Reglan

You should tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Acetaminophen (Tylenol, others)
• Antihistamines
• Aspirin
• Atropine (in Lonox, in Lomotil)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal)
• Digoxin (Lanoxicaps, Lanoxin)
• Haloperidol (Haldol)
• Insulin
• Ipratropium (Atrovent)
• Lithium (Eskalith, Lithobid)
• Levodopa (in Sinemet, in Stalevo)
• Medications for anxiety, blood pressure, irritable bowel disease, motion sickness, nausea, Parkinson's disease, ulcers, or urinary problems
• Monoamine oxidase inhibitors (MAOIs) including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• Narcotic medications for pain
• Sedatives
• Sleeping pills
• Tetracycline (Bristacycline, Sumycin)
• Tranquilizers

Reglan and Alcohol

You shouldn't consume alcohol while taking this medication. Drinking alcohol can increase your risk for developing side effects.

Reglan and Other Interactions

Reglan may make you drowsy, so avoid driving or operating machinery until you know how this medicine affects you.

Reglan comes as an oral tablet, dissolving tablet, and liquid to take by mouth. Follow your doctor's instructions carefully when taking this medication; don't take more or less of the drug than is prescribed.

If you take the disintegrating tablet, make sure you use dry hands to remove the tablet from the package. If the tablet breaks or crumbles, throw it away and remove a new tablet.

The following are typical dosage schedules:

For GERD: The typical dose of Reglan for treating symptoms of GERD is 10-15 milligrams (mg), four times daily. Each dose is typically given 30 minutes before a meal.

For gastroparesis: The typical dose of Reglan for treating gastroparesis is 10 mg, four times daily. Each dose is typically given 30 minutes before a meal and at bedtime.

Reglan Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Reglan

If you miss a dose of Reglan, take it as soon as you remember.

However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule. Don't take extra doses to make up for a missed one.

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 clear-cut relationship to metoclopramide. Rarely, hallucinations have been reported.

Extrapyramidal Reactions (EPS)

Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS).

Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS).

Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS).

Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage.

Neuroleptic Malignant Syndrome

Rare occurrences of neuroleptic malignant syndrome (NMS) have been reported. This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, 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 clear-cut relationship to metoclopramide. Methemoglobinemia, in adults and especially with overdosage in neonates (see OVERDOSE). Sulfhemoglobinemia in adults.

Allergic Reactions

A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.

Miscellaneous

Visual disturbances. Porphyria.

• ANI Pharmaceuticals, Inc.

• Baxter Healthcare Corporation

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Reglan there are no specific foods that you must exclude from your diet when receiving this medication.

Contraindications

• Mechanical obstruction or perforation or other situations in which stimulation of GI motility might be dangerous.5 267

• GI hemorrhage5 267 (however, has been used to empty the stomach of blood prior to endoscopy in patients with acute upper GI hemorrhage).4 125

• Pheochromocytoma (due to potential for hypertensive crisis).5 267

• History of seizure disorders.4 5 267

• Concomitant therapy with drugs likely to cause extrapyramidal reactions (e.g., phenothiazines, butyrophenones).4 5 267

• Known intolerance to metoclopramide.5 267

• Known hypersensitivity to metoclopramide or any ingredient in the formulation.5 267

Warnings/Precautions

Warnings

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements involving the tongue, face, mouth, or jaw, and sometimes the trunk and/or extremities, may occur; movements may be choreoathetotic in appearance.5 93 94 130 157 158 159 267 270 271 272 (See Boxed Warning.)

Reported in about 20% of patients receiving the drug for ≥12 weeks.5 267 270 271 Avoid use of metoclopramide for >12 weeks in all but rare cases where therapeutic benefit is thought to outweigh risk of developing tardive dyskinesia.5 267 272

Although risk of developing tardive dyskinesia may be increased in geriatric patients, women, and patients with diabetes mellitus, it is not possible to predict which patients will develop metoclopramide-induced tardive dyskinesia.5 267 270 271 272 Risk of occurrence and irreversibility increases with increasing duration of therapy and total cumulative dose.5 267 271 272

Discontinue metoclopramide in patients who develop signs or symptoms of tardive dyskinesia.5 267 270 271 There is no known effective treatment for tardive dyskinesia; however, tardive dyskinesia may remit, either partially or completely, in some patients within several weeks to months after discontinuance.5 267 271

