COMPOSITION:
Levopraid-25 Tablets Each tablet contains levosulpiride
.25 mg
CHEMICAL CLASSIFICATION:
Levosulpiride is a substituted benzamide, chemically it is S-(-)-N(1-methytpyrolydine-2-il-methyl 1-5-) sulfamoil-benzamide
PHARMACOLOGICAL CLASSIFICATION:
Antidopafninergic (A Selective DA2 receptors antagonist) in the central nervous system and in the peripheral submucosal and myoenteric plexus of the gastrointestinal tract.
PROPERTIES:
The biochemical, pharmacological and clinical data obtained from the two sulpiride isomers indicate that the antidopaminergic action, both on a central and peripheral level is due to the levogyre enantiomer (levosulpiride).
Levopraid increases
the tone and range of gastric contractions in patient affected by gastric stasis and consequently retailed gastric voiding, relaxes the pyloric sphincter and increases the duodenal and jejunal peristalsis leading to accelerated gastric voiding and intestinal transit. Owing to these peculiar features, the pharmaceutic may be employed in endoscopic studies for overcoming spasm and pnmary or reflected pyloric hypermyotonia, in the radiology of the digestive tract for shortening examination time, for promoting antral ejection of the contrasting medium and for avoiding troublesdme compressive motions.
Levopraid exerts a regulation action
both on the central and peripheral nervous circuits controlling the dynamics of the digestive system. Controlled clinical studies demonstrate that Levopraid is active for digestive disturbances (anorexia, nausea, vomit etc.) of an organic, functional and hiatrogenous nature. Levosulpiride considerably reduces the emsis induced by the most powerful antiblastic agents (cisplatme, antracycline). Alone or in combination, in patients affected by metopodynia it exerts in a considerable pharmacological influence, by reducing the frequency, duration and intensity of crisis periods.
Levopraid will generally not alter the cardiac-respiratory parameters, the kidney or
bladder functions or the emetic crisis.
PHARMACOKINETICS:
After oral administration, the bioavailability of L-Sulpiride is about 30%. Peak-plasma concentration occurs after about 3 hours and It has plasma half life of about 9.7 hours. It is mostly eliminiated by the kidneys in the urine.
INDICATIONS:
1. Gastroesophageal Reflux Disease (GERD)
2. Irritable Bowel syndroms (IBS)
3. Dyspeptic syndrome (anorexia, meteriosm, sense of epigastric tension, postprandial cephalgia, pyrosis, eruptions, diarrhoea, stipsis) due to retarded gastric voiding related to organic factors (diabetic gastroperesis, neoplasia etc.) and/or functional factors (visceral somatization in anxious depressive individuals):
Essential Cephalgia:
Vasomotor^ affections (classic, common, ophthalmic, cluster-type migraine) and muscular tension conditions: Vomit and Nausea (post operatorial or induced by antiblastic pharmaceutics)
Vertigo Of A Central And/Or Peripheral Origin.
DOSAGE AND ADMINISTRATION:
Tablets: 1 tablet of 25 mg 3 times per day before meals, according to medical prescription. CONTRAINDICATIONS:
Levosulpiride is contraindicated to patients affected by pheochromocytoma. as it may cause a hypertensive crisis, probably due to the release of cathecoiamines from the tumor. Such hypertensive crisis, may be controlled by phentolamine, Levosulpiride is contraindicated in patients with a known hypersensitivity or intolerance to the drug, tt must not be used in epilepsy, in manic conditions and in the manic stages of manic-depressive psychoses. In regard to the supposed correlations between the hyperprolactinerTiyzing effect of most psychotropic drugs and mammary dysplasias, it will be appropriate not to administer levosulpiride in subjects affected by malignant mastopathies.
SIDE EFFECTS:
For prolonged administration, certain disturbances such as amenorrhea, gynecomastia, galactorrhea and alteration of the libido, observed in particular occasions, are referable to a reversible effect of Levosulpiride on the functionality of the hypothalamus-pituitary-gonadal axis, similar to that known for many neuroleptics.
PRECAUTIONS FOR USE:
No secondary effect have been observed at the dosage recommended in interna' medicine, however at higher dosages somnolence, numbness and dyskinesia may occur, due to their potential dangers, patients under treatment must be made aware of these risks in order to avoid driving vehicles and attending to operations requiring total attention.
Levosulpiride must not be used when stimulating gastrointestinal motility may be harmful, for instance in presence of gastrointestinal bleedings, mechanical obstructions or perforations.
USE DURING PREGNANCY AND LACTATION:
Not to be used during presumed or confirmed' pregnancy and during the lactation period.
DRUG INTERACTION:
The effects of levosulpiride on the gastrointestinal motility may be opposed by ami cholinergic, narcotic or analgesic-drugs.
The association with psychopharmacological agents requires particular care and vigilance by the physician, in order to avoid, any unexpected side effect due to interaction. The simultaneous intake of alcohol must be avoided
OVERDOSAGE:
In internal medicine nor extrapyramidal or sleep disturbances have ever been observed, which may eventually occur at very high dosages. Interrupting the therapy or redbcing the dosage depending on the physician's judgement will be sufficient in this case.
STORAGE:
Store at room temperature (15-3Q°C) away from children's reach. SHELL LIFE: 60 month (5 years) in undamaged packaging when stored properly PRESENTATION: Cardboard box containing 2x10.s tablets of 25mg each in PVC/PVDC aluminium blisters.
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