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  • Pramin
    / Rafa


    Active Ingredient
    Metoclopramide (as HCl) 10 mg / 2 ml, 10.52 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 x 10 mg/2 cc

    full basket chart 1744 16425, 16201

    Ampoule

    50 X 10 mg/2 ml

    full basket chart 28702 16364

    Tablets

    30 X 10 mg

    full basket chart 1748 16202

    Related information


    Dosage

    Adult patients: For all adult indications except diabetic gastroparesis and facilitation of diagnostic procedures:  The recommended dose is 10 mg, 1 to 3 times a day. The maximum recommended daily dose is 30 mg or 0.5 mg/kg bodyweight. The maximum recommended treatment period is usually 5 days.
    Pediatric patients: For all pediatric indications except facilitation of diagnostic procedures: The recommended dose is 0.1 mg to 0.15 mg/kg bodyweight, 1 to 3 times a day. The maximum recommended daily dose is 0.5 mg/kg bodyweight. The tablets are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms are more appropriate for use in this population group. (Note: The tablets may be cut in half using the scored line). The maximum recommended treatment period is usually 5 days.
    Diabetic gastroparesis (adults): Use of Pramin for diabetic gastroparesis may involve a treatment duration longer than 5 days. Therefore, use in this clinical setting should be limited to those patients for whom the potential benefit outweighs the risk acording to the judgement of the treating physician. The recommended dose for diabetic gastroparesis is 10 mg half an hour before each meal for 2-8 weeks, depending on the response and the likelihood of continued well-being on cessation of treatment. The initial route of administration depends on the severity of the observable symptoms. If only the earliest manifestations of gastric stasis are present, the oral route is indicated. However, if the symptoms are more severe, 10 mg i.v. therapy by slow injection should be instituted (for up to 10 days) until symptoms subside. After 10 days, oral administration should be used for maintenance. Since diabetic gastric stasis is frequently recurrent, Pramin therapy should be reinstituted at the earliest manifestation. In patients with diabetic gastroparesis, the maximum recommended treatment period is usually 3 months. Treatment for longer than 3 months should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
    For full details see prescribing information.


    Indications

    Tablets, Ampoules: Suppression of cisplatin (also in combination), induced emesis.


    Contra-Indications

    Hypersensitivity to the active substance or to one of the excipients listed. When gastrointestinal motility stimulation poses a threat: gastrointestinal hemorrhage; mechanical obstruction or perforation of the digestive tract. In known or suspected pheochromocytoma carriers because of the risk of severe hypertensive episodes. Known history of tardive dyskinesia when taking neuroleptics or metoclopramide. Epilepsy (increased frequency and intensity of seizures). Parkinson’s disease. Concomitantly with levodopa or dopamine agonists Known history of methemoglobinemia with metoclopramide or NADH cytochrome-b5 reductase deficiency. In children under 1 year of age because of increased risk of extrapyramidal disorders.


    Special Precautions

    Nervous system disorders: Extrapyramidal disorders may occur, in particular in children and young adults, and/or when high doses are used. These reactions usually occur at the beginning of treatment, and can appear after a single dose. When metoclopramide is given intravenously, extrapyramidal disorders are less likely at slower infusion rates. In case of these extrapyramidal symptoms, metoclopramide therapy should be suspended immediately. These effects are generally completely reversible after suspension of treatment, but may require a symptomatic therapy (benzodiazepines in children, and/or anticholinergic antiparkinson drugs in adults). An interval of at least 6 hours must be maintained between each dose, even in case of vomiting or rejection of the dose, in order to avoid an overdose. Prolonged treatment with metoclopramide may lead to tardive dyskinesia, potentially irreversible especially in elderly patients. The treatment duration must not exceed 3 months because of the risk of tardive dyskinesia. In case of appearance of clinical signs of tardive dyskinesia,treatment must be suspended. Neuroleptic malignant syndrome has been documented with metoclopramide taken concomitantly with neuroleptics or in monotherapy. Treatment with metoclopramide must be suspended immediately in case of appearance of neuroleptic malignant syndrome symptoms and appropriate treatment implemented. Particular attention must be paid in patients with underlying neurological pathologies and in patients treated with other centrally acting drugs. Parkinson disease symptoms can also be exacerbated by metoclopramide.
    Methemoglobinemia: Cases of methemoglobinemia, possibly due to a NADH cytochrome-b5 reductase deficiency, have been reported. In this case, treatment must be suspended immediately and definitively, and appropriate steps taken (for instance treatment with methylene blue).
    Cardiac disorders: Severe cardiovascular adverse reactions, including cases of severe bradycardia, circulatory failure (shock), cardiac arrest and QT interval prolongation have been reported rarely when metoclopramide is administered by injection, in particular intravenously. Metoclopramide must be administered with caution, in particular when administered intravenously in elderly patients, patients with cardiac conduction disturbances (including QT interval prolongation), patients with uncorrected electrolyte imbalance, bradycardia and patients taking other medicines known to prolong the QT interval.
    Renal and hepatic impairment: In case of severe renal or hepatic impairment, a reduced dosage is recommended. Pramin tablets contain lactose. Their use is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary illnesses).
    Tablets contain Lectose.
    For full details see prescribing information.