Metoclopramide may suppress or partially suppress signs of tardive dyskinesia, thereby masking the underlying disease process; effect of this suppression on the long-term course of tardive dyskinesia is unknown.5 267 Do not use metoclopramide for symptomatic control of tardive dyskinesia.5 267

Potential for extrapyramidal reactions,4 5 90 91 125 169 205 206 207 267 especially in pediatric patients and adults <30 years of age or when high doses (e.g., IV doses for prophylaxis of cancer chemotherapy-induced nausea and vomiting) are administered.5 91 169 267

Commonly manifested as acute dystonic reactions or akathisia; stridor and dyspnea (possibly due to laryngospasm) reported rarely.5 267

Generally occur within 24–48 hours after starting therapy5 205 206 207 267 and usually subside within 24 hours following drug discontinuance.4 90 205

Most patients respond rapidly to treatment with diazepam4 or an agent with central anticholinergic activity (e.g., diphenhydramine hydrochloride 20–50 mg orally, IM, or IV;5 267 275 276 benztropine 1–2 mg IM5 267 ).4 5 170 206 207 267

Parkinsonian symptoms (e.g., tremor, rigidity, bradykinesia, akinesia) occur rarely; may be associated with usual160 or excessive metoclopramide doses62 or decreased renal function.9 54

Possible exacerbation of parkinsonian symptoms;5 9 54 62 160 267 use with caution, if at all, in patients with parkinsonian syndrome.5 267

More common during first 6 months of therapy but occur occasionally after longer periods.5 267

Symptoms generally subside within 2–3 months following drug discontinuance.5 267

NMS (characterized by hyperthermia, varying levels of consciousness, muscular rigidity, and autonomic dysfunction) reported rarely.5 208 267

Important to determine whether untreated or inadequately treated extrapyramidal reactions and serious medical illness (e.g., pneumonia, systemic infection) may coexist.5 267 Also consider the possibility of central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever, and primary CNS pathology.5 267

Immediately discontinue metoclopramide and other drugs not considered essential, provide intensive symptomatic treatment, monitor patient, and treat any concomitant serious medical condition for which specific therapies are available.5 267 Dantrolene and bromocriptine have been used in the treatment of NMS, but their efficacy has not been established and there currently is no specific drug therapy.5 267

Mild to severe depression (including suicidal ideation and suicide) has occurred in patients with or without prior history of depression.5 210 211 215 267

Use with extreme caution and only when anticipated benefits outweigh possible risks in patients with a history of mental depression, especially those with suicidal tendencies.5 267

Sensitivity Reactions

Theoretical potential for patients who are allergic to procainamide to exhibit cross-sensitivity to metoclopramide (since the drugs are structurally similar).11 12

General Precautions

When deciding whether to use metoclopramide or NG suction to prevent postoperative nausea and vomiting, consider the possibility that metoclopramide theoretically could produce increased pressure on suture lines following GI anastomosis or closure.267

Possible transient increases in plasma aldosterone concentrations and sodium retention; closely monitor patients (e.g., those with CHF or cirrhosis) at risk of developing fluid retention and volume overload or hypokalemia.3 5 69 267

Discontinue metoclopramide if fluid retention or volume overload occurs at any time during therapy.5 267

Possible increase in circulating catecholamines in hypertensive patients; use with caution in these patients.5 267

Drowsiness may occur, particularly at higher dosages.5 267 Performance of activities requiring mental alertness and physical coordination (operating machinery, driving a motor vehicle) may be impaired.5 267

Adverse reactions, particularly CNS reactions, may occur following discontinuance of drug.5 Some patients may experience withdrawal symptoms including dizziness, nervousness, and/or headaches following discontinuance.5

Patients with cytochrome-b5 reductase deficiency have an increased risk of methemoglobinemia and/or sulfhemoglobinemia when metoclopramide is administered.5 267

Methylene blue is not recommended for treatment of metoclopramide-induced methemoglobinemia in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.5 267

Specific Populations

Category B.5 267

Distributed into milk.5 139 140 267 Use caution in nursing women.5 267

Manufacturers currently recommend use in children only to facilitate intubation of the small intestine;267 however, has been effective for the management of gastric stasis†178 180 181 and gastroesophageal reflux†179 182 in infants and children.

