Metoclopramide 5 mg/5mL
Metoclopramide · SOLUTION · ATLANTIC BIOLOGICALS CORP.
Metoclopramide is a solution containing metoclopramide at 5 mg/5mL, taken oral. Manufactured by ATLANTIC BIOLOGICALS CORP..
Key Facts
- Brand Name
- Metoclopramide
- Generic Name
- Metoclopramide
- NDC Code (Product)
17856-1190- Manufacturer
- ATLANTIC BIOLOGICALS CORP.
- Strength
- 5 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA071402
- Marketing Start
- 05/18/2015
Recall History
VistaPharm, Inc.
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Teva Pharmaceuticals USA, Inc
Presence of foreign tablets/capsules.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
VistaPharm, Inc.
Defective Container: Product leaks when inverted.
VistaPharm, Inc.
Defective Container: Lids on unit dose cups are not fully qualified.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Hospira Inc.
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Teva Pharmaceuticals USA
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration. Symptomatic Gastroesophageal Reflux Metoclopramide Oral Solution is 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 post-prandial 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 12-week trial using doses of 15 mg 4 times daily. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric sta…
Dosage & Administration
DOSAGE AND ADMINISTRATION Therapy with metoclopramide oral solution should not exceed 12 weeks in duration. For the Relief of Symptomatic Gastroesophageal Reflux Administer from 10 mg to 15 mg metoclopramide orally up to 4 times daily 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE ). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose. Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using 4 times daily therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS ). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endos…
Warnings
WARNINGS Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks. Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benztropine mesylate, 1 …
Contraindications
CONTRAINDICATIONS 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.
Drug Interactions
Drug Interactions The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers. The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors. Absorption of drugs from the stomach may be diminished (e.g. digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine). Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.
Adverse Reactions
ADVERSE REACTIONS In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue, and lassitude occur in approximately 10% of patients receiving the most commonly prescribed dosage of 10 mg 4 times daily. (see PRECAUTIONS ). Insomnia, headache, confusion, dizziness or mental depression with suicidal ideation (see WARNINGS ) occur less frequently. The incidence of drowsiness is greater at higher doses. There are isolated reports of convulsive seizures without clearcut relationship to metoclopramide. Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, …
Frequently Asked Questions
What is Metoclopramide used for?
Metoclopramide contains Metoclopramide. It is a solution taken oral. Consult your doctor for specific uses.
Is Metoclopramide a controlled substance?
Metoclopramide is not classified as a controlled substance by the DEA.
What is the generic name for Metoclopramide?
The generic name for Metoclopramide is Metoclopramide. There are 1 other brand versions of Metoclopramide.
What is the NDC code for Metoclopramide 5 mg/5mL?
The NDC (National Drug Code) for Metoclopramide 5 mg/5mL is 17856-1190, listed by ATLANTIC BIOLOGICALS CORP..
Other Metoclopramide Dosages
- Metoclopramide10 mg/2mL76045-213
- Metoclopramide10 mg/163187-235
- Metoclopramide5 mg/5mL63629-1961
- Metoclopramide5 mg/5mL64950-344
- Metoclopramide10 mg/170518-0669
- Metoclopramide5 mg/mL0409-5255
- Metoclopramide5 mg/mL83634-779
- Metoclopramide10 mg/160687-631
- Metoclopramide5 mg/5mL62559-190
- Metoclopramide5 mg/166267-841
Other Metoclopramide Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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