Metoclopramide Actavis 10

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Metoclopramide hydrochloride 10 mg
Available from:
Teva Pharma (New Zealand) Limited
INN (International Name):
Metoclopramide hydrochloride 10 mg
Dosage:
10 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Metoclopramide hydrochloride 10 mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified talc Stearic acid Titanium dioxide
Prescription type:
Prescription
Manufactured by:
Ipca Laboratories Limited
Therapeutic indications:
ADULTS (20 years and over) Digestive Disorders Metoclopramide restores normal co-ordination and tone to the upper digestive tract and relieves symptoms of gastroduodenal dysfunction including: · Dyspepsia · Heartburn · Flatulence · Sickness · Regurgitation of bile · Pain These symptoms may be associated with such conditions as: · Peptic ulcer · Duodenitis · Reflux oesophagitis · Gastritis · Hiatus hernia · Cholelithiasis and post-cholecystectomy dyspepsia Nausea and Vomiting Metoclopramide is indicated in the treatment of nausea and vomiting associated with: · Gastrointestinal disorders · Cyclical vomiting · Intolerance to cytotoxic medicines · Congestive heart failure · Deep x-ray or cobalt therapy · Post anaesthetic vomiting Migraine Metoclopramide 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. parac
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/Alu in an outer carton - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Alu in an outer carton - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
Authorization number:
TT50-9370a
Authorization date:
2013-08-15

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NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

Metoclopramide Actavis 5, film coated tablets, 5 mg

Metoclopramide Actavis 10, film coated tablets, 10 mg

2.

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.

3.

PHARMACEUTICAL FORM

Metoclopramide Actavis 5: White to off-white, circular, biconvex film coated tablets plain on both

sides.

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.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Adults (20 years and over)

Digestive Disorders

Metoclopramide Actavis restores normal co-ordination and tone to the upper digestive tract and

relieves symptoms of gastroduodenal dysfunction including:

Dyspepsia

Heartburn

Flatulence

Sickness

Regurgitation of bile

Pain.

These symptoms may be associated with such conditions as:

Peptic ulcer

Duodenitis

Reflux oesophagitis

Gastritis

Hiatus hernia

Cholelithiasis and post-cholecystectomy dyspepsia.

Nausea and Vomiting

Metoclopramide Actavis is indicated in the treatment of nausea and vomiting associated with:

Gastrointestinal disorders

Cyclical vomiting

Intolerance to cytotoxic medicines

Congestive heart failure

Deep x-ray or cobalt therapy

Post-anaesthetic vomiting.

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Migraine

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 Conditions

Post-operative gastric hypotonia

Post-vagotomy syndrome.

Metoclopramide Actavis promotes normal gastric emptying and restores motility in vagotomised

patients, and where postoperative symptoms suggest gastroduodenal dysfunction.

Diagnostic Procedures

Radiology

Duodenal intubation.

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

intubation procedures.

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.

4.2

Dose and method of administration

Dose

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.

Adults

The recommended dosage for adults, 20 years and older, is 10 mg three times daily.

For patients less than 60kg, see Table 1.

Special populations

Elderly population

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.

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Young Adults and Children

Metoclopramide

Actavis

should

only

used

after

careful

examination

avoid

masking

underlying disorder e.g. cerebral irritation. In the treatment of this group attention should be given

primarily

body

weight

treatment

should

begin

lower

dosage

where

stated.

Metoclopramide Actavis should be used as second line therapy in these patients.

Table 1

Young Adults:

15 – 19 years

60kg & over

10 mg three times daily

30kg – 59kg

5 mg three times daily

Diagnostic Indications

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:

Table 2

Adults:

20 years and over

10 mg – 20 mg

Young adults:

15 – 19 years

10 mg

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

population.

4.3

Contraindications

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

perforation.

Metoclopramide

Actavis

contraindicated

patients

with

phaeochromocytoma

because

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

the medicine.

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.

4.4

Special warnings and precautions for use

Dystonic reactions

These

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.

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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

symptomatic

suppression

upon

long-term

course

syndrome

unknown.

Therefore

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

phenothiazines,

care

should

exercised

event

both

medicines

being

prescribed

concurrently.

Neuroleptic Malignant Syndrome

This

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

dependent

in

vitro

factor

potential

importance

prescription

metoclopramide

contemplated in a patient with previously detected breast cancer. Although disturbances such as

galactorrhoea,

amenorrhoea,

gynaecomastia,

impotence

have

been

reported

with

prolactin

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

administration).

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.

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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.

Metoclopramide

induced

depression

been

reported

patients

without

prior

history

depression. Metoclopramide should be given to patients with a prior history of depression only if the

expected benefits outweigh the potential risks.

Metoclopramide

should

used

with

caution

patients

with

hypertension

intravenously

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.

4.5

Interaction with other medicines and other forms of interaction

effects

metoclopramide

gastrointestinal

motility

antagonised

anticholinergic

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).

4.6

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

available.

4.7

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.

4.8

Undesirable effects

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.

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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

be given.

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.

Hypersensitive

reactions,

Parkinsonian

symptoms

including

tremor,

rigidity,

bradykinesia

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/

4.9

Overdose

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

supportive

therapy.

Antiparkinson

antihistamine/anticholinergic

medicines

such

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).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for functional gastrointestinal disorders; Propulsives, ATC code:

A03FA01

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

acetylcholine.

effect

metoclopramide

motility

dependent

intact

vagal

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

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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.

5.2

Pharmacokinetic properties

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.

There

marked

variability

peak

plasma

concentrations

metoclopramide

after

oral

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).

5.3

Preclinical safety data

None.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Pregelatinised maize starch, microcrystalline cellulose, maize starch, colloidal anhydrous silica,

stearic acid, hypromellose, macrogol 6000, titanium dioxide and purified talc.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

36 months

6.4

Special precautions for storage

Store below 25°C. Protect from light.

6.5

Nature and contents of container

PVC/Aluminium foil blister strips. Pack sizes of 100 or 500 tablets.

6.6

Special precautions for disposal

No special requirements for disposal.

7.

MEDICINE SCHEDULE

Prescription Medicine

8.

SPONSOR

Teva Pharma (New Zealand) Limited

PO Box 128 244

Remuera

Auckland 1541

Telephone: 0800 800 097

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9.

DATE OF FIRST APPROVAL

22 May 2014

10.

DATE OF REVISION OF THE TEXT

22 May 2017

SUMMARY TABLE OF CHANGES

Section changed

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

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