEO 300MG TABLET should not be stopped without consulting a doctor since it may cause withdrawal symptoms such as muscle stiffness, and/or unusual body movements. Consult your doctor before stopping the medicine who may stop the medicine if recommended.
How AMAZEO 300MG TABLET WORKS?
AMAZEO 300MG TABLET works by blocking dopamine D2 receptors (proteins responsible for synthesis and release of dopamine) in brain which results in reduced synthesis of dopamine thus improving thoughts, feelings and behaviour and thereby treating symptoms of schizophrenia in affected individuals.
Can AMAZEO 300MG TABLET be used during pregnancy?
No, AMAZEO 300MG TABLET should not be used during pregnancy or in women planning for pregnancy since it may affect the fetus. Consult your doctor before taking the medicine.
REFERENCES
1. K.D. Tripathi. Drugs Used in Mental Illness: Antipsychotic and Antimanic Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page - 443.
2. M P Curran,C M Perry. Amisulpride: a review of its use in the management of schizophrenia. NIH National Library of Medicine. National Center for Biotechnology Information. [Revised in 2001] [Accessed 25th April 2022] https://pubmed.ncbi.nlm.nih.gov/11735643/
3. Diogo Telles-Correia, António Barbosa, Helena Cortez-Pinto, Carlos Campos, Nuno B F Rocha, and Sérgio Machado. Psychotropic drugs and liver disease: A critical review of pharmacokinetics and liver toxicity. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. [Revised in February 2017] [Accessed 25th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5292604/
4. AMISYT – 25. East West Pharma India Pvt. Ltd. [Accessed on 25th April 2022] https://www.intaspharma.com/products/
5. SOLTUS-300. Intas Pharmaceuticals Ltd. [Accessed on 25th April 2022] https://www.intaspharma.com/products/
6. Delpharm Dijon. Electronic Medicines Compendium (EMC). [Revised in February 2021] [Accessed on 25th April 2022] https://www.medicines.org.uk/emc/files/pil.3965.pd
USEFUL DIAGNOSTIC TESTS
- CT scan
- MRI scan
AUTHOR DETAILS
Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 13 Oct 2022 | 05:59 PM(IST)
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