    Side Effects

    The adverse effects are listed by system-organ. The adverse effects have been classified by order of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to <1 /10); uncommon (≥1/1000 to <1/100); rare(≥ 1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated on the basis of the available data).
    Gastrointestinal disorders: Common: Diarrhea.
    General disorders & administration site conditions: Common: Asthenia.
    Nervous system disorders: Very common: Somnolence. Common: Extrapyramidal disorders (in particular in children and young adults and/or when the recommended dose is exceeded, including after a single dose), Parkinson’s syndrome, akathisia.
    Psychiatric disorders: Common: Depression.
    Vascular disorders: Common: Low blood pressure, in particular with intravenous route.
    For full details see prescribing information.


    Drug interactions

    Concomitant use contraindicated: Mutual antagonism between dopamine agonists or levodopa and metoclopramide.
    Concomitant use not recommended: Alcohol increases metoclopramide’s sedative effect.
    Concomitant use to be taken into account: Because of metoclopramide’s prokinetic effect, the absorption of certain medicines may be modified.
    Anticholinergics & morphine derivatives: Mutual antagonism between anticholinergics and morphine derivatives and metoclopramide on digestive motility.
    CNS depressants (morphine derivatives, anti-anxiety medication, sedative H1-antihistamines, sedative antidepressants, barbiturates, clonidine and related drugs) Addition of the sedative effects of the CNS depressants and metoclopramide.
    Neuroleptics: Risk of addition of the effects on the appearance of extrapyramidal disorders.
    Serotonergic medicines: Increased risk of serotonin syndrome if taken concurrently with serotonergic medicines such as SSRIs.
    Digoxin: Metoclopramide may reduce digoxin’s bioavailability. The plasma concentrations of the digoxin must be closely monitored.
    Cyclosporin: Metoclopramide increases cyclosporin’s bioavailability (46% Cmax increase and 22% systemic exposure increase). The plasma concentrations of the cyclosporin must be closely monitored. The clinical result is uncertain.
    Mivacurium and suxamethonium: Injection of metoclopramide may prolong the duration of the neuromuscular blockade, by plasma cholinesterase inhibition.
    Strong CYP2D6 inhibitors: Increased metoclopramide exposure parameters if metoclopramide is taken concomitantly with strong CYP2D6 inhibitors such as fluoxetine and paroxetine. While the clinical relevance is unknown, monitoring of adverse effects is necessary. Risk of addition of the methemoglobinizing effects, in particular in neonates (in whom the use is contraindicated).


    Pregnancy and Lactation

    Pregnancy: Based on a large amount of data for pregnant women (over 1000 pregnancies) there is no evidence of any malformative or fetotoxic effect. Metoclopramide can be used during pregnancy if necessary. For pharmacological reasons (by analogy with other neuroleptics), if metoclopramide is taken in the final stages of pregnancy, a neonatal extrapyramidal syndrome cannot be excluded. Metoclopramide should not be taken in the final stages of pregnancy. If it is used, the neonate must be placed under observation.
    Lactation: Little metoclopramide passes into the breast milk. Adverse effects in the breast-fed neonate cannot be excluded. Therefore, metoclopramide is not recommended during breast-feeding. Suspension of the therapy should be considered during breast-feeding.


    Overdose

    Symptoms: Extrapyramidal symptoms, drowsiness, impaired awareness, confusion, hallucinations, even cardiopulmonary arrest may occur.
    Management: In case of extrapyramidal symptoms, whether or not connected with an overdose, treatment is only symptomatic (benzodiazepines in children, benzodiazepines and/or anticholinergic antiparkinson drugs in adults). Symptomatic treatment and continuous observation of the cardiovascular and respiratory functions must be carried out according to the clinical status.


    Manufacturer
    Rafa Laboratories Ltd.
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