reglan
®
tablets (metoclopramide tablets, USP)
Rx Only
WARNING: TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious
movement disorder that is often irreversible. The risk of developing tardive
dyskinesia increases with duration of treatment and total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or
symptoms of tardive dyskinesia. There is no known treatment for tardive
dyskinesia. In some patients, symptoms may lessen or resolve after
metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in
all but rare cases where therapeutic benefit is thought to outweigh the risk of
developing tardive dyskinesia.
See WARNINGS
DESCRIPTION
For oral administration, reglan
®
tablets (metoclopramide tablets, USP) 10 mg are white,
scored, capsule-shaped tablets engraved “REGLAN” on one side and “ANI 10” on the
opposite side.
Each tablet contains:
Metoclopramide base .................................................. 10 mg
(as the monohydrochloride monohydrate)
Inactive Ingredients
Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Stearic Acid.
reglan
®
tablets (metoclopramide tablets, USP) 5 mg are green, elliptical-shaped tablets
engraved “REGLAN” over “5” on one side and “ANI” on the opposite side.
Each tablet contains:
Metoclopramide base .................................................... 5 mg
(as the monohydrochloride monohydrate)
Inactive Ingredients
Corn starch, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, Lactose,
Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid.
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
Reference ID: 3018416
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
benzamide monohydrochloride monohydrate. Its molecular formula is
C
14
H
22
ClN
3
O
2
•HCl•H
2
O. Its molecular weight is 354.3.
CLINICAL PHARMACOLOGY
Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating
gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to
sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility
is not dependent on intact vagal innervation, but it can be abolished by anticholinergic
drugs.
Metoclopramide increases the tone and amplitude of gastric (especially antral)
contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis
of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal
transit. It increases the resting tone of the lower esophageal sphincter. It has little, if any,
effect on the motility of the colon or gallbladder.
In patients with gastroesophageal reflux and low LESP (lower esophageal sphincter
pressure), single oral doses of metoclopramide produce dose-related increases in LESP.
Effects begin at about 5 mg and increase through 20 mg (the largest dose tested). The
increase in LESP from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts
between 2 and 3 hours. Increased rate of stomach emptying has been observed with
single oral doses of 10 mg.
The antiemetic properties of metoclopramide appear to be a result of its antagonism of
central and peripheral dopamine receptors. Dopamine produces nausea and vomiting by
stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide
blocks stimulation of the CTZ by agents like l-dopa or apomorphine which are known to
increase dopamine levels or to possess dopamine-like effects. Metoclopramide also
abolishes the slowing of gastric emptying caused by apomorphine.
Like the phenothiazines and related drugs, which are also dopamine antagonists,
metoclopramide produces sedation and may produce extrapyramidal reactions, although
these are comparatively rare (see 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.
Reference ID: 3018416
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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 to 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 to 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.
Adult Pharmacokinetic Data
Parameter Value
Vd (L/kg) ~ 3.5
Plasma Protein Binding ~ 30%
t
1/2
(hr) 5 to 6
Oral Bioavailability 80%±15.5%
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.
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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
μg/L) higher compared to that observed after the first dose (29 μg/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
μg/L (mean, 152 μg/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 μg/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.
INDICATIONS AND USAGE
The use of reglan
®
tablets is recommended for adults only. Therapy should not
exceed 12 weeks in duration.
Symptomatic Gastroesophageal Reflux
reglan
®
tablets are indicated as short-term (4 to 12 weeks) therapy for adults with
symptomatic, documented gastroesophageal reflux who fail to respond to conventional
therapy.
The principal effect of metoclopramide is on symptoms of postprandial and daytime
heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to
particular situations, such as following the evening meal, use of metoclopramide as single
doses prior to the provocative situation should be considered, rather than using the drug
throughout the day. Healing of esophageal ulcers and erosions has been endoscopically
demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no
documented correlation between symptoms and healing of esophageal lesions, patients
with documented lesions should be monitored endoscopically.
Diabetic Gastroparesis (Diabetic Gastric Stasis)
reglan
®
tablets (metoclopramide tablets, USP) is indicated for the relief of symptoms
associated with acute and recurrent diabetic gastric stasis. The usual manifestations of
Reference ID: 3018416
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Tardive Dyskinesia
(See Boxed Warnings)
Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially
irreversible and disfiguring disorder characterized by involuntary movements of the face,
tongue, or extremities. The risk of developing tardive dyskinesia increases with the
duration of treatment and the total cumulative dose. An analysis of utilization of patterns
showed that about 20% of patients who used metoclopramide took it longer than 12
weeks. Treatment with metoclopramide for longer than the recommended 12 weeks
should be avoided in all but rare cases where therapeutic benefit is thought to outweigh
the risk of developing TD.
