Metoclopramide Injection USP 10mg/2ml Taj Pharma

  1. Name of the medicinal product

Metoclopramide Injection USP 10mg/2ml Taj Pharma

  1. Qualitative and quantitative composition

a) Metoclopramide Injection USP 10mg/2ml
Each m1 contains:
Metoclopramide                                   5mg
Sodium Chloride                               8.5mg
Water for injection                                 q.s

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Solution for injection.

Clear, colourless, sterile solution.

  1. Clinical particulars

4.1 Therapeutic indications

Adult population

Metoclopramide 5mg/ml Solution for Injection is indicated in adults for:

– Prevention of post operative nausea and vomiting (PONV)

– Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting

– Prevention of radiotherapy induced nausea and vomiting (RINV).

Paediatric population

Metoclopramide 5mg/ml Solution for Injection is indicated in children (aged 1-18 years) for:

– Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option

– Treatment of established post operative nausea and vomiting (PONV) as a second line option

4.2 Posology and method of administration

Posology

The solution can be administered intravenously or intramuscularly.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes).

All indications (adult population)

For prevention of PONV a single dose of 10mg is recommended.

For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10 mg, repeated up to three times daily.

The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.

The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible.

All indications (paediatric population aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by intravenous route. The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosing table

Age Body Weight Dose Frequency
1-3 years 10-14 kg 1 mg Up to 3 times daily
3-5 years 15-19 kg 2 mg Up to 3 times daily
5-9 years 20-29 kg 2.5 mg Up to 3 times daily
9-18 years 30-60 kg 5 mg Up to 3 times daily
15-18 years Over 60kg 10 mg Up to 3 times daily

The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Special population

Elderly

In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment:

In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).

Hepatic impairment:

In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).

Paediatric population

Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

Method of administration:

A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).

4.3 Contraindications

– Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

– Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk

– Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes

– History of neuroleptic or metoclopramide-induced tardive dyskinesia

– Epilepsy (increased crises frequency and intensity)

– Parkinson’s disease

– Combination with levodopa or dopaminergic agonists (see section 4.5)

– Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.

– Use in children less than 1 year of age due to an increased risk of extrapyramidal disorders (see section 4.4)

It should not be administered to patients where gastro intestinal conditions might be adversely affected, as in gastrointestinal obstruction, perforation, haemorrhage or immediately after surgery.

Metoclopramide should not be used during breast-feeding (see 4.6).

4.4 Special warnings and precautions for use

Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria.

Neurological Disorders

Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions occur usually at the beginning of the treatment and can occur after a single administration. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).

The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear.

Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs (see section 4.3)

Symptoms of Parkinson’s disease may also be exacerbated by metoclopramide.

Metoclopramide should be used with caution in patients with hypertension, since there is limited evidence that the drug may increase circulating catecholamines in such patients.

Because metoclopramide can stimulate gastro-intestinal mobility, the drug theoretically could produce increased pressure on the suture lines following gastro-intestinal anastomosis or closure.

Methaemoglobinemia

Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

Cardiac Disorders

There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following administration of metoclopramide by injection, particularly via the intravenous route (see section 4.8).

Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).

Special care should be taken when administering Metoclopramide intravenously to patients with “sick sinus syndrome” or other cardiac conduction disturbances.

Renal and Hepatic Impairment

In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended (see section 4.2).

This medicinal product contains less than 1 mmol sodium (23mg) per 2ml, i.e. essentially ‘sodium- free’.

Metoclopramide 5mg/ml Solution for Injection contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm.

4.5 Interaction with other medicinal products and other forms of interaction

Contraindicated combination

Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3).

Combination to be avoided

Alcohol potentiates the sedative effect of metoclopramide.

Combination to be taken into account

Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.

Anticholinergics and morphine derivatives

Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.

Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related)

Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.

Neuroleptics

Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.

Serotonergic drugs

The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.

Digoxin

Metoclopramide may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required.

Cyclosporine

Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%). Careful monitoring of cyclosporine plasma concentration is required. The clinical consequence is uncertain.

Mivacurium and suxamethonium

Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).

Strong CYP2D6 inhibitors

Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine. Although the clinical significance is uncertain, patients should be monitored for adverse reactions.

The effects of certain other drugs with potential central stimulant effects, e.g. monoamine oxidase inhibitors and sympathomimetics, may be modified when prescribed with metoclopramide and their dosage may need to be adjusted accordingly.

