Metoclopramide Generic Name: metoclopramide (MET oh KLOE pra mide) Brand Names: Metozolv ODT, Reglan What is metoclopramide?

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 purposes not listed in this medication guide. How should I take metoclopramide? NEVER TAKE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of metoclopramide can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include tremors or other uncontrollable muscle movements. The longer you take metoclopramide, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women, diabetics, and older adults. Take exactly as prescribed by your doctor. Metoclopramide is usually taken for only 4 to 12 weeks. Follow the directions on your prescription label. Take metoclopramide 30 minutes before eating. Metoclopramide is usually taken before meals and at bedtime. Your doctor may want you to take the medication as needed only with meals that usually cause heartburn. Follow your doctor's instructions. Measure the liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. To take metoclopramide orally disintegrating tablet (Metozolv): =Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. If the tablet breaks, throw it away and take out a new one. =Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. =Swallow several times as the tablet dissolves. You do not need to drink liquid to help the tablet dissolve. Store metoclopramide at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. 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. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include drowsiness, confusion, tremors or uncontrolled muscle movements in your face or neck, or seizure (convulsions). Metoclopramide side effects *Get emergency medical help if you have any of these signs of an allergic reaction to metoclopramide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop

taking 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, neck, arms, or legs; =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 metoclopramide 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. Metoclopramide Dosing Information =Usual Adult Metoclopramide Dose for Nausea/Vomiting: Parenteral: 10 to 20 mg IV or IM at or near the end of surgery and repeated every 4 to 6 hours as needed. =Usual Adult Dose for Gastroesophageal Reflux Disease: Parenteral: 10 to 15 mg, IV or IM, 4 times a day 30 minutes before meals and at bedtime. Oral: 10 to 15 mg 4 times a day 30 minutes before meals and at bedtime. Therapy should generally not exceed 12 weeks. =Usual Adult Metoclopramide Dose for Small Intestine Intubation: 10 mg IV one time during the procedure. =Usual Adult Dose for Radiographic Exam: 10 mg IV one time to facilitate gastric emptying. =Usual Adult Metoclopramide Dose for Gastroparesis: Parenteral: 10 mg 4 times a day, IV or IM, 30 minutes before meals and at bedtime. Therapy should generally be continued for 2 to 8 weeks. Oral: 10 mg 4 times a day 30 minutes before meals and at bedtime. Therapy should generally be continued for 2 to 8 weeks. =Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced: IV infusion: 1 to 2 mg/kg/dose (depending on the emetogenic potential of the agent) IV 30 minutes before administration of chemotherapy. The dose may be repeated twice at 2 hour intervals following the initial dose. If vomiting is still not suppressed, the same dose may be repeated 3 more times at 3 hour intervals. If vomiting is suppressed following 3 doses, the dose may be decreased by 50% for 3 doses at 3 hour intervals. =Usual Adult Dose for Migraine: 10 to 20 mg IV once. =Usual Pediatric Metoclopramide Dose for Nausea/Vomiting -- Postoperative: Less than or equal to 14 years: 0.1 to 0.2 mg/kg/dose IV; repeat every 6 to 8 hours as needed. Greater than 14 years: 10 mg IV; repeat every 6 to 8 hours as needed. =Usual Pediatric Metoclopramide Dose for Gastroesophageal Reflux Disease: Neonates, Infants, and Children: Oral, IM, or IV: 0.4 to 0.8 mg/kg/day in 4 divided doses. =Usual Pediatric Dose for Small Intestine Intubation: Less than 6 years: 0.1 mg/kg IV one time 6 to 14 years: 2.5 to 5 mg IV one time Greater than 14 years: 10 mg as a single dose =Usual Pediatric Metoclopramide Dose for Nausea/Vomiting -- Chemotherapy Induced: Oral or IV: 1 to 2 mg/kg/dose every 2 to 4 hours (maximum of 5 doses/day); pretreatment with

diphenhydramine will decrease risk of extrapyramidal reactions to this dosage. (Usual Adult Dose for Nausea/Vomiting Parenteral: 10 to 20 mg IV or IM at or near the end of surgery and repeated every 4 to 6 hours as needed.)

Metoclopramide Pregnancy Warnings Metoclopramide has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. However, metoclopramide has been used during pregnancy for its antiemetic and gastric prokinetic effects. Metoclopramide is only recommended for use during pregnancy when benefit outweighs risk. Metoclopramide rapidly crosses the placenta near term. Fetal plasma concentrations are approximately 60% to 70% of maternal serum concentrations. While administration of metoclopramide at term is associated with significant increases in maternal serum prolactin levels, no changes were noted in cord arterial or venous plasma prolactin levels. In addition, metoclopramide does not affect maternal plasma TSH or estradiol levels. A case of acute porphyria in a female patient treated for hyperemesis gravidarum with metoclopramide in the 10th, 12th, and 18th week of pregnancy is reported in the literature. A normal infant was delivered at term. Data on the safety and efficacy of metoclopramide during pregnancy are primarily limited to the last trimester. More data are needed to evaluate safety in the first and second trimesters. Until then, the use of metoclopramide should typically be limited to the management of severe nausea and vomiting in the last trimester and to decrease gastric emptying time in the prevention of Mendelson's syndrome during labor and delivery. Data collected by five teratogenic information centers on women (n=126) that had taken metoclopramide (range, 10 to 40 mg) for nausea and vomiting during the first trimester of pregnancy (range duration of therapy, 1 to 35 days) suggests that the administration of metoclopramide during the first trimester of pregnancy is probably not associated with an increased risk of fetal malformations, decreased birth weight, or spontaneous abortions. Metoclopramide Breastfeeding Warnings In one study involving 23 women, metoclopramide milk concentrations ranged from 20 to 157 ng/mL following the oral administration of metoclopramide 10 mg three times a day for two weeks. Milk concentrations were consistently higher than corresponding serum concentrations. The estimated maximum exposure of the infant ranged from 6 to 24 mcg/kg/day in the early puerperium and from 1 to 13 mcg/kg/day in the late puerperium. Metoclopramide was detected in the serum of only one infant. In four of seven infants studied, plasma prolactin levels were elevated during maternal metoclopramide treatment compared to prolactin levels of control infants. Plasma thyrotropin concentrations in the infants were unaffected. In another study, infant serum prolactin, TSH, and free thyroxine concentrations were unaffected by maternal metoclopramide therapy (10 mg three times a day for 3 weeks). Metoclopramide is excreted into human milk. The American Academy of Pediatrics considers metoclopramide use during lactation to be of concern, citing the potent nervous system effects of

the drug. The manufacturer recommends caution.