1. NAME OF THE MEDICINAL PRODUCT

Fentanyl Citrate Injection USP 100mcg/2ml Taj Pharma
Fentanyl Citrate Injection USP 250mcg/5ml Taj Pharma
Fentanyl Citrate Injection USP 1000mcg/20ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Fentanyl Citrate Injection USP 100mcg/2ml
Each ml contains:
Fentanyl Citrate equivalent to 50mcg (0.05mg) fentanyl base.
Water for Injection                  q.s

b) Fentanyl Citrate Injection USP 250mcg/5ml
Each ml contains:
Fentanyl Citrate equivalent to 50mcg (0.05mg) fentanyl base.
Water for Injection                  q.s

c) Fentanyl Citrate Injection USP 1000mcg/20ml
Each ml contains:
Fentanyl Citrate equivalent to 50mcg (0.05mg) fentanyl base.
Water for Injection                  q.s

For a full list of excipients, see section 6.1

  1. PHARMACEUTICAL FORM

Clear, colourless, sterile solution for Injection

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Fentanyl citrate is an opioid analgesic used:

In low doses to provide analgesia during short surgical procedures.

In high doses as an analgesic/respiratory depressant in patients requiring assisted ventilation.

In combination with a neuroleptic in the technique of neuroleptanalgesia.

In the treatment of severe pain, such as the pain of myocardial infarction.

4.2 Posology and method of administration

Routes of administration

Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4)

Intravenous administration, either as a bolus or by infusion.

Intramuscular administration.

To avoid bradycardia, it is recommended to administer a small intravenous dose of an anti-cholinergic just before anaesthetic induction.

Posology

Fentanyl Injection 50 micrograms/ml, by the intravenous route, can be administered to both adults and children. The dose of Fentanyl Injection 50 micrograms/ml should be individualised according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia.

Adults

The usual dosage regime is as follows:

InitialSupplemental
Spontaneous respiration50-200 micrograms50 micrograms
Assisted ventilation300-3500 micrograms100-200 micrograms

Doses in excess of 200 micrograms are for use in anaesthesia only.

As a premedicant, 1-2 ml Fentanyl Injection 50 micrograms/ml may be administered intramuscularly 45 minutes before induction of anaesthesia.

After intravenous administration in unpremedicated adult patients, 2 ml of Fentanyl Injection 50 micrograms/ml may be expected to provide sufficient analgesia for 10 – 20 minutes in surgical procedures involving low pain intensity. 10 ml Fentanyl Injection 50 micrograms/ml injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcg/kg Fentanyl Injection 50 micrograms/ml will provide intense analgesia for some four to six hours for intensely stimulating surgery.

Fentanyl Injection 50 micrograms/ml may also be given as an infusion. In ventilated patients, a loading dose of Fentanyl Injection 50 micrograms/ml may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of Fentanyl Injection 50 micrograms/ml may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post-operatively, the infusion should be terminated at about 40 minutes before the end of surgery.

Lower infusion rates, e.g. 0.05-0.08 mcg/kg/minute are necessary if spontaneous ventilation is to be maintained. Higher infusion rates (up to 3 mcg/kg/minute) have been used in cardiac surgery.

Fentanyl Injection is chemically incompatible with the induction agents thiopentone and methohexitone because of wide differences in pH.

Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of initial dose should be taken into account in determining supplemental doses.

Paediatric population

Children aged 12 to 17 years old: Follow adult dosage.

Children aged 2 to 11 years old:

The usual dosage regimen in children is as follows:

AgeInitialSupplemental
Spontaneous Respiration2-11 yrs1-3 mcg/kg1-1.25 mcg/kg
Assisted Ventilation2-11 years1-3 mcg/kg1-1.25 mcg/kg

Use in children:

Analgesia during operation, enhancement of anaesthesia with spontaneous respiration.