Although the risk of developing TD in the general population may be increased among
the elderly, women, and diabetics, it is not possible to predict which patients will develop
metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD
will become irreversible increase with duration of treatment and total cumulative dose.
Metoclopramide should be discontinued in patients who develop signs and symptoms of
TD. There is no known effective treatment for established cases of TD, although in some
patients, TD may remit, partially or completely, within several weeks to months after
metoclopramide is withdrawn.
Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby
masking the underlying disease process. The effect of this symptomatic suppression upon
the long-term course of TD is unknown. Therefore, metoclopramide should not be used
for the symptomatic control of TD.
Neuroleptic Malignant Syndrome (NMS)
There have been rare reports of an uncommon but potentially fatal symptom complex
sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with
metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity,
altered consciousness, and evidence of autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis and cardiac arrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a
diagnosis, it is important to identify cases where the clinical presentation includes both
serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or
inadequately treated extrapyramidal signs and symptoms (EPS). Other important
considerations in the differential diagnosis include central anticholinergic toxicity, heat
stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS)
pathology.
The management of NMS should include 1) immediate discontinuation of
metoclopramide and other drugs not essential to concurrent therapy, 2) intensive
symptomatic treatment and medical monitoring, and 3) treatment of any concomitant
serious medical problems for which specific treatments are available. Bromocriptine and
dantrolene sodium have been used in treatment of NMS, but their effectiveness have not
been established (see ADVERSE REACTIONS).
Reference ID: 3018416
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PRECAUTIONS
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.
Because metoclopramide produces a transient increase in plasma aldosterone, certain
patients, especially those with cirrhosis or congestive heart failure, may be at risk of
developing fluid retention and volume overload. If these side effects occur at any time
during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after
stopping the use of reglan
®
. A small number of patients may experience a withdrawal
period after stopping reglan
®
that could include dizziness, nervousness, and/or headaches.
Information for Patients
The use of reglan
®
is recommended for adults only. 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.
For additional information, patients should be instructed to see the Medication Guide for
reglan
®
tablets.
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.
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
Reference ID: 3018416
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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.
Pregnancy Category B
Reproduction studies performed in rats, mice and rabbits by the I.V., I.M., S.C., 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.
Nursing Mothers
Metoclopramide is excreted in human milk. Caution should be exercised when
metoclopramide is administered to a nursing mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established (see
OVERDOSAGE).
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 b
5
reductase 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.)
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
®
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For current labeling information, please visit https://www.fda.gov/drugsatfda
should generally be discontinued before initiating any specific anti-parkinsonian agents
(see WARNINGS and DOSAGE AND ADMINISTRATION – For the Relief of
Symptomatic Gastroesophageal Reflux).
The elderly may be at greater risk for tardive dyskinesia (see WARNINGS – Tardive
Dyskinesia).
Sedation has been reported in reglan
®
users. Sedation may cause confusion and manifest
as over-sedation in the elderly (see CLINICAL PHARMACOLOGY,
PRECAUTIONS – Information for Patients and 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 (see DOSAGE
AND ADMINISTRATION – For the Relief of Symptomatic Gastroesophageal
Reflux and Use in Patients with Renal or Hepatic Impairment).
Other Special Populations
Patients with NADH-cytochrome b
5
reductase 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).
ADVERSE REACTIONS
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 occur in approximately 10% of patients
receiving the most commonly prescribed dosage of 10 mg q.i.d. (see PRECAUTIONS).
Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation
(see WARNINGS) occur less frequently. The incidence of drowsiness is greater at
higher doses. There are isolated reports of convulsive seizures without clearcut
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. Symptoms include involuntary movements of limbs, facial
grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of
Reference ID: 3018416
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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, altered
consciousness, muscular rigidity, and autonomic dysfunction (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 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 clearcut
relationship to metoclopramide. Methemoglobinemia, in adults and especially with
overdosage in neonates (see OVERDOSAGE). Sulfhemoglobinemia in adults.
Reference ID: 3018416
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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.
OVERDOSAGE
Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal
reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic
properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-
limiting and usually disappear within 24 hours.
Hemodialysis removes relatively little metoclopramide, probably because of the small
amount of the drug in blood relative to tissues. Similarly, continuous ambulatory
peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage
would need to be adjusted to compensate for losses through dialysis. Dialysis is not likely
to be an effective method of drug removal in overdose situations.
Unintentional overdose due to misadministration has been reported in infants and
children with the use of metoclopramide oral solution. While there was no consistent
pattern to the reports associated with these overdoses, events included seizures,
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).
DOSAGE AND ADMINISTRATION
Therapy with reglan
®
tablets should not exceed 12 weeks in duration.
