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teva pharmaceuticals usa, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg - metoclopramide tablets are indicated for the: - treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. - relief of symptoms in adults with acute and recurrent diabetic gastroparesis. limitations of use : metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see use in specific populations ( 8.4) ]. metoclopramide is contraindicated: - in patients with a history of tardive dyskinesia (td) or a dystonic reaction to metoclopramide [see warnings and precautions ( 5.1, 5.2) ]. - when stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). - in patients with pheochromocytoma or other catecholamine-releasing paragangliomas. metoclopramide may cause a hypertensive/pheochromocytoma cr

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nucare pharmaceuticals,inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 10 mg - metoclopramide tablets are indicated for the:metoclopramide tablets are indicated for the: - treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. - relief of symptoms in adults with acute and recurrent diabetic gastroparesis. limitations of use : metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [ see use in specific populations ( 8.4) ]. metoclopramide is contraindicated:metoclopramide is contraindicated: - in patients with a history of tardive dyskinesia (td) or a dystonic reaction to metoclopramide [ see warnings and precautions ( 5.1, 5.2) ].in patients with a history of tardive dyskinesia (td) or a dystonic reaction to metoclopramide [ see warnings and precautions ( 5.1, 5.2) ]. - when stimu

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cardinal health 107, llc - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg in 1 ml - diabetic gastroparesis (diabetic gastric stasis) metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy metoclopramide injection, usp is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. the prevention of postoperative nausea and vomiting metoclopramide injection, usp is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. small bowel intubation metoclopramide injection, usp may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. radiological examination metoclopramide injection, usp may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine. metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction or perforation. metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. such hypertensive crises may be controlled by phentolamine. metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

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rebel distributors corp - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 10 mg - the use of metoclopramide  tablets is recommended for adults only. therapy should not exceed 12 weeks in duration. metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. the principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. if symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. as there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. metoclopramide tablets, usp are indicated for the relief of

Stati Uniti - Ingliż - NLM (National Library of Medicine)

cardinal health 107, llc - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg - metoclopramide tablets are indicated for the:metoclopramide tablets are indicated for the: limitations of use : metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [ see use in specific populations ( 8.4) ]. metoclopramide is contraindicated:metoclopramide is contraindicated: risk summary published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. there are potential risks to the neonate following exposure in utero to metoclopramide during delivery [ see clinical considerations ]. in animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (mrhd) [ see data ]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. monitor neonates for extrapyramidal signs [ see warnings and precautions ( 5.1, 5.2), use in specific populations ( 8.4) ]. data animal data reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the mrhd calculated on body surface area and in pregnant rabbits at about 12 times the mrhd calculated on body surface area. no evidence of adverse developmental effects due to metoclopramide were observed. risk summary limited published data report the presence of metoclopramide in human milk in variable amounts. breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [ see data ]. metoclopramide elevates prolactin levels [ see warnings and precautions ( 5.7) ]; however, the published data are not adequate to support drug effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metoclopramide and any potential adverse effects on the breastfed child from metoclopramide or from the underlying maternal condition. clinical considerations monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [ see warnings and precautions ( 5.1, 5.2), use in specific populations ( 8.4) ]. data in published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. in one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum. metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. the safety and effectiveness of metoclopramide in pediatric patients have not been established. dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [ see warnings and precautions ( 5.1, 5.2) ]. in addition, neonates have reduced levels of nadh-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [ see use in specific populations ( 8.8) ]. metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (td), may be greater in patients with impaired renal function [ see use in specific populations ( 8.6), clinical pharmacology ( 12.3) ]. elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of metoclopramide in elderly patients [ see boxed warning, dosage and administration ( 2.2, 2.3), warnings and precautions ( 5.1) ]. the clearance of metoclopramide is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. reduce the metoclopramide dosage in patients with moderate and severe renal impairment (creatinine clearance less than or equal to 60 ml/minute), including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [ see dosage and administration ( 2.2, 2.3), clinical pharmacology ( 12.3) ]. patients with severe hepatic impairment (child-pugh c) have reduced systemic metoclopramide clearance (by approximately 50%) compared to patients with normal hepatic function. the resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. there is no pharmacokinetic data in patients with moderate hepatic impairment (child-pugh b). reduce metoclopramide dosage in patients with moderate or severe (child-pugh b or c) hepatic impairment [ see dosage and administration ( 2.2, 2.3) ]. there is no dosage adjustment required for patients with mild hepatic impairment (child-pugh a). in addition, metoclopramide, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [ see warnings and precautions ( 5.6) ]. monitor patients with hepatic impairment for the occurrence of fluid retention and volume overload. metoclopramide-treated patients with nadh-cytochrome b 5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. for patients with glucose-6-phosphate dehydrogenase (g6pd) deficiency with metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended. methylene blue may cause hemolytic anemia in patients with g6pd deficiency, which may be fatal [ see overdosage ( 10) ]. metoclopramide is a substrate of cyp2d6. the elimination of metoclopramide may be slowed in patients who are cyp2d6 poor metabolizers (compared to patients who are cyp2d6 intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to metoclopramide [ see clinical pharmacology ( 12.3) ]. reduce the metoclopramide dosage in patients who are poor cyp2d6 metabolizers [ see dosage and administration ( 2.2, 2.3) ].

Stati Uniti - Ingliż - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - chlorpropamide (unii: wtm2c3il2x) (chlorpropamide - unii:wtm2c3il2x) - chlorpropamide 250 mg - chlorpropamide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. chlorpropamide tablets are contraindicated in patients with: - known hypersensitivity to any component of this medicine. - type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.

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mylan pharmaceuticals inc. - tolbutamide (unii: 982xcm1foi) (tolbutamide - unii:982xcm1foi) - tolbutamide 500 mg - tolbutamide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type ii) whose hyperglycemia cannot be controlled by diet alone. in initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. caloric restriction and weight loss are essential in the obese diabetic patient. proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. the importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. if this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. use of tolbutamide tablets must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary res

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teva pharmaceuticals usa, inc. - disopyramide phosphate (unii: n6bom1935w) (disopyramide - unii:gfo928u8mq) - disopyramide 100 mg - disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. disopyramide phosphate is contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree av block (if no pacemaker is present), congenital q-t prolongation, or known hypersensitivity to the drug.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

mayne pharma inc. - disopyramide phosphate (unii: n6bom1935w) (disopyramide - unii:gfo928u8mq) - disopyramide 100 mg - disopyramide phosphate capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. because of the proarrhythmic effects of disopyramide, its use with lesser arrhythmias is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of disopyramide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. disopyramide phosphate capsules are contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree av block (if no pacemaker is present), congenital q-t prolongation, or known hypersensitivity to the drug.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

avkare - disopyramide phosphate (unii: n6bom1935w) (disopyramide - unii:gfo928u8mq) - disopyramide 100 mg - disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. treatment of patients with asymptomatic ventricular premature contractions should be avoided. initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. disopyramide phosphate is contraindicated in the presence of cardiogenic shock, preexisting second- or third-degree av block (if no pacemaker is present), congenital q-t prolongation, or known hypersensitivity to the drug.