Consumer Information for: METOCLOPRAMIDE HYDROCHLORIDE INJECTION
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Metoclopramide Hydrochloride Injection 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 Hydrochloride Injection, when used before surgery, can help reduce vomiting after surgical procedures.
What it does
Metoclopramide Hydrochloride Injection 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 Hydrochloride Injection if you:
- are allergic (hypersensitive) to metoclopramide or any of the other ingredients listed in “What the non-medicinal 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 Hydrochloride Injection is metoclopramide hydrochloride.
What the non-medicinal ingredients are
The non-medicinal ingredients are: sodium chloride, hydrochloric acid and/or sodium hydroxide and water for injection.
What dosage form it comes in
Metoclopramide Hydrochloride Injection is 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
- 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.
Before Metoclopramide Hydrochloride Injection 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 Hydrochloride Injection 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
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 Hydrochloride Injection, such as anticholinergic drugs.
Metoclopramide Hydrochloride Injection 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 Hydrochloride Injection, such as sedatives, hypnotics, narcotics, and anxiolytics.
Metoclopramide Hydrochloride Injection 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 Hydrochloride Injection may be increased or decreased by your doctor, as appropriate.
Overdose
In case of drug overdose, contact a health care practitioner (or doctor), hospital emergency department or regional poison control centre, 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.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| 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 Hydrochloride Injection, contact your healthcare professional.
How to store
Metoclopramide Hydrochloride Injection is stored between 15 and 30ºC, protected from light. Unused portion should be discarded.
Solutions of metoclopramide that have been prepared by dilution of the injection are stable for up to 48 hours when stored at room temperature and exposed to normal light conditions.
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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
For more information, please contact your healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at 1-800-361-3062
Or by written request at:
145 Jules-Léger
Boucherville, Québec
J4B 7K8
Or by email at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: November 18, 2014
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