1. Name of the medicinal product

Metoclopramide Injection USP 10mg/2ml (5mg/ml) Taj Pharma

  1. Qualitative and quantitative composition

Metoclopramide Injection USP 10mg/2ml (5mg/ml) Taj Pharma
Each ml contains:
Metoclopramide hydrochloride USP
Equivalent to Metoclopramide hydrochloride (anhydrous) 5mg
Hydrochloric acid or NaOH (pH Adjustment)

  1. Pharmaceutical form

Sterile Liquid Injection for Infusion.

  1. Clinical particulars
  • Therapeutic indications

Paediatric population:

Metoclopramide Taj Pharma 5mg/ml Injection is indicated in children (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

For other indications, the use in the paediatric population is not recommended.

Adult population:

Metoclopramide Taj Pharma 5mg/ml 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)

Posology and method of administration

The solution can be administered intravenously or intramuscularly.

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

All indications (paediatric patients aged 1-18 years)

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

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).

Dosing table

AgeBody WeightDoseFrequency
1-3 years10-14kg1mgUp to 3 times daily
3-5 years15-19 kg2mgUp to 3 times daily
5-9 years20-29 kg2.5mgUp to 3 times daily
9-18 years30-60 kg5mgUp to 3 times daily
15-18 yearsOver 60 kg10mgUp 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).

All indications ( adult patients)

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 10mg, repeated up to three times daily

The maximum recommended daily dose is 30mg 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.

The maximum recommended treatment duration is 5 days.

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 ≤ 15ml/min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (Creatinine clearance 15-60ml/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 Taj Pharma is contraindicated in children aged less than 1 year (see section 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 phaeochromocytoma, due to the risk of severe hypertension episodes
  • History of neuroleptic or Metoclopramide Taj Pharma-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 Taj Pharma 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)
  • Metoclopramide Taj Pharma 5mg/ml Injection should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.
  • Metoclopramide Taj Pharma should not be used during breast-feeding (see Section 4.6).

Special warnings and precautions for use

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 Taj Pharma 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 Taj Pharma administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Prolonged treatment with Metoclopramide Taj Pharma 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 Taj Pharma in combination with neuroleptics as well as with Metoclopramide Taj Pharma monotherapy (see section 4.8). Metoclopramide Taj Pharma 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).

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

Symptoms of Parkinson’s disease may also be exacerbated by Metoclopramide Taj Pharma.

Methaemoglobinaemia

Methaemoglobinaemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, Metoclopramide Taj Pharma 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 Taj Pharma by injection, particularly via the intravenous route (see section 4.8).

Special care should be taken when administering Metoclopramide Taj Pharma, 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).

Renal and Hepatic Impairment

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

Metoclopramide Taj Pharma may cause elevation of serum prolactin levels.

Care should be exercised when using Metoclopramide Taj Pharma 5mg/ml Injection in patients with a history of atopy (including asthma) or porphyria.

Special care should be taken when administering Metoclopramide Taj Pharma 5mg/ml Injection intravenously to patients with “sick sinus syndrome” or other cardiac conduction disturbances.

  • Interaction with other medicinal products and other forms of interaction

Contraindicated combination

Levodopa or dopaminergic agonists and Metoclopramide Taj Pharma have a mutual antagonism (see section 4.3).

Combination to be avoided

Alcohol potentiates the sedative effect of Metoclopramide Taj Pharma.

Combination to be taken into account

Due to the prokinetic effect of Metoclopramide Taj Pharma, the absorption of certain drugs may be modified.

Anticholinergics and morphine derivatives

Anticholinergics and morphine derivatives may both have a mutual antagonism with Metoclopramide Taj Pharma 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 Taj Pharma are potentiated.

Neuroleptics

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

Serotonergic drugs

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

Digoxin

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

Cyclosporine

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

Strong CYP2D6 inhibitors

Metoclopramide Taj Pharma 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 Taj Pharma and their dosage may need to be adjusted accordingly.

Aspirin, paracetamol

The effect of Metoclopramide Taj Pharma 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 Taj Pharma injection may reduce plasma concentrations of atovaquone.

  • 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 Taj Pharma can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of Metoclopramide Taj Pharma administration at the end of pregnancy, extrapyramidal syndrome in the newborn cannot be excluded. Metoclopramide Taj Pharma should be avoided at the end of pregnancy. If Metoclopramide Taj Pharma is used, neonatal monitoring should be undertaken.

Breastfeeding

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

  • Effects on ability to drive and use machines

Metoclopramide Taj Pharma has moderate influence on the ability to drive and use machines.

