Metozolv ODT

Generic Name: metoclopramide
Date of Approval: September 4, 2009
Company: Salix Pharmaceuticals, Ltd.

Treatment for: Diabetic Gastroparesis; Gastroesophageal Reflux Disease (GERD)

FDA Approves Metozolv ODT

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The U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv ODT (metoclopramide HCl) 5mg and 10mg orally disintegrating tablets. Metozolv ODT is indicated for the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.

Metozolv ODT melts on the tongue without the need for water, and offers patients who have trouble swallowing tablets a more convenient option than traditional metoclopramide tablets.

What is Metozolv ODT?

Metozolv ODT contains metoclopramide which increases muscle contractions in upper digestive tract. This speeds up the rate at which the stomach empties into the intestines.

Metozolv ODT is used to treat slow gastric emptying in people with diabetes (also called diabetic gastroparesis), which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals.

Metozolv ODT is also used short-term for the relief of heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms.

Metozolv ODT may also be used for other purposes not listed in this medication guide.

Important information about Metozolv ODT

You should not take this medication 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 taking Metozolv ODT, tell your doctor if you have kidney or liver disease, congestive heart failure, diabetes, or a history of depression.

Avoid drinking alcohol. It can increase some of the side effects of this medicine. There are many other medicines that can interact with Metozolv ODT. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Do not take Metozolv ODT in larger amounts than recommended, or for longer than 3 months. High doses or long-term use of this medicine may cause tremors or other uncontrollable muscle movements, especially in older women.

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). After you stop taking Metozolv ODT, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Before taking Metozolv ODT

You should not take this medication 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).

Before taking Metozolv ODT, tell your doctor if you have

• kidney disease;
• liver disease (especially cirrhosis);
• congestive heart failure;
• diabetes (your insulin dose may need adjusting); or
• a history of depression.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Metozolv ODT.

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

How should I take Metozolv ODT?

Take Metozolv ODT exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take it in larger amounts than recommended, or for longer than 3 months. High doses or long-term use of Metozolv ODT may cause tremors or other uncontrollable muscle movements, especially in older women. Follow the directions on your prescription label.

Do not take Metozolv ODT in larger amounts or for longer than 3 months.

Metozolv ODT is designed to melt on the tongue without the need for water.

Metozolv ODT is usually taken before meals and at bedtime. Your doctor may want you to take the medication as needed. Follow your doctor's instructions.

Store this medicine at room temperature away from moisture and heat.

After you stop taking Metozolv ODT, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, confusion, tremors or uncontrolled muscle movements in face or neck, or seizure (convulsions).

What should I avoid while taking Metozolv ODT?

Narcotic pain medicine, sleeping pills, and medicine for anxiety can add to sleepiness caused by Metozolv ODT. Tell your doctor if you regularly use any of these other medicines. Avoid drinking alcohol. It can increase some of the side effects of this medicine. Metozolv ODT can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Metozolv ODT side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Metozolv ODT and call your doctor at once if you have any of these serious side effects:

• tremors, or restless muscle movements in your eyes, tongue, jaw, or neck;
• mask-like appearance of the face;
• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
• depressed mood, thoughts of suicide or hurting yourself;
• hallucinations, anxiety, agitation, jittery feeling, trouble staying still;
• swelling, fluid retention;
• jaundice (yellowing of your skin or eyes); or
• seizure (convulsions).

Less serious Metozolv ODT side effects may include:

• feeling restless, drowsy, tired, or dizzy;
• headache, sleep problems (insomnia);
• nausea, diarrhea;
• breast tenderness or swelling;
• changes in your menstrual periods; or
• urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Metozolv ODT?

Before taking Metozolv ODT, tell your doctor if you are taking any of the following medicines:

• acetaminophen (Tylenol);
• cyclosporine (Gengraf, Neoral, Sandimmune);
• digoxin (digitalis, Lanoxin);
• glycopyrrolate (Robinul);
• levodopa (Larodopa, Atamet, Parcopa, Sinemet);
• mepenzolate (Cantil);
• tetracycline (Brodspec, Panmycin, Robitet, Sumycin, Tetracap, and others);
• atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• bladder or urinary medications such as darifenacin (Enablex), tolterodine (Detrol), or solifenacin (Vesicare);
• bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), or propantheline (Pro-Banthine); or
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with Metozolv ODT. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Metozolv ODT.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Metozolv ODT only for the indication prescribed.

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