Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2445
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Reglan (Injection, Solution)
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For the Relief of
Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric
Stasis): If only the
earliest manifestations of diabetic gastric stasis are present,
oral administration of metoclopramide may be initiated. However,
if severe symptoms are present, therapy should begin with REGLAN
Injection (IM or IV). Doses of 10 mg may be administered slowly
by the intravenous route over a 1- to 2-minute period. Administration of REGLAN Injection (metoclopramide injection,
USP) up to 10 days may be required before symptoms subside, at
which time oral administration of metoclopramide may be
instituted.<br/>For the Prevention
of Nausea and Vomiting Associated with Emetogenic Cancer
Chemotherapy: For doses
in excess of 10 mg, REGLAN Injection should be diluted in 50 mL
of a parenteral solution. The
preferred parenteral solution is Sodium Chloride Injection
(normal saline), which when combined with REGLAN Injection, can
be stored frozen for up to 4 weeks. REGLAN Injection is degraded
when admixed and frozen with Dextrose-5% in Water. REGLAN
Injection diluted in Sodium Chloride Injection, Dextrose-5% in
Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer's Injection,
or Lactated Ringer's Injection may be stored up to 48 hours
(without freezing) after preparation if protected from light.
All dilutions may be stored unprotected from light under normal
light conditions up to 24 hours after preparation. Intravenous
infusions should be made slowly over a period of not less than
15 minutes, 30 minutes before beginning cancer chemotherapy and
repeated every 2 hours for two doses, then every 3 hours for
three doses. The initial
two doses should be 2 mg/kg if highly emetogenic drugs such as
cisplatin or dacarbazine are used alone or in combination. For
less emetogenic regimens, 1 mg/kg per dose may be adequate. If
extrapyramidal symptoms should occur, inject 50 mg
Benadryl (diphenhydramine hydrochloride)
intramuscularly, and EPS usually will subside.<br/>For the Prevention
of Postoperative Nausea and Vomiting: REGLAN
Injection should be given intramuscularly near the end of
surgery. The usual adult dose is 10 mg; however, doses of 20 mg
may be used.<br/>To Facilitate Small
Bowel Intubation: If the tube
has not passed the pylorus with conventional maneuvers in 10
minutes, a single dose (undiluted) may be administered slowly by
the intravenous route over a 1- to 2-minute period. The
recommended single dose is: Pediatric patients above 14 years of
age and adults���10 mg metoclopramide base. Pediatric patients
(6-14 years of age)���2.5 to 5 mg metoclopramide base; (under 6
years of age)���0.1 mg/kg metoclopramide base.<br/>To Aid in
Radiological Examinations: In patients
where delayed gastric emptying interferes with radiological
examination of the stomach and/or small intestine, a single dose
may be administered slowly by the intravenous route over a 1- to
2-minute period. For dosage,
see intubation above.<br/>Use in Patients
With Renal or Hepatic Impairment: Since
metoclopramide is excreted principally through the kidneys, in
those patients whose creatinine clearance is below 40 mL/min,
therapy should be initiated at approximately one-half the
recommended dosage. Depending upon clinical efficacy and safety
considerations, the dosage may be increased or decreased as
appropriate. SeeOVERDOSAGE 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. NOTE: Parenteral drug products
should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and
container permit.
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Metoclopramide
hydrochloride is a white crystalline, odorless substance, freely soluble
in water. Chemically, it is
4���amino-5-chloro���N���[2���(diethylamino)ethyl]���2���methoxy benzamide
monohydrochloride monohydrate. Molecular weight: 354.3. CHClNO��HCl��HO REGLAN Injection
(metoclopramide injection, USP) is a clear, colorless, sterile solution
with a pH of 4.5-6.5 for intravenous (IV) or intramuscular (IM)
administration. This product is
light sensitive. It should be inspected before use and discarded if
either color or particulate is observed. 2 mL single dose
vials; 10 mL and 30 mL single dose vials Each 1 mL contains:
Metoclopramide base 5 mg (as the monohydrochloride monohydrate) Sodium
Chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when
necessary, with hydrochloric acid and/or sodium hydroxide.