Techniques that involve analgesia in a spontaneous breathing child should only be used as part of an anaesthetic technique, or given as part of a sedation/analgesia technique with experienced personnel in an environment that can manage sudden chest wall rigidity requiring intubation, or apnoea requiring airway support (see section 4.4).

It is important when estimating the required dose to assess the likely degree of surgical stimulation, the effect of premedicant drugs, and the duration of the procedure.

Obese patients:

In obese patients there is a risk of overdosing if the dose is calculated based on body weight. Obese patients should have dosage calculated according to their estimated ideal body mass.

Renal Impairment

In patients with renal impairment reduced dosing of fentanyl should be considered and these patients should be observed carefully for signs of fentanyl toxicity (see section 5.2 Pharmacokinetic properties).

4.3 Contraindications

Hypersensitivity to the Fentanyl citrate or to any of the excipients listed in section 6.1 Respiratory depression, obstructive airways disease. Concurrent administration with monoamine oxidase inhibitors, or within 2 weeks of their discontinuation. Known intolerance to fentanyl citrate or other morphinomimetics.

4.4 Special warnings and precautions for use

Warnings:

Tolerance and dependence may occur. Following intravenous administration of fentanyl, a transient fall in blood pressure may occur, especially in hypovolaemic patients. Appropriate measures to maintain a stable arterial pressure should be taken.

Respiratory Depression

As with all potent opioids, profound analgesia is accompanied by marked respiratory depression, which may persist into or recur in the early postoperative period. Care should be taken after large doses or infusions of fentanyl to ensure that adequate spontaneous breathing has been established and maintained before discharging the patient from the recovery area.

Significant respiratory depression will occur following the administration of fentanyl in doses in excess of 200 mcg. This, and the other pharmacological effects of fentanyl, can be reversed by specific narcotic antagonists (e.g. naloxone). Additional doses of the latter may be necessary because the respiratory depression may last longer than the duration of action of the opioid antagonist.

Resuscitation equipment and opioid antagonists should be readily available. Hyperventilation during anaesthesia may alter the patients response to CO2, thus affecting respiration postoperatively.

Administration in labour may cause respiratory depression in the new-born infant.

Cardiac disease

Bradycardia and possibly asystole can occur if the patient has received an insufficient amount of anticholinergic, or when fentanyl is combined with non-vagolytic muscle relaxant. Bradycardia can be antagonised by atropine.

Muscle rigidity

Muscular rigidity (morphine-like effect) may occur.

Rigidity, which may also involve the thoracic muscles, can be avoided by the following measures:

– slow I.V. injection (usually sufficient for lower doses)

– premedication with benzodiazepines

– use of muscle relaxants.

Non-epileptic (myo)clonic movement can occur

Special dosing conditions

The use of rapid bolus injections of opioids should be avoided in patients with compromised intracerebral compliance; in such patients the transient decrease in the mean arterial pressure has occasionally been accompanied by a transient reduction of the cerebral perfusion pressure.

It is wise to reduce dosage in the elderly and debilitated patients.

In uncontrolled hypothyroidism, pulmonary disease, decreased respiratory reserve, alcoholism and liver or renal impairment the dosage should be titrated with care and prolonged post-operative monitoring may be required.

Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.

Myasthenia gravis

In patients with myasthenia gravis, careful consideration should be applied in the use of certain anticholinergic agents and neuromuscular-blocking pharmaceutical agents prior to, and during, the administration of a general anaesthetic regimen which includes administering intravenous fentanyl.

Precautions:

Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway.

Interaction with neuroleptics:

If fentanyl is administered with a neuroleptic, the user should be familiar with the special properties of each drug, particularly the difference in duration of action. When such a combination is used, there is a higher incidence of hypotension. Neuroleptics can induce extrapyramidal symptoms that can be controlled with anti-Parkinson agents.

Bile duct:

As with other opioids, due to the anticholinergic effects, administration of fentanyl may lead to increases of bile duct pressure and, in isolated cases, spasms of the Sphincter of Oddi might be observed.

