Reglan

DRUG DESCRIPTION

For oral administration, reglan® tablets (metoclopramide tablets, USP) 10 mg are white, scored, capsule-shaped tablets engraved REGLAN (metoclopramide) on one side and SP 10 on the opposite side.

Each tablet contains

Metoclopramide base .................................................. 10 mg (as the monohydrochloride monohydrate)

Inactive Ingredients

Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Stearic Acid.

reglan® tablets (metoclopramide tablets, USP) 5 mg are green, elliptical-shaped tablets engraved REGLAN (metoclopramide) 5 on one side and SP on the opposite side.

Each tablet contains

Metoclopramide base .................................................... 5 mg (as the monohydrochloride monohydrate)

Inactive Ingredients

Corn starch, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, Lactose, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid.

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 C14H22CIN3O2•HCl•H2O. Its molecular weight is 354.3.

Reglan®  
(metoclopramide) Structural Formula Illustration

What are the possible side effects of metoclopramide (Metozolv ODT, Reglan)?

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 metoclopramide 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;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might...

Read All Potential Side Effects and See Pictures of Reglan »

What are the precautions when taking metoclopramide (Reglan)?

Before taking metoclopramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blockage/hole in the intestines/stomach, breast cancer, diabetes, high blood pressure, kidney problems, heart failure, mental/mood problems (such as depression, thoughts of suicide), Parkinson's disease, liver problems (such as cirrhosis, porphyria), pheochromocytoma, seizures, a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency).

This drug may make you dizzy or drowsy. Do not drive,...

Read All Potential Precautions of Reglan »


Reglan Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, tiredness, trouble sleeping, agitation, headache, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as anxiety, confusion, depression, thoughts of suicide), decreased sexual ability, inability to keep still/need to pace, muscle spasms/uncontrolled muscle movements (such as twisting neck, arching back), abnormal breast-milk production, enlarged/tender breasts, swelling of the hands/feet, changes in menstruation in women.

This medication may cause side effects that look like Parkinson's disease. Tell your doctor immediately if any of these unlikely side effects occur: shaking (tremors), slowed/difficult movement, muscle stiffness, mask-like facial expression.

This drug may infrequently cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome). Seek immediate medical attention if you notice any of the following rare but very serious side effects: fever, rigid muscles, increased sweating, fast heartbeat, confusion.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking metoclopramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blockage/hole in the intestines/stomach, breast cancer, diabetes, high blood pressure, kidney problems, heart failure, mental/mood problems (such as depression, thoughts of suicide), Parkinson's disease, liver problems (such as cirrhosis, porphyria), pheochromocytoma, seizures, a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Liquid products may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit alcohol. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have high or low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Children may be more sensitive to the side effects of this drug, especially muscle spasms.

Older adults may be more sensitive to the effects of this drug, especially drowsiness, tardive dyskinesia, and Parkinson's type muscle problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.


Reglan Patient Information Including Side Effects

Brand Names: Metozolv ODT, Reglan

Generic Name: metoclopramide (Pronunciation: MET oh KLOE pra mide)

  • What is metoclopramide (Reglan)?
  • What are the possible side effects of metoclopramide (Reglan)?
  • What is the most important information I should know about metoclopramide (Reglan)?
  • What should I discuss with my healthcare provider before taking metoclopramide (Reglan)?
  • How should I take metoclopramide (Reglan)?
  • What happens if I miss a dose (Reglan)?
  • What happens if I overdose (Reglan)?
  • What should I avoid while taking metoclopramide (Reglan)?
  • What other drugs will affect metoclopramide (Reglan)?
  • Where can I get more information?

What is metoclopramide (Reglan)?

Metoclopramide increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines.

Metoclopramide is used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms.

Metoclopramide is also 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.

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

What are the possible side effects of metoclopramide (Reglan)?

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 metoclopramide 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;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • 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 side effects may include:

  • feeling restless, drowsy, tired, or dizzy;
  • headache, sleep problems (insomnia);
  • nausea, vomiting, 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 is the most important information I should know about metoclopramide (Reglan)?

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 metoclopramide, 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 metoclopramide.

There are many other medicines that can interact with metoclopramide. 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 it in larger amounts than recommended, or for longer than 3 months. High doses or long-term use of metoclopramide may cause tremors or other uncontrollable muscle movements, especially in older women.

Stop using metoclopramide 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 metoclopramide, 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.

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