Warnings
Do not use if you are on a low salt diet
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement afte use. These could be signs of a serious condition.
Do not use
Do not use if you cannot swallow without chewing
Ask a doctor before use if
-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
When using this product
-do not use within 1 hour after taking an antacid or milk
-do not chew or crush tablet(s)
-you may have stomach discomfort, faintness or cramps
Stop use and ask a doctor if
-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
-you need to use a laxative for more than 1 week
Pregnancy/Breastfeeding
ask a health professions before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use
Do not use if you cannot swallow without chewing
Ask a doctor before use if
-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
Stop use and ask a doctor if
-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
-you need to use a laxative for more than 1 week
For External Use Only
Do Not Get In Eyes
Do not use on:
Allergy alert: Do not use if you are allergic to polyethylene glycol
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Ask a doctor or pharmacist before use if you are taking a prescription drug
When using this product you may have loose, watery, more frequent stools
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 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 to 2 mg intramuscularly, may also be used to reverse these reactions.
Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide. Patients with preexisting Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking metoclopramide.
Tardive Dyskinesia (see Boxed Warnings)
Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization of patterns showed that about 20% of patients who used metoclopramide took it longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.
Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose.
Metoclopramide should be discontinued in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn.
Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, metoclopramide should not be used for the symptomatic control of TD.
Neuroleptic Malignant Syndrome (NMS)
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS).
There is currently no manufacturer warning information available for this drug.
Use for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours
Indications and Usage
A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.
Other Information
The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration.
Symptomatic Gastroesophageal Reflux
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.
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.
Metoclopramide hydrochloride 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-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:
C14H22ClN3O2 •HCl•H2O M.W. 354.3
Each tablet for oral administration contains 5 mg or 10 mg metoclopramide (present as the hydrochloride).
Inactive Ingredients
Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.