DISLEP​ ​TABLETS

Indications

• Functional dyspepsia
• Gastroparesis
• Nausea and vomiting
• Psychiatric disorders (e.g., depression)

Dosage

Children: For children, dosing must be determined based on the specific condition and the child's weight, and it is essential to refer to the BNF for Children for accurate dosing recommendations.

Adults: The usual adult dose is 25 to 50 mg three times daily before meals, depending on the severity of symptoms and clinical response.

Mechanism of action

Levosulpiride acts primarily as a selective antagonist of dopamine D2 receptors in the gastrointestinal tract and central nervous system. By blocking these receptors, it enhances gastrointestinal motility and reduces nausea and vomiting. Additionally, it may exert antidepressant effects through its action on central dopamine pathways.

Pharmacodynamics

Levosulpiride increases gastric emptying and intestinal transit, alleviating symptoms of gastric stasis. Its antagonistic action on dopamine receptors results in increased prolactin secretion, which can contribute to its therapeutic effects in certain mood disorders. The drug's impact on gastrointestinal motility is particularly beneficial in functional disorders.

Pharmacokinetics

Levosulpiride is absorbed relatively quickly after oral administration, with peak plasma concentrations occurring within 1 to 3 hours. It is metabolized in the liver, and its elimination half-life is approximately 6 to 8 hours. The majority of the drug is excreted unchanged in the urine, with a small portion undergoing hepatic metabolism.

Contra-indications

• Hypersensitivity to levosulpiride or any of its components
• Pheochromocytoma
• Prolactinoma
• Epilepsy and history of seizures
• Severe renal impairment

Adverse effects

• Drowsiness
• Extrapyramidal symptoms
• Galactorrhea
• Menstrual disorders
• Weight gain
• Dry mouth
• Constipation
• Nausea

Interactions

• Antihypertensive agents may have additive hypotensive effects
• CNS depressants may enhance sedative effects
• Antipsychotics may increase the risk of extrapyramidal symptoms

Precautions

• Use with caution in patients with a history of depression
• Monitor for signs of tardive dyskinesia
• Use with caution in the elderly or those with cardiovascular disease
• Discontinue if symptoms of neuroleptic malignant syndrome occur

Pregnancy

Levosulpiride should only be used if the potential benefit justifies the risk to the fetus. Limited data on safety in pregnancy.

Breast-feeding

Levosulpiride is excreted in breast milk. Caution is advised, and breastfeeding should be avoided if possible.

Storage

Store in a cool, dry place away from direct light. Keep out of reach of children.

Formulations

• Tablets 25 mg
• Tablets 100 mg
• Injectable solution 50 mg/2 ml