This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use REGLANTABLETS safely and effectively. See full prescribing information for
REGLAN TABLETS.
REGLAN® (metoclopramide) tablets, for oral use
Initial U.S. Approval: 1979
WARNING: TARDIVE DYSKINESIA
See full prescribing information for complete boxed warning.
• Reglan can cause tardive dyskinesia (TD), a serious movement disorderthat is often irreversible. There is no known treatment for TD. The riskof developing TD increases with duration of treatment and total
cumulative dosage (5.1)• Discontinue Reglan in patients who develop signs or symptoms of TD(5.1)• Avoid treatment with Reglan for longer than 12 weeks because of therisk of developing TD with longer-term use (5.1, 2.1, 2.2, 2.3)----------------------------RECENT MAJOR CHANGES-------------------------­
Boxed Warning
8/2017
Indications and Usage (1)8/2017
Dosage and Administration, Dosage for Gastroesophageal Reflux (2.2) 8/2017
Dosage and Administration, Dosage for Acute and Recurrent Diabetic
Gastroparesis (2.3)
8/2017
Contraindications (4)8/2017Warnings and Precautions, Tardive Dyskinesia (5.1)
8/2017Warnings and Precautions, Other Extrapyramidal Symptoms (5.2)
8/2017Warnings and Precautions, Neuroleptic Malignant Syndrome (5.3)
8/2017Warnings and Precautions, Hyperprolactinemia (5.7)
8/2017----------------------------INDICATIONS AND USAGE--------------------------Reglan tablets are indicated for the:• Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal
reflux in adults who fail to respond to conventional therapy. (1)• Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
(1)
Limitations of Use:Reglan tablets are not recommended for use in pediatric patients due to the riskof tardive dyskinesia (TD) and other extrapyramidal symptoms as well as therisk of methemoglobinemia in neonates. (1, 8.4)

Acute and Recurrent Diabetic Gastroparesis (2.3)• Administer 10 mg, 30 minutes before each meal and at bedtime (maximumof 40 mg per day) for 2 to 8 weeks
Dosage Adjustment in Specific Populations (2.2, 2.3)
• For gastroesophageal reflux and acute and recurrent diabetic gastroparesis,
see Full Prescribing Information for recommended dosage reductions for
elderly patients, in patients with moderate or severe hepatic or renal
impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers.
---------------------DOSAGE FORMS AND STRENGTHS---------------------­
Tablets: 5 mg and 10 mg metoclopramide (3)------------------------------CONTRAINDICATIONS------------------------------­• History of TD or dystonic reaction to metoclopramide (4)• When stimulation of gastrointestinal motility might be dangerous (4)• Pheochromocytoma, catecholamine-releasing paragangliomas (4)• Epilepsy (4)• Hypersensitivity to metoclopramide (4)-----------------------WARNINGS AND PRECAUTIONS-----------------------­• Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), andNeuroleptic Malignant Syndrome (NMS): Avoid concomitant use of otherdrugs known to cause TD/EPS/NMS and avoid use in patients with
Parkinson’s Disease. If symptoms occur, discontinue Reglan and seek
immediate medical attention. (5.1, 5.2, 5.3, 7.1, 7.2)
• Depression and suicidal ideation/suicide: Avoid use. (5.4)------------------------------ADVERSE REACTIONS------------------------------­• Most common adverse reactions (> 10%) are restlessness, drowsiness,fatigue, and lassitude. (6)To report SUSPECTED ADVERSE REACTIONS, contact ANI
Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
------------------------------DRUG INTERACTIONS------------------------------­• Antipsychotics: Potential for additive effects, including TD, EPS, and
NMS; avoid concomitant use. (7.1)• CNS depressants: Increased risk of CNS depression. Avoid concomitant
use and monitor for adverse reactions. (7.1)• Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, andparoxetine): See Full Prescribing Information for recommended dosage
reductions. (2.2, 2.3, 7.1)
• MAO inhibitors: Increased risk of hypertension; avoid concomitant use.
(5.5, 7.1)
• Additional drug interactions: See Full Prescribing Information. (7.1, 7.2)------------------------DOSAGE AND ADMINISTRATION---------------------Gastroesophageal Reflux (2.2)• Administer Reglan continuously or intermittently:
o Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at
See 17 for PATIENT COUNSELING INFORMATION and Medication
bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
Guide.
o Intermittent: Single doses up to 20 mg prior to provoking situation.
Revised: 08/2017_______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 NADH-Cytochrome b5 Reductase Deficiency
8.9 CYP2D6 Poor Metabolizers
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATIONWARNING: TARDIVE DYSKINESIA
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Dosage for Gastroesophageal Reflux
2.3 Dosage for Acute and Recurrent Diabetic Gastroparesis
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Tardive Dyskinesia
5.2 Other Extrapyramidal Symptoms
5.3 Neuroleptic Malignant Syndrome
5.4 Depression
5.5 Hypertension
5.6 Fluid Retention
5.7 Hyperprolactinemia
5.8 Effects on the Ability to Drive and Operate Machinery
6 ADVERSE REACTIONS*Sections or subsections omitted from the full prescribing information are not
7 DRUG INTERACTIONS
listed.
7.1 Effects of Other Drugs on Metoclopramide
7.2 Effects of Metoclopramide on Other Drugs_______________________________________________________________________________________________________________________________________

