Amipride

Amipride50 mg

Tablet

Amisulpride

Beacon Pharmaceuticals Ltd.

Product Code : 814
MRP 200.00
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Medicine overview

Indications of Amipride 50 mg

Amipride 50 mg tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including ... Read moreAmipride 50 mg tablet is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms.Amipride 50 mg injection is indicated in adults for: Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. Treatment of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Theropeutic Class

Atypical neuroleptic drugs

Pharmacology

Amipride 50 mg binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, Amipride 50 mg displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain Amipride 50 mg’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of Amipride 50 mg to produce extrapyramidal side effects may be related to its preferential limbic activity.

Dosage & Administration of Amipride 50 mg

For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with Amipride 50 mg. Doses should be adjusted according to individual response. Doses should preferably be administered before meals. Amipride 50 mg should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Dosage of Amipride 50 mg

Oral dose: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with Amipride 50 mg. Doses should be adjusted according to individual responses. Doses should preferably be administered before meals. Amipride 50 mg should be administered twice daily for doses above 400 mg. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.Injectable dose: The recommended injectable adult dosage of Amipride 50 mg and infusion rate by indication is shown in the table below: Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia. Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

Contraindications

Hypersensitivity to the active ingredient or to other ingredients of the product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer. Phaeochromocytoma. Children up to puberty. Lactation.

Pregnancy & Lactation

pregnancy Category C. The safety of Amipride 50 mg during human pregnancy has not been established, and therefore use of Amipride 50 mg is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amipride 50 mg has been found in the breast milk of treated women. Breast-feeding is contraindicated.

Precautions & Warnings

Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome that has been reported in association with anti psychotic medicines, including Amipride 50 mg. Neuroleptic malignant syndrome is characterised by hyperthermia, muscle rigidity, autonomic instability, and elevated CPK, may occur. In the event of any symptoms which could suggest NMS, in particular hyperthermia, particularly with high daily doses, all antipsychotic medicines including Amipride 50 mg should be discontinued. Amipride 50 mg can lower the seizure threshold. Therefore patients with a history of seizures should be closely monitored during Amipride 50 mg therapy.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Use In Special Populations

Elderly: Amipride 50 mg should be used with particular caution because of a possible risk of hypotension or sedation.Children: The efficacy and safety of Amipride 50 mg from puberty to the age of 18 years have not been established: there are limited data available on the use of Amipride 50 mg in adolescents in schizophrenia. Therefore, the use of Amipride 50 mg from puberty to the age of 18 years is not recommended. In children up to puberty, the use of Amipride 50 mg is contraindicatedUse in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of Amipride 50 mg has not been studied. Amipride 50 mg should be used with caution in patients with moderate or severe hepatic impairment.Use in renal impairment: Amipride 50 mg is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered

Drug Classes

Atypical neuroleptic drugs

Mode Of Action

Amipride 50 mg binds selectively to the human dopaminergic D2 and D3 receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes. Unlike classical and atypical neuroleptics, Amipride 50 mg displays low affinity for serotonin, α- adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites. In the rodent, it preferentially blocks post synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamineinduced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects. This atypical pharmacological profile may explain Amipride 50 mg’s antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of Amipride 50 mg to produce extrapyramidal side effects may be related to its preferential limbic activity.

Pregnancy

pregnancy Category C. The safety of Amipride 50 mg during human pregnancy has not been established, and therefore use of Amipride 50 mg is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. Amipride 50 mg has been found in the breast milk of treated women. Breast-feeding is contraindicated.

Pediatric Uses

Elderly: Amipride 50 mg should be used with particular caution because of a possible risk of hypotension or sedation.Children: The efficacy and safety of Amipride 50 mg from puberty to the age of 18 years have not been established: there are limited data available on the use of Amipride 50 mg in adolescents in schizophrenia. Therefore, the use of Amipride 50 mg from puberty to the age of 18 years is not recommended. In children up to puberty, the use of Amipride 50 mg is contraindicatedUse in hepatic impairment: The impact of hepatic impairment on hepatic metabolism and hepato-biliary excretion of Amipride 50 mg has not been studied. Amipride 50 mg should be used with caution in patients with moderate or severe hepatic impairment.Use in renal impairment: Amipride 50 mg is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased and intermittent treatment should be considered
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.