Aspirin, paracetamol: The effect of metoclopramide on gastric motility may modify the absorption of other concurrently administered oral drugs from the gastro-intestinal tract either by diminishing absorption from the stomach or by enhancing the absorption from the small intestine (e.g. the effects of paracetamol and aspirin are enhanced).

Atovaquone: Metoclopramide may reduce its plasma concentrations.

4.6 Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded. Metoclopramide should be avoided at the end of pregnancy. If metoclopramide is used, neonatal monitoring should be undertaken.

Breast-feeding

Metoclopramide is excreted in breast milk at low level. Adverse reactions in the breast-fed baby cannot be excluded. Therefore metoclopramide is not recommended during breast-feeding. Discontinuation of metoclopramide in breast-feeding women should be considered.

4.7 Effects on ability to drive and use machines

Metoclopramide has moderate influence on the ability to drive and use machines. Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

4.8 Undesirable effects

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

System Organ Class Adverse reactions
Blood and lymphatic system disorders
Not known Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates (see section 4.4)

Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicinal products

Cardiac disorders
Uncommon Bradycardia, particularly with intravenous formulation
Not known Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4); Atrioventricular block, Sinus arrest particularly with intravenous formulation; Electrocardiogram QT prolonged; Torsade de Pointes;
Endocrine disorders*
Uncommon Amenorrhoea, Hyperprolactinaemia,
Rare Galactorrhoea
Not known Gynaecomastia
Gastrointestinal disorders
Common Diarrhoea
General disorders and administration site conditions
Common Asthenia
Immune system disorders
Uncommon Hypersensitivity
Not known Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation
Nervous system disorders
Very common Somnolence
Common Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4), Parkinsonism, Akathisia
Uncommon Dystonia, including oculogyric crisis, Dyskinesia, Depressed level of consciousness
Rare Convulsion especially in epileptic patients
Not known Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Psychiatric disorders
Common Depression
Uncommon Hallucination
Rare Confusional state
Vascular disorder
Common: Hypotension, particularly with intravenous formulation
Not known Shock, syncope after injectable use Acute hypertension in patients with phaeochromocytoma (see section 4.3), Transient increase in blood pressure

* Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).

The following reactions, sometimes associated, occur more frequently when high doses are used:

– Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).

– Drowsiness, decreased level of consciousness, confusion, hallucination.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Symptoms

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).

A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Agents stimulating gastro-intestinal motility

Mechanism of action

The action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastro-intestinal tract, where it has the effect of encouraging normal peristaltic action. This provides for a fundamental approach to the control of those conditions were disturbed gastro-intestinal motility is a common underlying factor.

Metoclopramide stimulates activity of the upper gastro-intestinal tract and restores normal co-ordination and tone. Gastric emptying is accelerated and the resting tone of the gastrooesophageal sphincter is increased. Metoclopramide is a dopamine-receptor antagonist with a direct anti-emetic effect on the medullary chemoreceptor trigger zone.

5.2 Pharmacokinetic properties

Absorption:

Metoclopramide is rapidly absorbed from the gastrointestinal tract and undergoes variable first-pass metabolism in the liver.

Biotransformation and Elimination:

It is excreted mainly in the urine as free and as conjugated metoclopramide and as metabolites. It crosses the placenta and is excreted in breast milk.

The elimination half-life is about 6 hours.

Renal impairment

The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).

Hepatic impairment

In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.

5.3 Preclinical safety data

No further relevant information other than that which is included with other sections of the Summary of Product Characteristics.

  1. Pharmaceutical particulars

6.1 List of excipients

Sodium Metabisulphite, Sodium Chloride, Dilute Hydrochloric Acid or Sodium Hydroxide, Water for Injections.

6.2 Incompatibilities

If this product is used for the treatment of nausea and vomiting associated with cytotoxic drugs, the cytotoxics should be administered as a separate infusion.

6.3 Shelf life

3 years (36 months).

6.4 Special precautions for storage

Do not store above 25°C.

Keep the ampoule in the outer carton in order to protect from light.

6.5 Nature and contents of container

2m1, clear glass ampoules, glass type 1 Ph.Eur. borosilicate glass packed in cardboard cartons to contain 10 x 2m1 ampoules.