Serotonin Syndrome:

Caution is advised when fentanyl is co-administered with drugs that affect the serotonergic neurotransmitter systems.

The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperoreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).

If serotonin syndrome is suspected, rapid discontinuation of fentanyl should be considered.

Paediatric population

Techniques that involve analgesia in a spontaneous breathing child should only be used as part of an anaesthetic technique, or given as part of a sedation/analgesia technique with experienced personnel in an environment that can manage sudden chest wall rigidity requiring intubation, or apnoea requiring airway support.

Fentanyl Injection contains 35 mg sodium per 10ml of solution, equivalent to 1.75% of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction

Effect of other drugs on fentanyl

The use of opioid premedication, barbiturates, benzodiazepines, neuroleptics, halogenic gases and other non-selective CNS depressants (e.g. alcohol) may enhance or prolong the respiratory depression of fentanyl.

When the patients have received CNS-depressants, the dose of fentanyl required will be less than usual.

Concomitant use with Fentanyl in spontaneously breathing patients may increase the risk of respiratory depression, profound sedation, coma, and death.

Fentanyl, a high clearance drug, is rapidly and extensively metabolised mainly by CYP3A4.

Itraconazole (a potent CYP3A4 inhibitor) at 200mg/day given orally for 4 days had no significant effect on the pharmacokinetics of IV fentanyl.

Oral ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of IV fentanyl by two thirds; however, peak plasma concentrations after a single dose of IV fentanyl were not affected.

When fentanyl is used in a single dose, the concomitant use of potent CYP3A4 inhibitors such as ritonavir requires special patient care and observation.

Co-administration of fluconazole or voriconazole (moderate CYP3A4 inhibitors) and fentanyl may result in an increased exposure to fentanyl.

With continuous treatment of fentanyl and concomitant administration of CYP3A4 inhibitors, a dose reduction of fentanyl may be required to avoid accumulation, which may increase the risk of prolonged or delayed respiratory depression.

Bradycardia and possibly cardiac arrest can occur when fentanyl is combined with non-vagolytic muscle relaxants.

The concomitant use of droperidol can result in a higher incidence of hypotension.

Serotonergic Drugs

Co-administration of fentanyl with a serotonergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.

Effect of fentanyl on other drugs

Following the administration of fentanyl, the dose of other CNS depressant drugs should be reduced. This is particularly important after surgery, because profound analgesia is accompanied by marked respiratory depression, which can persist or recur in the postoperative period. Administration of a CNS depressant, such as a benzodiazepine, during this period may disproportionally increase the risk for respiratory depression.

Plasma concentration of etomidate increased considerably (by a factor of 2 to 3) when combined with fentanyl

The total plasma clearance and volume of distribution of etomidate is decreased by a factor 2 to 3 without a change in half-life when administered with fentanyl.

Simultaneous administration of fentanyl and intravenous midazolam results in an increase in the terminal plasma half-life and a reduction in the plasma clearance of midazolam. When these drugs are co-administered with fentanyl their dose may need to be reduced.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of fentanyl in pregnant women. Fentanyl can cross the placenta in early pregnancy. Studies in animals have shown some reproductive toxicity (see Section 5.3, Preclinical safety data). The potential risk for humans is unknown.

Administration during childbirth (including Caesarean section) is not recommended because fentanyl crosses the placenta and the foetal respiratory centre is particularly sensitive to opioids. If fentanyl is nevertheless administered, assisted ventilation equipment must be immediately available for the mother and infant if required. An antidote for the child should always be at hand.

Breast-feeding

Fentanyl is excreted into human milk. It is therefore recommended that breast feeding is not initiated within 24 hours of treatment. The risk/benefit of breast feeding following fentanyl administration should be considered.