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FULL PRESCRIBING INFORMATIONWARNING: TARDIVE DYSKINESIA•••

Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often
irreversible. There is no known treatment for TD. The risk of developing TD
increases with duration of treatment and total cumulative dosage [see Warnings andPrecautions (5.1)].
Discontinue Reglan in patients who develop signs or symptoms of TD. In somepatients, symptoms may lessen or resolve after Reglan is stopped [see Warnings andPrecautions (5.1)].
Avoid treatment with Reglan for longer than 12 weeks because of the increased riskof developing TD with longer-term use [see Warnings and Precautions (5.1) andDosage and Administration (2.2, 2.3)].

1 INDICATIONS AND USAGE
Reglan tablets are indicated for the:• Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults
who fail to respond to conventional therapy.
• Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use:Reglan tablets are not recommended for use in pediatric patients due to the risk of developing
tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk ofmethemoglobinemia in neonates [see Use in Specific Populations (8.4)].
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Avoid treatment with Reglan for longer than 12 weeks because of the increased risk ofdeveloping TD with longer-term use [see Dosage and Administration (2.2, 2.3), Warnings andPrecautions (5.1)].
2.2 Dosage for Gastroesophageal Reflux
Reglan tablets may be administered continuously or intermittently in patients with symptomatic
gastroesophageal reflux who fail to respond to conventional therapy:
Continuous Dosing
The recommended adult dosage of Reglan is 10 to 15 mg four times daily for 4 to 12 weeks. The
treatment duration is determined by endoscopic response. Administer the dosage thirty minutes
before each meal and at bedtime. The maximum recommended daily dosage is 60 mg.

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Table 1 displays the recommended daily dosage and maximum daily dosage for adults anddosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B orC), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6(CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.
Intermittent Dosing
If symptoms only occur intermittently or at specific times of the day, administer Reglan in single
dose up to 20 mg prior to the provoking situation. Consider dosage reductions for the populations
and situations in Table 1.
Table 1. Recommended Reglan Tablet Dosage in Patients with Gastroesophageal Reflux

Recommended Dosage
Adult patients
Mild hepatic impairment (Child-Pugh A)
Elderly patients [see Use in Specific Populations (8.5)]

10 to 15 mg four times daily(thirty minutes before eachmeal and at bedtime)

Maximum
Recommended
Daily Dosage

60 mg

5 mg1 four times daily (thirty
minutes before each meal andat bedtime)

Moderate or severe hepatic impairment (Child-Pugh B orC) [see Use in Specific Populations (8.7)]
CYP2D6 poor metabolizers [see Use in Specific
Populations (8.9)]5 mg four times daily (thirty
minutes before each meal andConcomitant use with strong CYP2D6 inhibitors (e.g.,
30 mg
at bedtime), or
quinidine, bupropion, fluoxetine, and paroxetine) [see10 mg taken three times daily
Drug Interactions (7.1)]
Moderate or severe renal impairment (creatinine clearance
less than or equal to 60 mL/minute) [see Use in Specific
Populations (8.6)]
Patients with End-Stage Renal Disease (ESRD) including
5 mg four times daily (thirty
those treated with hemodialysis and continuous
minutes before each meal and20 mg
ambulatory peritoneal dialysis [see Use in Specificat bedtime) or 10 mg twice
Populations (8.6)]
daily
1
Elderly patients may be more sensitive to the therapeutic or adverse effects of Reglan; therefore, consider a lower
starting dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 to 15 mg four times
daily based upon response and tolerability.

2.3 Dosage for Acute and Recurrent Diabetic Gastroparesis
The recommended adult dosage for the treatment of acute and recurrent diabetic gastroparesis is
10 mg four times daily for 2 to 8 weeks, depending on symptomatic response. Avoid Reglan
treatment for greater than 12 weeks [see Warnings and Precautions (5.1)]. Administer the
dosage thirty minutes before each meal and at bedtime. The maximum recommended daily
dosage is 40 mg.
Table 2 displays the recommended daily dosage and maximum daily dosage for adults anddosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or
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C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6(CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors.
If patients with diabetic gastroparesis have severe nausea or vomiting and are unable to take oral
Reglan tablets, consider starting therapy with metoclopramide injection given intramuscularly or
intravenously for up to 10 days (see the prescribing information for metoclopramide injection).
After patients are able to take oral therapy, switch to Reglan tablets.
Table 2. Recommended Reglan Tablet Dosage in Patients with Acute and Recurrent
Diabetic Gastroparesis

Recommended Dosage
Adult Patients
Mild hepatic impairment (Child-Pugh A)
Elderly patients [see Use in Specific Populations (8.5)]

10 mg four times daily (30minutes before each meal andat bedtime)

Maximum
Recommended
Daily Dosage

40 mg

5 mg1 four times daily (30minutes before each meal andat bedtime)

