New Zealand - English - Medsafe (Medicines Safety Authority)
NEW ZEALAND DATA SHEET
Metoclopramide Actavis 5, film coated tablets, 5 mg
Metoclopramide Actavis 10, film coated tablets, 10 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg of metoclopramide hydrochloride.
For the full list of excipients, see section 6.1.
Metoclopramide Actavis 5: White to off-white, circular, biconvex film coated tablets plain on both
Metoclopramide Actavis 10: White to off-white, circular, biconvex film coated tablets with breakline
on both sides. The tablet can be divided into equal doses.
Adults (20 years and over)
Metoclopramide Actavis restores normal co-ordination and tone to the upper digestive tract and
relieves symptoms of gastroduodenal dysfunction including:
Regurgitation of bile
These symptoms may be associated with such conditions as:
Cholelithiasis and post-cholecystectomy dyspepsia.
Nausea and Vomiting
Metoclopramide Actavis is indicated in the treatment of nausea and vomiting associated with:
Intolerance to cytotoxic medicines
Congestive heart failure
Deep x-ray or cobalt therapy
Metoclopramide Actavis 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 antimigraine therapy (e.g. paracetamol) which may otherwise be
impaired in such patients.
Post-operative gastric hypotonia
Metoclopramide Actavis promotes normal gastric emptying and restores motility in vagotomised
patients, and where postoperative symptoms suggest gastroduodenal dysfunction.
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
Young Adults and Children
The use of Metoclopramide Actavis in patients under 20 years should be restricted to the following
and used only as second line therapy:
Severe intractable vomiting of known cause
Vomiting associated with radiotherapy and intolerance to cytotoxic medicines
As an aid to gastrointestinal intubation
As part of the premedication before surgical procedures.
Dose and method of administration
The dosage recommendations given below should be strictly adhered to if side effects of the dystonic
type are to be avoided. It should be noted that total daily dosage of Metoclopramide Actavis,
especially for children and young adults, should not normally exceed 0.5 mg/kg body weight or 30 mg
daily. Maximum recommended treatment duration is 5 days in all age groups.
The recommended dosage for adults, 20 years and older, is 10 mg three times daily.
For patients less than 60kg, see Table 1.
As for adults. To avoid adverse reactions adhere strictly to dosage recommendations and where
prolonged therapy is considered necessary, patients should be regularly reviewed.
Renal and hepatic impairment
In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at
reduced dosage. Metoclopramide is metabolised in the liver and the predominant route of elimination
of metoclopramide and its metabolites is via the kidney.
Young Adults and Children
underlying disorder e.g. cerebral irritation. In the treatment of this group attention should be given
Metoclopramide Actavis should be used as second line therapy in these patients.
15 – 19 years
60kg & over
10 mg three times daily
30kg – 59kg
5 mg three times daily
A single dose of Metoclopramide Actavis may be given 5-10 minutes before the examination.
Subject to body weight considerations (see above) the following dosages are recommended:
20 years and over
10 mg – 20 mg
15 – 19 years
Method of administration
Metoclopramide Actavis should not be used in children under the age of 15 years since the product
range does not have the strengths or dose forms required to deliver the smaller doses required for this
age group. Other pharmaceutical forms/strengths may be more appropriate for administration to this
Metoclopramide Actavis should not be used whenever stimulation of gastrointestinal motility might
be dangerous, for example, in the presence of gastrointestinal haemorrhage,mechanical obstruction, or
medicine may cause a hypertensive crisis, probably due to release of catecholamines from the tumour.
Such hypertensive crises may be controlled by phentolamine.
Metoclopramide Actavis is contraindicated in patients with known hypersensitivity or intolerance to
Metoclopramide Actavis is contraindicated:
patients with porphyria
metoclopramide should not be used in patients with epilepsy since it may increase the frequency
and severity of seizures.
metoclopramide should not be administered to patients receiving other medicines which are likely
to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions
may be increased.
Special warnings and precautions for use
occur in approximately 1% of patients given metoclopramide. These occur more frequently in
children and young adults and may occur after a single dose.