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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 . 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.<br/>Pharmacokinetics: Metoclopramide is rapidly and well absorbed. Relative to an
intravenous dose of 20 mg, the absolute oral bioavailability of
metoclopramide is 80%��15.5% as demonstrated in a crossover
study of 18 subjects. Peak plasma concentrations occur at about
1-2 hr after a single oral dose. Similar time to peak is
observed after individual doses at steady state. In a single
dose study of 12 subjects, the area under the drug
concentration-time curve increases linearly with doses from 20
to 100 mg. Peak concentrations increase linearly with dose; time
to peak concentrations remains the same; whole body clearance is
unchanged; and the elimination rate remains the same. The
average elimination half-life in individuals with normal renal
function is 5���6 hr. Linear kinetic processes adequately describe
the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally
administered dose appears in the urine within 72 hr. Of the 85%
eliminated in the urine, about half is present as free or
conjugated metoclopramide. The drug is
not extensively bound to plasma proteins (about 30%). The whole
body volume of distribution is high (about 3.5 L/kg) which
suggests extensive distribution of drug to the tissues. Renal
impairment affects the clearance of metoclopramide. In a study
with patients with varying degrees of renal impairment, a
reduction in creatinine clearance was correlated with a
reduction in plasma clearance, renal clearance, non-renal
clearance, and increase in elimination half-life. The kinetics
of metoclopramide in the presence of renal impairment remained
linear however. The reduction in clearance as a result of renal
impairment suggests that adjustment downward of maintenance
dosage should be done to avoid drug accumulation. In
pediatric patients, the pharmacodynamics of metoclopramide
following oral and intravenous administration are highly
variable and a concentration-effect relationship has not been
established. There are
insufficient reliable data to conclude whether the
pharmacokinetics of metoclopramide in adults and the pediatric
population are similar. Although there are insufficient data to
support the efficacy of metoclopramide in pediatric patients with symptomatic gastroesophageal reflux (GER) or cancer
chemotherapy-related nausea and vomiting, its pharmacokinetics
have been studied in these patient populations. In an
open-label study, six pediatric patients (age range, 3.5 weeks
to 5.4 months) with GER received a metoclopramide 0.15 mg/kg
oral solution every 6 hours for 10 doses. The mean peak plasma
concentration of metoclopramide after the tenth dose was 2���fold
(56.8��g/L) higher compared to that observed after the first
dose (29��g/L) indicating drug accumulation with repeated
dosing. After the tenth dose, the mean time to reach peak
concentrations (2.2 hr), half-life (4.1 hr), clearance
(0.67 L/h/kg), and volume of distribution (4.4 L/kg) of
metoclopramide were similar to those observed after the first
dose. In the youngest patient (age, 3.5 weeks), metoclopramide
half-life after the first and the tenth dose (23.1 and 10.3 hr,
respectively) was significantly longer compared to other infants
due to reduced clearance. This may be attributed to immature
hepatic and renal systems at birth. Single
intravenous doses of metoclopramide 0.22 to 0.46 mg/kg (mean,
0.35 mg/kg) were administered over 5 minutes to 9 pediatric
cancer patients receiving chemotherapy (mean age, 11.7 years;
range, 7 to 14 yr) for prophylaxis of cytotoxic-induced
vomiting. The metoclopramide plasma concentrations extrapolated
to time zero ranged from 65 to 395��g/L (mean, 152��g/L). The
mean elimination half-life, clearance, and volume of
distribution of metoclopramide were 4.4 hr (range, 1.7 to
8.3 hr), 0.56 L/h/kg (range, 0.12 to 1.20 L/h/kg), and 3.0 L/kg
(range, 1.0 to 4.8 L/kg), respectively. In another
study, nine pediatric cancer patients (age range, 1 to 9 yr)
received 4 to 5 intravenous infusions (over 30 minutes) of
metoclopramide at a dose of 2 mg/kg to control emesis. After the
last dose, the peak serum concentrations of metoclopramide
ranged from 1060 to 5680��g/L. The mean elimination half-life,
clearance, and volume of distribution of metoclopramide were
4.5 hr (range, 2.0 to 12.5 hr), 0.37 L/h/kg (range, 0.10 to
1.24 L/h/kg), and 1.93 L/kg (range, 0.95 to 5.50 L/kg),
respectively.
