Amazeo 100 Tab

AMAZEO 100 TAB by TORRENT PHARMACEUTICALS LTD

AMAZEO 100 TAB is a medication manufactured by Torrent Pharmaceuticals Ltd., primarily used in the management of certain mental health conditions and for preventing nausea.

Name

• Common Name: Amisulpride
• Brand Name: AMAZEO 100 TABLET (also referred to as AMAZEO 100MG TABLET)

Composition Each film-coated tablet contains Amisulpride I.P. 100 mg.

Uses AMAZEO 100 TAB is prescribed for:

• Schizophrenia: It treats both acute and chronic schizophrenia, including positive symptoms (such as delusions, hallucinations, and thought disorders) and negative symptoms (like blunted affect, emotional, and social withdrawal). It works by affecting certain chemical messengers (neurotransmitters), like dopamine, in the brain to help restore balance and improve thoughts, feelings, and behavior.
• Postoperative Nausea and Vomiting: It is also used to prevent and treat nausea and vomiting that may occur after surgery.

Dosage and Administration

• AMAZEO 100 TAB is for oral consumption and can be taken with or without food.
• Doses up to 300 mg per day can typically be taken as a single dose, preferably at bedtime to minimize daytime sleepiness.
• Doses exceeding 300 mg should generally be administered twice daily (half in the morning and half in the evening).
• Tablets should be swallowed whole with a glass of water and should not be crushed, chewed, or broken.
• The exact dosage and duration of treatment are determined by a healthcare professional based on the individual's medical condition, age, and response to therapy.
• Do not discontinue the medication abruptly, as this can lead to withdrawal symptoms or a worsening of the original condition. Gradual dose reduction under medical supervision is advised.

Side Effects

• Common Side Effects: Nausea, vomiting, dry mouth, constipation, weight gain, decreased blood pressure (orthostatic hypotension), dizziness, drowsiness/sleepiness, blurred vision, insomnia, erectile dysfunction, increased prolactin levels in the blood, anxiety, agitation, restlessness, tremors, and excessive salivation. In some cases, it may lead to unusual breast milk production, breast pain, absence of menstrual periods in women, or breast enlargement in men.
• Serious Side Effects (Seek immediate medical attention): Signs of an allergic reaction (e.g., swelling of hands, face, lips, throat causing difficulty swallowing/breathing, itchy rash), seizures or fits, neuroleptic malignant syndrome (symptoms include high temperature, sweating, stiff muscles, fast heartbeat, confusion, drowsiness), blood clots (e.g., swelling, pain, redness in legs, chest pain, difficulty breathing), liver problems (fatigue, loss of appetite, abdominal pain, yellowing of eyes or skin), severe chest pain, changes in heart rate, increased frequency of infections, or severe skin allergy.

Precautions

• Contraindications: AMAZEO 100 TAB should not be used if there is a known allergy to Amisulpride or any other ingredients. It is contraindicated in children under 18 years, during pregnancy, and while breastfeeding. It should also be avoided in patients with breast cancer, prolactin-dependent tumors, pheochromocytoma, pituitary gland prolactinoma, or if taking levodopa.
• Warnings: Exercise caution in elderly patients due to an increased risk of severe adverse effects, hypotension, or sedation. It should be used with caution in patients with kidney, liver, or heart problems, diabetes, low potassium levels (hypokalemia), seizure disorders, or Parkinson's disease.
• Interactions: Alcohol consumption should be avoided as it may worsen side effects. Due to potential dizziness and drowsiness, activities requiring alertness, such as driving or operating machinery, should be avoided until you know how the medicine affects you.
• Monitoring: Regular monitoring of weight, blood sugar, and cholesterol levels is recommended, as the medicine can contribute to metabolic changes.

Storage Keep AMAZEO 100 TAB out of the sight and reach of children. Store at a temperature not exceeding 30⁰C, protected from light and moisture.

What is AMAZEO 100 TAB used for?

AMAZEO 100 TAB is an antipsychotic medication primarily used to treat schizophrenia, a mental disorder characterized by hallucinations, delusions, and disordered thinking and behavior. It can help manage both positive symptoms (like delusions and hallucinations) and negative symptoms (such as emotional and social withdrawal). Additionally, it is used to prevent and treat postoperative nausea and vomiting.

