Amisant 100

AMISANT 100 Tablet

Name:

• Brand Name: Amisant 100
• Common Name: Amisulpride

Composition:

• Active Ingredient: Amisulpride 100 mg

Uses: Amisant 100 Tablet is an atypical antipsychotic primarily used to treat schizophrenia, a mental disorder characterized by hallucinations, delusions, disorganized thinking, and abnormal behavior. It helps restore chemical imbalances in the brain to improve thoughts, behavior, and quality of life. Additionally, it possesses anti-emetic properties and is prescribed to prevent and treat postoperative nausea and vomiting.

Dosage and Administration: Amisant 100 Tablet should be taken orally as prescribed by a doctor, with or without food. It is advisable to take it at the same time each day to maintain a consistent level in the body. Doses up to 300 mg can be taken anytime, preferably at bedtime to minimize daytime sleepiness. Doses exceeding 300 mg are typically divided into morning and evening administrations. The tablet should be swallowed whole and not crushed, chewed, or broken. Do not stop taking this medicine suddenly without consulting your doctor, as it may lead to withdrawal symptoms or worsening of your condition.

Side Effects:

• Common Side Effects: Dry mouth, constipation, weight gain, decreased blood pressure, dizziness, drowsiness, nausea, vomiting, involuntary muscle contractions (dystonia, akathisia, parkinsonism), increased prolactin levels in the blood, blurred vision, insomnia, erectile dysfunction, and anxiety.
• Serious Side Effects: Signs of an allergic reaction (swelling of face/throat, difficulty breathing), fits or seizures, neuroleptic malignant syndrome (high temperature, sweating, stiff muscles, fast heartbeat, confusion), and blood clots (swelling, pain, redness in legs, chest pain, difficulty breathing).

Precautions:

• Amisant 100 is contraindicated in individuals allergic to amisulpride or any other ingredients.
• It should not be used in children below 18 years of age.
• Caution is advised in elderly patients over 65 due to an increased risk of severe adverse effects.
• Inform your doctor if you are pregnant, planning a pregnancy, or breastfeeding, as Amisant 100 is generally not recommended in these situations.
• Patients with breast cancer, prolactin-dependent tumors, pheochromocytoma (adrenal gland tumor), or pituitary tumors should avoid this medicine.
• Use with caution in patients with a history of heart conditions, kidney disease, liver disease, diabetes, seizures, or Parkinson's disease.
• Avoid alcohol consumption as it may worsen side effects.
• This medicine may cause dizziness, drowsiness, or blurred vision; therefore, avoid driving or operating machinery if you experience these symptoms.
• Inform your doctor about all ongoing medications to avoid undesirable drug interactions.

Storage: Keep Amisant 100 Tablet out of the sight and reach of children. Store below 30°C.

What is AMISANT 100 used for?

AMISANT 100 (Amisulpride) is primarily used to treat schizophrenia, a mental disorder characterized by disturbances in thinking, emotions, perception of reality, and behavior, including symptoms like hallucinations, delusions, and disorganized thinking. It is effective for both acute and chronic schizophrenia, helping to manage both positive symptoms (e.g., delusions, hallucinations) and negative symptoms (e.g., emotional and social withdrawal). In some formulations (intravenous), Amisulpride is also used to prevent and treat postoperative nausea and vomiting (PONV) in adults.

How does AMISANT 100 work?

Amisulpride, the active ingredient in AMISANT 100, belongs to a class of medicines called atypical antipsychotics. It works by selectively blocking dopamine D2 and D3 receptors in the brain. Schizophrenia is associated with an overactivity of dopamine in the brain. By blocking these receptors, Amisulpride helps to restore the balance of dopamine activity, thereby improving disturbed thoughts, feelings, and behavior. At lower doses, it can increase dopamine levels by blocking presynaptic receptors, which may help with negative symptoms, while at higher doses, it blocks postsynaptic receptors to manage positive symptoms.

What is the usual dosage for AMISANT 100?