Fertility

There are no clinical data on the effects of fentanyl on male or female fertility. In animal studies, some tests on rats showed reduced female fertility at maternal toxic doses (see section 5.3 Preclinical safety data).

4.7 Effects on ability to drive and use machines

Where early discharge is envisaged, patients should be advised not to drive or to operate machinery for 24 hours following administration.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

  • The medicine is likely to affect your ability to drive
  • Do not drive until you know how the medicine affects you
  • It is an offence to drive while under the influence of this medicine
  • However, you would not be committing an offence (called ‘statutory defence’) if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

o It was not affecting your ability to drive safely

4.8 Undesirable effects

The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anaesthetic. These subjects took at least 1 dose of fentanyl IV and provided safety data. Based on pooled safety data from these clinical trials, the most commonly reported (≥ 5% incidence) Adverse Drug Reactions (ADRs) were (with % incidence): nausea (26.1); vomiting (18.6); muscle rigidity (10.4); hypotension (8.8); hypertension (8.8); bradycardia (6.1) and sedation (5.3).

Including the above-mentioned ADRs, Table 1 displays ADRs that have been reported with the use of fentanyl IV from either clinical trials or postmarketing experience.

The displayed frequency categories use the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1,1000); very rare (<10,000); and not known (cannot be estimated from the available clinical trial data).

Table 1: Adverse Drug Reactions

System Organ ClassAdverse Drug Reactions
Frequency Category
Very common (≥1/10)Common (≥1/100 to <1/10)Uncommon (≥1/1,000 to <1/100)Not Known
Immune System DisordersHypersensitivity (such as anaphylactic shock, anaphylactic reaction, urticaria)
Psychiatric disordersAgitationEuphoric mood
Nervous System DisordersMuscle rigidity (which may also involve the thoracic muscles)Dyskinesia;

Sedation;

Dizziness

HeadacheConvulsions;

Loss of consciousness;

Myoclonus

Eye DisordersVisual disturbance
Cardiac DisordersBradycardia;

Tachycardia;

Arrythmia

Cardiac arrest
Vascular DisordersHypotension;

Hypertension;

Venous pain

Phlebitis;

Blood pressure fluctuation

Respiratory, Thoracic and Mediastinal DisordersLaryngospasm;

Bronchospasm;

Apnoea

Hyperventilation;

Hiccups

Respiratory depression
Gastrointestinal DisordersNausea;

Vomiting

Skin and Subcutaneous Tissue DisordersAllergic dermatitisPruritis
General Disorders and Administration Site ConditionsChills;

Hypothermia

Injury Poisoning and Procedural ComplicationsPostoperative confusionAirway complication of anaesthesia

When a neuroleptic is used with fentanyl the following adverse reactions may be observed: chills and/or shivering, restlessness, postoperative hallucinatory episodes and extrapyramidal symptoms (see Section 4.4).

Reporting of suspected adverse reactions

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

4.9 Overdose

Symptoms and signs:

The manifestations of fentanyl overdosage are generally an extension of its pharmacological action. Depending on the individual sensitivity, the clinical picture is determined by the degree of respiratory depression, which varies from bradypnoea to apnoea.

Treatment:

Hypoventilation or apnoea:O2 administration, assisted or controlled respiration.
Respiratory depression:Specific narcotic antagonist (e.g. naloxone). This does not preclude the use of immediate countermeasures.

The respiratory depression may last longer than the effect of the antagonist; additional doses of the latter may therefore be required

Muscular rigidity:Intravenous neuromuscular blocking agent to facilitate assisted or controlled respiration.

The patient should be carefully observed; body warmth and adequate fluid intake should be maintained. If hypotension is severe or if it persists, the possibility of hypovolaemia should be considered and, if present, it should be controlled with appropriate parenteral fluid administration.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anaesthetic general, opioid anaesthetic.

