Full Prescribing Info
Solian 200 mg: Each tablet contains amisulpride 200 mg.
Solian 400 mg: Each tablet contains amisulpride 400 mg.
Pharmacology: Pharmacodynamics: Antipsychotic: Amisulpride is an antipsychotic drug belonging to the class of substituted benzamides.
Its pharmacodynamic profile is characterized by selective and predominant affinity for D2 and D3 dopaminergic receptors of the limbic system. Amisulpride has no affinity for serotoninergic receptors or other neuroreceptors such as histaminic, cholinergic and adrenergic receptors.
At high doses, in animal studies, amisulpride preferentially blocks the dopaminergic neurons of the mesolimbic system compared to those in the striatal system. This specific affinity could explain the predominant antipsychotic effects of amisulpride compared with its extrapyramidal effects.
At low doses, amisulpride preferentially blocks the presynaptic D2/D3 dopaminergic receptors, which could explain its effects on negative symptoms.
In a controlled, double-blind study versus haloperidol in 191 patients with acute schizophrenia, amisulpride significantly improved secondary negative symptoms in comparison with haloperidol.
Pharmacokinetics: Gender: In man, amisulpride exhibits two absorption peaks: The first is reached rapidly one hour after dosing, and the second occurs three to four hours after administration.
The corresponding plasma levels are 39+3 and 54+4 ng/mL, respectively, following the administration of a 50 mg dose.
The distribution volume is 5.8 L/kg. Plasma protein binding is low (16%) and does not suggest any drug interaction at this level. Absolute bioavailability is 48%.
Amisulpride is weakly metabolised: Two inactive metabolites have been identified and present 4% of the total quantity eliminated.
Following repeated doses, amisulpride does not accumulate and the pharmacokinetic parameters remain unchanged.
The elimination half-life is approximately 12 hours after an oral dose.
Amisulpride is eliminated in the urine in unchanged form. Half (50%) of the IV dose is eliminated in the urine, usually over the first 24 hours (90% of urinary excretion).
Renal clearance is about 330 mL/min.
A high-carbohydrate meal significantly lowers the AUC, Tmax and Cmax values for amisulpride, while a high-fat meal does not affect these parameters. The effect of these results during treatment with amisulpride is not known.
Elderly Patients: The pharmacokinetic data available regarding elderly subjects aged above 65 years show an increase of between 10-30% for Cmax, T½ and AUC values after a single dose of 50 mg.
No data are available for repeated doses.
Hepatic Impairment: Amisulpride is poorly metabolised, so it is not necessary to reduce dosage in patients with hepatic insufficiency.
Renal Impairment: The elimination half-life is not modified in patients with renal insufficiency, whilst total clearance is reduced by a factor of 2.5 to 3.
The AUC of amisulpride is doubled in patients with mild renal insufficiency, and is nearly 10 times greater in patients with moderate renal insufficiency.
Toxicology: Non-Clinical Safety Data: The toxicological profile of amisulpride is dominated by the pharmacological effects of the compound. Toxicity studies after repeated administration showed no target organ impairment.
The compound has no teratogenic or genotoxic effects. Carcinogenesis studies have demonstrated hormone-dependent tumours in rodents. These are not of any clinical relevance in man.
Decreased fertility related to the pharmacological properties of the product (prolactin-mediated effects) was observed in animals.
Amisulpride (Solian) is indicated for the treatment of psychoses, particularly acute or chronic schizophrenic disorders characterized by positive symptoms (e.g. delirium, hallucinations, thought disorders) and/or negative symptoms (e.g. blunted emotions, emotional and social withdrawal), including when the negative symptoms predominate.
Dosage/Direction for Use
Usually, if the daily dose is ≤400 mg, it will be administered as a once daily intake. If the daily dose exceeds 400 mg, it will be administered as two daily intakes.
Predominantly Negative Episodes: The recommended dosage is 50 to 300 mg/day. Dosage should be adjusted on an individual basis. The optimum dosage is about 100 mg/day.
Mixed Episodes with Positive and Negative Symptoms: At the beginning of the treatment, the dosage should be that which enables the control of the positive symptoms, i.e., 400 to 800 mg/day. The dosage should then be adjusted individually as a function of the patient's response, so as to obtain the minimum effective dose.
Acute Psychotic Episodes: At the beginning of treatment, it is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, switching thereafter to oral treatment. The recommended dosage via the oral route is 400 to 800 mg; the maximum dosage should never exceed 1200 mg. Thereafter, the dosage should be maintained or adjusted, as a function of the patient's response. In all cases, the dosage of maintenance therapy should be established individually with the minimum effective dose.
