Austell Metoclopramide 5 mg Injection

The name of your medicine is AUSTELL METOCLOPRAMIDE. The active ingredient is metoclopramide hydrochloride, belonging to a group of medicines called anti-emetics. It works on a part of your brain that prevents you from feeling sick (nausea) and being sick (vomiting). AUSTELL METOCLOPRAMIDE is used for the treatment of:

• Digestive disorders Treatment of conditions associated with gastric statis or hypomotility.
• Nausea and vomiting AUSTELL METOCLOPRAMIDE is an effective anti-emetic agent used in the control of nausea and vomiting associated with the following conditions: Intolerance to essential drugs possessing emetic properties, uraemic conditions, malignant disease, gastro-intestinal disorders and post anaesthetic vomiting.
• Diagnostic radiology In patients where delayed gastric emptying interferes with radiological examination of stomach or small intestines.
• Duodenal intubation The action of AUSTELL METOCLOPRAMIDE in promoting stomach emptying, combined with its anti-emetic effect, has proved a useful aid to gastro-intestinal intubation procedure.
• Young and adults and children The use of AUSTELL METOCLOPRAMIDE in patients under 20 years should be restricted to the following: Severe intractable vomiting of known cause. As an aid to gastro-intestinal intubation and diagnostic radiology.

AUSTELL METOCLOPRAMIDE should not be administered to you:

• if you are hypersensitive (allergic) to metoclopramide or any of the other ingredients of AUSTELL METOCLOPRAMIDE (listed in section 6).
• if you are taking medicines called “phenothiazines” (antipsychotic medicine).
• if you have or have had bleeding, perforation or blockage of the stomach or intestines, or if you have had an operation on your stomach or intestines recently.
• if you suffer from high blood pressure due to tumour of the adrenal gland (a condition known as pheochromocytoma).
• if you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with AUSTELL METOCLOPRAMIDE.
• if you suffer from epilepsy.
• if you suffer from a condition called “Parkinson’s disease”.
• if you are taking a medicine called levodopa (a medicine used to treat Parkinson’s disease).
• if you have ever had an abnormal blood pigment level (methaemoglobinaemia) or NADH cytochrome - b5 deficiency.
• Do not give AUSTELL METOCLOPRAMIDE to a child less than 1 (one) of age (see below “Children and adolescents”).
• if you are pregnant or breastfeeding.
• if you suffer from convulsive disorders.
• if you suffer from a condition called “porphyria”.

Warnings and precautions

Tell your doctor or health care provider before being given AUSTELL METOCLOPRAMIDE injection:

• if you are elderly as there is an increased risk of extrapyramidal reactions (extreme restlessness, involuntary movements, and uncontrollable speech). These reactions usually at the beginning of the treatment and can occur after a single administration.
• Caution is advised in patients with a history of mental depression.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself AUSTELL METOCLOPRAMIDE. It will be given to you by a person who is qualified to do so. AUSTELL METOCLOPRAMIDE will be given intravenously or intramuscularly. Carefully follow all instructions given to you by your doctor, nurse or pharmacist. Your doctor will tell you how long your treatment with AUSTELL METOCLOPRAMIDE will last. If you have the impression that the effect of AUSTELL METOCLOPRAMIDE is too strong or too weak, tell your doctor or pharmacist.

Dose

AUSTELL METOCLOPRAMIDE is used in the following conditions: Severe intractable vomiting when mechanical obstruction has been excluded, chemotherapy or radiotherapy-induced vomiting, as an aid to gastro-intestinal intubation, and in premedication.

Parenteral: On no account should AUSTELL METOCLOPRAMIDE ampoules be diluted for injection since this will upset the isotonicity and the stability of the medicine.

Children

15 years and over with a mass of 60 kg or more: 10 mg (1 ampoule) 1 - 3 times daily I.V or I.M. depending on the severity of the condition.

Children 15 years and over with a mass of less than 60 kg: 5 mg (1,0 mL of a 10 mg/2 mL ampoule) I.V. or I.M. 1 - 3 times daily.

Children 5 - 14 years: 2,5 mg (0,5 mL of 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.

Children 3 - 5 years: 1 mg (0,2 mL of a 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.

Children 1 - 3 years: 0.5 mg (0,1 mL of a 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.

Dosage for Diagnostic Radiology: Intravenous: 10 – 20 mg (1 - 2 ampoules) 5 – 15 minutes before the barium meal. Intramuscular: 10 – 20 mg (1 - 2 ampoules) 10 – 15 minutes before the barium meal. The dosage recommendations given should be strictly adhered to if side effects of the dystonic type are to be avoided (see Warnings and Precautions). AUSTELL METOCLOPRAMIDE should only be used after careful examination to avoid masking an underlying disorder e.g. cerebral irritation. The total daily dose of AUSTELL METOCLOPRAMIDE should not exceed 0.5 mg per kg body weight. Adults with liver or kidney problems Talk to your doctor if you have liver or kidney problems. The dose should be reduced if you have severe liver or kidney problems. Total clearance of metoclopramide is significantly reduced in patients with renal impairment and hence dosage reduction of at least 50 % have been recommended in patients with moderate to severe renal impairment.

AUSTELL METOCLOPRAMIDE can have side effects. Not all side effects reported for AUSTELL METOCLOPRAMIDE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving AUSTELL METOCLOPRAMIDE, please consult your health care provider for advice. If any of the following happens, stop using AUSTELL METOCLOPRAMIDE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are very serious side effects. If you have them, you may have had a serious reaction to AUSTELL METOCLOPRAMIDE. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• chest pain, angina, changes in the way your heart beats, for example, if you notice it beating faster, cardiac arrest (particularly with the injectable route)
• shock (severe decrease of heart pressure) (particularly with the injectable route)
• uncontrollable movements (often involving head or neck). These may occur in children or young adults and particularly when high doses are used. These signs usually occur at the beginning of treatment and may even occur after one single administration. These movements will stop when treated appropriately
• high fever, high blood pressure, fitting, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome
• fitting (especially in patients with epilepsy).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• depression
• uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)
• symptoms similar to Parkinson’s disease (rigidity, tremors)
• feeling restless
• decrease in blood pressure (particularly with the injectable route)
• diarrhoea, constipation
• feeling drowsy, feeling weak (asthenia).

Less frequent side effects:

• raised levels of a hormone called prolactin in the blood which may cause milk production in men and in women who are not breastfeeding
• irregular periods
• visual disturbances and involuntary upward deviation of the eye ball
• hallucination (seeing or hearing things that are not there), feeling confused
• decreased level of consciousness.

Side effects with frequency unknown:

• abnormal blood pigments levels, which may change the colour of your skin
• abnormal development of breasts (gynecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• sudden increase in blood pressure in patients with tumour of the adrenal gland (pheochromocytoma)
• very high blood pressure
• urinary incontinence
• retention of fluid in the body
• pain at the site of infection.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AUSTELL METOCLOPRAMIDE.

Store all medicines out of reach of children. Your doctor, pharmacist or healthcare professional knows how to store AUSTELL METOCLOPRAMIDE. The doctor or nurse who is administering AUSTELL METOCLOPRAMIDE to you, will make sure that the medicine is not used after the expiry date printed on the vial. Store at or below 25 °C. Protect from light. Do not transfer the medicine to any other container. Return all unused medicines to your pharmacist. Do not dispose unused medicines in drains and sewerage system (e.g. toilets).