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Metoclopramide
Overview
What is Metoclopramide?
For oral
administration, Metoclopramide tablets, USP 10 mg are white to off
white, capsule shaped, biconvex tablets with "RF11" embossed on one
side and score line on the other side.
Each tablet contains:
10 mg of metoclopramide base as metoclopramide hydrochloride USP
What does Metoclopramide look like?
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What are the available doses of Metoclopramide?
Sorry No records found.
What should I talk to my health care provider before I take Metoclopramide?
Sorry No records found
How should I use Metoclopramide?
The use of metoclopramide tablets is
recommended for adults only. Therapy should not exceed 12 weeks in
duration.
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.
Therapy with metoclopramide tablets should
not exceed 12 weeks in duration.
Experience with esophageal erosions and ulcerations is limited, but healing
has thus far been documented in one controlled trial using q.i.d. therapy at 15
mg/dose, and this regimen should be used when lesions are present, so long as it
is tolerated (see Because of the poor correlation between symptoms and endoscopic
appearance of the esophagus, therapy directed at esophageal lesions is best
guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be
recommended.
The initial route of administration should be determined by the severity of
the presenting symptoms. If only the earliest manifestations of diabetic gastric
stasis are present, oral administration of metoclopramide tablets may be
initiated. However, if severe symptoms are present, therapy should begin with
metoclopramide injection (consult labeling of the injection prior to initiating
parenteral administration).
Administration of metoclopramide injection up to 10 days may be required
before symptoms subside, at which time oral administration may be instituted.
Since diabetic gastric stasis is frequently recurrent, metoclopramide tablets
therapy should be reinstituted at the earliest manifestation.
See section for
information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple
conjugation. Its safe use has been described in patients with advanced liver
disease whose renal function was normal.
What interacts with Metoclopramide?
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.
What are the warnings of Metoclopramide?
FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.
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.
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 or
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.
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 dantroline sodium have been used in treatment of
NMS, but their effectiveness have not been established (see
What are the precautions of Metoclopramide?
Array
Because metoclopramide produces a transient increase in plasma aldosterone,
certain patients, especially those with cirrhosis or congestive heart failure,
may be at risk of developing fluid retention and volume overload. If these side
effects occur at any time during metoclopramide therapy, the drug should be
discontinued.
Adverse reactions, especially those involving the nervous system, may occur
after stopping the use of metoclopramide tablets. A small number of patients may
experience a withdrawal period after stopping metoclopramide tablets that could
include dizziness, nervousness and/or headaches.
Array
For additional information, patients should be instructed to see the
Medication Guide for Metoclopramide tablets.
Array
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.
in vitro
An Ames mutagenicity test performed on metoclopramide was negative.
Array
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OVERDOSAGE
Care should be exercised in administering metoclopramide to neonates since
prolonged clearance may produce excessive serum concentrations (see In addition, neonates have reduced levels of NADH-cytochrome breductase which, in combination with the aforementioned
pharmacokinetic factors, make neonates more susceptible to methemoglobinemia
(see
The safety profile of metoclopramide in adults cannot be extrapolated to
pediatric patients. Dystonias and other extrapyramidal reactions associated with
metoclopramide are more common in the pediatric population than in adults. (See
and
Array
The risk of developing parkinsonian–like side effects increases with
ascending dose. Geriatric patients should receive the lowest dose of
metoclopramide tablets that is effective. If parkinsonian like symptoms develop
in a geriatric patient receiving metoclopramide tablets, metoclopramide tablets,
should generally be discontinued before initiating any specific
anti-parkinsonian agentssee and
The elderly may be at greater risk for tardive dyskinesia (see
Sedation has been reported in metoclopramide tablets users. Sedation may
cause confusion and manifest as over-sedation in the elderly (see and
Metoclopramide tablets is known to be substantially excreted by the kidney
and the risk of toxic reactions to this drug may be greater in patients with
impaired renal function (see
For these reasons, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased renal function, concomitant disease, or other drug
therapy in the elderly (see and
OVERDOSAGE
What are the side effects of Metoclopramide?
Array
WARNINGS
Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel
rigidity, mask-like facies (see
Tardive dyskinesia most frequently is characterized by involuntary movements
of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of
the trunk and/or extremities; movements may be choreoathetotic in appearance.
(see
Motor restlessness (akathisia) may consist of feelings of anxiety, agitation,
jitteriness, and insomnia, as well as inability to sit still, pacing, foot
tapping. These symptoms may disappear spontaneously or respond to a reduction in
dosage.
WARNINGS
Array
Array
Array
OVERDOSAGE
Array
Array
What should I look out for while using Metoclopramide?
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.
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.
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 or
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.
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 dantroline sodium have been used in treatment of
NMS, but their effectiveness have not been established (see
What might happen if I take too much Metoclopramide?
Symptoms of
overdosage may include drowsiness, disorientation and extrapyramidal
reactions. Anticholinergic or antiparkinson drugs or antihistamines
with anticholinergic properties may be helpful in controlling the
extrapyramidal reactions. Symptoms are self-limiting and usually
disappear within 24 hours.
