United States - English - NLM (National Library of Medicine)

remedyrepack inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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 crisis, probably due to release of catecholamines from the tumor [ see warnings and precautions ( 5.5) ]. - in patients with epilepsy. metoclopramide may increase the frequency and severity of seizures [ see adverse reactions ( 6) ]. - in patients with hypersensitivity to metoclopramide. reactions have included laryngeal and glossal angioedema and bronchospasm [ see adverse reactions ( 6) ]. 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) ].

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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: 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 a

United States - English - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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

Malta - English - Medicines Authority

syri pharma limited floor 0 1 wml, 1 windmill lane dublin 2, d02 f206, ireland - metoclopramide hydrochloride - oral solution - metoclopramide hydrochloride 5 mg/5ml - drugs for functional gastrointestinal disorders

Malta - English - Medicines Authority

crescent pharma international limited 260, triq san albert, gzira gzr 1150, malta - metoclopramide hydrochloride - tablet - metoclopramide hydrochloride 10.5 mg - drugs for functional gastrointestinal disorders

United States - English - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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

United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - the use of metoclopramide   tablets, usp is recommended for adults only. therapy should not exceed 12 weeks in duration. symptomatic gastroesophageal reflux:  metoclopramide tablets, usp 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 endoscopic

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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: 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 m

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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: 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

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - 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 crisis, probably due to release of catecholamines from the tumor [see warnings and precautions (5.5) ]. - in patients with epilepsy. metoclopramide may increase the frequency and severity of seizures [see adverse reactions (6) ]. - in patients with hypersensitivity to metoclopramide. reactions have included laryngeal and glossal angioedema and bronchospasm [see adverse reactions (6) ]. 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 b5 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 b5 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) ].