Pediatric Patients: The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established: There are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore, the use of amisulpride from puberty to the age of 18 years is not recommended; in children up to puberty amisulpride is contraindicated (see Contraindications).
Hepatic Impairment: Amisulpride is poorly metabolised, so it is not necessary to reduce the dose in patients with hepatic insufficiency.
Renal Impairment: Amisulpride is eliminated by renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 mL/min and to a third in patients with CRCL between 10-30 mL/min.
As there is no experience in patients with severe renal impairment (CRCL <10 mL/min) particular care is recommended in these patients (see Precautions).
Signs and Symptoms: Exaggerations of the known pharmacological effects of the drug have been reported. These include drowsiness, sedation, hypotension, extrapyramidal symptoms and coma.
Fatal outcomes have been reported mainly in combination with other psychotropic agents.
Management: In cases of acute overdose, the possibility of multiple drug intakes should be considered.
Since amisulpride is weakly dialysed, hemodialysis is of no use to eliminate the drug. There is no specific antidote to amisulpride. Appropriate supportive measures should therefore be instituted: Close supervision of vital functions and continuous cardiac monitoring (risk of prolongation of QT interval) until the patient recovers.
If severe extrapyramidal symptoms occur, anticholinergic agents should be administered.
Hypersensitivity to the active ingredient or to other ingredients of the medicinal product.
Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaeochromocytoma; children up to puberty; lactation.
Combination with the following medications which could induce torsade de pointes: Class Ia antiarrhythmic agents such as quinidine, disopyramide; class III antiarrhythmic agents such as amiodarone, sotalol; other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin (see Interactions).
Combination with levodopa (see Interactions).
As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal complication, characterised by hyperthermia, muscle rigidity and autonomic instability, and elevated CPK creatine phosphokinase may occur. In the event of hyperthermia particularly with high daily doses, all antipsychotic drugs including amisulpride should be discontinued.
As with other antidopaminergic agents, caution should be also exercised when prescribing amisulpride to patients with Parkinson's disease since it may cause worsening of the disease. Amisulpride should be used only if neuroleptic treatment cannot be avoided.
Prolongation of the QT Interval: Amisulpride induces a dose-dependent prolongation of the QT interval (see Adverse reactions). This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes.
Before any administration, and if possible, according to the patient's clinical status, it is recommended to monitor factors which could favour the occurrence of this rhythm disorder, such as for example: Bradycardia less than 55 bpm; electrolyte imbalance, in particular hypokalaemia; congenital prolongation of the QT interval; on-going treatment with a medication likely to produce pronounced bradycardia (<55 bpm), hypokalaemia, decreased intracardiac conduction, or prolongation of the QT interval (see Interactions).
Stroke: In randomized clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs, or other populations of patients cannot be excluded. Amisulpride should be used with caution in patients with stroke risk factors.
Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death in clinical trials with atypical antipsychotics were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
Venous Thromboembolism: Cases of venous thromboembolism, sometimes fatal, have been reported with antipsychotic drugs. Therefore, Amisulpride (Solian) should be used with caution in patients with risk factors for thromboembolism (see Adverse Reactions).
Breast Cancer: Amisulpride may increase prolactin levels. Therefore, caution should be exercised and patients with a history or a family history of breast cancer should be closely monitored during amisulpride therapy.
Benign Pituitary Tumour: Amisulpride may increase prolactin levels. Cases of benign pituitary tumours such as prolactinoma have been observed during amisulpride therapy (see Adverse Reactions). In case of very high levels of prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary imaging should be performed. If the diagnosis of pituitary tumour is confirmed, the treatment with amisulpride must be stopped (see Contraindications).
Special Precautions
Hyperglycemia has been reported in patients treated with some atypical antipsychotic agents, including amisulpride, therefore patients with an established diagnosis of diabetes mellitus or with risk factors for diabetes who are started on amisulpride, should get appropriate glycaemic monitoring.
Amisulpride may lower the seizure threshold. Therefore, patients with a history of epilepsy should be closely monitored during amisulpride therapy.
Amisulpride is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased or intermittent treatment could be considered (see Dosage & Administration).
In elderly patients, amisulpride, like other neuroleptics, should be used with particular caution because of a possible risk of hypotension or sedation.
Withdrawal symptoms have been described after abrupt cessation of high therapeutic doses of antipsychotic drugs. The emergence of involuntary movement disorders (such as akathisia, dystonia, and dyskinesia) has been reported with amisulpride. Therefore, gradual withdrawal of amisulpride is advisable.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Amisulpride (Solian). Unexplained infections or fever may be evidence of blood dyscrasia (see Adverse Reactions), and requires immediate haematological investigation.
