LEVOGAMOTIL Tablet

In the treatment of the following diseases due to functional indigestion: abdominal distention, epigastric discomfort, heart burn, belching.

Dosage and administration

Usual adults’ dosage: 1 tablet, 3 times before meals.

1) Pregnant women or women of childbearing potential who might become pregnant.

2) Patients with gastro-intestinal tract bleeding, mechanical disorder or perforation.

3) Patients with pheochromocytoma; hypertension due to release of catecholamine may be induced.

4) Patients with a hypersensitivity to levosulpiride or intolerability.

5) Patients with epilepsy, mania, or patients in manic step of manic-depressive psychosis

6) It is thought that there’s an interaction between hypomazia and hyperprolactinemia, which most psychotropic drugs have. Therefore, the drug should not be administered in patients with malignant mastopathy.

1) Endocrine system: Occasionally, amenorrhoea suspected to result from diencephalic pathocrine (disorders in secretion of gonadotropin or prolactin), continuous lactation, gynecomastia may occur. The patients should be carefully observed, and if they occur, the administration should be discontinued.

2) Extrapyramidal system: Rarely involuntary motion surrounding lips and so on due to the long-term therapy may be developed, and it can be prolonged even after the discontinuance of the use.

3) Gastro-intestinal system: Occasionally, dipsia, heartburn, nausea, vomiting, diarrhea, and constipation may occur.

4) Circulatory system: Hypertension.

5) Miscellaneous: If eruption or edema occurs infrequently, the administration should be discontinued. And occasionally heat, malaise, insomnia, drowsiness, dizziness, and titubation may occur, and rarely impotence may occur. In the long-term use, such side effects as amenorrhea, gynecomastia, galactorrhea, and increase or decrease of sexual desire may occur. They are the effect on the 2nd cervical vertebrae of hypothalamic hypophysis gonad, which is reversible.

1) Since the prokinetic activity of the drug may be antagonized by anticholinergic agents (e.g. atropine, methyl scopolamine etc.) or analgesic agents, the concomitant use with those agents is not recommended.

2) Nausea, vomiting, anorexia, as index in saturation of digitalis drugs, ma be masked. Therefore, the patients receiving digitalis drugs should be carefully observed, and also the administration should be cautioned.

3) Since the concomitant use of the drug with other benzamide drugs (e.g. methochlopramide, etc.) may cause disorder of endocrinal function or extrapyramidal symptoms, the administration should be cautioned.

4) The concomitant use of the drug with psychotropic drugs should be warned to avoid unexpected reactions due to the drug interactions. And alcohol should not be taken concomitantly.

See the package insert about the details below:

Pregnancy

The drug should not be administered to pregnant women or women of childrearing potential who might become pregnant and should be used only when the expected benefits clearly outweigh the potential risks to the fetus.

Lactation

Since safety use in lactation has not been established, the drug should be used only when the expected benefits clearly outweigh the potential risks to the fetus.

The following patients should be carefully administered:

1) Patients with hypertension

2) Children: since extrapyramidal symptoms may develop, overdose should be warned.

3) The elderly.

General precautions

1) Prior to prescribing the drug, a patient should be advised that there’ll be such side effects as lactation, increase in secretion of prolactin due to pathocrine regulation of diencephalon.

2) Since pathocrine regulation of diencephalons or extrapyramidal symptom may occur, the safety and effectiveness in use should be carefully considered.

3) Patients, under the therapy, should be warned not to drive or operate machinery.

Others

1) Since the drug has an antiemetic activity, which may mask vomiting associated with encephalophyma, ileus, or intoxication due to the other drugs, the patients should be carefully observed and the administration cautioned.

2) Contraction of testis and fertility study in animal studies on chronic toxicity has demonstrated that the drug caused the reduced fertility.

3) In the long-term therapy with a large dose to rats and mice, tumor generation on p.gland, mammary etc. line was higher than the control group.

1) Levopride effectively increases gastrointestinal motility by acting on the gastrointestinal tract.

2) It is excellent for treating dyspeptic symptoms closely related to stress, anxiety and psychological factors.