Metozolv ODT

Name: Metozolv ODT

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include

  • drowsiness
  • confusion
  • seizures
  • unusual, uncontrollable movements
  • lack of energy
  • bluish coloring of the skin
  • headache
  • shortness of breath

What are some things I need to know or do while I take Metozolv ODT?

  • Tell all of your health care providers that you take Metozolv ODT (metoclopramide orally disintegrating tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • It may take several weeks to see the full effects.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Avoid alcohol or other drugs and natural products that slow your actions.
  • If you stop taking Metozolv ODT all of a sudden, you may have signs of withdrawal. Tell your doctor if you have any bad effects.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • If you are 65 or older, use Metozolv ODT with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Trouble swallowing.
  • Shakiness, trouble moving around, or stiffness.
  • Restlessness.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Enlarged breasts.
  • Nipple discharge.
  • Change in sex ability.
  • Period (menstrual) changes.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Patients who take Metozolv ODT may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.

Metozolv ODT Description

Metozolv ODT is an orally disintegrating tablet formulation of metoclopramide hydrochloride.  The 5 mg strength is a round white tablet debossed on one side with a “5” and plain on the other side; it is comprised of 5 mg metoclopramide (as 5.91 mg of metoclopramide hydrochloride ) with gelatin, mannitol, mint flavoring, and Acesulfame K (artificial sweetener).  The 10 mg strength is a round white tablet debossed on one side with a “10” and plain on the other side; it is comprised of 10 mg metoclopramide (as 11.82 mg of metoclopramide hydrochloride) with gelatin, mannitol, mint flavoring, and Acesulfame K. 

The active ingredient, metoclopramide hydrochloride, is a white crystalline, odorless substance, freely soluble in water.  Chemically, it is 4‑amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.  Its molecular formula is C14H22ClN3O2•HCl•H2O.  Its molecular weight is 354.3. The structural formula is shown in Figure 1.

Figure 1

Metozolv ODT includes the following inactive ingredients:  gelatin, mannitol, mint flavoring, Acesulfame potassium (artificial sweetener), and trace amounts of sodium chloride and sodium hydroxide.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Box of 100 Tablets, 5 mg

NDC 65649-431-02

100 Tablets

Rx only

METOZOLV®ODT

(metoclopramide HCl)
Orally Disintegrating Tablets

5 mg*

*Contains 5.91 mg metoclopramide hydrochloride equivalent to 5 mg metoclopramide

Dispense the enclosed Medication Guide to each patient.


Salix Pharmaceuticals, Inc.


PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Blister Sleeve 10 Tablets, 5 mg

NDC 65649-431-02

10 orally disintegrating tablets
Dispense the accompanying Medication Guide to each patient.

Rx only

METOZOLV®ODT

(metoclopramide HCl)
Orally Disintegrating Tablets

5 mg


Important information

NEVER TAKE METOZOLV ODT IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS.

High doses or long-term use of Metozolv ODT can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Metozolv ODT, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women, diabetics, and older adults.

You should not take Metozolv ODT if you are allergic to metoclopramide, or if you have bleeding or blockage in your stomach or intestines, epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).

Before you take Metozolv ODT, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression.

Do not drink alcohol. It can increase some of the side effects of Metozolv ODT.

There are many other medicines that can interact with Metozolv ODT. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop using Metozolv ODT and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

Before taking this medicine

You should not take Metozolv ODT if you are allergic to metoclopramide, or if you have:

  • bleeding or blockage in your stomach or intestines;

  • a perforation (hole) in your stomach or intestines;

  • epilepsy or other seizure disorder; or

  • an adrenal gland tumor (pheochromocytoma).

To make sure you can safely take Metozolv ODT, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • liver disease (especially cirrhosis);
  • congestive heart failure, a heart rhythm disorder;

  • high blood pressure;

  • breast cancer;

  • Parkinson's disease;

  • diabetes (your insulin dose may need adjusting); or

  • depression or mental illness.

FDA pregnancy category B. Metozolv ODT is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Metoclopramide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Metozolv ODT may contain phenylalanine. Talk to your doctor before using this form of metoclopramide if you have phenylketonuria (PKU).

Metozolv ODT should not be given to a child.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include drowsiness, confusion, tremors or uncontrolled muscle movements in your face or neck, or seizure (convulsions).

What should I avoid?

Avoid drinking alcohol. It can increase some of the side effects of Metozolv ODT. Metoclopramide may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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