Moderate or severe hepatic impairment (Child-Pugh B orC) [see Use in Specific Populations (8.7)]
CYP2D6 poor metabolizers [see Use in Specific
Populations (8.9)]5 mg four times daily (30Concomitant use with strong CYP2D6 inhibitors (e.g.,
minutes before each meal and20 mg
quinidine, bupropion, fluoxetine, and paroxetine) [seeat bedtime)
Drug Interactions (7.1)]
Moderate or severe renal impairment (creatinine clearance
less than 60 mL/minute) [see Use in Specific Populations(8.6)]
Patients with End-Stage Renal Disease (ESRD) including
those treated with hemodialysis and continuous
5 mg twice daily
10 mg
ambulatory peritoneal dialysis [see Use in Specific
Populations (8.6)]
1
Elderly patients may be more sensitive to the therapeutic or adverse effects of Reglan; therefore, consider a lower
dosage of 5 mg four times daily with titration to the recommended adult dosage of 10 mg four times daily based
upon response and tolerability.

3 DOSAGE FORMS AND STRENGTHS
Tablets:•

5 mg metoclopramide: green, elliptical-shaped, debossed “REGLAN” over “5” on one sideand “ANI” on the opposite side•

10 mg metoclopramide: white, double edge scored, capsule-shaped, debossed “REGLAN” on
one side and “ANI 10” on the opposite side

4 CONTRAINDICATIONS
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Reglan is contraindicated:
•
•
•
•
•

In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide[see Warnings and Precautions (5.1, 5.2)].
When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence ofgastrointestinal hemorrhage, mechanical obstruction, or perforation).
In patients with pheochromocytoma or other catecholamine-releasing paragangliomas.
Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release ofcatecholamines from the tumor [see Warnings and Precautions (5.5)].
In patients with epilepsy. Reglan may increase the frequency and severity of seizures [seeAdverse Reactions (6)].
In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal andglossal angioedema and bronchospasm [see Adverse Reactions (6)].

5 WARNINGS AND PRECAUTIONS
5.1 Tardive Dyskinesia
Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible anddisfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or
extremities. Movements may be choreoathetotic in appearance. The risk of developing TD andthe likelihood that TD will become irreversible increases with duration of treatment and total
cumulative dosage. Additionally, the risk of developing TD is increased among the elderly,
especially elderly women [see Use in Specific Populations (8.5)], and in patients with diabetes
mellitus. Due to the risk of developing TD, avoid treatment with Reglan for longer than 12
weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2, 2.3)].
Discontinue Reglan immediately 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 Reglan is withdrawn.
Reglan itself may suppress, or partially suppress, the signs of TD, thereby masking theunderlying disease process. The effect of this symptomatic suppression upon the long-termcourse of TD is unknown. Reglan is contraindicated in patients with a history of TD [seeContraindications (4)]. Avoid Reglan in patients receiving other drugs that are likely to cause
TD (e.g., antipsychotics).
5.2 Other Extrapyramidal Symptoms
In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS),
parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical
attention if such symptoms occur and to discontinue Reglan.
•

Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patientstreated with metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more
frequently in adults less than 30 years of age and at higher than recommended dosages. EPS
occurred more frequently in pediatric patients compared to adults (Reglan is not approved for
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use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting
metoclopramide. Symptoms included involuntary movements of limbs and facial grimacing,torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, ordystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor anddyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine
mesylate may be used to treat these adverse reactions. Avoid Reglan in patients receiving
other drugs that can cause EPS (e.g., antipsychotics).
Parkinsonian symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) haveoccurred after starting metoclopramide, more commonly within the first 6 months, but also
after longer periods. Symptoms generally have subsided within 2 to 3 months after
discontinuation of Reglan. Avoid Reglan in patients with Parkinson’s disease and other
patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms.
Avoid treatment with Reglan for more than 12 weeks [see Dosage and Administration (2.2,
2.3), Warnings and Precautions (5.1)].
Motor restlessness (akathisia) has developed and consisted of feelings of anxiety, agitation,jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping. If symptoms
resolve, consider restarting at a lower dosage.

5.3 Neuroleptic Malignant Syndrome
Metoclopramide may cause a potentially fatal symptom complex called neuroleptic malignant
syndrome (NMS). NMS has been reported in association with metoclopramide overdosage andconcomitant treatment with another drug associated with NMS. Avoid Reglan in patients
receiving other drugs associated with NMS, including typical and atypical antipsychotics.
Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, andmanifestations of autonomic instability (irregular pulse or blood pressure, tachycardia,
diaphoresis, and cardiac arrhythmias). Additional signs may include elevated creatine
phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Patients with such
symptoms should be evaluated immediately.
In the diagnostic evaluation, consider the presence of other serious medical conditions (e.g.,pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs andsymptoms. Other important considerations in the differential diagnosis include central
anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, serotonin syndrome,and primary central nervous system pathology.
Management of NMS includes:•••

Immediate discontinuation of Reglan and other drugs not essential to concurrent therapy [seeDrug Interactions (7.1)].
Intensive symptomatic treatment and medical monitoring.
Treatment of any concomitant serious medical problems for which specific treatments areavailable.

