📄 Patient Information Leaflet
Please read this patient information leaflet carefully.
If you have any questions or are unsure about anything, please ask your doctor or pharmacist.
Keep this leaflet, you may want to read it again.
💊 WHAT DOES THE MEDICINE CONTAINS?
• Each 2ml ampoule contains: metoclopramide Hydrochloride BP equivalent to anhydrous metoclopramide Hydrochloride 10mg, water for injection BP q.s.
• Metoclopramide is a gastrointestinal drug, a substituted benzamide used for its prokinetic and antiemetic properties.
• It stimulates the motility of the upper gastrointestinal tract without affecting gastric, biliary or pancreatic secretion and increase gastric peristalsis, leading to accelerated gastric emptying and intestinal transit time.
🩺 WHAT IS MEDICINE USED FOR?
• Metoclopramide is used in disorders of decreased gastrointestinal motility such as gastroparesis or ileus.
• In gastro-oesophageal reflux disease and dyspepsia.
• In nausea and vomiting associated with various gastrointestinal disorders with migraine, after surgery and with cancer therapy.
💉 HOW IS THE MEDICINE USED?
• In order to reduce the risks of neurological and other adverse effects, metoclopramide should be used to a maximum of 5 days.
• The recommended adult dose intramuscularly or by slow intravenous injection (over at least 3 minutes) is 10mg three times daily.
• Single doses of 10mg to 20mg may be given intravenously or intramuscularly when required, such as before a diagnostic procedure.
• High doses of metoclopramide have been used in the treatment of the nausea and vomiting associated with cancer chemotherapy.
• The loading dose of metoclopramide before cancer therapy is 2 to 4 mg/kg given as a continuous intravenous infusion, given as a continuous intravenous infusion over 15 to 20 minutes.
• It is followed by a maintenance dose of 3 to 5 mg/kg, again as a continuous intravenous infusion, given over 8 to 12 hours.
• Alternatively, initial doses of up to 2mg/kg by intravenous infusion over at least 15 minutes may be given before cancer therapy and repeated every 2 hours.
• The total dose by either continuous or intermittent infusion should not normally exceed 10mg/kg in 24 hours.
• Metoclopramide in children and young adults is restricted to a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established postoperative nausea and vomiting.
• It may be used for up to 5 days in children aged 1 years and over.
Parenteral (intramuscular and intravenous) doses for all indications are:
• For those aged 15 to 19 years and weighing 60kg and over: 10mg three times daily.
• 15 to 19 years (30 to 59 kg): 5mg three times daily.
• 9 to 14 years (30 kg and over): 5mg three times daily.
• 5 to 9 years (20 to 29kg): 2.5mg three times daily.
• 3 to 5 years (15 to 19kg): 2mg two or three times daily.
• 1 to 3 years (10 to 14 kg): 1mg two or three times daily.
Alternative dose for postoperative nausea and vomiting (1 to 20 years):
• 150 micrograms/kg given by slow intravenous injection.
• Further doses can be given 6 hours apart to a maximum of 500 micrograms/kg in 24 hours.
• Where body-weight is below that specified for a given age group, the dose should reflect the weight rather than the age, so that a lower dose is chosen.
Reminder:
• This medicine has been prescribed just for you.
• Never offer your medicine to other people.
• It may not be suitable for them even if their symptoms seem the same as yours.
🚫 WHEN SHOULD THE MEDICINE NOT BE USED?
• This medicine is unsuitable for people who are allergic to metoclopramide or any of its ingredients.
• Metoclopramide should not be used when stimulation of muscular contractions might adversely affect gastrointestinal conditions as in gastrointestinal hemorrhage, obstruction, and perforation or for a few days after surgery.
• Metoclopramide should also not be used in patients with phaeochromocytoma.
• Metoclopramide should also not be used in patients with epilepsy as the frequency and severity of seizures may be increased.
⚠️ WHAT PRECAUTIONS SHOULD BE TAKEN?
Tell your doctor before being given metoclopramide Hydrochloride Injection:
• If you are pregnant or think you may be pregnant.
• If you are planning to become pregnant.
• If you are breast feeding.
• If you are allergic to metoclopramide or to any of its ingredients.
• If you are an elderly.
• If you are a child or young adult.
• If you suffer from hypertension.
• If you suffer from renal or hepatic impairment, Parkinson’s disease, or a history of depression, atopy (including asthma).
• Intravenous Metoclopramide should be given with caution to patients at increased risk of cardiovascular reactions, including those with cardiac conduction abnormalities such as sick sinus syndrome.
• Metoclopramide may cause drowsiness or impaired reactions.
• Patients should not drive or operate machinery.
🤰 PREGNANCY AND BREAST FEEDING
• Safe use of metoclopramide Hydrochloride injection during pregnancy and breast feeding is not established.