Persistent tardive dyskinesia
Tardive dyskinesia may appear in some patients on long-term therapy or may appear after treatment
has been discontinued. The risk appears to be greater in elderly patients on high dose therapy,
especially females. The symptoms are persistent and in some patients appear to be irreversible. The
syndrome is characterised by rhythmical involuntary movement of the tongue, face, mouth or jaw (eg.
protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these
may be accompanied by involuntary movement of extremities. There is no known effective treatment
for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome.
Although the risk of tardive dyskinesia with metoclopramide has not been extensively studied, one
published study reported a tardive dyskinesia prevalence of 20% among patients treated for at least 3
months. Both the risk of developing the syndrome and the likelihood that it will become irreversible
are believed to increase with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms
of tardive dyskinesia. It has been suggested that fine vermicular movements of the tongue may be an
early sign of the syndrome, and, if the medications stopped at that time, the syndrome may not
develop. Tardive dyskinesia may remit partially or completely within several weeks to months after
metoclopramide is withdrawn. Metoclopramide itself, however, may suppress (or partially suppress)
the signs of tardive dyskinesia thereby masking the underlying disease process. The effect of this
metoclopramide should not be used for the symptomatic control of tardive dyskinesia. Prolonged
treatment (greater than 12 weeks) with metoclopramide should be avoided in all rare cases where the
therapeutic benefit is thought to outweigh the risk to the patient of developing tardive dyskinesia.
Care should be exercised in patients being treated with other centrally active medications.
Since extrapyramidal symptoms may occur with both metoclopramide and neuroleptics such as
Neuroleptic Malignant Syndrome
has been reported with metoclopramide in combination with neuroleptics as well as with
metoclopramide monotherapy (see Undesirable Effects).
Metoclopramide elevates prolactin levels and the elevation persists during chronic administration.
Tissue culture experiments indicate that approximately one third of human breast cancers are prolactin
contemplated in a patient with previously detected breast cancer. Although disturbances such as
elevating medicines, the clinical significance of elevated serum prolactin levels is unknown for most
patients. An increase in mammary neoplasms has been found in rodents after chronic administration
of prolactin stimulating neuroleptic medications.
Neither clinical studies nor epidemiological studies conducted to date, however, have shown an
association between chronic administration of these medicines and mammary tumorigenesis; the
available evidence is too limited to be conclusive at this time.
The frequency and severity of seizures or extrapyramidal reactions may be increased in epileptic
patients given metoclopramide.
Following operations such as pyloroplasty or gut anastomosis, metoclopramide therapy should be
withheld for three or four days as vigorous muscular contractions may not help healing.
Special care should be taken in cases of severe renal insufficiency (see Dose and method of
The symptomatic relief provided by metoclopramide may delay recognition of serious disease. It
should not be prescribed until diagnosis has been established, and should not be substituted for
appropriate investigation of the patient's symptoms.
Metoclopramide should not be given to children unless a clear indication has been established for its
use, because of the higher incidence of adverse reactions in this age group.
If vomiting persists, the patient should be reassessed to exclude the possibility of an underlying
disorder eg. cerebral irritation.
Patients should be cautioned about engaging in activities requiring mental alertness for a few hours
after the medicine has been administered.
depression. Metoclopramide should be given to patients with a prior history of depression only if the
expected benefits outweigh the potential risks.
administered metoclopramide has been shown to release catecholamines.
Metoclopramide can exacerbate Parkinsonian symptoms; therefore it should be used with caution, if
at all, in patients with Parkinsonian syndrome.
Interaction with other medicines and other forms of interaction
medicines and narcotic analgesics.
Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics,
narcotics or tranquillisers.
Since metoclopramide accelerates abnormally slow gastric and small bowel peristaltic activity, it may
change absorption of orally administered medicines.
The absorption of medicines from the small bowel may be accelerated (eg. paracetamol, tetracycline,
L-dopa), whereas absorption of medicines from the stomach may be diminished (eg. digoxin).
Fertility, pregnancy and lactation
Use in pregnancy (Category A)
Adequate human data on use during pregnancy are not available.
Use in lactation
Adequate human data on use during lactation and adequate animal reproduction studies are not
Effects on ability to drive and use machines
Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the
vision and also interfere with ability to drive or to operate machines.
The most frequent adverse reactions to metoclopramide are restlessness, drowsiness, fatigue and
lassitude, which occur in approximately 10% of patients.
Less frequently, insomnia, headache, dizziness, nausea, or bowel disturbances may occur. Rare (less
than 1 in 1,000) cases of acute depression have been reported. Anxiety or agitation may occur.