Metoclopramide Taj Pharma may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

  • 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 ClassFrequencyAdverse reactions
Blood and lymphatic system disorders
Not knownMethaemoglobinaemia, 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
UncommonBradycardia, particularly with intravenous formulation
Not knownCardiac 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*
UncommonAmenorrhoea, Hyperprolactinaemia,
RareGalactorrhoea
Not knownGynaecomastia
Gastrointestinal disorders
CommonDiarrhoea
General disorders and administration site conditions
CommonAsthenia
Not KnownInjection site inflammation and local phlebitis
Immune system disorders
UncommonHypersensitivity
Not knownAnaphylactic reaction (including anaphylactic shock) particularly with intravenous formulation
Nervous system disorders
Very commonSomnolence
CommonExtrapyramidal 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
UncommonDystonia (including visual disturbances and oculogyric crisis), Dyskinesia, Depressed level of consciousness
RareConvulsion especially in epileptic patients
Not knownTardive 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
CommonDepression
UncommonHallucination
RareConfusional state
Vascular disorder
Common:Hypotension, particularly with intravenous formulation
Not knownShock, syncope after injectable use. Acute hypertension in patients with phaeochromocytoma (see section 4.3).

Transient increase in blood pressure

Skin disorder
Not knownSkin reactions such as rash, pruritus, angioedema and urticaria

*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. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

Symptoms

Extrapyramidal disorders, drowsiness, a 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
  • Pharmacodynamic properties

Pharmacotherapeutic group: Agents stimulating gastro-intestinal motility

Mechanism of action

The action of Metoclopramide Taj Pharma 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 where disturbed gastro-intestinal motility is a common underlying factor.

Metoclopramide Taj Pharma 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 Taj Pharma is a dopamine-receptor antagonist with a direct anti-emetic effect on the medullary chemoreceptor trigger zone.

  • Pharmacokinetic properties

Absorption:

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

Biotransformation and Elimination:

Metoclopramide Taj Pharma is metabolised in the liver and the predominant route of elimination of Metoclopramide Taj Pharma and its metabolites is via the kidney. It crosses the placenta and is excreted in breast milk. The elimination half-life is about 6 hours.

Renal impairment

The clearance of Metoclopramide Taj Pharma 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 Taj Pharma has been observed, associated with a 50% reduction in plasma clearance.

  • Preclinical safety data

No additional data available.

  1. Pharmaceutical particulars
  • List of excipients

Sodium Chloride

Citric Acid Monohydrate

Sodium Citrate

Water for Injections

Hydrochloric acid

Sodium hydroxide

Nitrogen

  • Incompatibilities

Any dilutions of Metoclopramide Taj Pharma 5mg/ml Injection should be protected from light during infusion. Degradation is indicated by a yellow discoloration. Such solution must not be used.

  • Shelf life

36 months

  • Special precautions for storage

Protect from light and store in a cool place.

  • Nature and contents of container

Type I clear glass ampoules 2ml, 10ml and 20ml packed in cardboard cartons as following pack size.

Pack Size:

The Injection is supplied in 2ml, 10ml and 20ml clear glass ampoules.

Each pack of Injection contains 5, 10, 15, 20 and 25 Ampoules.

Not all pack sizes may not be marketed.

  • Special precautions for disposal and other handling

Metoclopramide Taj Pharma Injection has been shown to be compatible with the following infusion solutions:

  • Sodium chloride Intravenous infusion BP (0.9% w/v)
  • Dextrose Intravenous Infusion BP (5% w/v)
  • Sodium chloride and Dextrose Intravenous Infusion BP (Sodium chloride 0.18% w/v and Dextrose 4% w/v)
  • Compound sodium lactate Intravenous Infusion BP (Ringer lactate solution, Hartman’s solution)

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 (5mg/ml) Taj Pharma

Package leaflet: Information for the patient

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

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

What is in this leaflet

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

1. What Metoclopramide Taj Pharma 5mg/ml Injection is and what it is used for

Metoclopramide Taj Pharma 5mg/ml Injection is an antiemetic.

It contains a medicine called “Metoclopramide Taj Pharma”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting)

Adult population

Metoclopramide Taj Pharma 5mg/ml 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 radiotherapy

Paediatric population

Metoclopramide Taj Pharma 5mg/ml Injection is used in children (aged 1-18 years) 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 surgery
  1. What you need to know before you are given Metoclopramide Taj Pharma 5mg/ml Injection

You should not be given Metoclopramide Taj Pharma 5mg/ml Injection if:

  • you are allergic to Metoclopramide Taj Pharma or any of the other ingredients of this medicine (listed in section 6).
  • you have bleeding, obstruction or a tear in your stomach or gut.
  • you have or may have a rare tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma).
  • you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine.
  • you have epilepsy
  • you have Parkinson’s disease
  • you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see below “Other medicines and Metoclopramide Taj Pharma 5mg/ml Injection).
  • you have ever had an abnormal blood pigment level (methaemoglobinaemia) or NADH cytochrome-b5 deficiency.
  • you are breastfeeding.

Do not give Metoclopramide Taj Pharma 5mg/ml injection to a child less than one year of age (see below “Children and adolescents”).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before receiving Metoclopramide Taj Pharma 5mg/ml Injection if:

  • you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems
  • you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
  • you are using other medicines known to affect the way your heart beats
  • you have any neurological (brain) problems
  • you have liver or kidney problems. The dose may be reduced (see section 3).
  • you are pregnant
  • you are taking any other medicine by mouth. It is possible that Metoclopramide Taj Pharma 5mg/ml injection may change the amount of the other medicine that gets into your body.
  • you are taking any drugs known as serotonergic drugs, as taking these medications with

Metoclopramide Taj Pharma 5mg/ml injection can cause side effects (such as restlessness, loss of coordination, fast heart beat, increased body temperature)

  • you are 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 (methaemoglobinaemia), the treatment should be immediately and permanently stopped.