Fentanyl is a synthetic opiate with a clinical potency of 50 to 100 times that of morphine. Its onset of action is rapid and its duration of action is short. In man, a single IV dose of 0.5-1 mg/70 kg body weight immediately produces a pronounced state of surgical anaesthesia, respiratory depression, bradycardia and other typical morphine-like effects. The duration of action of the peak effects about 30 minutes. All potent morphine-like drugs produce relief from pain, ventilatory depression, emesis, constipation, physical dependence, certain vagal effects and varying degrees of sedation. Fentanyl, however, differs from morphine not only by its short duration of action but also by its lack of emetic effect and minimal hypotensive activity in animals.

5.2 Pharmacokinetic properties

Some pharmacokinetic parameters for fentanyl are as follows:

Urinary excretion = 8%

Bound in plasma = 80%

Clearance (ml/min/kg) = 13±2

Volume of distribution (litres/kg) = 4.0±0.4

Estimates of terminal half-life range from 141 to 853 minutes.

Renal impairment

Data obtained from a study administering IV fentanyl in patients undergoing renal transplantation suggest that the clearance of fentanyl may be reduced in this patient population. If patients with renal impairment receive fentanyl, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see section 4.2 Posology and method of administration).

Obese Patients

An increase in clearance of fentanyl is observed with increased body weight. In patients with a BMI >30, clearance of fentanyl increases by approximately 10% per 10 kg increase of the fat free mass (lean body mass).

5.3 Preclinical safety data

In vitro fentanyl showed, like other opioid analgesics, mutagenic effects in a mammalian cell culture assay, only at cytotoxic concentrations and along with metabolic activation. Fentanyl showed no evidence of mutagenicity when tested in in vivo rodent studies and bacterial assays. In a two-year rat bioassay, fentanyl was not carcinogenic.

Some tests on female rats showed reduced fertility as well as embryo mortality. These findings were related to maternal toxicity and not a direct effect of the drug on the developing embryo. There was no evidence of teratogenic effects.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Chloride , Sodium Hydroxide , Water for Injections

6.2 Incompatibilities

The product is chemically incompatible with the induction agents thiopentone and methohexitone because of the wide differences in pH.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Protect from light.

Keep container in the outer carton.

Do not store above 25°C.

Keep out of the sight and reach of children

6.5 Nature and contents of container

2 ml or 10 ml clear glass ampoules, glass type I borosilicate glass, packed in cardboard cartons and contain 10 x 2 ml/10 ml ampoules.

Not all pack sizes maybe marketed.

6.6 Special precautions for disposal and other handling

CD(2), For IV or IM injection

If only part used, discard the remaining solution.

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

Fentanyl Citrate Injection USP 100mcg/2ml Taj Pharma
Fentanyl Citrate Injection USP 250mcg/5ml Taj Pharma
Fentanyl Citrate Injection USP 1000mcg/20ml Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fentanyl 50 micrograms/ml Solution for Injection Fentanyl Citrate

(referred to as Fentanyl Injection in this leaflet)

Read all of this leaflet carefully before you are given Fentanyl Injection.

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

What is in this leaflet:

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

 

  1. WHAT FENTANYL INJECTION IS AND WHAT IT IS USED FOR

Fentanyl belongs to a group of medicines called opioid analgesics, often used in anaesthesia or as a painkiller.

Fentanyl Injection can be used in the following situations:

  • In low doses it is used to provide pain relief during short surgical procedures.
  • Where breathing is assisted, it is used in higher doses as an anaesthetic and analgesic.
  • It may also be given in combination with a tranquilliser to induce both calmness and pain relief.
  • For the treatment of severe pain.
  1. WHAT YOU NEED TO KNOW BEFORE HAVING FENTANYL INJECTION

You should not be given Fentanyl Injection if you:

  • are allergic (hypersensitive) to fentanyl citrate or other opioid medicines or any of the other ingredients (listed in section 6).
  • suffer from asthma, shallow breathing or other breathing difficulties.
  • are taking or have recently (within the last two weeks) taken any drugs used to treat depression known as Monoamine Oxidase Inhibitors (MAOI’s) (see ‘Taking other medicines).
  • you are in labour or before the cord is clamped during a Caesarean section. Fentanyl injection may affect the baby’s breathing.