5.4 Depression

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Depression has occurred in metoclopramide-treated patients with and without a history ofdepression. Symptoms have included suicidal ideation and suicide. Avoid Reglan use in patientswith a history of depression.
5.5 Hypertension
Metoclopramide may elevate blood pressure. In one study in hypertensive patients, intravenously
administered metoclopramide was shown to release catecholamines; hence, avoid use in patientswith hypertension or in patients taking monoamine oxidase inhibitors [see Drug Interactions(7.1)].
There are also clinical reports of hypertensive crises in patients with undiagnosed
pheochromocytoma. Reglan is contraindicated in patients with pheochromocytoma or othercatecholamine-releasing paragangliomas [see Contraindications (4)]. Discontinue Reglan in any
patient with a rapid rise in blood pressure.
5.6 Fluid Retention
Because Reglan produces a transient increase in plasma aldosterone, patients with cirrhosis orcongestive heart failure may be at risk of developing fluid retention and volume overload.
Discontinue Reglan if any of these adverse reactions occur.
5.7 Hyperprolactinemia
As with other dopamine D2 receptor antagonists, metoclopramide elevates prolactin levels.
Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary
gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal
steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, andimpotence have been reported with prolactin-elevating drugs, including metoclopramide.
Hyperprolactinemia may potentially stimulate prolactin-dependent breast cancer. However, someclinical studies and epidemiology studies have not shown an association between administrationof dopamine D2 receptor antagonists and tumorigenesis in humans [see Nonclinical Toxicology(13.1)].
5.8 Effects on the Ability to Drive and Operate Machinery
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. Concomitant use ofcentral nervous system (CNS) depressants or drugs associated with EPS may increase this effect(e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid Reglan or the interacting
drug, depending on the importance of the drug to the patient [see Drug Interactions (7.1)].
6 ADVERSE REACTIONS

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The following adverse reactions are described, or described in greater detail, in other sections of
the labeling:
•
•
•
•
•
•
•
•

Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1)]
Other extrapyramidal effects [see Warnings and Precautions (5.2)]
Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]
Depression [see Warnings and Precautions (5.4)]
Hypertension [see Warnings and Precautions (5.5)]
Fluid retention [see Warnings and Precautions (5.6)]
Hyperprolactinemia [see Warnings and Precautions (5.7)]
Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8)]

The following adverse reactions have been identified from clinical studies or postmarketing
reports of metoclopramide. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
The most common adverse reactions (in approximately 10% of patients receiving 10 mg of
metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In
general, the incidence of adverse reactions correlated with the dosage and duration of
metoclopramide administration.
Adverse reactions, especially those involving the nervous system, occurred after stopping
metoclopramide including dizziness, nervousness, and headaches.
Central Nervous System Disorders• Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and otherextrapyramidal symptoms• Convulsive seizures• Hallucinations• Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients
who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, ordepression with suicidal ideation occurred less frequently.
• Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic
agents).
Endocrine Disorders: Fluid retention secondary to transient elevation of aldosterone.
Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia
Cardiovascular Disorders: Acute congestive heart failure, possible atrioventricular block,hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention
Gastrointestinal Disorders: Nausea, bowel disturbances (primarily diarrhea)
Hepatic Disorders: Hepatotoxicity, characterized by, e.g., jaundice and altered liver function
tests, when metoclopramide was administered with other drugs with known hepatotoxic potential
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Renal and Urinary Disorders: Urinary frequency, urinary incontinence
Hematologic Disorders: Agranulocytosis, neutropenia, leukopenia, methemoglobinemia,
sulfhemoglobinemia
Hypersensitivity Reactions: Bronchospasm (especially in patients with a history of asthma),
urticaria; rash; angioedema, including glossal or laryngeal edema
Eye Disorders: Visual disturbances
Metabolism Disorders: Porphyria
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Metoclopramide
Table 3 displays the effects of other drugs on metoclopramide.
Table 3. Effects of Other Drugs on Metoclopramide
Antipsychotics
Clinical Impact

Potential for additive effects, including increased frequency and severity of tardive
dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant
syndrome (NMS).
Intervention
Avoid concomitant use [see Warnings and Precautions (5.1, 5.2, 5.3)].
Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above
Clinical Impact
Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal
symptoms [see Clinical Pharmacology (12.3)].
Reduce the Reglan dosage [see Dosage and Administration (2.2, 2.3)].
Intervention
Examplesquinidine, bupropion, fluoxetine, and paroxetine
Monoamine Oxidase Inhibitors
Clinical Impact
Increased risk of hypertension [see Warnings and Precautions (5.5)].
Intervention
Avoid concomitant use.
Central Nervous System (CNS) DepressantsClinical Impact
Increased risk of CNS depression [see Warnings and Precautions (5.8)].
Intervention
Avoid Reglan or the interacting drug, depending on the importance of the drug to thepatient.
Examplesalcohol, sedatives, hypnotics, opiates and anxiolytics
Drugs that Impair Gastrointestinal Motility
Clinical Impact
Decreased systemic absorption of metoclopramide.
Intervention
Monitor for reduced therapeutic effect.
Examplesantiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates
Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations
Clinical Impact
Decreased therapeutic effect of metoclopramide due to opposing effects on dopamine.
Intervention
Monitor for reduced therapeutic effect.
Examplesapomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, androtigotine