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 above “Do not use Metoclopramide Taj Pharma 5mg/ml Injection if”).

Other medicines and Metoclopramide Taj Pharma 5mg/ml Injection

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Metoclopramide Taj Pharma 5mg/ml Injection works or Metoclopramide Taj Pharma 5mg/ml Injection 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 Taj Pharma 5mg/ml Injection if”)
  • anticholinergics (medicines used to relieve stomach cramps or spasms)
  • morphine derivatives (medicines used to treat severe pain)
  • sedative medicines
  • any medicines used to treat mental health problems
  • digoxin (medicine used to treat heart failure)
  • cyclosporine (medicine used to treat certain problems with the immune system)
  • mivacurium and suxamethonium (medicines used to relax muscles)
  • fluoxetine and paroxetine (medicine used to treat depression)
  • atovaquone (to treat pneumonia)
  • neuroleptic medicines (for mental illness or nausea and vomiting)
  • pain killers such as aspirin or paracetamol or stronger pain killers called opioids

Metoclopramide Taj Pharma 5mg/ml Injection with alcohol

Alcohol should not be consumed during treatment with Metoclopramide Taj Pharma because it increases the sedative effect of Metoclopramide Taj Pharma 5mg/ml Injection.

Pregnancy and breast feeding

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine. If necessary, Metoclopramide Taj Pharma 5mg/ml Injection may be given during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Breast-feeding

Metoclopramide Taj Pharma 5mg/ml Injection is not recommended if you are breast-feeding because Metoclopramide Taj Pharma 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 Taj Pharma 5mg/ml Injection.

This may affect your vision and also interfere with your ability to drive and use machines.

  1. How Metoclopramide Taj Pharma 5mg/ml Injection is given

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 adults patients

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 10mg, repeated up to 3 times daily.

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

For the prevention of nausea and vomiting that may occur after surgery: a single dose of 10mg is recommended.

All indications (paediatric patients aged 1-18 years)

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

The maximum dose in 24 hours is 0.5mg/kg body weight.

Dosing table

Age

 

Body WeightDoseFrequency
1-3 years10-14Kg1mgUp to 3 times daily
3-5 years15-19Kg2mgUp to 3 times daily
5-9 years20-29Kg2.5mgUp to 3 times daily
1-3 years30-60Kg5mgUp to 3 times daily
1-3 years>60Kg10mgUp 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.

Older 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.

Children and adolescents

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

If you receive more Metoclopramide Taj Pharma 5mg/ml Injection than you should

Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have a reduced level of consciousness, be confused, have hallucinations and cardio-respiratory arrest (your heart and breathing stop). Your doctor may prescribe you a treatment for these if necessary.

If you forget to use Metoclopramide Taj Pharma 5mg/ml Injection

Do not have 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, nurse or pharmacist.

  1. Possible side effects

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

Stop the treatment and talk straight away to your doctor, pharmacist 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 severe.

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

  • feeling drowsy.

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’s disease (rigidity, tremor)
  • feeling restless
  • blood pressure decrease (particularly with intravenous route)
  • diarrhoea
  • feeling weak.

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 in women who are not breast-feeding
  • irregular periods
  • visual disturbances and involuntary upward deviation of eye ball
  • hallucination
  • decreased level of consciousness
  • slow heartbeat (particularly with intravenous route)
  • allergy

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 the injectable route)
  • shock (severe decrease of heart pressure) (particularly with the injectable route)
  • fainting (particularly with the intravenous route)
  • allergic reaction which may be severe (particularly with the intravenous route)
  • Sudden increase in blood pressure in patients with tumour of the adrenal gland (pheochromocytoma)
  • very high blood pressure.

If you get any side effects, talk to your doctor, pharmacist 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, pharmacist 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 Taj Pharma 5mg/ml 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/ carton after “EXP:”

The expiry date refers to the last day of that month.

Your injection will be stored at less than 25°C and protected from light.

  1. Contents of the pack and other information

What Metoclopramide Taj Pharma 5mg/ml Injection contains

  • The active ingredient is Metoclopramide Taj Pharma hydrochloride. Each 1ml of solution contains Metoclopramide Taj Pharma hydrochloride equivalent to 5mg of anhydrous Metoclopramide Taj Pharma hydrochloride in a sterile solution for injection.
  • The other ingredients are sodium chloride, citric acid monohydrate, sodium citrate, hydrochloric acid, sodium hydroxide, nitrogen and sterile water for injections.

What Metoclopramide Taj Pharma 5mg/ml Injection looks like and contents of the pack

Pack Size:

The injection is supplied in 2ml, 10ml and 20ml clear glass ampoules.

Each pack of Injection contains 5, 10, 15, 20 and 25 Ampoules.

Not all pack sizes may not be marketed.

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