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Reproduction studies performed in ratsmice and rabbits by the IMIVsubcutaneousSCand oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramideThere arehoweverno adequate and well-controlled studies in pregnant womenBecause animal reproduction studies are not always predictive of human responsethis drug should be used during pregnancy only if clearly needed.

Restlessnessdrowsinessfatigueand lassitude may occur in patients receiving the recommended prescribed dosage of Reglan InjectionInsomniaheadacheconfusiondizzinessor mental depression with suicidal ideation also may occursee WARNINGSIn cancer chemotherapy patients being treated with 1-2 mg/kg per doseincidence of drowsiness is about 70There are isolated reports of convulsive seizures without clear-cut relationship to metoclopramideRarelyhallucinations have been reported.

A 77-week study was conducted in rats with oral doses up to about 40 times the maximum recommended human daily doseMetoclopramide elevates prolactin levels and the elevation persists during chronic administrationTissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitroa factor of potential importance if the prescription of metoclopramide is contemplated in a patient with previously detected breast cancerAlthough disturbances such as galactorrheaamenorrheagynecomastiaand impotence have been reported with prolactin-elevating drugsthe clinical significance of elevated serum prolactin levels is unknown for most patientsAn increase in mammary neoplasms has been found in rodents after chronic administration of prolactinstimulating neuroleptic drugs and metoclopramideNeither clinical studies nor epidemiologic studies conducted to datehoweverhave shown an association between chronic administration of these drugs and mammary tumorigenesisthe available evidence is too limited to be conclusive at this time.

Reglan Injectionmetoclopramide injectionUSPis a clearcolorlesssterile solution with a pH of 4.5-6.5 for intravenousIVor intramuscularIMadministration.

For the Relief of Symptoms As s ociated with Diabetic Gas tropares isDiabetic Gas tric Stas isAdminister 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeksdepending upon response and the likelihood of continued well-being upon drug discontinuation.

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