Reglan Metoclopramide Hydrochloride
Refer to the “Also Known As” section to reference different products that include the same medication as Reglan.
Brand Name: Reglan
Generic Name: METOCLOPRAMIDE HYDROCHLORIDE
Drug Type: HUMAN PRESCRIPTION DRUG
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)].
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
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:
Your chances for getting tardive dyskinesia increase:
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:
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:
Reglan is not recommended for use in children.
Do not take REGLAN if you:
Before taking REGLAN, tell your healthcare provider about all of your medical conditions, including if you:
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:
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?
What should I avoid while taking REGLAN?
What are the possible side effects of REGLAN?
Call your healthcare provider and get medical help right away if you:
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?
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
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. Revised: August 2017