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7.2 Effects of Metoclopramide on Other Drugs
Table 4 displays the effects of metoclopramide on other drugs.
Table 4. Effects of Metoclopramide on Other Drugs
Dopaminergic Agonists and Drugs Increasing Dopamine Concentrations
Clinical Impact
Opposing effects of metoclopramide and the interacting drug on dopamine. Potential
exacerbation of symptoms (e.g., parkinsonian symptoms).
Intervention
Avoid concomitant use [see Warnings and Precautions (5.2)].
ExamplesApomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine
Succinylcholine, Mivacurium
Clinical Impact
Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular
blockade.
Intervention
Monitor for signs and symptoms of prolonged neuromuscular blockadeDrugs with Absorption Altered due to Increased Gastrointestinal Motility
Clinical Impact
The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI)motility by metoclopramide may impact absorption of other drugs leading to decreased orincreased drug exposure.
Intervention
Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oralsuspension*, fosfomycin): Monitor for reduced therapeutic effect of the interacting drug.
For digoxin monitor therapeutic drug concentrations and increase the digoxin dose asneeded (see prescribing information for digoxin).
Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine): Monitor
therapeutic drug concentrations and adjust the dose as needed. See prescribing information
for the interacting drug.
InsulinClinical Impact

Increased GI motility by metoclopramide may increase delivery of food to the intestinesand increase blood glucose.
Intervention
Monitor blood glucose and adjust insulin dosage regimen as needed.
* Interaction does not apply to posaconazole delayed-release tablets

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Published studies, including retrospective cohort studies, national registry studies, and metaanalyses, do not report an increased risk of adverse pregnancy-related outcomes with use of
metoclopramide during pregnancy.
There are potential risks to the neonate following exposure in utero to metoclopramide during
delivery [see Clinical Considerations]. In animal reproduction studies, no adverse
developmental effects were observed with oral administration of metoclopramide to pregnant
rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose
(MRHD) [see Data].

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The estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown. All pregnancies have a background risk of birth defects, loss or otheradverse outcomes. In the U.S. general population, the estimated background risk of major birthdefects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%,
respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Metoclopramide crosses the placental barrier and may cause extrapyramidal signs andmethemoglobinemia in neonates with maternal administration during delivery. Monitor neonates
for extrapyramidal signs [see Warnings and Precautions (5.1, 5.2), Use in Specific Populations(8.4)].
Data
Animal Data
Reproduction studies have been performed following administration of oral metoclopramide
during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface
area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No
evidence of adverse developmental effects due to metoclopramide were observed.
8.2 Lactation
Risk Summary
Limited published data report the presence of metoclopramide in human milk in variable
amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse
reactions, including intestinal discomfort and increased intestinal gas formation [see Data].
Metoclopramide elevates prolactin levels [see Warnings and Precautions (5.7)]; however, thepublished data are not adequate to support drug effects on milk production. The developmental
and health benefits of breastfeeding should be considered along with the mother’s clinical needfor Reglan and any potential adverse effects on the breastfed child from Reglan or from theunderlying maternal condition.
Clinical Considerations
Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs(dystonias) and methemoglobinemia [see Warnings and Precautions (5.1, 5.2), Use in Specific
Populations (8.4)].
Data
In published clinical studies, the estimated amount of metoclopramide received by the breastfed
infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily
amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day
in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks
postpartum.
8.4 Pediatric Use

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Reglan is not recommended for use in pediatric patients due to the risk of tardive dyskinesia(TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
The safety and effectiveness of Reglan in pediatric patients have not been established.
Dystonias and other extrapyramidal symptoms associated with metoclopramide are morecommon in pediatric patients than in adults [see Warnings and Precautions (5.1, 5.2)]. In
addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more
susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use inneonates [see Use in Specific Populations (8.8)].
8.5 Geriatric Use
Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse
reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal
function [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Elderly patientsare more likely to have decreased renal function and may be more sensitive to the therapeutic oradverse effects of metoclopramide; therefore, consider a reduced dosage of Reglan in elderly
patients [see Boxed Warning, Dosage and Administration (2.2, 2.3), Warnings and Precautions(5.1)].
8.6 Renal Impairment
The clearance of metoclopramide is decreased and the systemic exposure is increased in patientswith moderate to severe renal impairment compared to patients with normal renal function,
which may increase the risk of adverse reactions. Reduce the Reglan dosage in patients withmoderate and severe renal impairment (creatinine clearance less than or equal to 60 mL/minute),
including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [seeDosage and Administration (2.2, 2.3), Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic metoclopramide
clearance (by approximately 50%) compared to patients with normal hepatic function. The
resulting increase in metoclopramide blood concentrations increases the risk of adverse
reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (ChildPugh B). Reduce Reglan dosage in patients with moderate or severe (Child-Pugh B or C) hepatic
impairment [see Dosage and Administration (2.2, 2.3)]. There is no dosage adjustment requiredfor patients with mild hepatic impairment (Child-Pugh A).
In addition, metoclopramide, by producing a transient increase in plasma aldosterone, may
increase the risk of fluid retention in patients with hepatic impairment [see Warnings andPrecautions (5.6)].
Monitor patients with hepatic impairment for the occurrence of fluid retention and volume
overload.
8.8 NADH-Cytochrome b5 Reductase Deficiency