Driving a Vehicle or Performing Other Hazardous Tasks: Even when used as recommended, amisulpride may cause somnolence so that the ability to drive vehicles or operate machinery can be impaired (see Adverse Reactions).
Use In Pregnancy & Lactation
Use in Pregnancy: In animals, amisulpride did not show reproductive toxicity. A decrease in fertility linked to the pharmacological effects of the drug (prolactin-mediated effect) was observed. No teratogenic effects of amisulpride were noted.
Very limited clinical data on exposed pregnancies are available. Therefore, the safety of amisulpride during human pregnancy has not been established. Use of the drug is not recommended during pregnancy unless the benefits justify the potential risks.
Neonates exposed to antipsychotics, including Amisulpride (Solian), during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery (see Adverse Reactions). There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Use in Lactation: It is not known whether amisulpride is excreted in breast milk, breast-feeding is therefore contraindicated.
Adverse Reactions
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; common ≥1 and <10%; uncommon ≥0.1 and <1%; rare ≥0.01 and <0.1%; very rare <0.01%; not known (cannot be estimated from available data).
Clinical Trials Data: The following adverse effects have been observed in controlled clinical trials. It should be noted that in some instances it can be difficult to differentiate adverse events from symptoms of the underlying disease.
Nervous System Disorders: Very Common: Extrapyramidal symptoms may occur: Tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50-300 mg/day.
Common: Acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Somnolence.
Uncommon: Tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long-term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms. Seizures.
Psychiatric Disorders: Common: Insomnia, anxiety, agitation, orgasmic dysfunction.
Gastrointestinal Disorders: Common: Constipation, nausea, vomiting, dry mouth.
Endocrine Disorders: Common: Amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and erectile dysfunction.
Metabolism and Nutrition Disorders: Uncommon: Hyperglycemia (see Precautions).
Cardiovascular Disorders: Common: Hypotension. Uncommon: Bradycardia.
Investigations: Common: Weight gain. Uncommon: Elevations of hepatic enzymes, mainly transaminases.
Immune System Disorders: Uncommon: Allergic reaction.
Post Marketing Data: In addition, cases of the following adverse reactions have been reported through spontaneous reporting only: Blood and Lymphatic System Disorders: Frequency Not Known: Leukopenia, neutropenia and agranulocytosis (see Precautions).
Metabolism and Nutrition Disorders: Frequency Not Known: Hypertriglyceridemia and hypercholesterolemia.
Psychiatric Disorders: Frequency Not Known: Confusion.
Endocrine Disorders: Frequency Not Known: Benign pituitary tumour such as prolactinoma (see Contraindications and Warnings).
Metabolism and Nutrition Disorders: Frequency Not Known: Hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Nervous System Disorders: Frequency Not Known: Neuroleptic Malignant Syndrome (see Warnings), which is a potentially fatal complication.
Cardiac Disorders: Frequency Not Known: QT interval prolongation and ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest, sudden death (see Warnings).
Vascular Disorders: Frequency Not Known: Venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see Warnings).
Skin and Subcutaneous Tissue Disorders: Frequency Not Known: Angioedema, urticaria.
Pregnancy, Puerperium and Perinatal Conditions: Frequency Not Known: Drug withdrawal syndrome neonatal (see Use in Pregnancy & Lactation).
Drug Interactions
Contraindicated Combinations: Medications which could induce torsades de pointes: Class Ia antiarrhythmic agents such as quinidine, disopyramide; class III antiarrhythmic agents such as amiodarone, sotalol; other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin.
Levodopa: Reciprocal antagonism of effects between levodopa and neuroleptics.
Combinations not Recommended: Amisulpride may enhance the central effects of alcohol.
Medications which enhance the risk of torsades de pointes or could prolong the QT interval.
Bradycardia-inducing medications such as beta-blockers, bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine, guanfacine; digitalis.
Medications which induce hypokalaemia: Hypokalemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides. Hypokalaemia should be corrected.
Neuroleptics such as pimozide, haloperidol; imipramine antidepressants; lithium.
Combinations to be Taken into Account: CNS depressants including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytics, clonidine and derivatives.
Antihypertensive drugs and other hypotensive medications.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
N05AL05 - amisulpride ; Belongs to the class of benzamides antipsychotics.
Tab (scored) 200 mg x 30's. FC tab 400 mg x 30's.
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