(met oh kloe pra' mide)
P / L : Caution - pregnancy & lactation (breast feeding)
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||
1) Digestive disorders: To restore normal tone and co-ordination to the upper digestive tract.
Relief of symptoms of gastroduodenal dysfunction such as heartburn, nausea and vomiting in flatulent dyspepsia, gastritis, reflux oesophagitis, Hiatus hernia, cholelithiasis, peptic ulcers and squelae of gastrectomy.
2) Anti-emetic: Treatment of nausea and vomiting associated with gastrointestinal disorders; intolerance to essential drugs including digitalis, antibacterial agents, tuberculostatic agents, cytostatic and cytotoxic drugs; cyclical vomiting; congestive heart failure; deep X-ray or cobalt therapy; post-anaesthetic vomiting.
3) Migraine: Metoclopramide relieves symptoms of nausea and vomiting, and overcomes gastric stasis associated with attacks of migraine. This improvement in gastric emptying assists the absorption of concurrently administered oral anti-migraine therapy (egparacetamol) which may otherwise be impaired in such patients.
4) Post-operative conditions: Post-operative gastric hypotonia; post-vagotomy syndrome. Metoclopramide promotes normal gastric emptying and restores motility in vagotomised patients, and where post-operative symptoms suggest gastroduodenal dysfunction.
5) Diagnostic procedures: Radiology; duodenal intubation. Metoclopramide speeds up the passage of a barium meal by decreasing gastric emptying time, co-ordinating peristalsis and dilating the duodenal bulb. Metoclopramide also facilitates duodenal intubation procedures.
Use in patients under 20 years must be restricted to the following:
1) Severe intractable vomiting of known cause.
2) Vomiting associated with radiotherapy and intolerance to cytotoxic drugs.
3) As an aid to gastrointestinal intubation.
4) As part of the premedication before surgical procedures.
Gastro-oesophageal reflux disease
Diabetic gastric stasis
Prevent delayed emesis following chemotherapy
15-18 yr and >60 kg: 10 mg. To be given as a single dose 5-10 minutes before examination. Child: 1 mth-3 yr and up to 14 kg: 100 mcg/kg (max 1 mg); 3-5 yr and 15-19 kg: 2 mg; 5-9 yr and 20-29 kg: 2.5 mg; 9-15 yr and 30-60 kg: 5 mg.
Renal impairment: Moderate to severe: Reduce dose by at least 50%.
Hepatic impairment: Dose reduction may be necessary.
Diabetic gastric stasis
Nausea and vomiting associated with cancer chemotherapy
Premedication for radiologic examination of the upper gastrointestinal tract
Adult: 10 mg. To be given as a single direct IV inj.
Intubation of the small intestine
Adult: 10 mg. To be given as a single direct IV inj.
Renal impairment: Moderate to severe: Reduce dose by at least 50%. Hepatic impairment: Dose reduction may be necessary.
Postoperative nausea and vomiting
|Overdosage||Drowsiness, ataxia, extrapyramidal symptoms, seizures, methemoglobinaemia (in infants).|
:: Sensitivity to metoclopramide, procaine, procainamide or any of the other ingredients in the product.
:: Gastrointestinal haemorrhage, mechanical obstruction, or perforation (stimulation of gastrointestinal motility may aggravate condition)
:: Phaeochromocytoma (may cause hypertensive crisis)
:: Previous history of dystonia with dopamine receptor antagonists
:: Metoclopramide should not be used following operations such as pyloroplasty or gut anastomosis until 3-4 days have elapsed, since vigorous muscular contractions may impair healing.
:: Metoclopramide is contraindicated in neonates.
|Special Precautions||Children, elderly. Renal or hepatic impairment, porphyria, epilepsy, Parkinson's disease, history of depression. Ability to drive or operate machineries may be impaired. Pregnancy and lactation. Monitor patients on prolonged therapy. Increased risk of tardive dyskinesia in patients on prolonged or high-dose treatment.|
|Adverse Drug Reaction(s)
||Extrapyramidal symptoms, restlessness, drowsiness, anxiety, diarrhoea, hypotension, hypertension, headache, depression, blood disorders (e.g. aganulocytosis, methaemoglobinaemia), hypersensitivity reactions (e.g. bronchospasm, rash), galactorrhoea or related disorders, transient increase in plasma aldosterone levels.
