Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/829
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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 bestored 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 dacarbazineare 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���14 years of age)���2.5 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 clearanceis 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. ADMIXTURE COMPATIBILITIES Metoclopramide Injection,
USP is compatible for mixing and injection with the following dosage
forms to the extent indicated below: Physically and Chemically Compatible Up to 48 Hours Cimetidine Hydrochloride
(SK&F), Mannitol, USP (Hospira), Potassium Acetate, USP (Invenex),
Potassium Phosphate, USP (Invenex). Physically Compatible Up to 48 Hours Ascorbic Acid, USP (Hospira), Benztropine Mesylate, USP
(MS&D), Cytarabine, USP (Upjohn), Dexamethasone Sodium Phosphate,
USP (Baxter, MS&D), Diphenhydramine Hydrochloride, USP (Parke-Davis),
Doxorubicin Hydrochloride, USP (Adria), Heparin Sodium, USP (Baxter),
Hydrocortisone Sodium Phosphate (MS&D), Lidocaine Hydrochloride,
USP (Baxter), Multi-Vitamin Infusion (must be refrigerated-USV), Vitamin
B Complex with Ascorbic Acid (Roche). Physically Compatible Up to 24 Hours (Do not use if precipitation occurs) Clindamycin Phosphate, USP (Upjohn), Cyclophosphamide,
USP (Mead-Johnson), Insulin, USP (Lilly). Conditionally Compatible(Use within one hour after mixing or may
be infused directly into the same running I.V. line) Ampicillin Sodium, USP (Bristol), Cisplatin (Bristol),
Erythromycin Lactobionate, USP (Hospira), Methotrexate Sodium, USP
(Lederle), Penicillin G Potassium, USP (Squibb), Tetracycline Hydrochloride,
USP (Lederle). Incompatible (Do Not Mix) Cephalothin Sodium, USP (Lilly), Chloramphenicol Sodium,
USP (Parke-Davis), Sodium Bicarbonate, USP (Hospira).
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Metoclopramide hydrochloride is a white or practically
white, crystalline, odorless or practically odorless powder. It is
very soluble in water, freely soluble in alcohol, sparingly soluble
in chloroform, practically insoluble in ether. Chemically it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide
monohydrochloride monohydrate. It has the following structural formula: Molecular formula: CHClNO���HCl���HO Metoclopramide Injection, USP is a sterile,
nonpyrogenic solution of metoclopramide hydrochloride in water for
injection. Each milliliter contains metoclopramide base 5 mg (as the
monohydrochloride monohydrate); 8.5 mg sodium chloride. May contain
hydrochloric acid and/or sodium hydroxide for pH adjustment; pH 4.4
(2.5 to 6.5). The solution contains no bacteriostat,
antimicrobial agent or added buffer and is intended for use only as
a single-dose injection. When smaller doses are required, the unused
portion should be discarded. This product is
light sensitive. It should be inspected before use and discarded if
either color or particulate is observed. Metoclopramide
Injection is intended for intravenous or intramuscular administration.
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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, 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. Linearkinetic 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 hrs. 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 downwardof 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: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Protect from
light by retaining in package until time of use. This product is light sensitive. It should be inspected before use
and discarded if either color or particulate is observed. Do not store open single-dose vials or ampuls for later
use, as they contain no preservative. Discard unused portion. Benadryl is a registered trademark of
Warner-Lambert Company. Cogentin is a registered trademark of Merck&Co., Inc. Revised: October, 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 be discontinued. 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 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
(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 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 and 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
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, and 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���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, inject50 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 pre-existing
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 autonomic
instability (irregular pulse or blood pressure, tachycardia, diaphoresis
and cardiac arrhythmias). The diagnostic evaluation
of patients with this syndrome is complicated. In arriving at a diagnosis,
it is important to identify cases where the clinical presentation
includes both serious medical illness (e.g., pneumonia, systemic infection,
etc.) and untreated or inadequately treated extrapyramidal signs and
symptoms (EPS). Other important considerations in the differential
diagnosis include central anticholinergic toxicity, heat stroke, malignant
hyperthermia, drug fever and primary central nervous system (CNS)
pathology. The management of NMS should include
1) immediate discontinuation of metoclopramide and other drugs not
essential to concurrent therapy, 2) intensive symptomatic treatment
and medical monitoring, and 3) treatment of any concomitant serious
medical problems for which specific treatments are available. Bromocriptine
and dantrolene sodium have been used in treatment of NMS, but their
effectiveness have not been established (see ADVERSE REACTIONS).
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Diabetic Gastroparesis (Diabetic Gastric Stasis). Metoclopramide
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 intestinaltransit 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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