For the relief of Symptomatic Gastroesophageal Reflux
Administer from 10 mg to 15 mg reglan
®
(metoclopramide hydrochloride, USP) orally up
to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being
treated and clinical response (see CLINICAL PHARMACOLOGY and
INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific
times of the day, use of metoclopramide in single doses up to 20 mg prior to the
provoking situation may be preferred rather than continuous treatment. Occasionally,
patients (such as elderly patients) who are more sensitive to the therapeutic or adverse
effects of metoclopramide will require only 5 mg per dose.
Experience with esophageal erosions and ulcerations is limited, but healing has thus far
been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this
regimen should be used when lesions are present, so long as it is tolerated (see
ADVERSE REACTIONS). Because of the poor correlation between symptoms and
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endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best
guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
For the Relief of Symptoms Associated with Diabetic Gastroparesis
(Diabetic Gastric Stasis)
Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for
two to eight weeks, depending upon response and the likelihood of continued well-being
upon drug discontinuation.
The initial route of administration should be determined by the severity of the presenting
symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral
administration of reglan
®
may be initiated. However, if severe symptoms are present,
therapy should begin with metoclopramide injection (consult labeling of the injection
prior to initiating parenteral administration).
Administration of metoclopramide injection up to 10 days may be required before
symptoms subside, at which time oral administration may be instituted. Since diabetic
gastric stasis is frequently recurrent, reglan
®
therapy should be reinstituted at the earliest
manifestation.
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.
HOW SUPPLIED
Each white, capsule-shaped, scored reglan
®
tablet (metoclopramide tablets, USP)
contains 10 mg metoclopramide base (as the monohydrochloride monohydrate).
Available in:
Bottles of 100 tablets (NDC 62559-166-01)
Each green, elliptical-shaped reglan
®
tablet (metoclopramide tablets, USP) contains 5 mg
metoclopramide base (as the monohydrochloride monohydrate). Available in :
Bottles of 100 tablets (NDC 62559-165-01)
Dispense tablets in tight, light-resistant container.
Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F
and 77°F).
Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
Reference ID: 3018416
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
For Medical Inquiries, call toll free at 1-800-308-6755.
www.anipharmaceuticals.com
PCS 9454
Rev 08/2011
Medication guide
REGLAN (REG-lan) Tablets
(metoclopramide tablets)
Read the Medication Guide that comes with REGLAN before you start taking it and each
time you get a refill. There may be new information. If you take another product that
contains metoclopramide (such as REGLAN injection, REGLAN ODT, or
metoclopramide oral syrup), you should read the Medication Guide that comes with that
product. Some of the information may be different. This Medication Guide does not take
the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about REGLAN?
REGLAN can cause serious side effects, including:
Tardive dyskinesia (abnormal muscle movements). These movements happen mostly
in the face muscles. You can not control these movements. They may not go away even
after stopping REGLAN. There is no treatment for tardive dyskinesia, but symptoms may
lessen or go away over time after you stop taking REGLAN.
Your chances for getting tardive dyskinesia go up:
• the longer you take REGLAN and the more REGLAN you take. You should not
take REGLAN for more than 12 weeks.
• if you are older, especially if you are a woman
• if you have diabetes
It is not possible for your doctor to know if you will get tardive dyskinesia if you take
REGLAN.
Call your doctor right away if you get movements you can not stop or control, such as:
• lip smacking, chewing, or puckering up your mouth
• frowning or scowling
• sticking out your tongue
• blinking and moving your eyes
• shaking of your arms and legs
Reference ID: 3018416
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For current labeling information, please visit https://www.fda.gov/drugsatfda
See the section "What are the possible side effects of REGLAN?" for more information
about side effects.
What is REGLAN?
REGLAN is a prescription medicine used:
• in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal
reflux disease (GERD) when certain other treatments do not work. REGLAN
relieves daytime heartburn and heartburn after meals. It also helps ulcers in the
esophagus to heal.
• to relieve symptoms of slow stomach emptying in people with diabetes. REGLAN
helps treat symptoms such as nausea, vomiting, heartburn, feeling full long after a
meal, and loss of appetite. Not all these symptoms get better at the same time.
It is not known if REGLAN is safe and works in children.
Who should not take REGLAN?
Do not take REGLAN if you:
• have stomach or intestine problems that could get worse with REGLAN, such as
bleeding, blockage or a tear in the stomach or bowel wall
• have an adrenal gland tumor called a pheochromocytoma
• are allergic to REGLAN or anything in it. See the end of this Medication Guide
for a list of ingredients in REGLAN.
• take medicines that can cause uncontrolled movements, such as medicines for
mental illness
• have seizures
What should I tell my doctor before taking REGLAN?
Tell your doctor about all your medical conditions, including if you have:
• depression
• Parkinson's disease
• high blood pressure
• kidney problems. Your doctor may start with a lower dose.
• liver problems or heart failure. REGLAN may cause your body to hold fluids.
• diabetes. Your dose of insulin may need to be changed.
