Metoclopramide Tablets

Name: Metoclopramide Tablets

How is this medicine (Metoclopramide Tablets) best taken?

Use this medicine (metoclopramide tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Take at least 30 minutes before eating and at bedtime unless your doctor has told you otherwise.

What do I do if I miss a dose?

  • If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine (metoclopramide tablets) is taken on an as needed basis. Do not take more often than told by the doctor.

Indications and Usage for Metoclopramide Tablets

The use of Metoclopramide Tablets, USP is recommended for adults only. Therapy should not exceed 12 weeks in duration.

Symptomatic Gastroesophageal Reflux

Metoclopramide Tablets, USP are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.

The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12 week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.

Diabetic Gastroparesis (Diabetic Gastric Stasis)

Metoclopramide Tablets, USP are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.

Overdosage

Symptoms of overdosage may include drowsiness, disorientation, and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours.

Hemodialysis removes relatively little metoclopramide, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis. Dialysis is not likely to be an effective method of drug removal in overdose situations.

Unintentional overdose due to misadministration has been reported in infants and children with the use of metoclopramide oral solution. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions, and lethargy.

Methemoglobinemia has occurred in premature and full-term neonates who were given overdoses of metoclopramide (1 to 4 mg/kg/day orally, intramuscularly or intravenously for 1 to 3 or more days). Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal (see PRECAUTIONS, Other Special Populations).

Metoclopramide Tablets Dosage and Administration

Therapy with Metoclopramide Tablets should not exceed 12 weeks in duration.

For the Relief of Symptomatic Gastroesophageal Reflux

Administer from 10 mg to 15 mg of metoclopramide tablet orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

For the Relief of Symptoms Associated With Diabetic Gastroparesis (Diabetic Gastric Stasis)

Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of Metoclopramide Tablets may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablet therapy should be reinstituted at the earliest manifestation.

Use in Patients With Renal or Hepatic Impairment

Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

See OVERDOSAGE section for information regarding dialysis.

Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

Medication guide

Metoclopramide Tablets, USP

MET-oh-KLOE-pra-mide

Rx only

Read the Medication Guide that comes with Metoclopramide Tablets before you start taking them and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide injection, metoclopramide orally disintegrating tablets, or metoclopramide oral syrup), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Metoclopramide Tablets?

Metoclopramide Tablets can cause serious side effects, including:

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

Your chances for getting tardive dyskinesia go up:

  1. the longer you take Metoclopramide Tablets and the more Metoclopramide Tablets you take. You should not take Metoclopramide Tablets for more than 12 weeks.
  2. if you are older, especially if you are a woman
  3. if you have diabetes

It is not possible for your doctor to know if you will get tardive dyskinesia if you take Metoclopramide Tablets .

Call your doctor right away if you get movements you can not stop or control, such as:

  1. lip smacking, chewing, or puckering up your mouth
  2. frowning or scowling
  3. sticking out your tongue
  4. blinking and moving your eyes
  5. shaking of your arms and legs

See the section "What are the possible side effects of Metoclopramide Tablets?" for more information about side effects.

What are Metoclopramide Tablets?

Metoclopramide Tablets are a prescription medicine used:

  1. in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide Tablets relieve daytime heartburn and heartburn after meals. They also help ulcers in the esophagus to heal.
  2. to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide Tablets help treat symptoms such as nausea, vomiting, heartburn, feeling full long after a meal, and loss of appetite. Not all these symptoms get better at the same time.

It is not known if Metoclopramide Tablets are safe and work in children.

Who should not take Metoclopramide Tablets?

Do not take Metoclopramide Tablets if you:

  1. have stomach or intestine problems that could get worse with Metoclopramide Tablets, such as bleeding, blockage or a tear in the stomach or bowel wall
  2. have an adrenal gland tumor called a pheochromocytoma
  3. are allergic to Metoclopramide Tablets or anything in them. See the end of this Medication Guide for a list of ingredients in Metoclopramide Tablets.
  4. take medicines that can cause uncontrolled movements, such as medicines for mental illness
  5. have seizures

What should I tell my doctor before taking Metoclopramide Tablets?