Take special care with Fentanyl Injection

Tell your doctor if you:

  • are pregnant, planning to become pregnant or are breast-feeding.
  • have an under active thyroid gland.
  • are suffering from lung disease.
  • suffer from a muscle disorder known as myasthenia gravis.
  • are suffering from liver or kidney disease.
  • are receiving opioid therapy or have a history of opioid abuse.
  • suffer from alcoholism.
  • are suffering from severe undiagnosed headaches or if you have recently suffered a head injury.
  • have been told you are suffering from low blood volume.
  • have pain in right upper side of your abdomen (bile duct).

If any of the above apply to you or your child, please consult your doctor.

Special Monitoring

  • Repeated use of fentanyl can result in tolerance and addiction.
  • Your doctor will take special care when giving you this medicine if you are elderly or weak due to ill health or if you are in labour.
  • Fentanyl Injection may make you breathe more slowly than usual or can cause shortness of breath. You will only be given this medicine where you can be carefully monitored until your breathing returns to normal.
  • Your blood pressure and heart rate may also be monitored.

Other medicines and Fentanyl Injection:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without prescription.

Fentanyl Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you have stopped taking them within the last 2 weeks. These drugs are known as Monoamine Oxidase Inhibitors (MAOI’s).

Please tell your doctor or nurse if you:

  • are taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) for depression (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).
  • are taking any major tranquilizer (antipsychotic) drug.

Medicines which may interact with Fentanyl Injection include:

  • CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, anti- histamines (medicines used to treat allergies) that make

you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic such as etomidate.

  • ritonavir, (a medication used to treat or prevent infection by viruses such as HIV) and other protease inhibitors such as indinavir and saquinavir.
  • droperidol (a drug used to treat anxiety and sickness).
  • muscle relaxants.
  • medicines used to treat fungal infections such as fluconazole or voriconazole.
  • midazolam (a medicine used to make you feel relaxed and sleepy before an operation).

The dose of etomidate and midazolam may need to be reduced if given together with Fentanyl Injection.

If you are taking any of the above medicines please tell your doctor as Fentanyl Injection may increase the effects of these drugs or prevent them from working properly.

Using Fentanyl Injection with food and drink:

You are advised not to drink alcohol during your treatment with Fentanyl Injection.

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Fentanyl Injection should not be used during childbirth as it can affect the baby’s breathing.

Fentanyl Injection is excreted into breast milk. Do not breast- feed or use breast milk that has been expressed for 24 hours after having Fentanyl Injection.

Effects on the ability to drive and use machines:

Do not drive or use any tools or machines for at least 24 hours after having Fentanyl Injection. You may be less alert than usual. This medicine can affect your ability to drive as it may make you sleepy or dizzy.

  • Do not drive while taking this medicine until you know how it affects you.
  • It is an offence to drive if this medicine affects your ability to drive.

However, you would not be committing an offence if:

  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Fentanyl Injection contains sodium

If you need to control your salt intake (controlled sodium diet) be aware that:

  • Fentanyl Injection contains 3.5 mg sodium in each ml of solution. This is equivalent to 0.18% of the recommended maximum daily dietary intake of sodium for an adult.
  • The contents of the ampoule may be diluted in a salt solution before being given to you. This salt solution also contains sodium.
  1. HOW FENTANYL INJECTION IS GIVEN

This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you need based on your age, body weight, general health and whether you are taking any other medicines.

Fentanyl Injection is given into a muscle or into a vein either by injection or infusion (drip). Under some circumstances your doctor may prescribe a dose higher than those stated here.

Adults and children aged 12 to 17 years old: As pre-medication before surgery

The usual dose is between 50 and 100 micrograms given into a muscle.