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Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at anincreased risk of developing methemoglobinemia and/or sulfhemoglobinemia. For patients withglucose-6-phosphate dehydrogenase (G6PD) deficiency with metoclopramide-induced
methemoglobinemia, methylene blue treatment is not recommended. Methylene blue may cause
hemolytic anemia in patients with G6PD deficiency, which may be fatal [see Overdosage (10)].
8.9 CYP2D6 Poor Metabolizers
Metoclopramide is a substrate of CYP2D6. The elimination of metoclopramide may be slowed inpatients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6
intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic andother adverse reactions to Reglan [see Clinical Pharmacology (12.3)]. Reduce the Reglan dosage
in patients who are poor CYP2D6 metabolizers [see Dosage and Administration (2.2, 2.3)].
10 OVERDOSAGE
Manifestations of metoclopramide overdosage included drowsiness, disorientation,
extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including,e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has
been reported in association with metoclopramide overdose and concomitant treatment withanother drug associated with NMS [see Warnings and Precautions (5.1, 5.2, 5.3)].
There are no specific antidotes for Reglan overdosage. If over-exposure occurs, call your Poison
Control Center at 1-800-222-1222 for current information on the management of poisoning or
overdosage.
Methemoglobinemia can be reversed by the intravenous administration of methylene blue.
However, methylene blue may cause hemolytic anemia in patients with glucose-6-phosphate
dehydrogenase (G6PD) deficiency, which may be fatal.
Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amountsof metoclopramide.
11 DESCRIPTION
Metoclopramide hydrochloride, the active ingredient of Reglan, is a dopamine-2 receptor
antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate)
is a white crystalline, odorless substance, freely soluble in water. Its chemical name is 4-amino­
5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.
The molecular formula is C14H22ClN3O2•HCl•H2O. Its molecular weight is 354.3. The structural
formula is:
O
Cl
H2N

N
H

N

HCl

H2O

O

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Reglan tablets are for oral administration. Reglan is available in 5 mg and 10 mg tablets.
••

Each Reglan 5 mg tablet contains 5 mg metoclopramide (equivalent to 5.91 mg of
metoclopramide hydrochloride USP). Inactive ingredients consist of corn starch, D&C
Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, lactose, microcrystalline
cellulose, silicon dioxide, and stearic acid.
Each Reglan 10 mg tablet contains 10 mg metoclopramide (equivalent to 11.82 mg
metoclopramide hydrochloride USP). Inactive ingredients consist of magnesium stearate,mannitol, microcrystalline cellulose, and stearic acid.

12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating
gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in
the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has notbeen fully established. 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 abolishedby 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 theresting tone of the lower esophageal sphincter. It has little, if any, effect on the motility of thecolon or gallbladder.
12.2 Pharmacodynamics
Gastroesophageal Reflux
In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP),
single oral doses of Reglan produced dose-related increases in LESP. Effects began at about
5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about
45 minutes and that of 20 mg lasted between 2 and 3 hours. Increased rate of stomach emptying
was observed with single oral doses of 10 mg.
12.3 Pharmacokinetics
Absorption
Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral metoclopramide is
80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations
occurred at about 1 to 2 hours after a single oral dose. Similar time to peak was observed after
individual doses at steady state.
In a single dose study of 12 subjects, the area under the drug concentration-time curve increased
linearly with doses from 20 to 100 mg (5 times the maximum recommended single dose). Peakconcentrations increased linearly with dose; time to peak concentrations remained the same;
whole body clearance was unchanged; and the elimination rate remained the same. The mean
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elimination half-life in subjects with normal renal function was 5 to 6 hours. Linear kinetic
processes adequately describe the absorption and elimination of metoclopramide.
Distribution
Metoclopramide 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 tothe tissues.
Elimination
Metabolism: Metoclopramide undergoes enzymatic metabolism via oxidation as well as
glucuronide and sulfate conjugation reactions in the liver. Monodeethylmetoclopramide, amajor oxidative metabolite, is formed primarily by CYP2D6, an enzyme subject to genetic
variability [see Dosage and Administration (2.2, 2.3), Use in Specific Populations (8.9)].
Excretion: Approximately 85% of the radioactivity of an orally administered dose appearedin the urine within 72 hours. After oral administration of 10 or 20 mg, a mean of 18% and
22% of the dose, respectively, was recovered as free metoclopramide in urine within 36
hours.
Specific Populations
Patients with Renal Impairment: In a study of 24 patients with varying degrees of renal
impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), thesystemic exposure (AUC) of metoclopramide in patients with moderate to severe renal
impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of
metoclopramide in patients with ESRD on dialysis was about 3.5-fold the AUC in subjects
with normal renal function [see Dosage and Administration (2.2, 2.3) and Use in Specific
Populations (8.6)].
Patients with Hepatic Impairment: In a group of 8 patients with severe hepatic impairment(Child-Pugh C), the average metoclopramide clearance was reduced by approximately 50%
compared to patients with normal hepatic function [see Dosage and Administration (2.2, 2.3)
and Use in Specific Populations (8.7)].
Drug Interaction Studies
Effect of Metoclopramide on CYP2D6 Substrates
Although in vitro studies suggest that metoclopramide can inhibit CYP2D6, metoclopramide
is unlikely to interact with CYP2D6 substrates in vivo at therapeutically relevant
concentrations.
Effect of CYP2D6 Inhibitors on Metoclopramide
In healthy subjects, 20 mg of metoclopramide and 60 mg of fluoxetine (a strong CYP2D6
inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days.
The patients who received concomitant metoclopramide and fluoxetine had a 40% and 90%
increase in metoclopramide Cmax and AUC0-∞, respectively, compared to patients who
received metoclopramide alone (see Table 5) [see Drug Interactions (7.1)].

