1. NAME OF THE MEDICINAL PRODUCT

Lidocaine and Adrenaline Injection BP 1% w/v Taj Pharma
Lidocaine and Adrenaline Injection BP 2% w/v Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITIONa) Each ml of solution for injection contains:
    Lidocaine hydrochloride
    monohydrate equivalent to
    lidocaine hydrochloride BP…………10mg
    Adrenaline (epinephrine) as the acid tartrate………………………………….5mg

    b) Each ml of solution for injection contains:
    Lidocaine hydrochloride
    monohydrate equivalent to
    lidocaine hydrochloride BP…………10mg
    Adrenaline (epinephrine) as the acid tartrate………………………………….5mg

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Solution for injection

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with Adrenaline is indicated for regional anaesthesia in adults and children above 12 years of age.

4.2 Posology and method of administration

Adults and children above 12 years of age

The dosage is adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the required effect should be given (see section 4.4). The maximum single dose of Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma when given with adrenaline is 500 mg.

The following table is a guide for the more commonly used techniques in the average adult. The figures reflect the expected average dose range needed. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.

The clinician’s experience and knowledge of the patient’s physical status are of importance in calculating the required dose. Elderly or debilitated patients require smaller doses, commensurate with age and physical status.

Type of block% Conc.Each doseIndication
mlmg
Field Block (e.g. minor nerve blocks and infiltration)
Infiltration1up to 15up to 150Surgical operations
Intercostals (per nerve)12-5

Max. 15 ml

20-50

Max. 150 mg

Surgical operations

Postoperative pain and fractured ribs

Pudendal110100Instrumental delivery
Major Nerve Block
Paracervical (each side)110100Surgical operations and dilatation of cervix

Obstetric pain relief

Sciatic215300Surgical operations

For local anaesthesia only.

Preservative containing solutions should not be used intracisternally, epidurally, intrathecally or by any route giving access to the cerebrospinal fluid, or intra- or retro-bulbary. The volume to be injected in a single dose should not exceed 15 ml, unless otherwise justified.

In general, surgical anaesthesia requires the use of higher concentrations and doses. When a less intense block is required, the use of a lower concentration is indicated. The volume of drug used will affect the extent and spread of anaesthesia.

Care should be taken to prevent acute toxic reactions by avoiding intravascular injection. Careful aspiration before and during the injection is recommended. An accidental intravascular injection may be recognised by a temporary increase in heart rate. The main dose, should be injected slowly, at a rate of 100-200 mg/min, or in incremental doses, while keeping in constant verbal contact with the patient. If toxic symptoms occur, the injection should be stopped immediately.

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to local anaesthetics of the amide type.

Hypersensitivity to methyl and/or propyl parahydroxybenzoate (methyl-/propyl paraben), or to their metabolite para amino benzoic acid (PABA). Formulations of lidocaine containing parabens should be avoided in patients allergic to ester local anaesthetics or their metabolite PABA.

The use of a vasoconstrictor is contraindicated for anaesthesia of fingers, toes, tip of nose, ears and penis.

4.4 Special warnings and precautions for use

Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. When performing major blocks, or using large doses, an IV cannula should be inserted before the local anaesthetic is injected. Clinicians should have received adequate and appropriate training in the procedure to be performed and should be familiar with the diagnosis and treatment of side effects, systemic toxicity or other complications (see sections 4.8 and 4.9).

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma  with Adrenaline should not be given intravenously.

The effect of local anaesthetics may be reduced if an injection is made into an inflamed or infected area.

Attempts should be made to optimise the patient’s condition before major blocks.

Although regional anaesthesia is frequently the optimal anaesthetic technique, some patients require special attention in order to reduce the risk of dangerous side effects:

– Patients with epilepsy.

– Patients with impaired respiratory function.

– Older people and patients in poor general condition.

– Patients with partial or complete heart conduction block – due to the fact that local anaesthetics may depress myocardial conduction.

– Patients with advanced liver disease or severe renal dysfunction.

– Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive (see section 4.5).

– Patients with acute porphyria. Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma  solution for injection is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used, e.g.:

– Injections in the head and neck regions may be made inadvertently into an artery, causing cerebral symptoms even at low doses.

– Paracervical block can sometimes cause foetal bradycardia/tachycardia, and careful monitoring of the foetal heart rate is necessary.

– There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma .

Solutions containing adrenaline should be used with caution in patients with hypertension, cardiac disease, cerebrovascular insufficiency hyperthyroidism, advanced diabetes and any other pathological condition that may be aggravated by the effects of adrenaline.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma  with adrenaline contains sodium metabisulphite, which may cause allergic reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulphite sensitivity in the general population is unknown and probably low. Sulphite sensitivity is seen more frequently in asthmatic than non-asthmatic people.

For local anaesthesia only.

Preservative containing solutions should not be used intracisternally, epidurally, intrathecally or by any route giving access to the cerebrospinal fluid, or intra- or retro-bulbary. The volume to be injected in a single dose should not exceed 15 ml, unless otherwise justified.

