levosulpiride + pantoprazole Tablets, sustained release (SR) 75 mg + 40 mg

Dossier type
Dossier status
Ready to file
Country of origin
GMP approvals
Manufacturer #20340


Levosulpiride is a substituted benzamide antipsychotic. It helps in treating Gastroesophageal Reflux Disease and irritable bowel syndrome. As a neuroleptics or tranquilizers, It is mainly used in the treatment of mental disorders like hallucinations, schizophrenia, bipolar disorder, anxiety disorder, and vertigo. It is also used to treat Stomach acid reflux and discomfort, loss of appetite, pain, tenderness, heartburn, loose motions, constipation, dyspeptic syndrome, and irritable bowel syndrome, Unexplained headaches, Nausea and vomiting in chemotherapy Dizziness, Depression, Schizophrenia, Depression, Irritable Bowel Syndrome, Mental disorder, Indigestion, Frequent persistent heartburn, Gastroesophageal reflux disease, Diabetic gastroparesis, Burning mouth syndrome and several other conditions It is a selective antagonist of dopamine D2 receptor activity on both central and peripheral levels. As an atypical neuroleptic and a prokinetic agent, it also claims to be able to elevate the mood. Recently, It has also been tested to treat premature ejaculation, as the root cause is both psychological as well as organic. Levosulpiride is sold under the brand names ESRAB LSR, LESURIDE & LEVAZEO among others. Depomed, Inc. filed the first know patents related to the development of Levosulpiride in 1997 for the duration of drug release within the stomach during the fed mode. Barbeau Donald L. later filed for a patent in 2003 for Sulpiride pharmaceutical compositions.

Dosage and administration

The dosage of Levosulpiride is dependent on the patient’s history of drug reactions, allergies, The severity of disease, Reaction to the first dose, condition of the patient’s health & history. This medicine has to be taken as prescribed by a doctor and is not recommended to be taken without a prescription. For best results, it should be taken at the same time every day, swallowed whole without breaking it. Even if the patient starts feeling better after the first dose, the full course, as prescribed the doctor has to take. The usual recommended adult dose is 25 mg, taken thrice a day. However, if the symptoms get worse, seek a doctor’s intervention immediately.

The price of Levosulpiride

Levosulpiride is not sold in the USA. In the global API marketplace, it is sold for $86 a kilo. In India, a supply of 10 tablets of 25mg strength costs the consumer $0.8 -$1.2. cHow does it work? Dopamine made in our body transmits signals in the brain and is responsible for mood and behavioral changes. In individuals with depressive disorders and schizophrenia, the activity of dopamine is elevated. Levosulpiride blocks dopamine actions and improve depression. In lower concentrations, it has actions to improve gut motility so is used to treat reflux of stomach acid, constipation, loose motions, and related problems.

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