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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.
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REGLAN Injection
(metoclopramide injection, USP) 5 mg metoclopramide base (as the
monohydrochloride monohydrate) per mL; available in: 2 mL single dose
vials in cartons of 25 (NDC 60977-451-01), 10 mL single dose
vials in cartons of 25 (NDC 60977-451-02), 30 mL single dose
vials in cartons of 25 (NDC 60977-451-03). Store vials in
carton until used. Do not store open single dose vials for later use, as
they contain no preservative. This product is
light sensitive. It should be inspected before use and discarded if
either color or particulate is observed. Dilutions may be stored unprotected from light
under normal light conditions up to 24 hours after
preparation. REGLAN Injection should be stored at
Controlled Room Temperature, 20��-25��C (68��-77��F) [see USP Controlled Room
Temperature]. Reglan is a
registered trademark of Schwartz Pharma, Inc. Manufactured by Baxter Healthcare Corporation Deerfield, IL 60015
USA For Product Inquiry
1 800 ANA DRUG (1-800-262-3784) MLT-23/2.0
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General: In one
study in hypertensive patients, intravenously administered
metoclopramide was shown to release catecholamines; hence,
caution should be exercised when metoclopramide is used in
patients with hypertension. Intravenous
injections of undiluted metoclopramide should be made slowly
allowing 1 to 2 minutes for 10 mg since a transient but intense
feeling of anxiety and restlessness, followed by drowsiness, may
occur with rapid administration. 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. Intravenous
administration of REGLAN Injection diluted in a parenteral
solution should be made slowly over a period of not less than 15
minutes. Giving a
promotility drug such as metoclopramide theoretically could put
increased pressure on suture lines following a gut anastomosis
or closure. This possibility should be considered and weighed
when deciding whether to use metoclopramide or nasogastric
suction in the prevention of postoperative nausea and
vomiting.<br/>Information for
Patients: Metoclopramide may impair the mental and/or physical abilities
required for the performance of hazardous tasks such as
operating machinery or driving a motor vehicle. The ambulatory
patient should be cautioned accordingly.<br/>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.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: A 77���week
study was conducted in rats with oral doses up to about 40 times
the maximum recommended human daily dose. Metoclopramide
elevates prolactin levels and the elevation persists during
chronic administration. Tissue culture experiments indicate that
approximately one-third of human breast cancers are
prolactin-dependent in
vitro, a factor of potential importance if the
prescription of metoclopramide is contemplated in a patient with
previously detected breast cancer. Although disturbances such as
galactorrhea, amenorrhea, gynecomastia, and impotence have been
reported with prolactin-elevating drugs, the clinical
significance of elevated serum prolactin levels is unknown for
most patients. An increase in mammary neoplasms has been found
in rodents after chronic administration of prolactin-stimulating
neuroleptic drugs and metoclopramide. Neither clinical studies
nor epidemiologic studies conducted to date, however, have shown
an association between chronic administration of these drugs and
mammary tumorigenesis; the available evidence is too limited to
be conclusive at this time. An Ames
mutagenicity test performed on metoclopramide was
negative.<br/>Pregnancy Category
B: Reproduction studies performed in rats, mice and rabbits by the
IM, IV, subcutaneous (SC), and oral routes at maximum levels
