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 for assessing the tumor promotion potential, a 2-week oral treatment with metoclopramide at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose based on body surface area) enhanced the tumorigenic effect of N-nitrosodiethylamine.
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.
Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 5 mg metoclopramide. Available in bottles of 100 (NDC 0093-2204-01) and 500 (NDC 0093-2204-05).
Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1,000 (NDC 0093-2203-10).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
Dispense in a tight, light-resistant container.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients or their caregivers that metoclopramide tablets can cause serious adverse reactions. Instruct patients to discontinue metoclopramide tablets 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 metoclopramide tablets.
Inform patients or their caregivers that metoclopramide tablets 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) ].
Dispense with Medication Guide available at: www.tevausa.com/medguides
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Parsippany, NJ 07054
Rev. R 8/2021
|Dispense with Medication Guide available at: www.tevausa.com/medguides|
Metoclopramide (met” oh kloe’ pra mide) Tablets
Read this Medication Guide before you start taking metoclopramide tablets and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide 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 metoclopramide tablets?
Metoclopramide tablets 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 metoclopramide tablets. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking metoclopramide tablets.
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 metoclopramide tablets.
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 metoclopramide tablets? ” for more information about side effects.
What are metoclopramide tablets?
Metoclopramide tablets are a prescription medicine used in adults:
Metoclopramide tablets are not recommended for use in children.
Do not take metoclopramide tablets if you:
Before taking metoclopramide tablets, 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.
Metoclopramide tablets may affect the way other medicines work, and other medicines may affect how metoclopramide tablets work.
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 metoclopramide tablets?
What should I avoid while taking metoclopramide tablets?
What are the possible side effects of metoclopramide tablets?
Call your healthcare provider and get medical help right away if you:
The most common side effects of metoclopramide tablets include:
You may have more side effects the longer you take metoclopramide tablets and the more metoclopramide tablets you take.
You may still have side effects after stopping metoclopramide tablets. You may have symptoms from stopping metoclopramide tablets 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 metoclopramide tablets. 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 metoclopramide tablets?
Keep metoclopramide tablets and all medicines out of the reach of children.
General information about the safe and effective use of metoclopramide tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets for a condition for which they were not prescribed. Do not give metoclopramide tablets to other people, even if they have the same symptoms that you have. They may harm them.
You can ask your pharmacist or healthcare provider for information about metoclopramide tablets that is written for health professionals. For more information, call 1-888-838-2872.
What are the ingredients in metoclopramide tablets?
Active ingredient: metoclopramide hydrochloride
Inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
|Manufactured In Croatia By: Pliva Hrvatska d.o.o., Zagreb, Croatia |
Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054
This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. E 8/2021
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.