Use with caution; incidence of extrapyramidal reactions is increased in children.5 91 125 156 267

Use with caution in neonates.5 267 Neonatal susceptibility to methemoglobinemia is increased due to prolonged clearance (may cause excessive serum concentrations) in combination with decreased neonatal levels of cytochrome-b5 reductase.5 267

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.5 267

Possible increased risk of tardive dyskinesia.5 267

Risk of adverse parkinsonian effects increases with increasing dosage; administer lowest effective dosage in geriatric patients.5 267 If parkinsonian symptoms develop, generally should discontinue metoclopramide before initiating specific antiparkinsonian therapy.5 267

Confusion and oversedation may occur.5 267

Substantially eliminated by kidneys; risk of adverse reactions may be greater in patients with impaired renal function.5 267 (See Renal Impairment under Dosage and Administration.)

Select dosage with caution because of age-related decreases in renal function and concomitant disease and drug therapy.5 267 (See Geriatric Patients under Dosage and Administration).

Possible increased risk of fluid retention and hypokalemia in patients with cirrhosis.3 5 69 267 (See Fluid and Electrolyte Effects under Cautions.)

Discontinue if fluid retention or volume overload occurs at any time during therapy.5 267

Clearance may be reduced.5 54 59 142 192 267 Possible increased risk of adverse effects.5 267 Use with caution; reduce dosage during prolonged therapy in patients with renal impairment.5 54 58 59 69 135 142 267 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Restlessness, drowsiness, fatigue, lassitude, nausea, bowel disturbances (principally diarrhea).4 5 90 125 267

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metoclopramide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metoclopramide in the elderly. However, elderly patients are more likely to have side effects such as tardive dyskinesia, confusion, or drowsiness, and age-related kidney problems, which may require an adjustment in the dose for patients receiving metoclopramide.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline
• Amoxapine
• Aripiprazole
• Asenapine
• Bupropion
• Chlorpromazine
• Citalopram
• Clomipramine
• Clozapine
• Desipramine
• Desvenlafaxine
• Doxepin
• Duloxetine
• Escitalopram
• Fluoxetine
• Fluphenazine
• Fluvoxamine
• Haloperidol
• Iloperidone
• Imipramine
• Loxapine
• Lurasidone
• Maprotiline
• Mesoridazine
• Mirtazapine
• Molindone
• Nefazodone
• Nortriptyline
• Olanzapine
• Paliperidone
• Paroxetine
• Perphenazine
• Pimozide
• Prochlorperazine
• Promazine
• Promethazine
• Protriptyline
• Quetiapine
• Risperidone
• Rivastigmine
• Thioridazine
• Thiothixene
• Trazodone
• Trifluoperazine
• Trimethobenzamide
• Venlafaxine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bromocriptine
• Digoxin
• Isocarboxazid
• Linezolid
• Milnacipran
• Phenelzine
• Rasagiline
• Selegiline
• Tramadol
• Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine
• Didanosine
• Levodopa
• Mivacurium
• Sertraline
• Succinylcholine
• Tacrolimus
• Thiopental

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abdominal or stomach bleeding or
• Intestinal blockage or perforation (hole in the intestine) or
• Pheochromocytoma (adrenal gland tumor) or
• Seizures or epilepsy—Should not be used in patients with these conditions.

• Asthma or
• Cirrhosis (liver disease) or
• Congestive heart failure or
• Diabetes or
• Heart rhythm problems (e.g., ventricular arrhythmia) or
• Hypertension (high blood pressure) or
• Mental depression, or history of or
• Neuroleptic malignant syndrome, history of or
• Parkinson's disease, history of—Use with caution. May make these conditions worse.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) or
• Nicotinamide adenine dinucleotide (NADH) cytochrome reductase deficiency (an enzyme problem)—May increase the risk for side effects affecting the blood.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Diabetic Gastroparesis (Diabetic Gastric Stasis)

Reglan Injection (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.

The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy

Reglan Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.

The Prevention of Postoperative Nausea and Vomiting

Reglan Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.

Small Bowel Intubation

Reglan Injection may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.

Radiological Examination

Reglan Injection may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.