Patient Medication Information: uses, side effects, how to take - Metoclopramide Injection USP
ABOUT THIS MEDICATION
What the medication is used for:
Metoclopramide Injection USP is a drug used to treat symptoms of slowed stomach emptying seen in people with gastritis, and in those recovering from certain types of gastric tests or surgery.
Metoclopramide Injection USP, when used before surgery, can help reduce vomiting after surgical procedures.
What it does:
Metoclopramide Injection USP is a drug used to help speed the movement of food through the stomach and intestines, by stimulating the muscles of the gastrointestinal tract.
When it should not be used:
Do not take Metoclopramide Injection USP if you:
- are allergic (hypersensitive) to metoclopramide or any of the other ingredients listed in “What the nonmedicinal ingredients are”.
- are experiencing bleeding (hemorrhage), a blockage (obstruction), or a tear (perforation) in your stomach or intestines.
- metoclopramide should not be used in children less than 1 year of age.
What the medicinal ingredient is:
The active substance of Metoclopramide Injection USP is metoclopramide hydrochloride.
What the nonmedicinal ingredients are:
The non-medicinal ingredients are: sodium chloride USP in water for injection. Sodium hydroxide and hydrochloric acid may be used to adjust pH.
What dosage forms it comes in:
Metoclopramide Injection USP is an injectable solution, available in single use amber glass vials in boxes of 10 x 2 mL, 5 x 10 mL and 1 x 30 mL.
WARNINGS AND PRECAUTIONS
Before Metoclopramide Injection USP is used, be sure to tell your doctor if you:
- have a history of bleeding (hemorrhage), a blockage (obstruction), or a tear (perforation) in your stomach or intestines.
- have a history of seizures (e.g. epilepsy).
are pregnant. Metoclopramide Injection USP should not be administered in pregnancy unless your doctor believes the benefit outweighs the risk to the fetus.
- are breastfeeding. Metoclopramide can pass into the breast milk and harm your baby. Talk to your doctor about the best way to feed your baby if you receive metoclopramide.
- have ever been diagnosed with breast cancer.
- have kidney problems.
have an adrenal gland tumour called pheochromocytoma.
- A condition called tardive dyskinesia (see description below) has occurred with long-term (over 12 weeks) use of metoclopramide and even after long-term treatment has been stopped. The chance of this occurring increases with duration of treatment, total cumulative dose and in the elderly, particularly elderly women.
Children:
- metoclopramide must not be used in children under 1 year of age.
- metoclopramide should not be used in children over 1 year of age unless the doctor believes the benefit outweighs the risk.
- extrapyramidal symptoms (e.g. shaking, tremor, stiffness and involuntary movement) may occur in children. Children's dosage should not exceed 0.5 mg/kg/day.
Contact your doctor immediately if the following occur while receiving metoclopramide:
- You develop symptoms of tardive dyskinesia or dystonia with symptoms such as involuntary movement of lips, eyes, tongue, face, head and limbs.
- You develop Parkinson’s symptoms such as tremor, restlessness, muscle rigidity, facial spasms, involuntary movements, and difficulty completing daily tasks.
- You develop symptoms of neuroleptic malignant syndrome with symptoms such as high temperature, muscle rigidity, irregular or fast heartbeat.
- You feel depressed or have thoughts about hurting or killing yourself.
INTERACTIONS WITH THIS MEDICATION
Some medications may block the effects of Metoclopramide Injection USP, such as anticholinergic drugs. Metoclopramide Injection USP may intensify the effect of alcohol and drugs absorbed from the intestines, such as neuroleptics.
Interactions may occur with monoamine oxidase inhibitors (e.g. some drugs used to treat depression).
Some drugs may increase the risk of drowsiness with Metoclopramide Injection USP, such as sedatives, hypnotics, narcotics, and anxiolytics.
Metoclopramide Injection USP may decrease the absorption of drugs from the stomach (e.g. digoxin) whereas absorption from the small bowel may be accelerated (e.g. acetaminophen, tetracyclines, levodopa, alcohol).
PROPER USE OF THIS MEDICATION
Usual dose:
Note: The total adult and pediatric daily dosage must not exceed 0.5 mg/kg body weight.
Depending how well you respond to treatment and safety considerations, your dosage of Metoclopramide Injection USP may be increased or decreased by your doctor, as appropriate.
Overdose:
If you think you, or a person you caring for, have taken too much Metoclopramide Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
The missed dose should be administered as soon as possible, except if it is almost time for your next scheduled dose. In this case the missed does should be skipped.
Extra medicine should not be administered to make up the missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Common side effects
The most common side effects are drowsiness and fatigue.
Other possible common side effects include insomnia, headache, dizziness and bowel disturbances.
If any of these affects you severely, tell your doctor.
If you notice any other side effects not mentioned in this leaflet, please inform your healthcare professional.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
|---|---|---|---|---|---|
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Rare | Muscular twitching |
| |||
| Restlessness |
| ||||
Facial Spasms or movements |
| ||||
| Unusual eye movements |
| ||||
| Involuntary or unusual movements |
| ||||
| Muscle rigidity |
| ||||
| Tremors |
| ||||
| High temperature, fast or irregular heartbeat |
| ||||
| Feeling depressed or thoughts about hurting or killing yourself |
| ||||
Hypersensitivity (allergic) reaction with symptoms such as rash, hives, breathing difficulty, swelling of the mouth, throat and extremities |
| ||||
This is not a complete list of side effects. For any unexpected effects while taking Metoclopramide Injection USP, contact your healthcare professional.
HOW TO STORE IT
Metoclopramide Injection USP is stored between 15°C and 30°C, protected from light. Unused portion should be discarded.
As with all parenteral drug products, IV admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discolouration or leakage should not be used.
MORE INFORMATION
If you want more information about Metoclopramide Injection USP:
- Talk to your healthcare professional;
Find the full Product Monograph that is prepared for healthcare professionals and includes the Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.omegapharma.ca), or
- by calling 1-800-363-0584.
Omega Laboratories Limited
Montreal, Quebec, H3M 3E4.
Last approved: October 30, 2023.
Reporting Side Effects
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.