How does AMAZEO 100 TAB work?

AMAZEO 100 TAB contains Amisulpride, which belongs to a class of medicines called atypical antipsychotics. It works by restoring the balance of certain natural chemical messengers, specifically dopamine, in the brain. It primarily blocks dopamine D2 receptors, correcting dopamine's overactivity, which helps to produce a calming effect and improve thoughts and behavior in individuals with schizophrenia. For nausea and vomiting, it blocks D2 receptors located in the chemoreceptor trigger zone (CTZ) of the brain responsible for inducing these sensations.

What is the usual dosage for AMAZEO 100 TAB?

The dosage of AMAZEO 100 TAB is determined by your doctor based on your medical condition and response to treatment, typically ranging from 50 mg to 800 mg daily, and sometimes up to 1200 mg daily. Your doctor may start with a lower dose and gradually increase it. Doses up to 300 mg can usually be taken once daily, preferably at the same time each day. For doses exceeding 300 mg, it is often prescribed to take half in the morning and half in the evening. The tablet can be taken with or without food, but should be swallowed whole and not crushed, chewed, or broken.

What are the possible side effects of AMAZEO 100 TAB?

Common side effects may include drowsiness, dizziness, dry mouth, constipation, weight gain, decreased blood pressure (especially upon standing), involuntary muscle contractions (dystonia, akathisia, parkinsonism), increased prolactin levels in the blood, blurred vision, difficulty sleeping (insomnia), erectile dysfunction, nausea, vomiting, restlessness, nervousness, fever, excessive sweating, changes in heart rate, tremor, and excessive salivation. This medicine may also lead to increased blood sugar, cholesterol, and triglyceride levels. If any side effects persist or worsen, consult your doctor.

Is AMAZEO 100 TAB safe during pregnancy or breastfeeding?

AMAZEO 100 TAB is generally not recommended during pregnancy unless absolutely necessary and prescribed by a doctor after weighing the potential benefits against the risks. Animal studies have shown harmful effects on the developing baby, and babies born to mothers who took this medicine in the last trimester may experience symptoms like muscle stiffness and drowsiness.

AMAZEO 100 TAB is considered unsafe during breastfeeding as it may pass into breast milk and potentially harm the baby. Consult your doctor for advice if you are breastfeeding.

Can AMAZEO 100 TAB be taken with other medications?

You should inform your doctor about all medications you are currently taking, including over-the-counter drugs, herbal supplements, and vitamins, to avoid potential interactions. AMAZEO 100 TAB should generally be avoided with alcohol, as it can increase adverse effects and drowsiness. It should not be taken with medications for Parkinson's disease (like levodopa) because their effects are opposite. Caution is advised or concomitant use may be contraindicated with certain heart rhythm medications (e.g., quinidine, amiodarone, sotalol), other antipsychotics, some antihistamines, and medications that lower heart rate or blood pressure.

What precautions should be taken while taking AMAZEO 100 TAB?

Due to potential side effects like drowsiness, dizziness, and blurred vision, avoid driving or operating heavy machinery until you understand how the medication affects you. To prevent dizziness or fainting when standing up, rise slowly from a sitting or lying position. Inform your doctor about any pre-existing medical conditions, especially kidney or liver problems, diabetes, Parkinson's disease, epileptic fits/seizures, heart conditions, breast cancer, or certain tumors (pheochromocytoma, prolactinoma). Regular monitoring of weight, blood sugar, and cholesterol levels is recommended. This medicine is not recommended for children under 18 years of age and should be used with caution in elderly patients.

What happens if a dose of AMAZEO 100 TAB is missed?

If you miss a dose of AMAZEO 100 TAB, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as this can lead to an overdose. It is important not to skip any doses and to complete the full course of treatment as advised by your doctor.

How should AMAZEO 100 TAB be stored?

AMAZEO 100 TAB should be stored at a temperature not exceeding 30°C. Keep it protected from light and moisture. Always keep this medicine out of the sight and reach of children.