Reglan Metoclopramide Hydrochloride

Get an overview of REGLAN (metoclopramide hydrochloride tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Reglan can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Reglan.

Drug Basics

Brand Name: Reglan

Generic Name: METOCLOPRAMIDE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2018-10-05

indications & 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 of methemoglobinemia in neonates [see Use in Specific Populations (8.4)].

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. Instruct patients 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 other extrapyramidal 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 aware that 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 such as operating machinery or driving a motor vehicle [see Warnings and Precautions ( 5.8)].

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

ani logo.jpg

9454

medication guide

REGLAN® (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 disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information 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 lessen 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 mouth
  • frowning or scowling
  • sticking 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:
    • oswelling of your tongue, throat, lips, eyes or face.
    • otrouble 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.
  • 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 to know 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 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 despression. You may have thoughts about hurting or killing yourself. Some people who have 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 of your 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:

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 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?

  • 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 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.

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

ani logo2.jpg

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.                                                                                                Revised: August 2017

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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