Aprogen Levosulpiride Tablet

Adult dose

Adults: Take 25 mg of levosulpiride orally 3 times daily before meals.

This medication should not be used in women who are pregnant or may become pregnant, and in breastfeeding women. It should not be administered to patients with gastrointestinal bleeding, mechanical obstruction, or perforation, as gastrointestinal stimulation may be harmful. Avoid use in patients with pheochromocytoma, those who are hypersensitive or intolerant to this medication, those with liver disease and manic states or in the manic phase of bipolar disorder. It is also preferable not to administer it to patients with malignant mammary dysplasia. Caution is especially advised in patients with hypertension, children, and the elderly; overdosage should be avoided in children as extrapyramidal symptoms are more likely to occur. This medication may cause amenorrhea, galactorrhea, gynecomastia, among other endocrine disorders; if such symptoms occur, treatment should be stopped immediately. There may be extrapyramidal symptoms like tremors, lingual torsion, and restlessness, which necessitate halting the administration if they occur. Prolonged use may result in involuntary movements, while gastrointestinal effects may include thirst, heartburn, nausea, vomiting, diarrhea, and constipation. Cardiovascular issues such as hypertension or arrhythmias may arise. Rarely reported serious side effects include neuroleptic malignant syndrome, which necessitates immediate discontinuation of the medication and medical treatment if symptoms like high fever, muscle rigidity, or altered consciousness occur. Other rare side effects may include rash, swelling, warmth, fatigue, insomnia, drowsiness, dizziness, imbalance, erectile dysfunction, and changes in libido. Patients receiving this medication are advised to avoid activities requiring concentration, such as driving or operating machinery. Additionally, this medication may interact with other drugs, particularly anticholinergic agents, narcotic analgesics, digitalis preparations, benzamide drugs, psychotropic medications, drugs prolonging the QT interval, and drugs causing electrolyte disturbances, so caution is needed. Safety during pregnancy and lactation has not been established, and elderly patients may have increased drug concentrations due to renal impairment, necessitating careful adjustment of dosage and administration intervals. Finally, this medication suppresses vomiting, which could mask symptoms of intoxication, bowel obstruction, or brain tumor-related vomiting; hence careful monitoring is necessary. Animal studies have reported testicular atrophy, reduced pregnancy rates, and an increased incidence of pituitary and mammary tumors, indicating caution is needed with long-term use.

• Amenorrhea
• galactorrhea
• gynecomastia
• tremors
• tongue twisting
• agitation
• involuntary movements around the mouth
• thirst
• heartburn
• nausea

This medication should be stored in a tightly closed container to protect it from air and moisture, at temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance

White round tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 1000 tablets/bottle, For export - 100 tablets/box [(10 tablets/PTP x 10)]