Metoclopramide Hydrochloride (Page 4 of 5)

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).

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 metoclopramide hydrochloride, USP 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 per 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 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 the 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 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.

HOW SUPPLIED

Metoclopramide Tablets, USP:

10 mg — White, round, scored tablets in bottles of 30.

Debossed: WPI on one side and 2229 on the other side.

Dispense in a tight, light-resistant container as defined in the USP.
Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: January 2012

Repackaged by:

Rebel Distributors Corp.

Thousand Oaks, CA 91320

MEDICATION GUIDE

Metoclopramide Tablets , USP

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 solution), 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 , USP ?

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:

  • the longer you take metoclopramide tablets and the more metoclopramide tablets you take. You should not take metoclopramide tablets 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 tardive dyskinesia if you take metoclopramide tablets.

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

See the section “What are the possible side effects of metoclopramide tablets, USP?” for more information about side effects.

What are metoclopramide tablets , USP ?

Metoclopramide is a prescription medicine used:

  • in adults for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal reflux disease (GERD) when certain other treatments do not work. Metoclopramide relieves daytime heartburn and heartburn after meals. It also helps ulcers in the esophagus to heal.
  • to relieve symptoms of slow stomach emptying in people with diabetes. Metoclopramide helps 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 is safe and works in children.

Who should not take metoclopramide tablets , USP ?

Do not take metoclopramide tablets if you:

  • 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
  • have an adrenal gland tumor called a pheochromocytoma
  • are allergic to metoclopramide tablets or anything in it. See the end of this Medication Guide for a list of ingredients in metoclopramide tablets.
  • take medicines that can cause uncontrolled movements, such as medicines for mental illness
  • have seizures

What should I tell my doctor before taking metoclopramide tablets , USP ?

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. Metoclopramide tablets 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 metoclopramide tablets will harm your unborn baby.
  • 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 p rescription and nonprescription medicines, vitamins, and herbal supplements. Metoclopramide 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:

  • another medicine that contains metoclopramide, such as metoclopramide orally disintegrating tablets or metoclopramide oral solution
  • a blood pressure medicine
  • a medicine for depression, especially an Monoamine Oxidase Inhibitor (MAOI)
  • insulin
  • a medicine that can make you sleepy, such an 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 , USP ?

  • Metoclopramide comes as a tablet you take by mouth.
  • Take metoclopramide tablets exactly as your doctor tells you. Do not change your dose unless your doctor tells you.
  • You should not take metoclopramide tablets for more than 12 weeks.
  • If you take too much metoclopramide tablets, call your doctor or Poison Control Center right away.

What should I avoid while taking metoclopramide tablets , USP ?

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

What are the possible side effects of metoclopramide tablets , USP ?

Metoclopramide tablets can cause serious side effects, including:

  • Tardive Dyskinesia (abnormal muscle movements). See “What is the most important information I should know about metoclopramide tablets, USP?”
  • 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 metoclopramide tablets become depressed. You may have thoughts about hurting or killing yourself. Some people who take metoclopramide have ended their own lives (suicide).
  • Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with metoclopramide. 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 metoclopramide tablets.

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

Common side effects of m etoclopramide include:

  • feeling restless, sleepy, tired, dizzy, or exhausted
  • headache
  • confusion
  • 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 , USP ?

  • Keep metoclopramide tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
  • Keep metoclopramide tablets in the bottle it comes in. Keep the bottle closed tightly.

Keep metoclopramide tablets and all medicines out of the reach of children.

General information about metoclopramide tablets , USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use metoclopramide tablets for a condition for which it was not prescribed. Do not give metoclopramide tablets to other people, even if they have the same symptoms that you have. It 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, go to www.watson.com or call 1-800-272-5525.

What are the ingredients in metoclopramide tablets , USP ?

Active ingredient: metoclopramide

Inactive ingredients: anhydrous lactose, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate and (5 mg only) D&C Yellow #10 and FD&C Blue #1.

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

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Watson Pharma, Inc. Parsippany, NJ 07054 USA

Revised: January 2012

Repackaged by:

Rebel Distributors Corp.

Thousand Oaks, CA 91320

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