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Table 5. Metoclopramide Pharmacokinetic Parameters in Healthy Subjects with andwithout Fluoxetine
Metoclopramide alone
Metoclopramide withParameter(mean ± SD)
fluoxetine(mean ± SD)
Cmax (ng/mL)
44 ±1562.7 ± 9.2
AUC0-∞ (ngˑh/mL)
313 ± 113591 ± 140
t1/2 (h)5.5 ± 1.1
8.5 ± 2.2
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
A 77-week study was conducted in rats with oral metoclopramide doses up to 40 mg/kg/day(about six times the maximum recommended human dose on body surface area basis).
Metoclopramide elevated prolactin levels and the elevation persisted during chronic
administration. An increase in mammary neoplasms was found in rodents after chronic
administration of metoclopramide [see Warnings and Precautions (5.7)]. In a rat model forassessing the tumor promotion potential, a 2-week oral treatment with metoclopramide at a doseof 260 mg/kg/day (about 35 times the maximum recommended human dose based on bodysurface area) enhanced the tumorigenic effect of N-nitrosodiethylamine.
Mutagenesis
Metoclopramide was positive in the in vitro Chinese hamster lung cell/HGPRT forward mutation
assay for mutagenic effects and in the in vitro human lymphocyte chromosome aberration assay
for clastogenic effects. It was negative in the in vitro Ames mutation assay, the in vitro
unscheduled DNA synthesis assay with rat and human hepatocytes, and the in vivo rat
micronucleus assay.
Impairment of Fertility
Metoclopramide at intramuscular doses up to 20 mg/kg/day (about three times the maximum
recommended human dose based on body surface area) was found to have no effect on fertility
and reproductive performance of male and female rats.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each green, elliptical-shaped Reglan tablet contains 5 mg metoclopramide. The tablet isdebossed “REGLAN” over “5” on one side and “ANI” on the opposite side. Available in bottlesof 100 tablets (NDC 62559-165-01).
Each white, double edge scored, capsule-shaped Reglan tablet contains 10 mg metoclopramide.
The tablet is debossed “REGLAN” on one side and “ANI 10” on the opposite side. Available inbottles of 100 tablets (NDC 62559-166-01).
Dispense tablets in tight, light-resistant container. Store tablets at controlled room temperature
between 20°C and 25°C (68°F and 77°F).

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17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients or their caregivers that Reglan can cause serious adverse reactions. Instructpatients to discontinue Reglan and contact a healthcare provider immediately if the following
serious reactions occur:• Tardive dyskinesia and other extrapyramidal reactions [see Warnings and Precautions (5.1,
5.2)]• Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)]• Depression and/or possible suicidal ideation [see Warnings and Precautions (5.4)]
Inform patients or their caregivers that concomitant treatment with numerous other medications
can precipitate or worsen serious adverse reactions such as tardive dyskinesia or otherextrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug
Interactions (7.1, 7.2)]. Explain that the prescriber of any other medication must be made awarethat the patient is taking Reglan.
Inform patients or their caregivers that Reglan can cause drowsiness or dizziness, or otherwise
impair the mental and/or physical abilities required for the performance of hazardous tasks suchas operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8)].
Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

9454

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MEDICATION GUIDEREGLAN® (REG-lan)(metoclopramide) tablets, oral use
Read this Medication Guide before you start taking REGLAN and each time you get a refill. There may be new information.
If you take another product that contains metoclopramide (such as REGLAN injection, metoclopramide orally disintegratingtablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of theinformation may be different. This information does not take the place of talking with your healthcare provider 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 cannot
control these movements. They may not go away even after stopping REGLAN. There is no treatment for tardive
dyskinesia, but symptoms may decrease or go away over time after you stop taking REGLAN.
Your chances for getting tardive dyskinesia increase:•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 an older woman.

•

if you have diabetes.

It is not possible for your healthcare provider to know if you will get tardive dyskinesia if you take REGLAN.
Call your healthcare provider right away if you get movements you cannot stop or control, such as:
•
•
•
•
•

lip smacking, chewing, or puckering up your mouthfrowning or scowlingsticking out your tongue
blinking and moving your eyes
shaking of your arms and legs

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 when certain other treatments do
not work.