• If you are pregnant, think that you may be pregnant or if you are breast feeding then you must tell your doctor.
• Your doctor will decide if metoclopramide hydrochloride injection can be given to you.
💊 WHAT TO BE AWARE OF IF YOU ARE TAKING ANY OTHER MEDICINE?
Tell your doctor if you are using (or intend to use) any other medicines.
The following medicines may affect how metoclopramide works or metoclopramide may affect how they work:
• Increased toxicity may occur if metoclopramide is given with other centrally active drugs.
• Metoclopramide should be used with caution in patients taking other drugs that can also cause extrapyramidal reactions.
• It should also be used with care with other drugs at central dopamine receptors such as pergolide.
• Combining Metoclopramide with CNS depressant drugs can lead to increased sedative effects.
• Antimuscarinics and opioid analgesics antagonize the gastrointestinal effects of Metoclopramide.
• The absorption of other drugs may be affected by Metoclopramide; it may either increase absorption from the stomach (as with digoxin) or increase absorption from the small intestine (for example with alcohol, ciclosporin, levodopa, aspirin or Paracetamol).
• The absorption of food may be affected requiring adjustment of the insulin regimen in diabetic patients.
• Metoclopramide may increase serum cholinesterase and may prolong neuromuscular blockade produced by suxamethonium and mivacurium.
• Metoclopramide may increase prolactin blood concentration and therefore interfere with drugs that have hypoprolactinaemic effect such as bromocriptine.
• The response to gonadorelin may be altered by Metoclopramide.
• Caution is required if Metoclopramide must be given to patients receiving MAOIs.
• Care is required if metoclopramide is used with drugs that affect cardiac conduction.
• Acute anxiety, rigidity, generalized tremor, opisthotonus and hypertension may occur when metoclopramide is used with certain drugs.
• Acute dystonia may occur when metoclopramide is used with fluoxetine.
• Involuntary twitching, tremor and stiffness of the jaw and tongue may occur when metoclopramide is used with sertraline.
• Serotonin syndrome with confusion, agitation, generalized shaking, myoclonus, facial twitching, diaphoresis, horizontal nystagmus and dilated pupils may occur when Metoclopramide is used with venlafaxine.
• Neurotoxicity may occur when Metoclopramide is used with carbamazepine.
😣 WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all Medicines, Metoclopramide may occasionally cause side effects in some patients.
Tell your doctor if you experience any of:
• Extrapyramidal symptoms (usually acute dystonic reactions); these are more common in children and young adults.
• Parkinsonism and tardive dyskinesia during prolonged treatment in elderly patients.
• CNS effects include restlessness, drowsiness, dizziness, anxiety, confusion, tremor, hallucinations.
• Depression (can be severe, with suicidal ideation and suicide), delirium, uncontrolled crying, acute akathisia (accompanied by restlessness, anxiety and irritability), agoraphobia, encephalopathy, insomnia (with or without daytime drowsiness), hypersensitivity psychosis (symptoms included hallucinations, delusional experiences, anxiety, restlessness and sleep disturbances)
• Gastrointestinal disturbances, dyspnoea, visual disturbances, urinary frequency and incontinence
• Headache, blood disorders, hypersensitivity reactions (rash, bronchospasm, and angioedema), neuroleptic malignant syndrome, disorders of cardiac conduction
• Transient flushing of the face and upper body may follow with high intravenous doses Metoclopramide
• Metoclopramide stimulates prolactin secretion and may cause galactorrea or related disorders (hyperprolactinaemia, pituitary
• Transient increases in plasma-aldosterone concentrations
• Agranulocytosis, methaemoglobinaemia, sulphaemoglobinaemia
• Hypotension, hypertension, supraventricular tachycardia bradycardia followed by total heart block and sinus arrest
• Acute dystonic-dyskinetic reactions. Symptoms include oculogyric crisis, opisthotonus, torticollis, trismus, a tetanus-like reaction, blue coloration of the tongue
• Pruritus, generalized urticaria, loss of consciousness
• Neuroleptic malignant syndrome
• Other side effects not listed above may occur in some patients.
• If you experience any of the side effects mentioned or are concerned about anything or you noticed anything unusual contact your doctor
⏱️ WHAT TO DO IF YOU MISS A DOSE
• A double dose of metoclopramide Hydrochloride injection must not be administered to make up for forgotten injections
🚨 WHAT TO DO IF YOU ARE GIVEN TOO MUCH
• Consult your doctor or local hospital causality department at once.
• Show the doctor the ampoules.
📦 HOW TO STORE YOUR MEDICINE
• Store the ampoules in the original packaging in a dry place at a temperature below 30°C.
• Protect from light.
• Store all medicines out of the reach of children.
• Don’t use this medicine if the expiry date printed on the pack or the label has passed.