Hemodialysis
removes relatively little metoclopramide, probably because of the small
amount of the drug in blood relative to tissues. Similarly, continuous
ambulatory peritoneal dialysis does not remove significant amounts of
drug. It is unlikely that dosage would need to be adjusted to
compensate for losses through dialysis. Dialysis is not likely to be an
effective method of drug removal in overdose situations.
Unintentional
overdose due to misadministration has been reported in infants and
children with the use of metoclopramide oral solution. While there was
no consistent pattern to the reports associated with these overdoses,
events included seizures, extra pyramidal reactions, and lethargy.
Methemoglobinemia
has occurred in premature and full-term neonates who were given
overdoses of metoclopramide (1 to 4 mg/kg/day orally, intramuscularly
or intravenously for 1 to 3 or more days). Methemoglobinemia can be
reversed by the intravenous administration of methylene blue. However,
methylene blue may cause hemolytic anemia in patients with G6PD
deficiency, which may be fatal (see
How should I store and handle Metoclopramide?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:Each white to off white, capsule shaped biconvex metoclopramide tablets, USP with "RF11" embossed on one side & score line on the other side contains 10 mg of metoclopramide base as metoclopramide hydrochloride USP. Available in:Dispense tablets in tight, light-resistant container.Store between 20° and 25°C (68° and 77°F) [See USP Controlled Room Temperature].Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Manufactured for:Ranbaxy Pharmaceuticals Inc.Jacksonville, FL 32257 USA.by: Ipca Laboratories Limited48, Kandivli Ind. Estate,Mumbai 400 067, India.To obtain the Medication Guide online please visit www.ranbaxyusa.com.October 2009Relabeling and Repackaging by:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Metoclopramide
stimulates motility of the upper gastrointestinal tract without
stimulating gastric, biliary, or pancreatic secretions. Its mode of
action is unclear. It seems to sensitize tissues to the action of
acetylcholine. The effect of metoclopramide on motility is not
dependent on intact vagal innervation, but it can be abolished by
anticholinergic drugs.
Metoclopramide
increases the tone and amplitude of gastric (especially antral)
contractions, relaxes the pyloric sphincter and the duodenal bulb, and
increases peristalsis of the duodenum and jejunum resulting in
accelerated gastric emptying and intestinal transit. It increases the
resting tone of the lower esophageal sphincter. It has little, if any,
effect on the motility of the colon or gallbladder.
In
patients with gastroesophageal reflux and low LESP (lower esophageal
sphincter pressure), single oral doses of metoclopramide produce
dose-related increases in LESP. Effects begin at about 5 mg and
increase through 20 mg (the largest dose tested). The increase in LESP
from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts between
2 and 3 hours. Increased rate of stomach emptying has been observed
with single oral doses of 10 mg.
The
antiemetic properties of metoclopramide appear to be a result of its
antagonism of central and peripheral dopamine receptors. Dopamine
produces nausea and vomiting by stimulation of the medullary
chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation
of the CTZ by agents like l-dopa or apomorphine, which are known to
increase dopamine levels or to possess dopamine-like effects.
Metoclopramide also abolishes the slowing of gastric emptying caused by
apomorphine.
Like the
phenothiazines and related drugs, which are also dopamine antagonists,
metoclopramide produces sedation and may produce extrapyramidal
reactions, although these are comparatively rare (see Metoclopramide
inhibits the central and peripheral effects of apomorphine, induces
release of prolactin and causes a transient increase in circulating
aldosterone levels, which may be associated with transient fluid
retention.
The onset
of pharmacological action of metoclopramide is 1 to 3 minutes following
an intravenous dose, 10 to 15 minutes following intramuscular
administration, and 30 to 60 minutes following an oral dose;
pharmacological effects persist for 1 to 2 hours.
Non-Clinical Toxicology
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.
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.
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 or 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.
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 dantroline sodium have been used in treatment of NMS, but their effectiveness have not been established (see
Sulfacetamide preparations are incompatible with silver preparations.
Because metoclopramide produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. If these side effects occur at any time during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of metoclopramide tablets. A small number of patients may experience a withdrawal period after stopping metoclopramide tablets that could include dizziness, nervousness and/or headaches.
For additional information, patients should be instructed to see the Medication Guide for Metoclopramide tablets.
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.
in vitro
An Ames mutagenicity test performed on metoclopramide was negative.
OVERDOSAGE
Care should be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations (see In addition, neonates have reduced levels of NADH-cytochrome breductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia (see
The safety profile of metoclopramide in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric population than in adults. (See and
The risk of developing parkinsonian–like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of metoclopramide tablets that is effective. If parkinsonian like symptoms develop in a geriatric patient receiving metoclopramide tablets, metoclopramide tablets, should generally be discontinued before initiating any specific anti-parkinsonian agentssee and
The elderly may be at greater risk for tardive dyskinesia (see
Sedation has been reported in metoclopramide tablets users. Sedation may cause confusion and manifest as over-sedation in the elderly (see and
Metoclopramide tablets is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see
For these reasons, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy in the elderly (see and
OVERDOSAGE
WARNINGS
Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see
Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance. (see
Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage.
WARNINGS
OVERDOSAGE
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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