Metozolv

Metozolv ODT is a prescription medication used to treat gastroesophageal reflux disease (GERD) when certain other treatments do not work and to relieve symptoms of slow stomach emptying in people with diabetes. 

Metozolv ODT belongs to a group of drugs called prokinetic agents, which speed the movement of food through the digestive system.

This medication comes as an orally disintegrating tablet and is usually taken four times a day, before meals and at bedtime.

Common side effects include headache, nausea, vomiting, tiredness, and sleepiness. 

Metozolv ODT is a prescription medicine used to:

• treat gastroesophageal reflux disease (GERD) when certain other treatments do not work (short-term)
• relieve symptoms of slow stomach emptying in people with diabetes

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Salix Pharmaceuticals, Inc.

Metozolv ODT can cause serious side effects. See "Drug Precautions".

Common side effects of Metozolv ODT include:

• headache
• nausea
• vomiting
• fatigue
• somnolence

You may have more side effects the longer you take Metozolv ODT and the more Metozolv ODT you take.

You may still have side effects after stopping Metozolv ODT. You may have symptoms from stopping (withdrawal) Metozolv ODT such as headaches, and feeling dizzy or nervous.

Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of Metozolv ODT.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1–800–FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• another medicine that contains Metozolv ODT
• a blood pressure medicine
• a medicine for depression, especially Monoamine Oxidase Inhibitors (MAOI's) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• insulin
• a medicine that can make you sleepy, such as anti-anxiety medicine, tranquilizers, sedatives, hypnotics, sleep medicines, and narcotics
• digoxin (Lanoxin)
• acetaminophen (Tyelnol)
• tetracycline
• levodopa
• alcohol
• cyclosporine (Neoral, Sandimmune, Gengraf)

Metozolv ODT can affect how fast your food will be delivered to your intestines, so the timing and dosage of insulin may needs to be adjusted.

If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Metozolv ODT can cause serious side effects, including:

Serious side effects have been reported including:

• Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping Metozolv ODT. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking Metozolv ODT.

Your chances for getting TD go up:

• the longer you take Metozolv ODT and the more Metozolv ODT you take. You should not take Metozolv ODT for more than 12 weeks.
• if you are older, especially if you are a woman
• if you have diabetes

It is not possible for your doctor to know if you will get TD if you take Metozolv ODT.

Call your doctor right away if you get movements you can not 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

• 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. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults under age 30.
• Depression, thoughts about suicide, and suicide. Some people who take Metozolv ODT become depressed. You may have thoughts about hurting or killing yourself. Some people who take Metozolv ODT have ended their own lives (suicide).

• Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with Metozolv ODT. 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.
• 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 receiving Metozolv ODT.
• High blood pressure. Metozolv ODT can cause your blood pressure to increase. 
• Too much body water. People who have certain liver problems or heart failure and take Metozolv ODT 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.

Call your doctor 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

Do not take Metozolv ODT if you:

• have stomach or intestine problems that could get worse with Metozolv ODT, such as bleeding, blockage or a tear in the stomach or bowel wall
• have an adrenal gland tumor called a pheochromocytoma
• are allergic to metoclopramide or anything in it
• take medicines that can cause uncontrolled movements, such as medicines for mental illness
• have seizures

Do not drink alcohol while taking Metozolv ODT. Alcohol may make some side effects of Metozolv ODT worse, such as feeling sleepy. 

Do not drive, work with machines, or do dangerous tasks until you know how Metozolv ODT affects you. Metozolv ODT may cause sleepiness.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Metozolv ODT there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor about all your medical conditions, including if you have:

• depression or mental illness
• Parkinson's disease
• high blood pressure
• kidney problems. Your doctor may start with a lower dose.
• liver problems or heart failure. Metozolv ODT may cause your body to hold fluids.
• heart rhythm problems
• diabetes. Your dose of insulin may need to be changed.
• breast cancer
• drink alcohol
• you are pregnant or plan to become pregnant
• you are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Metozolv ODT falls into category B. There are no well-done studies that have been done in humans with Metozolv ODT. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Metozolv ODT has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Metozolv ODT, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Metozolv ODT exactly as prescribed. Do not change your dose unless your doctor tells you.

Metozolv ODT comes as a tablet that melts in your mouth. Metozolv ODT is usually taken four times a day (30 minutes before meals and at bedtime). For some patients less frequent dosing may be appropriate. 

• You should not take Metozolv ODT for more than 12 weeks. 

To take Metozolv ODT: 

1. Leave the tablet in the sealed blister Metozolv ODT pack until you are ready to take it. 
2. Use dry hands to open a blister and take out a tablet. If the tablet breaks or crumbles throw it away and take a new tablet out of the blister pack. 
3. Put the tablet on your tongue right away. Let it melt and then swallow. You do not need water to take Metozolv ODT.

If you take too much Metozolv ODT, call your doctor or Poison Control Center.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• your kidney function
• your weight

Metozolv ODT dosing for GERD:

• The usual recommended Metozolv ODT (metoclopramide) dose for the treatment of GERD is 10 mg or 15 mg taken up to four times a day (before meals and at bedtime).

Metozolv ODT is approved for short-term treatment of GERD (up to 12 weeks).

Metozolv ODT dosing for Diabetic Gastroparesis:

• The usual recommended Metozolv ODT (metoclopramide) dose for the treatment of diabetic gastroparesis is 10 mg taken four times a day before meals and at bedtime.
• Treatment may continue for two to eight weeks.
• If severe diabetic gastroparesis symptoms are present, therapy may begin with an injectable form (IM or IV) of metoclopramide.

If you take too much Metozolv ODT, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Metozolv ODT is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep Metozolv ODT at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Metozolv ODT in the bottle it comes in. Keep the bottle closed tightly.

Keep Metozolv ODT and all medicines out of the reach of children.

WARNING: TARDIVE DYSKINESIA

Treatment with Metozolv ODT can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.

Metozolv ODT therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after Metozolv ODT treatment is stopped.

Treatment with Metozolv ODT for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.