ranging from 12 to 250 times the human dose have demonstrated no
impairment of fertility or significant harm to the fetus due to
metoclopramide. There are, however, no adequate and
well-controlled studies in pregnant women. Because animal
reproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if
clearly needed.<br/>Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be
exercised when metoclopramide is administered to a nursing
mother.<br/>Pediatric Use: Safety and
effectiveness in pediatric patients have not been established
except as stated to facilitate small bowel intubation (seeOVERDOSAGE and DOSAGE
AND ADMINISTRATION). Care should
be exercised in administering metoclopramide to neonates since prolonged clearance may produce excessive serum concentrations
. In addition, neonates have reduced levels of
NADH-cytochrome breductase which, in combination
with the aforementioned pharmacokinetic factors, make neonates
more susceptible to methemoglobinemia . 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 WARNINGS and ADVERSE
REACTIONS���Extrapyramidal Reactions.)<br/>Geriatric Use: Clinical
studies of REGLAN did not include sufficient numbers of subjects
aged 65 and over to determine whether elderly subjects respond
differently from younger subjects. The risk of
developing parkinsonian-like side effects increases with
ascending dose. Geriatric patients should receive the lowest
dose of REGLAN that is effective. If parkinsonian-like symptoms
develop in a geriatric patient receiving REGLAN, REGLAN should
generally be discontinued before initiating any specific
anti-parkinsonian agents . The elderly
may be at greater risk for tardive dyskinesia . Sedation
has been reported in REGLAN users. Sedation may cause confusion
and manifest as over-sedation in elderly (see CLINICAL PHARMACOLOGY, PRECAUTIONS���Information for
Patientsand ADVERSE
REACTIONS���CNS Effects). REGLAN 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 DOSAGE
AND ADMINISTRATION - Use in Patients With Renal or
Hepatic Impairment). 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 (seeUse in Patients With Renal or Hepatic Impairment).<br/>Other Special
Populations: Patients
with NADH-cytochrome breductase deficiency are at
an increased risk of developing methemoglobinemia and/or
sulfhemoglobinemia when metoclopramide is administered. In
patients with G6PD deficiency who experience
metoclopramide-induced methemoglobinemia, methylene blue
treatment is not recommended .
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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 REGLAN syrup. While there was no consistent
pattern to the reports associated with these overdoses, events included
seizures, extrapyramidal reactions, and lethargy. Methemoglobinemia
has occurred in premature and full-term neonates who were given
overdoses of metoclopramide (1���4 mg/kg/day orally, intramuscularly or
intravenously for 1���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 PRECAUTIONS���Other Special Populations).
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Metoclopramide hydrochloride
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Reglan (Injection, Solution)
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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:<br/>CNS Effects: Restlessness, drowsiness, fatigue, and lassitude may occur in
patients receiving the recommended prescribed dosage of REGLAN
Injection. Insomnia, headache, confusion, dizziness, or mental
depression with suicidal ideation also may occur . In cancer chemotherapy patients being treated with
1-2 mg/kg per dose, incidence of drowsiness is about 70%. There
are isolated reports of convulsive seizures without clear-cut
relationship to metoclopramide. Rarely, hallucinations have been
reported.<br/>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.