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

  1. depression
  2. Parkinson's disease
  3. high blood pressure
  4. kidney problems. Your doctor may start with a lower dose.
  5. liver problems or heart failure. Metoclopramide Tablets may cause your body to hold fluids.
  6. diabetes. Your dose of insulin may need to be changed.
  7. breast cancer
  8. you are pregnant or plan to become pregnant. It is not known if Metoclopramide Tablets will harm your unborn baby.
  9. you are breast-feeding. Metoclopramide 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 Metoclopramide Tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Metoclopramide Tablets and some other medicines may interact with each other and may not work as well, or cause possible side effects. Do not start any new medicines while taking Metoclopramide Tablets until you talk with your doctor.

Especially tell your doctor if you take:

  1. another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets, or metoclopramide oral syrup
  2. a blood pressure medicine
  3. a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI)
  4. insulin
  5. a medicine that can make you sleepy, such as anti-anxiety medicine, sleep medicines, and narcotics.

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.

How should I take Metoclopramide Tablets?

  1. Metoclopramide Tablets come as a tablet you take by mouth.
  2. Take Metoclopramide Tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you.
  3. You should not take Metoclopramide Tablets for more than 12 weeks.
  4. If you take too many Metoclopramide Tablets, call your doctor or Poison Control Center right away.

What should I avoid while taking Metoclopramide Tablets?

  1. Do not drink alcohol while taking Metoclopramide Tablets. Alcohol may make some side effects of Metoclopramide Tablets worse, such as feeling sleepy.
  2. Do not drive, work with machines, or do dangerous tasks until you know how Metoclopramide Tablets affect you. Metoclopramide Tablets may cause sleepiness.

What are the possible side effects of Metoclopramide Tablets?

Metoclopramide Tablets can cause serious side effects, including:

  1. Tardive dyskinesia (abnormal muscle movements). See "What is the most important information I need to know about Metoclopramide Tablets?"
  2. 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.
  3. Depression, thoughts about suicide, and suicide. Some people who take Metoclopramide Tablets become depressed. You may have thoughts about hurting or killing yourself. Some people who take Metoclopramide Tablets have ended their own lives (suicide).
  4. Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with Metoclopramide Tablets. 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.
  5. 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 Metoclopramide Tablets.

Call your doctor and get medical help right away if you:

  1. feel depressed or have thoughts about hurting or killing yourself
  2. have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating
  3. have muscle movements you cannot stop or control
  4. have muscle movements that are new or unusual

Common side effects of Metoclopramide Tablets include:

  1. feeling restless, sleepy, tired, dizzy, or exhausted
  2. headache
  3. confusion
  4. trouble sleeping

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

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

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

How should I store Metoclopramide Tablets?

  1. Keep Metoclopramide Tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  2. Keep Metoclopramide Tablets in the bottle they come in. Keep the bottle closed tightly.

Keep Metoclopramide Tablets and all medicines out of the reach of children.

General information about Metoclopramide Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Metoclopramide Tablets for a condition for which they were not prescribed. Do not give Metoclopramide Tablets to other people, even if they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about Metoclopramide Tablets.If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Metoclopramide Tablets that is written for health professionals. For more information, call 1-888-838-2872.

What are the ingredients in Metoclopramide Tablets, USP?

Active ingredient: metoclopramide hydrochloride, USP

Inactive ingredients: corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured in Croatia by:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured for:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11969 R1
5/16

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 51079-886-20

Metoclopramide
Tablets, USP
5 mg

100 Tablets (10 x 10)

Each tablet contains metoclopramide
hydrochloride, USP equivalent to 5 mg
metoclopramide.

Usual Dosage: See accompanying
prescribing information and
Medication Guide.

Stored at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured in Croatia by:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured for:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rx only

S-11972 R1

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

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