During surgery if you are able to breathe on your own The usual initial dose is between 50 and 200 micrograms, followed by a further dose of 50 micrograms if needed

During surgery if your breathing is assisted

The usual initial dose is between 300 and 3500 micrograms, followed by a further dose of 100-200 micrograms if needed.

By Infusion (drip)

The usual initial dose is 1 microgram per kilogram every minute for the first 10 minutes, followed by a further dose of 0.1 microgram per kilogram every minute for the duration of your operation. The drip will normally be stopped 40 minutes before the end of your operation.

Elderly:

If you are elderly you will be given a reduced dose.

Use in children aged 2 to 11 years old:

During surgery if your child is able to breathe on their own The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of 1-1.25 micrograms per kilogram of body weight if needed.

During surgery if your child’s breathing is assisted

The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of between 1-1.25 micrograms per kilogram of body weight if needed.

If you are given more Fentanyl Injection than you  should be:  As Fentanyl Injection will be given to you in hospital by a doctor it is unlikely you will be given too much, however tell your  doctor or nurse if you think you have been given too much of this medicine or you begin to experience breathing difficulties, dizziness or symptoms of low blood pressure or muscle stiffness.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Fentanyl Injection can cause side effects, although not everybody gets them.

If any of the following symptoms occur tell your doctor or nurse

immediately. These are symptoms of a serious allergic reaction.

  • sudden wheeziness and tightness of chest.
  • swelling of eyelids, face or lips.
  • skin lumps or hives.
  • skin rash (red spots), itchiness, fever.

Very common side effects (affect more than 1 in 10 people) include:

  • muscle stiffness.
  • feeling sick (nausea), or being sick (vomiting).

Common side effects (affect less than 1 in 10 people)

  • feeling agitated.
  • jerky or uncoordinated movements.
  • blurred vision, blind spots or haloes around lights (visual disturbances).
  • a slow or irregular heartbeat.
  • unusually low or high blood pressure.
  • pain along your veins.
  • choking caused by cramping (spasm) of the muscles of your throat.
  • wheezing or difficulty breathing.
  • stopping breathing for a short period of time. If necessary your breathing will be helped by a machine (ventilator).
  • an itchy rash or redness of the skin.

Uncommon side effects (affect less than 1 in 100 people) include:

  • a feeling of extreme happiness (euphoria).
  • swelling and clotting along a vein.
  • changes in blood pressure.
  • breathing faster than usual.
  • decrease in body temperature or chills.
  • breathing complications.

Other side effects (frequency not known) include:

  • a serious allergic reaction (see symptoms above).
  • convulsions (fits or seizures).
  • loss of consciousness.
  • muscle twitching.
  • stopping of the heart (cardiac arrest).
  • slow or shallow breathing.
  • itching of the skin.

Other side effects can occur when Fentanyl Injection is used with a type of medicine called neuroleptics. These include:

  • chills or shivering.
  • seeing or hearing things that aren’t real (hallucinations).
  • Unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs.
Reporting of side effects

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

5.  HOW TO STORE FENTANYL INJECTION

Keep all medicines out of the sight and reach of children.

This product has an expiry date on the ampoule label. The doctor or nurse will check that the product has not passed this date. If only part of the solution is used, the remainder should be discarded.

Do not store above 25°C and keep container in the outer carton to protect from light.

6.  CONTENTS OF THE PACK AND OTHER INFORMATION
What Fentanyl Injection contains

Active ingredient: Fentanyl Citrate 78.5 micrograms/ml equivalent to 50 micrograms/ml Fentanyl.

Other ingredients: sodium chloride, sodium hydroxide, water for injections

What Fentanyl Injection looks like and the contents of the pack

The clear colourless sterile solution is presented in 2 or 10 ml clear glass ampoules in packs of 10 ampoules.

Not all pack sizes maybe marketed.

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