The dosage of AMISANT 100 is adjusted individually by a doctor based on the patient's condition. For schizophrenia, the usual oral dose ranges from 50mg to 800mg per day, though in some cases, it may be increased up to 1200mg daily. Doses up to 400mg per day can often be taken as a single daily dose, preferably before a meal, and at the same time each day. Higher doses (above 400mg) are usually split into two separate doses, taken in the morning and evening. Your doctor may start with a lower dose if necessary.

What are the possible side effects of AMISANT 100?

Common side effects of AMISANT 100 can include dizziness, drowsiness, difficulty sleeping (insomnia), anxiety, agitation, dry mouth, constipation, weight gain, and blurred vision. Some individuals may experience involuntary muscle contractions (dystonia), inability to stay still (akathisia), or symptoms similar to Parkinson's disease. Increased prolactin levels in the blood are also common, which can lead to breast enlargement or milk secretion in both men and women, and menstrual changes in women.

More serious, but less common, side effects include changes in heart rhythms (QT prolongation), which may cause fainting or irregular heartbeats. A rare but serious side effect is neuroleptic malignant syndrome, characterized by a high temperature, sweating, stiff muscles, and confusion. If you experience any severe or persistent side effects, you should contact your doctor immediately.

Is AMISANT 100 safe during pregnancy or breastfeeding?

Pregnancy: The use of Amisulpride during pregnancy is generally recommended only if clearly needed and if the potential benefits outweigh the risks. There is insufficient data on its use in pregnant women regarding drug-related risks of birth defects or miscarriage. Neonates exposed to antipsychotic drugs like Amisulpride during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms after birth. If you are pregnant or planning to become pregnant, discuss this with your doctor.

Breastfeeding: AMISANT 100 is generally not recommended for breastfeeding mothers. Amisulpride can concentrate in breast milk. Some experts suggest that patients consider interrupting breastfeeding and discarding breast milk for 48 hours after administration, especially for intravenous formulations. While some reports indicate low serum levels in infants and no observed adverse effects, a safer alternative may be preferred, particularly for newborns or preterm infants. Amisulpride can also increase serum prolactin levels, which may affect breast milk production.

Can AMISANT 100 be taken with other medications?

AMISANT 100 can interact with many other medications, and caution is advised. It should not be taken with levodopa, a medication for Parkinson's disease, as their effects are opposite and can reduce the effectiveness of both drugs while increasing the risk of unwanted effects. It is crucial to inform your doctor about all other medications you are taking, including over-the-counter medicines, herbal remedies, and supplements. Significant interactions can occur with:

• Medicines that affect heart rate or rhythm: (e.g., quinidine, disopyramide, amiodarone, sotalol).
• Other antipsychotics (e.g., chlorpromazine, clozapine, haloperidol).
• Medicines for high blood pressure (e.g., diltiazem, verapamil, clonidine).
• Painkillers (e.g., morphine, pethidine, tramadol, indomethacin, aspirin, acetaminophen).
• Antihistamines that cause sleepiness (e.g., promethazine, diphenhydramine).
• Alcohol: Avoid alcohol as it can increase dizziness and drowsiness.

What precautions should be taken while taking AMISANT 100?

Before taking AMISANT 100, inform your doctor if you have any existing medical conditions, especially heart problems (due to the risk of QT prolongation), kidney problems (as dose adjustment may be needed), diabetes (blood sugar may need monitoring), Parkinson's disease, breast cancer, a tumor on your adrenal gland (pheochromocytoma), or a pituitary gland tumor. AMISANT 100 can cause drowsiness, dizziness, or blurred vision. Therefore, avoid driving or operating machinery until you know how the medicine affects you. If you experience dizziness when standing up, rise slowly. Do not stop taking AMISANT 100 suddenly, as this can lead to withdrawal symptoms or a worsening of your condition.

What happens if a dose of AMISANT 100 is missed?

If you forget to take a dose of AMISANT 100, 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 forgotten dose.

How should AMISANT 100 be stored?

AMISANT 100 should be stored in a cool, dry place, away from direct sunlight. It is important to keep the medicine in its original packaging and out of the sight and reach of children. Do not store it above 25°C. Do not use the medicine after the expiry date printed on the carton.