Potentially Fatal: Neuroleptic malignant syndrome; cardiac conduction disorders may occur with IV dosage form.
|Drug Interactions||Increased sedative effects with CNS depressants. GI effects antagonised by antimuscarinics and opioids. Reduces absorption of digoxin. Increases absorption of ciclosporin, levodopa, aspirin, paracetamol. Interferes with hypoprolactinaemic effect of bromocriptine. Inhibits serum cholinesterase and prolongs neuromuscular blockade produced by suxamethonium and mivacurium.
Potentially Fatal: Serotonin syndrome with sertraline (SSRI).
|Food Interaction||Avoid ethanol (may increase CNS depression).|
|Lab Interference||Increased aminotransferase, increased amylase.|
|Pregnancy Category (FDA)||Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).|
|Pharmacology||Metoclopramide enhances the motility of the upper GI tract and increases gastric emptying without affecting gastric, biliary or pancreatic secretions. It increases duodenal peristalsis which decreases intestinal transit time, and increases lower oesophageal sphincter tone. It is also a potent central dopamine-receptor antagonist and may also have serotonin-receptor (5-HT3) antagonist properties.
Absorption: Rapidly and almost completely absorbed from the GI tract (oral); peak plasma concentrations after 1-2 hr.
Distribution: Widely distributed; crosses the blood-brain barrier and placenta; enters breast milk.
Metabolism: Extensively hepatic.
Excretion: Via urine (as unchanged drug, sulfate or glucuronide conjugates and metabolites), faeces; 4-6 hr (terminal elimination half-life).
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|MAXIL||Nipa Pharmaceuticals Ltd.||Metoclopramide hydrochlor 10mg||Tablet||100's: 34.00 MRP|
|MAXIL Syrup||Nipa Pharmaceuticals Ltd.||Metoclopramide hydrochlor 5mg/5ml||Syrup||100ml: 14.11 MRP|
|MAXOCOL||Medimet Pharmaceuticals Ltd||Metoclopramide hydrochlor 10mg||Tablet||100's: 34.00 MRP|
|MAXOCOL Syrup||Medimet Pharmaceuticals Ltd||Metoclopramide hydrochloride 5mg/5ml||Syrup||100ml: 15.77 MRP|
|MECLID||Jayson Pharmaceuticals Ltd.||Metoclopramide hydrochloride 10mg||Tablet||100's: 32.00 MRP|
|MECLID Injection||Jayson Pharmaceuticals Ltd.||Metoclopramide hydrochloride 10mg/2ml||Injection||10 amps: 35.50 MRP|
|METOCOL||Opsonin Pharma Limited||Metoclopramide hydrochloride 1mg/ml||Drop||15ml: 9.50 MRP|
|METOCOL Syrup||Opsonin Pharma Limited||Metoclopramide hydrochloride 5mg/5ml||Syrup||100ml: 13.00 MRP|
|MOTILON Drop||Sanofi||Metoclopramide hydrochloride 1mg/ml||Drop||15ml: 9.80 MRP|
|MOTILON Injection||Sanofi||Metoclopramide hydrochloride 10mg/2ml||Injection||10 amps: 37.64 MRP|
|MOTILON Syrup||Sanofi||Metoclopramide hydrochloride 5mg/5ml||Syrup||100ml: 15.83 MRP|
|MOTILON Tablet||Sanofi||Metoclopramide hydrochloride 10mg||Tablet||500's: 170.00 MRP|
|NUTRAMID||The Acme Laboratories Ltd.||Metoclopramide hydrochloride 10mg||Tablet||100's: 34.00 MRP|
|NUTRAMID Drop||The Acme Laboratories Ltd.||Metoclopramide hydrochloride 1mg/ml||Drop||15ml: 9.64 MRP|
|NUTRAMID Syrup||The Acme Laboratories Ltd.||Metoclopramide hydrochloride 5mg/5ml||Syrup||60ml: 10.65 MRP|
Taking metoclopramide may cause you to develop a muscle problem called tardive dyskinesia. If you develop tardive dyskinesia, you will move your muscles, especially the muscles in your face in unusual ways. You will not be able to control or stop these movements. Tardive dyskinesia may not go away even after you stop taking metoclopramide. The longer you take metoclopramide, the greater the risk that you will develop tardive dyskinesia. Therefore, your doctor will probably tell you not to take metoclopramide for longer than 12 weeks. The risk that you will develop tardive dyskinesia is also greater if you are taking medications for mental illness, if you have diabetes, or if you are elderly, especially if you are a woman. Call your doctor immediately if you develop any uncontrollable body movements, especially lip smacking, mouth puckering, chewing, frowning, scowling, sticking out your tongue, blinking, eye movements, or shaking arms or legs.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with metoclopramide and each time you refill your prescription. Read the information carefully and ask your doctor if you have any questions.
