Solian

(Amisulpride)

The active ingredient in Solian is amisulpride. It acts mainly by blocking dopamine receptors in the brain. In people with schizophrenia, dopamine activity can become irregular, contributing to psychotic symptoms. By targeting these receptors, Solian helps correct this imbalance.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Solian. However, the following is a synopsis of the general guidelines for the use of Solian:

• Swallow the tablets whole with water; do not crush or chew them.
• Solian may be taken with or without food, usually once or twice a day.
• Try to take the dose at the same time each day to maintain steady levels in your body.
• If you miss a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not double your next tablet to make up for a missed dose.
• Do not stop taking Solian suddenly, as this can cause withdrawal symptoms or a return of psychotic episodes.
• Avoid drinking alcohol or taking other sedating drugs such as antihistamines while using Solian, as these can increase drowsiness.

Some mild or common side effects of Solian seen in clinical trials as compared to placebo include:

• Drowsiness or fatigue.
• Constipation.
• Dry mouth.
• Blurred vision.
• Weight gain.
• Insomnia or agitation.
• Dizziness or low blood pressure (hypotension).
• Muscle stiffness or tremor.
• Increased prolactin levels can cause breast pain, milk secretion, or menstrual changes.

Some individuals may experience serious side effects while using Solian. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Prolonged or irregular heartbeat, especially in people with heart rhythm conditions or when combined with drugs such as amiodarone, sotalol, or quinidine.
• Symptoms of high prolactin levels include breast enlargement or production of milk, even in men.
• Involuntary movements of the face, tongue, or limbs (tardive dyskinesia).
• Uncontrolled muscle contractions or spasms (dystonia), or uncontrolled restlessness (akathisia).
• Signs of Neuroleptic Malignant Syndrome: high fever, muscle stiffness, confusion, sweating, or irregular pulse.
• Seizures or fainting.
• Allergic reaction, including rash, hives, swelling, or trouble breathing.

These are not all of the possible side effects of Solian. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Solian, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Heart disease, history of irregular heartbeat, or low blood pressure.

A family history of sudden cardiac death or abnormal QT interval.

Kidney problems, as dosage adjustment may be required.

Parkinson’s disease or a history of movement disorders.

Tumours of the pituitary gland (prolactinoma) or breast cancer.

Seizure disorders or epilepsy.

Low potassium or magnesium levels in your blood.

A tendency toward bradycardia (slow heartbeat).

Do not use Solian if you:

Are allergic to amisulpride or any of the ingredients in the tablets.

Have a tumour that depends on prolactin, such as breast cancer or prolactinoma.

Have a known or suspected phaeochromocytoma (a tumour of the adrenal gland).

Are taking levodopa, a medication used to treat Parkinson’s disease.

Have severe kidney impairment.

Have a known prolonged QT interval or are taking medications that can cause torsades de pointes, such as amiodarone, quinidine, or sotalol.

Are under 18 years of age, as safety and efficacy have not been established for children.

Some improvement in agitation and hallucinations may occur within a few days, but it can take several weeks to see the full benefit for schizophrenia symptoms.

When Solian is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Levodopa, as its effects are blocked by Solian.
• Medications that prolong the QT interval, such as amiodarone, sotalol, quinidine, and certain antidepressants.
• Antihistamines or sleeping pills that cause drowsiness.
• Drugs used to lower blood pressure, as Solian, may enhance their effects and cause hypotension.
• Antidepressants or lithium, which may increase the risk of side effects.
• Antipsychotic medications such as haloperidol or clozapine may increase the likelihood of extrapyramidal symptoms.
• Drugs affecting electrolytes, such as diuretics, which may lead to low potassium or magnesium levels.

Brand-name Solian is available in film-coated tablet form for oral use. The most common strengths include:

Solian 50 mg tablets.

Solian 100 mg tablets.

Solian 200 mg tablets.

Solian 400 mg tablets.

It should be stored at room temperature away from the reach of children or pets.

Solian tablets are manufactured and distributed by Sanofi Aventis (Singapore) Pte Ltd.

Yes, it is available from several manufacturers of generic drugs.

Do not stop taking Solian without consulting your healthcare provider. Suddenly stopping the medication may cause withdrawal symptoms such as nausea, sweating, insomnia, or a return of psychotic episodes.

There is limited information on the use of Solian during pregnancy. It should only be used if the expected benefit to the mother outweighs the potential risk to the baby. Newborns exposed to antipsychotic medications during the third trimester may experience tremor, stiffness, or feeding difficulties after birth.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Amisulpride can pass into breast milk. Because of potential effects on a nursing infant, Solian should not be used while breastfeeding unless directed by your doctor.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.