6.6 Special precautions for disposal and other handling

If only part of an ampoule is used, discard the remaining solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Metoclopramide Injection USP 10mg/2ml

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you

  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor or
  • If you get any side effects, talk to your doctor or This includes any possible side effects not listed in this leaflet See section 4.

The product is known by METOCLOPRAMIDE 5mg/ml Solution for Injection but will be referred to as Metoclopramide Injection throughout the rest of this leaflet.

What is in this leaflet

  1. What Metoclopramide Injection is and what it is used for
  2. What you need to know before you are given Metoclopramide Injection
  3. How you will be given metoclopramide Injection
  4. Possible side effects
  5. How to store Metoclopramide Injection
  6. Contents of the pack and other information

 

  1. What metoclopramide injection is and what it is used for

Metoclopramide Injection is an antiemetic. It contains a medicine called “metoclopramide”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).

Adult population

Metoclopramide Injection is used in adults:

  • to prevent nausea and vomiting that may occur after surgery
  • to treat nausea and vomiting including nausea and vomiting which may occur with a migraine
  • to prevent nausea and vomiting caused by

Paediatric population

Metoclopramide Injection is used in children (aged 1-18 years) only if other treatment does not work or cannot be used:

  • to prevent delayed nausea and vomiting that may occur after chemotherapy
  • to treat nausea and vomiting that has occurred after
  1. What you need to know before you are given metoclopramide injection

Do not use Metoclopramide Injection

  • if you are allergic to Metoclopramide or any of the other ingredients of this medicine (listed in section 6)
  • if you are breast-feeding
  • if you have bleeding, obstruction or a tear in your stomach or gut
  • if you have had a stomach or bowel operation within the previous four days
  • if you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma)
  • if you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine
  • if you have epilepsy
  • if you have Parkinson’s disease
  • if you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see “Other medicines and Metoclopramide Injection” below)
  • if you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency. Do not give Metoclopramide Injection to a child less than 1 year of age (see “Children and adolescents” below).
Warnings and precautions

Talk to your doctor or nurse before you are given Metoclopramide injection:

  • if you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems
  • if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
  • if you are using other medicines known to affect the way your heart beats
  • if you have any neurological (brain) problems
  • if you have liver or kidney problems. The dose may be reduced (see section 3)
  • if pregnant or if you are breast-feeding
  • if taking any other medicine by mouth. It is possible that metoclopramide injection may change the amount of the other medicine that gets into your body
  • if taking any drugs known as serotonergic drugs, as taking these medications with metoclopramide injection can cause side effects (such as restlessness, loss of co-ordination, fast heart beat increased body temperature)
  • if suffering from porphyria (a rare inherited blood disease).

Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped.

Even though some of the above may appear obvious, it is important that your doctor is aware if any of them apply to you.

If you are receiving this medicine for vomiting, and if the vomiting does not stop, tell your doctor. He will want to do some tests to find out what is the cause of your vomiting.

Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.

Children and adolescents

Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see “Do not use Metoclopramide injection” above).

Other medicines and Metoclopramide Injection

Tell your doctor or nurse if you are using, have recently used or might use any other medicines. This is because some medicines can affect the way this medicine works or this medicine can affect how other medicines work. These medicines include the following:

  • levodopa or other medicines used to treat Parkinson’s disease (see above “Do not use Metoclopramide injection if”)
  • morphine derivatives (medicines used to treat severe pain)
  • sedative medicines
  • digoxin (medicine used to treat heart failure)
  • fluoxetine and paroxetine (medicine used to treat depression)
  • anticholinergics (medicines used to relieve stomach cramps or spasms)
  • antidepressants (e.g. other phenothiazines, lithium)
  • neuroleptic medicines (for mental illness or nausea and vomiting)
  • medicines for fits (anticonvulsants)
  • medicines to reduce the level of the hormone prolactin in your body (e.g. bromocriptine, cabergoline)
  • any medicines used to treat mental health problems
  • atovaquone (to treat pneumonia)
  • pain killers such as aspirin or paracetamol or stronger pain killers called opioids
  • any other drugs to treat nausea and vomiting
  • mivacurium and suxamethonium (medicines used to relax muscles)
  • cyclosporine (medicine used to treat certain problems with the immune system).

Metoclopramide Injection with food, drink and alcohol

Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Metoclopramide Injection.