A single instance of supraventricular tachycardia following intramuscular administration has been
reported. There have been very rare (less than 1 in 10,000) cases of abnormalities of cardiac
conduction (such as bradycardia and heart block) in association with intravenous metoclopramide.
Raised serum prolactin levels have been observed during metoclopramide therapy: this may result in
galactorrhoea, irregular periods and gynacecomastia.
Although uncommon at normal dosage, various extrapyramidal reactions to metoclopramide, usually
of the dystonic type, have been reported. Reactions include: spasm of the facial muscles, trismus,
rhythmic protrusion of the tongue, a bulbar type of speech, spasm of the extraocular muscles
including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There
may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of
starting treatment and the effects usually disappear within 24 hours of withdrawal of the medicine,
however, close observation is required and in cases of more severe reactions, an antiparkinson
medication such as benztropine or an anticholinergic antihistamine such as diphenhydramine should
Tardive dyskinesia, which may be persistent, has been reported particularly in elderly patients
undergoing long-term therapy with metoclopramide.
Very rare (less than 1 in 10,000) occurrences of the Neuroleptic Malignant Syndrome have been
reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness,
muscle rigidity, autonomic instability and elevated levels of CPK and must be treated urgently
(recognised treatments include dantrolene and bromocriptine). Metoclopramide Actavis should be
stopped immediately if this syndrome occurs.
Methaemoglobinaemia has also been reported.
akinesia, respiratory failure, urinary incontinence, depression, very rare reports of abnormalities of
cardiac conduction (bradycardia, asystole, heart block, sinus arrest and cardiac arrest) have been
reported following intravenous administration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows
continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked
to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/
Extrapyramidal side effects are the most frequently reported adverse reactions to overdosage. Very
rarely AV block has been observed. Management of overdosage consists of close observation and
diphenhydramine hydrochloride have effectively controlled extrapyramidal reactions. Haemodialysis
appears ineffective in removing metoclopramide. Similarly, continuous ambulatory peritoneal dialysis
does not remove significant amounts of the medicine.
For advice on the management of overdose please contact the National Poisons Centre on 0800
POISON (0800 764766).
Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders; Propulsives, ATC code:
Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric,
biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitise tissues to the action
innervation, but it can be abolished by anticholinergic medicines.
Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes
the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum
resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the
lower oesophageal sphincter. It has little, if any effect on the motility of the colon or gall bladder.
Metoclopramide has dopamine antagonist activity. Like the phenothiazines and related medicines,
which are also dopamine antagonists, metoclopramide produces sedation and may produce extra-
pyramidal reactions (see Special warnings and precautions for use).
Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of
prolactin and causes a transient increase in circulating aldosterone levels.
The onset of pharmacological action is 1 to 3 minutes following an intravenous dose, 10 to 15 minutes
following intramuscular administration, and 30 to 60 minutes following an oral dose; pharmacological
effects persist for 1 to 2 hours.
administration, which appears to be due to interindividual differences in first-pass metabolism.
Plasma protein binding is 13 to 22%. About 80% of the drug is excreted in the urine in the first 24
hours, approximately half as the glucuronide and sulfate conjugates and half as unchanged drug.
Elimination half-life varies in different studies from 2.5 to 5 hours. Impaired renal function results in
reduced clearance of metoclopramide and an increased half-life (15 hours).
Preclinical safety data
List of excipients
Pregelatinised maize starch, microcrystalline cellulose, maize starch, colloidal anhydrous silica,
stearic acid, hypromellose, macrogol 6000, titanium dioxide and purified talc.
Special precautions for storage
Store below 25°C. Protect from light.
Nature and contents of container
PVC/Aluminium foil blister strips. Pack sizes of 100 or 500 tablets.
Special precautions for disposal
No special requirements for disposal.
Teva Pharma (New Zealand) Limited
PO Box 128 244
Telephone: 0800 800 097
DATE OF FIRST APPROVAL
22 May 2014
DATE OF REVISION OF THE TEXT
22 May 2017
SUMMARY TABLE OF CHANGES
Summary of new information
Update to the SPC-style format
4.1 & 4.2
Updated to include maximum dose in mg and treatment
duration of 5 days.
Sponsor company name and address details updated