• breast cancer
• you are pregnant or plan to become pregnant. It is not known if REGLAN will
harm your unborn baby.
• you are breast-feeding. REGLAN can pass into breast milk and may harm your
baby. Talk with your doctor about the best way to feed your baby if you take
REGLAN.
Reference ID: 3018416
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Tell your doctor about all the medicines you take, including prescription and non-
prescription medicines, vitamins, and herbal supplements. REGLAN and some other
medicines may interact with each other and may not work as well, or cause possible side
effects. Do not start any new medicines while taking REGLAN until you talk with your
doctor.
Especially tell your doctor if you take:
• another medicine that contains metoclopramide, such as REGLAN ODT, or
metoclopramide oral syrup
• a blood pressure medicine
• a medicine for depression, especially an Monoamine Oxidase Inhibitor (MAOI)
• insulin
• a medicine that can make you sleepy, such as anti-anxiety medicine, sleep
medicines, and narcotics.
If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.
Know the medicines you take. Keep a list of them and show it to your doctor and
pharmacist when you get a new medicine.
How should I take REGLAN?
• REGLAN comes as a tablet you take by mouth.
• Take REGLAN exactly as your doctor tells you. Do not change your dose unless
your doctor tells you.
• You should not take REGLAN for more than 12 weeks.
• If you take too much REGLAN, call your doctor or Poison Control Center right
away.
What should I avoid while taking REGLAN?
• Do not drink alcohol while taking REGLAN. Alcohol may make some side
effects of REGLAN worse, such as feeling sleepy.
• Do not drive, work with machines, or do dangerous tasks until you know how
REGLAN affects you. REGLAN may cause sleepiness.
What are the possible side effects of REGLAN?
Reglan can cause serious side effects, including:
• Tardive dyskinesia (abnormal muscle movements). See "What is the most
important information I need to know about REGLAN?"
• Uncontrolled spasms of your face and neck muscles, or muscles of your body,
arms, and legs (dystonia). These muscle spasms can cause abnormal movements
Reference ID: 3018416
This label may not be the latest approved by FDA.
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and body positions. These spasms usually start within the first 2 days of
treatment. These spasms happen more often in children and adults under age 30.
• Depression, thoughts about suicide, and suicide. Some people who take
REGLAN become depressed. You may have thoughts about hurting or killing
yourself. Some people who take Reglan have ended their own lives (suicide).
• Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious
condition that can happen with Reglan. NMS can cause death and must be treated
in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems
thinking, very fast or uneven heartbeat, and increased sweating.
• Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving
or keeping your balance. If you already have Parkinson's disease, your symptoms
may become worse while you are receiving REGLAN.
Call your doctor and get medical help right away if you:
• feel depressed or have thoughts about hurting or killing yourself
• have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat,
and increased sweating
• have muscle movements you cannot stop or control
• have muscle movements that are new or unusual
Common side effects of Reglan include:
• feeling restless, sleepy, tired, dizzy, or exhausted
• headache
• confusion
• trouble sleeping
You may have more side effects the longer you take REGLAN and the more REGLAN
you take. You may still have side effects after stopping REGLAN. You may have
symptoms from stopping (withdrawal) REGLAN such as headaches, and feeling dizzy or
nervous.
Tell your doctor about any side effects that bother you or do not go away. These are not
all the possible side effects of REGLAN.
Call your doctor for medical advice about side effects. You may report side effects to
FDA at 1-800-FDA-1088.
How should I store REGLAN?
• Keep REGLAN at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep REGLAN in the bottle it comes in. Keep the bottle closed tightly.
Keep REGLAN and all medicines out of the reach of children.
Reference ID: 3018416
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
General information about REGLAN
Medicines are sometimes prescribed for purposes other than those listed in a Medication
Guide. Do not use REGLAN for a condition for which it was not prescribed. Do not give
REGLAN to other people, even if they have the same symptoms that you have. It may
harm them.
This Medication Guide summarizes the most important information about REGLAN. If
you would like more information, talk with your doctor. You can ask your doctor or
pharmacist for information about REGLAN that is written for health professionals. For
more information, go to www.anipharmaceuticals.com or call toll free at 1-800-308-
6755.
What are the ingredients in REGLAN?
Active ingredient: metoclopramide
Inactive ingredients:
REGLAN 10 mg tablets: magnesium stearate, mannitol, microcrystalline
cellulose, stearic acid
REGLAN 5 mg tablets: corn starch, D&C yellow 10 aluminum lake, FD&C blue
1 aluminum lake, lactose, microcrystalline cellulose, silicon dioxide, stearic acid
Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
For Medical Inquiries, call toll-free 1-800-308-6755.
www.anipharmaceuticals.com
PCS 9455
Rev. 08/2011
Revised August 2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Reference ID: 3018416
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda