Metoclopramide Nasal Spray

IMPORTANT WARNING:

Using metoclopramide nasal spray may cause you to develop a muscle problem called tardive dyskinesia. If you develop tardive dyskinesia, you will move your muscles, especially the muscles in your face in unusual ways. You will not be able to control or stop these movements. Tardive dyskinesia may not go away even after you stop using metoclopramide nasal spray. The longer you take metoclopramide, the greater the risk that you will develop tardive dyskinesia. Therefore, your doctor will probably tell you not to take metoclopramide products for longer than 12 weeks. The risk that you will develop tardive dyskinesia is also greater if you are taking medications for mental illness, if you have diabetes, or if you are elderly, especially if you are a woman. Call your doctor immediately if you develop any uncontrollable body movements, especially lip smacking, mouth puckering, chewing, frowning, scowling, sticking out your tongue, blinking, eye movements, or shaking arms or legs.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with metoclopramide nasal spray and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of using metoclopramide nasal spray.

WHY is this medicine prescribed?

Metoclopramide nasal spray is used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and feeling of fullness that lasts long after meals. Metoclopramide is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Metoclopramide nasal spray comes as a solution (liquid) to spray into the nose. It is usually sprayed into one nostril 4 times a day, 30 minutes before each meal and at bedtime for 2 to 8 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use metoclopramide nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

To use the nasal spray, follow these steps:

1. Remove the cap and the safety clip from the nasal spray pump.
2. If you are using the nasal spray pump for the first time, you must prime the pump. Hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. Point the bottle upright and away from your eyes. Press down and release the nozzle to release 10 sprays into the air away from the face. If you have not used your nasal spray for more than 14 days, reprime the pump with 10 sprays.
3. Close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril. Point the tip toward the back and outer side of the nose. Use your forefinger and middle finger to press firmly down on the nozzle and release a spray. Following the spray, sniff gently and breathe out slowly through your mouth.
4. Wipe the applicator with a clean tissue and cover it with the cap.

If you are not sure that the nasal spray entered your nose, do not repeat the dose, and continue your regular dosing schedule.

What SPECIAL PRECAUTIONS should I follow?

Before using metoclopramide nasal spray,

• tell your doctor and pharmacist if you are allergic to metoclopramide, any other medications, or any of the ingredients in metoclopramide nasal spray. Ask your doctor or pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: antipsychotics (medications to treat mental illness) such as haloperidol (Haldol); apomorphine (Kynmobi); atovaquone (Mepron, in Malarone); bromocriptine (Parlodel, Cycloset); bupropion (Aplenzin, Forfivo, Wellbutrin, in Contrave); cabergoline; cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diphenoxylate (in Lomotil), fluoxetine (Prozac, Sarafem, in Symbyax) fosfomycin (Monurol); insulin; levodopa (in Rytary, in Sinemet, in Stalevo); loperamide (Imodium); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate); opioid-containing medications for pain; paroxetine (Paxil, Pexeva); posaconazole (Noxafil); pramipexole (Mirapex); quinidine (in Nuedexta); ropinirole (Requip); rotigotine (Neupro); sedatives; sirolimus (Rapamune); sleeping pills; tacrolimus (Astagraf, Prograf); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects. Many other medications may also interact with metoclopramide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had blockage, bleeding, or a tear in your stomach or intestines; pheochromocytoma (tumor on a small gland near the kidneys); problems controlling or moving your muscles after taking any other medication; or seizures. Your doctor will probably tell you not to use metoclopramide nasal spray.

• tell your doctor if you have or have ever had Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); high blood pressure; depression or other mental illness; breast cancer; asthma; glucose-6-phosphate dehydrogenase (G-6PD) deficiency (an inherited blood disorder); NADH cytochrome B5 reductase deficiency (an inherited blood disorder); heart failure, irregular heartbeat, or other heart problems; or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using metoclopramide nasal spray, call your doctor.

• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects of metoclopramide worse.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Metoclopramide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• unpleasant taste in mouth
• drowsiness
• excessive tiredness
• weakness
• headache
• dizziness
• diarrhea
• nausea
• breast enlargement or discharge
• missed menstrual period
• decreased sexual ability
• frequent urination
• inability to control urination

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• tightening of the muscles, especially in the jaw or neck
• depression
• thinking about harming or killing yourself
• fever
• muscle stiffness
• confusion
• fast, slow, or irregular heartbeat
• sweating
• restlessness
• nervousness or jitteriness
• agitation
• difficulty falling asleep or staying asleep
• pacing
• foot tapping
• slow or stiff movements
• blank facial expression
• uncontrollable shaking of a part of the body
• difficulty keeping your balance
• rash
• hives
• swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• high-pitched sounds while breathing

Metoclopramide may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the bottle it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of the bottle 4 weeks after opening, even if there is some solution left in the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

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

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.