In cancer chemotherapy patients receiving 1���2 mg/kg per dose,
the incidence is 2% in patients over the ages of 30���35, and 25%
or higher in pediatric patients and adult patients less than 30
years of age who have not had prophylactic administration of
diphenhydramine. 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, stridor and
dyspnea possibly dueto laryngospasm; ordinarily these symptoms
are readily reversed by diphenhydramine . Parkinsonian-like symptoms may include bradykinesia, tremor,
cogwheel rigidity, mask-like facies . 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 . 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.<br/>Neuroleptic
Malignant Syndrome: Rare
occurrences of neuroleptic malignant syndrome (NMS) have been
reported. This potentially fatal syndrome is comprised of the
symptom complex of hyperthermia, muscular rigidity, altered
consciousness, and autonomic instability .<br/>Endocrine
Disturbances: Galactorrhea, amenorrhea, gynecomastia, impotence secondary to
hyperprolactinemia . Fluid retention secondary to transient elevation of
aldosterone .<br/>Cardiovascular: Hypotension, hypertension, supraventricular tachycardia,
bradycardia, fluid retention, acute congestive heart failure and
possible atrioventricular (AV) block .<br/>Gastrointestinal: Nausea and
bowel disturbances, primarily diarrhea.<br/>Hepatic: Rarely,
cases of hepatotoxicity, characterized by such findings as
jaundice and altered liver function tests, when metoclopramide
was administered with other drugs with known hepatotoxic
potential.<br/>Renal: Urinary
frequency and incontinence.<br/>Hematologic: A few cases
of neutropenia, leukopenia, or agranulocytosis, generally
without clear-cut relationship to metoclopramide.
Methemoglobinemia in adults and especially with overdosage in
neonates . Sulfhemoglobinemia in adults.<br/>Allergic Reactions: A few cases
of rash, urticaria, or bronchospasm, especially in patients with
a history of asthma. Rarely, angioneurotic edema, including
glossal or laryngeal edema.<br/>Miscellaneous: Visual
disturbances. Porphyria. Transient
flushing of the face and upper body, without alterations in
vital signs, following high doses intravenously.
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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���40 mg/day of metoclopramide. These usually are seen during the first
24���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 used in prophylaxis of vomiting due to cancer chemotherapy. 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 Benadryl
(diphenhydramine hydrochloride) intramuscularly, and they usually will
subside. Cogentin (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���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.<br/>Tardive Dyskinesia: Tardive
dyskinesia, a syndrome consisting of potentially irreversible,
involuntary, dyskinetic movements, may develop in patients
treated with metoclopramide. Although the prevalence of the
syndrome appears to be highest among the elderly, especially
elderly women, it is impossible to predict which patients are
likely to develop the syndrome. Both the risk of developing the
syndrome and the likelihood that it will become irreversible are
believed to increase with the duration of treatment and the
total cumulative dose. Less
commonly, the syndrome can develop after relatively brief
treatment periods at low doses; in these cases, symptoms appear
more likely to be reversible. There is no
known treatment for established cases of tardive dyskinesia
although the syndrome may remit, partially or completely, within
several weeks-to-months after metoclopramide is withdrawn.
Metoclopramide itself, however, may suppress (or partially
suppress) the signs of tardive dyskinesia, thereby masking the
underlying disease process. The effect of this symptomatic
suppression upon the long-term course of the syndrome is
unknown. Therefore, the use of metoclopramide for the
symptomatic control of tardive dyskinesia is not
recommended.<br/>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 (seeADVERSE
REACTIONS).
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Diabetic
Gastroparesis (Diabetic Gastric Stasis): REGLAN
(metoclopramide hydrochloride, USP) is indicated for the relief
of symptoms associated with acute and recurrent diabetic gastric
stasis.<br/>The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: REGLAN
Injection is indicated for the prophylaxis of vomiting
associated with emetogenic cancer chemotherapy.<br/>The Prevention of
Postoperative Nausea and Vomiting: REGLAN
Injection is indicated for the prophylaxis of postoperative
nausea and vomiting in those circumstances where nasogastric
suction is undesirable.<br/>Small Bowel
Intubation: REGLAN Injection may be used to facilitate small bowel intubation in
adults and pediatric patients in whom the tube does not pass the
pylorus with conventional maneuvers.<br/>Radiological
Examination: REGLAN
Injection may be used to stimulate gastric emptying and
intestinal transit of barium in cases where delayed emptying
interferes with radiological examination of the stomach and/or
small intestine.
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Reglan
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