Talk to your doctor about the risks of taking metoclopramide.
Why is Metoclopramide prescribed?
Metoclopramide is used to relieve heartburn and speed the healing of ulcers and sores in the esophagus (tube that connects the mouth to the stomach) in people who have gastroesophageal reflux disease (GERD; condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus) that did not get better with other treatments. Metoclopramide is also used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and feeling of fullness that lasts long after meals. Metoclopramide is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.
How should Metoclopramide be used?
Metoclopramide comes as a tablet, an orally disintegrating (dissolving) tablet, and a solution (liquid) to take by mouth. It is usually taken 4 times a day on an empty stomach, 30 minutes before each meal and at bedtime. When metoclopramide is used to treat symptoms of GERD, it may be taken less frequently, especially if symptoms only occur at certain times of day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take metoclopramide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking the orally disintegrating tablet, use dry hands to remove the tablet from the package just before you take your dose. If the tablet breaks or crumbles, throw it away and remove a new tablet from the package. Gently remove the tablet and immediately place it on the top of your tongue. The tablet will usually dissolve in about one minute and can be swallowed with saliva.
If you are taking metoclopramide to treat the symptoms of slow stomach emptying caused by diabetes, you should know that your symptoms will not improve all at once. You may notice that your nausea improves early in your treatment and continues to improve over the next 3 weeks. Your vomiting and loss of appetite may also improve early in your treatment, but it may take longer for your feeling of fullness to go away.
Continue to take metoclopramide even if you feel well. Do not stop taking metoclopramide without talking to your doctor. You may experience withdrawal symptoms such as dizziness, nervousness, and headaches when you stop taking metoclopramide.
Other uses for Metoclopramide
Metoclopramide is also sometimes used to treat the symptoms of slowed stomach emptying in people who are recovering from certain types of surgery, and to prevent nausea and vomiting in people who are being treated with chemotherapy for cancer. Ask your doctor about the risks of using Metoclopramide to treat your condition.
Metoclopramide may be prescribed for other uses; ask your doctor for more information.
What special precautions to follow?
Before taking metoclopramide,
[*Please note, the Brand names in Brackets () are examples only and might be different]
- tell your doctor and pharmacist if you are allergic to metoclopramide, any other medications, or any of the ingredients in metoclopramide tablets or solution. Ask your doctor or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen; antihistamines; aspirin; atropine; cyclosporine (Gengraf, Neoral, Sandimmune); barbiturates such as pentobarbital and secobarbital; digoxin; haloperidol; insulin; ipratropium; lithium; levodopa (in Sinemet, in Stalevo); medications for anxiety, blood pressure, irritable bowel disease, motion sickness, nausea, Parkinson's disease, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors, including isocarboxazid, phenelzine , selegiline, and tranylcypromine; narcotic medications for pain; sedatives; sleeping pills; tetracycline; or tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
- tell your doctor if you have or have ever had blockage, bleeding, or a tear in your stomach or intestines; pheochromocytoma (tumor on a small gland near the kidneys); or seizures. Your doctor will probably tell you not to take metoclopramide.
- tell your doctor if you have or have ever had Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); high blood pressure; depression; breast cancer; asthma;glucose-6-phosphate dehydrogenase (G-6PD) deficiency (an inherited blood disorder); NADH cytochrome B5 reductase deficiency (an inherited blood disorder); or heart, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking metoclopramide, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking metoclopramide.
- you should know that Metoclopramide may make you drowsy. Do not drive a car or operate machinery until you know how Metoclopramide affects you.
- ask your doctor about the safe use of alcohol while you are taking Metoclopramide. Alcohol can make the side effects of metoclopramide worse.
What special dietary instructions to follow?
Unless your doctor tells you otherwise, continue your regular diet.
What to do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Metoclopramide cause?
Metoclopramide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
breast enlargement or discharge
missed menstrual period
decreased sexual ability
inability to control urination
Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:
tightening of the muscles, especially in the jaw or neck
thinking about harming or killing yourself
fast, slow, or irregular heartbeat
nervousness or jitteriness
difficulty falling asleep or staying asleep
slow or stiff movements
blank facial expression
uncontrollable shaking of a part of the body
difficulty keeping your balance
swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
sudden weight gain
difficulty breathing or swallowing
high-pitched sounds while breathing
Metoclopramide may cause other side effects. Consult your doctor if you have any unusual problems while you are taking Metoclopramide.
Ref: MedlinePlus, U.S. Natl. Library of Medicine
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