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Metoclopramide (Metoclopramide)

Trade Name : Metoclopramide

NuCare Pharmaceuticals,Inc.

TABLET

Strength 10 mg/1

METOCLOPRAMIDE HYDROCHLORIDE Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Metoclopramide (Metoclopramide) which is also known as Metoclopramide and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 10 mg/1 per ml. Read more

Metoclopramide (Metoclopramide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Boxed Warning
  • Indications and Usage (n n n ) 8/2017n nn
  • Dosage and Administration, Dosage for Gastroesophageal Reflux (n n n ) 8/2017n nn
  • Dosage and Administration, Dosage for Acute and Recurrent Diabetic Gastroparesis (n n n ) 8/2017n nn
  • Contraindications (n n n ) 8/2017n nn
  • Warnings and Precautions, Tardive Dyskinesia (n n n ) 8/2017n nn
  • Warnings and Precautions, Other Extrapyramidal Symptoms (n n n ) 8/2017n nn
  • Warnings and Precautions, Neuroleptic Malignant Syndrome (n n n ) 8/2017n nn
  • Warnings and Precautions, Hyperprolactinemia (n n n ) 8/2017n nn
  • WARNING: TARDIVE DYSKINESIA
  • See full prescribing information for complete boxed warning.
  • Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage (n n n )n n n
  • Discontinue metoclopramide in patients who develop signs or symptoms of TD (n n n )n n n
  • Avoid treatment with metoclopramide for longer than 12 weeks because of the risk of developing TD with longer-term use (n n n , n n n , n n n , n n n )n n n
  • Metoclopramide tablets are indicated for the:Metoclopramide tablets are indicated for the:
  • Arrayn- 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 [n n n n ].nn
  • Metoclopramide tablets are indicated for the:
  • Limitations of Use
  • Metoclopramide tablets are 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. (n n n , n n n )n nn
  • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. (n n n )n n n
  • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. (n n n )n n n
  • Gastroesophageal Reflux
  • Acute and Recurrent Diabetic Gastroparesis
  • Dosage Adjustment in Specific Populations
  • Tablets:
  • Tablets: 5 mg and 10 mg metoclopramide (n n n )n nn
  • Metoclopramide is contraindicated:Metoclopramide is contraindicated:
  • History of TD or dystonic reaction to metoclopramide (n n n )n n n
  • When stimulation of gastrointestinal motility might be dangerous (n n n )n n n
  • Pheochromocytoma, catecholamine-releasing paragangliomas (n n n )n n n
  • Epilepsy (n n n )n n n
  • Hypersensitivity to metoclopramide (n n n )n n n
  • No data
  • Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS)
  • Depression and suicidal ideation/suicide
  • The following adverse reactions are described, or described in greater detail, in other sections of the labeling:
  • The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration.
  • Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches.
  • Central Nervous System Disorders
  • Endocrine Disorders
  • Cardiovascular Disorders
  • Gastrointestinal Disorders
  • Hepatic Disorders
  • Renal and Urinary Disorders
  • Hematologic Disorders
  • Hypersensitivity Reactions
  • Eye Disorders
  • Metabolism Disorders
  • To report SUSPECTED ADVERSE REACTIONS, contact
  • TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872
  • or FDA at 1-800-FDA-1088 or n n n n
  • Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude. (n n n )n n n
  • No data
  • Antipsychotics
  • CNS depressants
  • Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine)
  • MAO inhibitors
  • Additional drug interactions
  • No data
  • Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS [n n n ].n nn
  • There are no specific antidotes for metoclopramide overdosage. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
  • Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal.
  • Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.
  • Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-n n n -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:n nn
  • Cn n n Hn n n ClNn n n On n n u2022HClu2022Hn n n O M.W. 354.3n nn
  • Metoclopramide tablets are for oral administration. Metoclopramide tablets are available in 5 mg and 10 mg tablets.
  • Inactive Ingredients
  • Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
  • No data
  • Carcinogenesis
  • A 77-week study was conducted in rats with oral metoclopramide doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Metoclopramide elevated prolactin levels and the elevation persisted during chronic administration. An increase in mammary neoplasms was found in rodents after chronic administration of metoclopramide [n n n ]. In a rat model for assessing the tumor promotion potential, a 2-week oral treatment with metoclopramide at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose based on body surface area) enhanced the tumorigenic effect of N-nitrosodiethylamine.n nn
  • Mutagenesis
  • Metoclopramide was positive in the n n n Chinese hamster lung cell/HGPRT forward mutation assay for mutagenic effects and in the n n n human lymphocyte chromosome aberration assay for clastogenic effects. It was negative in the n n n Ames mutation assay, the n n n unscheduled DNA synthesis assay with rat and human hepatocytes, and the n n n rat micronucleus assay.n nn
  • Impairment of Fertility
  • Metoclopramide at intramuscular doses up to 20 mg/kg/day (about three times the maximum recommended human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
  • Each white, round, scored, debossed u201cTEVAu201d on one side and u201c2203u201d above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide.
  • NDC 66267-827-04 Bottles of 4
  • NDC 66267-827-06 Bottles of 6
  • NDC 66267-827-08 Bottles of 8
  • Dispense in a tight, light-resistant container. Store tablets at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Inform patients or their caregivers that metoclopramide can cause serious adverse reactions. Instruct patients to discontinue metoclopramide and contact a healthcare provider immediately if the following serious reactions occur:
  • Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [n n n ]. Explain that the prescriber of any other medication must be made aware that the patient is taking metoclopramide.n nn
  • Inform patients or their caregivers that metoclopramide can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [n n n ].n nn
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. Q 8/2017
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. D 8/2017
  • No data

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