• to relieve the symptoms of slow stomach emptying in people with diabetes.
Reglan is not recommended for use in children.
Do not take REGLAN if you:•have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking
REGLAN or a medicine that works like REGLAN.

•

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 a type of tumor that can cause high blood pressure such as pheochromocytoma.

•

have epilepsy (seizures). REGLAN can increase your chance for seizures and make them worse.

•

are allergic to metoclopramide. REGLAN can cause serious allergic reactions. Stop taking REGLAN right away
and get emergency help if you have any of these symptoms:
o swelling of your tongue, throat, lips, eyes or face.
o trouble swallowing or breathing.
oskin rash, hives, sores in your mouth, or skin blisters.

Before taking REGLAN, tell your healthcare provider about all of your medical conditions, including if you:•have diabetes. Your dose of insulin may need to be changed.

•

had problems controlling your muscle movements after taking any medicine.

•have Parkinson’s disease.

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have a type of tumor that can cause high blood pressure (pheochromoctyoma).

•have kidney or liver disease.

•

have or had depression or mental illness.

•have high blood pressure.

•

have heart failure or heart rhythm problems.

•

have breast cancer.

•

drink alcohol.

•

have seizures•

are pregnant or plan to become pregnant. REGLAN may harm your unborn baby if taken during the end of
pregnancy. Talk to your healthcare provider if you become pregnant while taking REGLAN.

•

are breastfeeding or plan to breastfeed. REGLAN can pass into your breast milk and may harm your baby. You
and your healthcare provider should decide if you will take REGLAN or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
REGLAN may affect the way other medicines work, and other medicines may affect how REGLAN works.
Tell your healthcare provider before you start or stop other medicines.
Especially tell your healthcare provider if you take:•another medicine that contains metoclopramide, such as REGLAN injection or metoclopramide oral solution•

a medicine for Parkinson’s disease•a blood pressure medicine•

a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI)•an anti-psychotic medicine, used to treat mental illness such as schizophrenia•

insulin• medicines that can make you sleepy, such as anti-anxiety medicines, sleep medicines, and narcotics
If you are not sure if your medicine is one listed above, ask your healthcare provider or pharmacist.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get
a new medicine.
How should I take REGLAN?
•

Take REGLAN exactly as your healthcare provider tells you. Do not change your dose unless your healthcare
provider tells you to.

•

REGLAN comes as a tablet you take by mouth.

•

You should not take REGLAN for more than 12 weeks.

•

Take REGLAN at least 30 minutes before each meal and at bedtime.

•

If you take too much REGLAN, call your poison control center at 1-800-222-1222 or go to the nearest emergency
room 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, operate machinery, or do other dangerous activities until you know how REGLAN affects you.
REGLAN may cause sleepiness or dizziness.

What are the possible side effects of REGLAN?
•

Tardive dyskinesia (abnormal muscle movements). See “What is the most important information I need toknow about REGLAN?”•

Other changes in muscle control and movement, such as:o Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs
(dystonia). These muscle spasms can cause abnormal movements and body positions, and speech
problems. These spasms usually start within the first 2 days of treatment. Rarely, these muscle spasms may
cause trouble breathing. These spasms happen more often in adults less than 30 years of age.
o 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 taking REGLAN.
o Being unable to sit still or feeling you need to move your hands, feet, or body (akathisia). Symptoms

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can include feeling jittery, anxious, irritated or unable to sleep (insomnia), feeling the need to walk around(pacing) and tapping your feet.
•

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.

•

Depression, thoughts about suicide, and suicide. Some people who take REGLAN become depressed, even if
they have no history of depression. You may have thoughts about hurting or killing yourself. Some people whohave taken REGLAN have ended their own lives (suicide).
High blood pressure. REGLAN can cause your blood pressure to increase.

••

Too much body water. People who have certain liver problems or heart failure and take REGLAN may hold too
much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling ofyour hands, legs, or feet.

•

Increased prolactin. Tell your doctor if your menstrual periods stop, your breasts get larger and make milk, or you
cannot have sex (impotence). These symptoms go away when you stop taking REGLAN.
Call your healthcare provider 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
The most common side effects of REGLAN include:•

restlessness•

drowsiness•tiredness• lack of energy
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 REGLAN such as
headaches, and feeling dizzy or nervous.
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all thepossible 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?
• Store REGLAN at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep REGLAN in the bottle it comes in and away from light. Keep the bottle closed tightly.
Keep REGLAN and all medicines out of the reach of children.
General information about the safe and effective use of REGLAN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REGLAN fora 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.
You can ask your pharmacist or healthcare provider for information about REGLAN that is written for health professionals.
What are the ingredients in REGLAN?
Active ingredient: metoclopramide
Inactive ingredients:
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
REGLAN 10 mg tablets: magnesium stearate, mannitol, microcrystalline cellulose, stearic acid
Manufactured by: ANI Pharmaceuticals, Inc., Baudette, MN 56623

For more information, go to www.anipharmaceuticals.com or call 1-800-308-6755.
This Medication Guide has been approved by the U.S. Food and Drug Administration

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