Amisulpride

Cipla Ltd ,

سیپلا لمیٹڈ

Cizorest 50 Tablet ,

Cizorest 50 گولی

DRUG STATUS

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Approvals

US. FDA / uk mhra / ema / pdma

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Essential Medicine

WHO / India

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Use in Pregnancy

Not Advised / Caution

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Pharmaceutical Class

ama / pdma

Summary

  • Amisulpride is primarily used to treat schizophrenia and other psychotic disorders. It can also be used in lower doses to treat depression in patients who have not responded well to other antidepressants.

  • Amisulpride works by blocking dopamine receptors in the brain. This helps manage symptoms like hallucinations and emotional disturbances often seen in schizophrenia and depression.

  • The usual adult dosage of Amisulpride for schizophrenia is 400-800 mg per day, divided into two doses. For negative symptoms, lower doses of 50-150 mg per day may be used. It's generally taken orally, with or without food.

  • Common side effects of Amisulpride include drowsiness, insomnia, headache, weight gain and dry mouth. More significant adverse effects may include tremors, rigidity, restlessness, and endocrine issues like increased prolactin levels.

  • Amisulpride should be used with caution in patients with a history of heart conditions. It should also be avoided in severe liver or kidney impairment, and in pregnant or breastfeeding women unless absolutely necessary. Patients with neuroleptic malignant syndrome or tardive dyskinesia should not take this medication.

Indications and Purpose

How does Amisulpride work?

Amisulpride works by modulating dopamine receptors in the brain. It primarily acts as an antagonist at the D2 and D3 dopamine receptors. By blocking these receptors in certain areas of the brain, it helps to reduce the symptoms of psychosis and schizophrenia, such as delusions and hallucinations. At lower doses, it can also enhance dopamine release in areas of the brain involved in mood regulation, which helps in treating depression.

 

 

How does one know if Amisulpride is working?

The benefit of Amisulpride is evaluated through clinical assessments, including monitoring improvements in symptoms of schizophrenia, acute psychosis, and depression. Healthcare providers assess changes in mood, behavior, and cognitive function, as well as track reductions in positive and negative symptoms. Rating scales, such as the Positive and Negative Syndrome Scale (PANSS), are commonly used to measure the severity of symptoms. Regular follow-ups and side effect monitoring help determine the effectiveness and adjust the dosage if necessary.

 

 

Is Amisulpride effective?

Evidence supporting the effectiveness of Amisulpride comes from clinical studies that show it significantly reduces symptoms of schizophrenia and acute psychosis. Research has demonstrated its efficacy in controlling positive symptoms (delusions, hallucinations) and, at lower doses, improving mood in depression. Studies indicate that Amisulpride is well-tolerated and provides therapeutic benefits comparable to other antipsychotics with fewer side effects, such as sedation or weight gain, commonly seen with other medications in the same class.

 

 

What is Amisulpride used for?

Amisulpride is primarily used to treat schizophrenia and other psychotic disorders. It is also used in lower doses for the treatment of depression in patients who have not responded well to other antidepressants. It helps alleviate symptoms such as delusions, hallucinations, and mood disturbances.

 

 

Directions for Use

How do I take Amisulpride?

Amisulpride can be taken with or without food. There are no specific food restrictions associated with this medication. It is important to take it exactly as prescribed by your doctor, typically in divided doses throughout the day. Ensure you follow the prescribed dosage and avoid stopping the medication abruptly without medical advice.

 

 

How long does it take for Amisulpride to start working?

Amisulpride may take several weeks to show noticeable effects, particularly for conditions like schizophrenia or depression. Typically, some improvement can be seen within 1 to 2 weeks, but it may take 4 to 6 weeks for the full therapeutic effect to be felt. Always follow your healthcare provider's guidance for the best results.

 

 

How should I dispose of Amisulpride?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of the medicines properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How should I store Amisulpride?

Amisulpride should be stored under the following conditions:

  • Keep it at room temperature, typically between 15°C to 25°C (59°F to 77°F).
  • Protect it from moisture and light.
  • Store it in its original packaging to maintain its stability.
  • Keep it out of reach of children.

 

What are the consequences to stopping Amisulpride?

Yes, stopping Amisulpride abruptly can lead to withdrawal symptoms or a return of symptoms related to the condition being treated, such as increased psychosis, agitation, or anxiety. It's important to taper off the medication under a doctor’s supervision to avoid withdrawal effects and ensure the proper management of your condition.

 

 

What is Amisulpride’s dose and duration?

The usual adult dosage of Amisulpride for schizophrenia is 400–800 mg per day, divided into two doses. For lower doses, typically 50–150 mg per day may be used for negative symptoms. It's generally taken orally, with or without food. The dosage may be adjusted based on the individual's response and tolerability. Always follow the prescribing doctor's instructions.

 

 

What should I do if I miss a dose of Amisulpride?

If you forget to take one or more doses: take your next dose at the normal time and in the normal amount. Do not take any more than your doctor prescribed.

Warnings and Precautions

Can Amisulpride be taken safely while breastfeeding?

Amisulpride is excreted in breast milk, but the effects on a breastfeeding infant are not well-studied. Due to the potential for serious side effects, such as sedation or movement disorders, it is generally advised to avoid using Amisulpride while breastfeeding unless absolutely necessary. If the medication is required, a healthcare provider may recommend either discontinuing breastfeeding or using an alternative treatment.

 

 

Can Amisulpride be taken safely while pregnant?

Amisulpride is classified as a Category C drug for pregnancy by the FDA, which means that risk to the fetus cannot be ruled out. Animal studies have shown some adverse effects, but there are insufficient human studies to assess its safety fully. It should only be used during pregnancy if the potential benefit outweighs the risks to the fetus. Pregnant women should consult their healthcare provider before using Amisulpride.

 

 

Can Amisulpride be taken safely while trying to conceive?

Amisulpride may have effects on fertility in both men and women. In animal studies, it has been shown to cause changes in hormone levels, which could potentially affect fertility. In humans, Amisulpride can cause hyperprolactinemia (elevated levels of prolactin), which may interfere with reproductive function, potentially leading to menstrual disturbances in women and sexual dysfunction in men. However, the exact impact on human fertility is not fully established, and any concerns should be discussed with a healthcare provider.

 

 

Can I take Amisulpride with other prescription drugs?

Amisulpride can interact with several prescription drugs. Key interactions include:

  1. Antipsychotics and other dopamine antagonists: Combined use can increase the risk of extrapyramidal symptoms (movement disorders) or sedation.
  2. Medications that prolong the QT interval: These, such as antiarrhythmic drugs (e.g., amiodarone), can increase the risk of cardiac arrhythmias, particularly torsades de pointes.
  3. Antihypertensives: Amisulpride may enhance the effects of blood pressure-lowering medications, increasing the risk of hypotension.
  4. Levodopa: Antagonistic effects with Amisulpride can reduce the efficacy of Levodopa in treating Parkinson's disease.
  5. Drugs affecting the CYP450 system: Amisulpride is metabolized minimally by the CYP450 enzymes, but caution should still be taken when combining with drugs that alter enzyme activity, such as ketoconazole or ritonavir.

 

Can I take Amisulpride with vitamins or supplements?

There are no well-documented significant interactions between Amisulpride and vitamins or supplements. However, it’s essential to avoid calcium or magnesium supplements when taking Amisulpride, as they may interfere with the absorption of the drug. Patients should also be cautious with supplements that may affect the heart's electrical activity, like potassium or magnesium, since Amisulpride can prolong the QT interval and increase the risk of arrhythmias. Always consult a healthcare provider before taking any new supplements while on Amisulpride.

 

 

What are Amisulpride possible harms and risks?

The most common side effects of Amisulpride include drowsiness, insomnia, headache, weight gain, and dry mouth. More significant adverse effects may include extrapyramidal symptoms (EPS) such as tremors, rigidity, and akathisia (restlessness). Endocrine issues, like increased prolactin levels, can lead to galactorrhea (milk production), amenorrhea (absence of menstruation), or sexual dysfunction. Tardive dyskinesia (involuntary movements) and QT prolongation (heart rhythm abnormalities) are rare but serious risks. Monitoring for these side effects is essential.

 

 

Who should avoid taking Amisulpride?

Amisulpride should be used with caution in patients with a history of cardiac arrhythmias or heart conditions due to the risk of QT prolongation. It is contraindicated in individuals with pheochromocytoma (a rare adrenal gland tumor) or a history of hypersensitivity to the drug. It should also be avoided in severe liver or kidney impairment. Pregnant or breastfeeding women should only use Amisulpride if absolutely necessary, as it can affect the fetus and infant. Patients with neuroleptic malignant syndrome (NMS) or tardive dyskinesia should not take this medication. Close monitoring is advised for those at risk of developing these conditions.

 

 

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