Reglan

Reglan 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. Reglan is also used to prevent nausea and vomiting that can happen with cancer chemotherapy, prevent nausea and vomiting that may happen after surgery, help make it easier to insert a tube into the small intestine, and help empty stomach contents or to help barium move through your intestine, when you get an X-ray examination of the stomach or small intestine.

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

This medication comes in tablet form. Reglan tablets are usually taken four times a day, before meals and at bedtime.

Reglan is also available as an injection which can be given into a vein (IV) or into the muscle (IM) by a healthcare professional.

Common side effects include restlessness, headache, and confusion. Reglan can cause dizziness and drowsiness.  Do not drive or operate machinery until you know how it will affect you.

Reglan 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
• prevent nausea and vomiting that can happen with cancer chemotherapy
• prevent nausea and vomiting that may happen after surgery, if your doctor decides that you should not be treated with a stomach tube and suction
• help make it easier to insert a tube into the small intestine, if the tube does not pass into the stomach normally
• help empty stomach contents or to help barium move through your intestine, when you get an X-ray examination of the stomach or small intestine

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

• ANI Pharmaceuticals, Inc.

• Baxter Healthcare Corporation

Reglan can cause serious side effects. See "Drug Precautions".

Common side effects of Reglan include:

• feeling restless, sleepy, tired, dizzy, or exhausted
• headache
• confusion
• trouble sleeping

Infusion related side effects can happen if Reglan injection is given too fast. You may feel very anxious and restless for a short time, and then become sleepy while you are receiving a dose of Reglan injection. Tell your doctor or nurse right away if this happens.

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

You may still have side effects after stopping Reglan. You may have symptoms from stopping (withdrawal) Reglan 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 Reglan.

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 Reglan
• 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)

Reglan 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.

Reglan 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 Reglan. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking Reglan.

Your chances for getting TD go up:

• the longer you take Reglan and the more Reglan you take. You should not take Reglan 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 Reglan.

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 Reglan become depressed. You may have thoughts about hurting or killing yourself. Some people who take Reglan have ended their own lives (suicide).

• Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with Reglan. 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 Reglan.

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 drink alcohol while receiving Reglan injection. Alcohol may make some side effects of Reglan injection worse, such as feeling sleepy.

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

Do not take Reglan if you:

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

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 Reglan 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
• Parkinson's disease
• high blood pressure
• kidney problems. Your doctor may start with a lower dose.
• liver problems or heart failure. Reglan may cause your body to hold fluids.
• diabetes. Your dose of insulin may need to be changed.
• breast cancer
• you are pregnant or plan to become pregnant. It is not known if Reglan will harm your unborn baby.
• you are breastfeeding. Reglan can pass into breast milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take Reglan.

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.

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

Reglan has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Reglan, 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 Reglan exactly as prescribed. Do not change your dose unless your doctor tells you.

Reglan comes in tablet form. The tablets are 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 Reglan for more than 12 weeks.

Reglan is also available as an injection which can be given into a vein (IV) or into the muscle (IM) by a healthcare professional.

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

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

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Reglan at the same time.

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

Reglan dosing for GERD:

• The usual recommended Reglan (metoclopramide) dose for the treatment of GERD is 10 mg or 15 mg taken four times a day before meals and at bedtime.
• For some patients, instead of the continuous dosing regimen, single doses of up to 20 mg are preferred.

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

Reglan dosing for Diabetic Gastroparesis:

• The usual recommended Reglan (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, Reglan therapy may begin with an injectable form (IM or IV) of Reglan.

Reglan dosing for prevention of nausea and vomiting associated with chemotherapy:

• The usual recommended Reglan (metoclopramide) dose range for the prevention of nausea and vomiting associated with chemotherapy is 1 mg/kg -2 mg/kg, and is to be given through the vein (IV). Reglan should be given 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.

Reglan dosing for prevention of nausea and vomiting after surgery:

• The usual recommended Reglan (metoclopramide) dose range for the prevention of nausea and vomiting after surgery is 10-20 mg, and is to be given into the muscle (IM).

Reglan dosing to facilitate small bowel intubation and to aid in radiological examinations:

• The usual recommended Reglan doses to facilitate small bowel intubation is the following is the following:
  • Pediatric patients above 14 years of age and adults:10 mg Reglan base
  • Pediatric patients (6-14 years of age): 2.5 to 5 mg Reglan base
  • Under 6 years of age: 0.1 mg/kg Reglan  base

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

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

Keep Reglan and all medicines out of the reach of children.

WARNING: TARDIVE DYSKINESIA

Treatment with metoclopramide 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.

Reglan 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 Reglan treatment is stopped.

Treatment with Reglan 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.