Pregnancy, breast-feeding and fertility

Pregnancy:

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or for advice before being given this medicine. If necessary, Metoclopramide Injection may be used during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Breast-feeding:

Metoclopramide Injection is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after using Metoclopramide Injection. This may affect your vision and also interfere with your ability to drive and use machines.

Metoclopramide Injection contains Sodium metabisulphite and Sodium
  • sodium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm
  • This medicinal product contains less than 1 mmol sodium (23mg) per dose, e. is essentially “sodium free”.
  1. How you will be given metoclopramide injection

The medicine will normally be given to you by a doctor or a nurse. It will be given as a slow injection into a vein (over at least 3 minutes) or by injection into a muscle.

In adult population

For the treatment of nausea and vomiting including nausea and vomiting which may occur with a migraine and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10 mg, repeated up to 3 times daily.

The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight.

For the prevention of nausea and vomiting that may occur after surgery prevention: a single dose of 10mg is recommended. All indications (paediatric population aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, given by slow injection into a vein. The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosing table

 

Age Body Weight Dose Frequency
1-3 years 10-14 kg 1 mg Up to 3 times daily
3-5 years 15-19 kg 2 mg Up to 3 times daily
5-9 years 20-29 kg 2.5 mg Up to 3 times daily
9-18 years 30-60 kg 5 mg Up to 3 times daily
15-18 years Over 60kg 10 mg Up to 3 times daily

The treatment should not exceed 48 hours for treatment of nausea and vomiting that has occurred after surgery.

The treatment should not exceed 5 days for prevention of delayed nausea and vomiting that may occur after chemotherapy.

Elderly people

The dose may need to be reduced depending on kidney problems, liver problems and overall health.

Adults with kidney problems

Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems.

Adults with liver problems

Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.

Use in Children and adolescents

Metoclopramide must not be used in children aged less than 1 year (see section 2).

If you are given more Metoclopramide Injection than you should

Contact your doctor straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucination and heart problems. Your doctor may prescribe you a treatment for these signs if necessary.

If you forget to use Metoclopramide Injection

Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop the treatment and talk straight away to your doctor or nurse if you experience one of the following signs while having this medicine:

  • 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, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome
  • itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing. These may be signs of an allergic reaction, which may be
Other side effects

Very common (may affect more than 1 in 10 people)

  • feeling

Common (may affect up to 1 in 10 people)

  • depression
  • uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)
  • symptoms similar to Parkinson disease (rigidity, tremor)
  • feel restless
  • blood pressure decrease (particularly with intravenous route)
  • diarrhoea
  • feeling

Uncommon (may affect up to 1 in 100 people)

  • raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding
  • irregular periods
  • involuntary upward deviation of eye ball
  • hallucination
  • decreased level of consciousness
  • slow heartbeat (particularly with intravenous route)

Rare (may affect up to 1 in 1,000 people)

  • confusional state
  • convulsion (especially in patients with epilepsy).

Not known (frequency cannot be estimated from the available data)

  • abnormal blood pigment levels: which may change the colour of your skin
  • abnormal development of breasts (gynaecomastia)
  • involuntary muscle spasms after prolonged use, particularly in elderly patients
  • high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome
  • changes in heart beat, which may be shown on an ECG test
  • cardiac arrest (particularly with injection route)
  • shock (severe decrease of heart pressure) (particularly with injection route)
  • fainting (particularly with intravenous route)
  • allergic reaction which may be severe (particularly with intravenous route)
  • sudden increase in blood pressure in patients with tumour of the adrenal gland (pheochromocytoma)
  • very high blood

If you get any side effects talk to your doctor or nurse. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store metoclopramide injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after Exp. Date. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light.  If only part of the ampoule is used, discard the remaining solution. For single use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Metoclopramide Injection contains

The active substance is metoclopramide hydrochloride. Each 2ml of Metoclopramide Injection contains metoclopramide hydrochloride equivalent to 10mg anhydrous metoclopramide hydrochloride.

The other excipients are sodium metabisulphite, sodium chloride, dilute hydrochloric acid or sodium hydroxide in water for injections.

What Metoclopramide Injection looks like and contents of the pack

Metoclopramide Injection is a clear, colourless, sterile solution for injection, presented in 2ml clear glass ampoules. They are packed in cardboard cartons containing 10 x 2ml ampoules.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com