Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4294
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Metoclopramide (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 metoclopramide 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 Metoclopramide Injection, USP up to 10 days may
be required before symptoms subside, at which time oral administration
of metoclopramide may be instituted. For the Prevention
of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: For doses in excess of 10 mg, Metoclopramide Injection, USP should
be diluted in 50 mL of a parenteral solution. The preferred parenteral solution is Sodium Chloride Injection (normal
saline), which when combined with Metoclopramide Injection, USP, can
be stored frozen for up to 4 weeks. Metoclopramide Injection, USP
is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide
Injection, USP 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. For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection, USP should be given intramuscularly near
the end of surgery. The usual adult dose is 10 mg; however, doses
of 20 mg may be used. 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 to 14
years of age)-2.5 mg to 5 mg metoclopramide base; (under 6 years of
age)-0.1 mg/kg metoclopramide base. 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. 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. See OVERDOSAGE 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. It has a molecular weight
of 354.3, a molecular formula of CHClNO���HCl���HO and the following
structural formula: Metoclopramide Injection, USP (metoclopramide hydrochloride)
is a clear, colorless, sterile solution with a pH of 2.5 to 6.5 for
intravenous or intramuscular administration. This product is light sensitive. It should be inspected before use
and discarded if either color or particulate is observed. Each mL contains: metoclopramide base 5 mg (as the monohydrochloride
monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP
qs. Contains no preservative. 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 (see WARNINGS). 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 and 10 to 15 minutes following intramuscular
administration, and 30 to 60 minutes following an oral dose. Pharmacological
effects persist for 1 to 2 hours. 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 hrs 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 hrs. 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 hours.
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 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 mcg/L) higher
compared to that observed after the first dose (29 mcg/L) indicating
drug accumulation with repeated dosing. After the tenth dose, the
mean time to reach peak concentrations (2.2 hrs), half-life (4.1 hrs),
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 hrs, 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 nine pediatric cancer patients receiving
chemotherapy (mean age, 11.7 years; range, 7 to 14 yrs) for prophylaxis
of cytotoxic-induced vomiting. The metoclopramide plasma concentrations
extrapolated to time zero ranged from 65 to 395 mcg/L (mean, 152 mcg/L).
The mean elimination half-life, clearance, and volume of distribution
of metoclopramide were 4.4 hrs (range, 1.7 to 8.3 hrs), 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 yrs) 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 mcg/L.
The mean elimination half-life, clearance, and volume of distribution
of metoclopramide were 4.5 hrs (range, 2.0 to 12.5 hrs), 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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PRESERVATIVE FREE. Metoclopramide Injection, USP,
5 mg/mL metoclopramide base (present as the monohydrochloride monohydrate)
is supplied in the following: To prevent needle-stick
injuries, needles should not be recapped, purposely bent, or broken
by hand. Store at 20
to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] Protect
from light. Retain in carton until ready to use. 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. Discard unused portion. Benadryl is
a registered trademark of Warner-Lambert Company. Cogentin is a registered trademark of Merck&Co., Inc. Revised: June, 2006
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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 bediscontinued. Intravenous administration of Metoclopramide Injection, USP, 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, Mutagenesis,
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. Teratogenic Effects.
Pregnancy Category B:: Reproduction studies
performed in rats, mice, and rabbits by the IV, IM, 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 ofhuman 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 (see OVERDOSAGE and DOSAGE
AND ADMINISTRATION). Care should be exercised in administering metoclopramide to neonates
since prolonged clearance may produce excessive serum concentrations
(see CLINICAL PHARMACOLOGY���Pharmacokinetics). 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 OVERDOSAGE). 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 metoclopramide 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 metoclopramide that is effective. If parkinsonian-like symptoms
develop in a geriatric patient receiving metoclopramide, metoclopramide
should generally be discontinued before initiating any specific anti-parkinsonian
agents (see WARNINGS). The elderly may be at
greater risk for tardive dyskinesia (see WARNINGS���Tardive Dyskinesia). Sedation has been reported in metoclopramide users. Sedation may
cause confusion and manifest as over-sedation in elderly (see CLINICAL PHARMACOLOGY, PRECAUTIONS���Information for Patients and ADVERSE REACTIONS���CNS Effects). Metoclopramide 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 (see USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT). 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 (see OVERDOSAGE).
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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 metoclopramide 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 mg/kg/day 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 PRECAUTIONS���Other Special Populations).
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Metoclopramide hydrochloride
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Metoclopramide (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. CNS Effects: Restlessness, drowsiness,
fatigue and lassitude may occur in patients receiving the recommended
prescribed dose of metoclopramide injection. Insomnia, headache, confusion,
dizziness or mental depression with suicidal ideation also may occur
(see WARNINGS). 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 a clear-cut 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 mg 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 due to laryngospasm; ordinarily
these symptoms are readily reversed by diphenhydramine (see WARNINGS). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel
rigidity, mask-like facies (see WARNINGS). 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 WARNINGS). 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. 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
(see WARNINGS). Endocrine Disturbances: Galactorrhea,
amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia
(see PRECAUTIONS). Fluid
retention secondary to transient elevation of aldosterone (see CLINICAL PHARMACOLOGY). Cardiovascular: Hypotension, hypertension,
supraventricular tachycardia, bradycardia, fluid retention, acute
congestive heart failure, and possible atrioventricular (AV) block
(see CONTRAINDICATIONS and PRECAUTIONS). Gastrointestinal: Nausea and bowel disturbances,
primarily diarrhea. 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. Renal: Urinary frequency and incontinence. Hematologic: A few cases of neutropenia,
leukopenia, or agranulocytosis, generally without a clear-cut relationship
to metoclopramide. Methemoglobinemia in adults and especially with
overdosage in neonates (see OVERDOSAGE). Sulfhemoglobinemia
in adults. 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. 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 mg/day 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
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 mg 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: 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. 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 autonomicinstability (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).
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Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide Injection, USP is indicated for the relief of symptoms
associated with acute and recurrent diabetic gastric stasis. The Prevention of Nausea and Vomiting Associated
with Emetogenic Cancer Chemotherapy. Metoclopramide Injection,
USP is indicated for the prophylaxis of vomiting associated with emetogenic
cancer chemotherapy. The Prevention
of Postoperative Nausea and Vomiting. Metoclopramide Injection,
USP is indicated for the prophylaxis of postoperative nausea and vomiting
in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation. Metoclopramide
Injection, USP 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. Radiological
Examination. Metoclopramide Injection, USP 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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Metoclopramide
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