Isaprandil 5mg Metoclopramide Hydrochloride 20 Effervescent Tablets

NAME
ISAPRANDIL

PHARMACOTHERAPEUTIC CATEGORY
Prokinetics.

ACTIVE PRINCIPLES
Metoclopramide hydrochloride.

EXCIPIENTS
Effervescent tablets: monobasic sodium citrate, potassium bicarbonate, sorbitol, anhydrous citric acid, potassium carbonate, lemon flavor, leucine, sodium saccharin, macrogol 6000. Effervescent granules: anhydrous citric acid, anhydrous sodium carbonate, sucrose, sodium saccharin, lemon flavor.

INDICATIONS
Adults: symptomatic treatment of hyperacidity (pain and heartburn), when accompanied by gastric slowing and nausea.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients or to other related substances from a chemical point of view; metoclopramide should not be used in cases where the stimulation of intestinal motility can be dangerous, for example in the presence of gastrointestinal bleeding, perforation, mechanical obstruction; metoclopramide is contraindicated in patients suffering from glaucoma, pheochromocytoma, epileptic disease, Parkinson's disease and other overt extrapyramidal diseases or during therapy with anticholinergics or during treatment with drugs potentially capable of causing extrapyramidal reactions; kidney failure; it is not advisable to use the product in subjects who have already shown tardive dyskinesias from drugs; first trimester of pregnancy and lactation; metoclopramide is contraindicated in neonates; children under 16.

DOSAGE
The use of the product is limited to adult patients. Tablets: one tablet before meals or at the time of the onset of disorders, in half a glass of water 2-3 times a day. Sachets: one sachet before meals or at the time of the onset of disorders, in half a glass of water 2-3 times a day. Do not exceed the recommended dose. In particular, elderly patients must comply with the minimum dosages indicated above. Pediatric population including adolescents: the use of the product is not recommended in the pediatric population.

STORAGE
Effervescent tablets: do not store above 30 degrees C; store in the original package. Effervescent granules: do not store above 25 degrees C; store in the original package.

WARNINGS
Extrapyramidal disorders may occur, particularly in children and young adults and / or when high doses are used. Particular caution must be adopted in the treatment of patients with hepatic or renal insufficiency, in whom the metabolization and elimination of metoclopramide can be substantially compromised with consequent alteration of its pharmacokinetic parameters. The possible increase in prolactin levels should be carefully considered in breast cancer patients. The concomitant use of metoclopramide with alcoholic beverages is not recommended. The effervescent tablets contain sorbitol. The effervescent granules (sachets) contain sucrose. In addition, one sachet contains 430 mg of sodium. This must be taken into account by patients on a low-sodium diet.

INTERACTIONS
The medicine should not be taken with narcotic analgesic drugs with anticholinergics, which antagonize their effects on gastrointestinal motility. The simultaneous administration of anti MAO, neuroleptics and phenothiazines, butyrophenones, thioxanthenes etc. (drugs which in themselves can cause both the appearance of extrapyramidal symptoms and dystonic reactions), enhances the central activity of ametoclopramide and increases the risk of undesirable effects. Synergistic effects at the level of the central nervous system can also occur with the simultaneous administration of sedatives, hypnotics, tranquilizers and alcoholic beverages. Metoclopramide, accelerating gastric emptying, can decrease the absorption of digoxin and theophylline, while it can accelerate that of alcohol, acetylsalicylic acid, paracetamol, tetracycline, levodopa. Some observations report, with metoclopramide, an increase in the bioavailability of cyclosporine and quinidine, as well as in the renal toxicity of cisplatin. By reducing the time of intestinal transit including food, treatment with the drug may require an adjustment of the insulin dosage in diabetes.

SIDE EFFECTS
The most reported undesirable effects with metoclopramide are agitation, somnolence and asthenia. Nervous system disorders and psychiatric disorders. Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following the administration of a single dose of the drug, particularly in children and young adults. The drug can cause various types of extrapyramidal reactions, generally of the dystonic type. They may include facial spasms, trismus, torticollis, extra-ocular muscle spasms with oculogyric crises, abnormal head positions. Prolonged use of metoclopramide can lead to the development of tardive dyskinesia in the elderly, a potentially irreversible syndrome characterized by difficulty in movement and abnormal accentuated muscle tone. The risk of developing the syndrome appears to be related to the duration of treatment and the cumulative dose. Tardive dyskinesia can recede, partially or completely, with the suspension of metoclopramide within a few months; your treatment, as an adequate one has not been identified, cannot be symptomatic. Central undesirable effects (depression) have also been reported. Cardiac side effects (supraventricular tachycardia), and renal side effects (decreased plasma or renal flow) have also been reported, therefore caution is recommended in the treatment of subjects with a history of disease affecting these organs. Blood and lymphatic system disorders: Methaemoglobinaemia which may be related to a deficiency of NADH cytochrome b5 reductase, particularly in neonates. Metoclopramide can stimulate the secretion of prolactin, which can be associated with galactorrhea and menstrual changes in women and impotence in men. Hypertensive crises, sometimes fatal, have been reported in patients with pheochromocytoma. Such seizures can be controlled by the use of phentolamine. The following have also been reported: insomnia, headaches, dizziness, nausea and vomiting, gynaecomastia, intestinal disorders, skin rash.

PREGNANCY AND BREASTFEEDING
The use of the product in the first trimester of pregnancy is contraindicated. As regards the use of the product in the further period, it should be noted that antiemetic products in general must be administered during pregnancy only in cases of overt symptoms, for which an alternative intervention is not possible and not in the frequent and simple cases of emesis gravidarum. and even less with its preventive purposes. Metoclopramide is excreted in breast milk, therefore it should not be administered during lactation unless, in the judgment of the physician, the benefits to the mother outweigh the potential risks to the infant. Alternatively, use artificial milk.