4.5 Interaction with other medicinal products and other forms of interaction

Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g. certain anti-arrhythmics, such as mexilitine, since the systemic toxic effects are additive. Specific interaction studies with lidocaine and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised (see also section 4.4).

Drugs that reduce the clearance of lidocaine (e.g. cimetidine or betablockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions should be of no clinical importance following short term treatment with lidocaine at recommended doses.

Solutions containing adrenaline should be used cautiously in patients taking tricyclic antidepressants, monoamine oxidase inhibitors or receiving potent general anaesthetic agents since severe, prolonged hypertension may be the result. In addition, the concurrent use of adrenaline-containing solutions and oxytocic drugs of the ergot type may cause severe, persistent hypertension and possibly cerebrovascular and cardiac accidents. Phenothiazines and butyrophenones may oppose the vasoconstrictor effects of adrenaline giving rise to hypotensive responses and tachycardia.

Solutions containing adrenaline should be used with caution in patients undergoing general anaesthesia with inhalation agents, such as halothane and enflurane, due to the risk of serious cardiac arrhythmias.

Non-cardioselective betablockers such as propranolol enhance the pressor effects of adrenaline, which may lead to severe hypertension and bradycardia.

4.6 Fertility, pregnancy and lactation

Pregnancy

Although there is no evidence from animal studies of harm to the foetus, as with all drugs, Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma  should not be given during early pregnancy unless the benefits are considered to outweigh the risks.

The addition of adrenaline may potentially decrease uterine blood flow and contractility, especially after inadvertent injection into maternal blood vessels.

Foetal adverse effects due to local anaesthetics, such as foetal bradycardia, seem to be most apparent in paracervical block anaesthesia. Such effects may be due to high concentrations of anaesthetic reaching the foetus.

Breast-feeding

Lidocaine may enter the mother’s milk, but in such small amounts that there is generally no risk of this affecting the neonate. It is not known whether adrenaline enters breast milk or not, but it is unlikely to affect the breast-fed child.

4.7 Effects on ability to drive and use machines

Besides the direct anaesthetic affect, local anaesthetics may have a very mild effect on mental function and co-ordination, even in the absence of overt CNS toxicity, and may temporarily impair locomotion and alertness.

4.8 Undesirable effects

In common with other local anaesthetics, adverse reactions to Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma  with Adrenaline are rare and are usually the result of excessively high blood concentrations due to inadvertent intravascular injection, excessive dosage, rapid absorption or occasionally to hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. In such circumstances systemic effects occur involving the central nervous system and/or the cardiovascular system.

The adverse reaction profile for Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma  with adrenaline is similar to those of other amide local anaesthetics. Adverse reactions caused by the drug per se are difficult to distinguish from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia), events caused directly (e.g. nerve trauma) or indirectly by the needle puncture.

Tabulated list of adverse reactions

Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to<1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data).

The following table gives a list of the frequencies of undesirable effects:

System Organ ClassFrequency ClassificationAdverse Drug Reaction
Immune system disordersRareAllergic reactions, anaphylactic reaction
Nervous system disordersCommonParaesthesia, dizziness
UncommonSigns and symptoms of CNS toxicity (convulsions, numbness of tongue and paraesthesia circumoral, tinnitus, tremor, dysarthria, hyperacusis, visual disturbances, CNS depression)
RareNeuropathy, peripheral nerve injury, arachnoiditis
Eye disordersRareDiplopia
Cardiac disordersCommonBradycardia
RareCardiac arrest, cardiac arrhythmias
Vascular disordersCommonHypotension, hypertension
Respiratory, thoracic and mediastinal disordersRareRespiratory depression
Gastrointestinal disordersCommonNausea, vomiting

4.8.1 Acute systemic toxicity

Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system (CVS). Such reactions are caused by high blood concentrations of a local anaesthetic, which may appear due to (accidental) intravascular injection, overdose or exceptionally rapid absorption from highly vascularised areas (see section 4.9). CNS reactions are similar for all amide local anaesthetics, while cardiac reactions are more dependent on the drug, both quantitatively and qualitativelySigns of toxicity in the central nervous system generally precede cardiovascular toxic effects, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as benzodiazepine or barbiturate.

Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are usually, circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis, tinnitus and visual disturbances. Dysarthria, muscular twitching or tremors are more serious and precede the onset of generalised convulsions. These signs must not be mistaken for a neurotic behaviour. Unconsciousness and grand mal convulsions may follow which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with respiration and possible loss of functional airways. In severe cases apnoea may occur. Acidosis hyperkalaemia, hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.

Recovery is due to redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion. Recovery may be rapid unless large amounts of the drug have been injected.

Cardiovascular system toxicity may be seen in severe cases and is generally preceded by signs of toxicity in the central nervous system. In patients under heavy sedation or receiving a general anaesthetic, prodromal CNS symptoms may be absent. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics, but in rare cases cardiac arrest has occurred without prodromal CNS effects.

In children, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during general anaesthesia.

4.8.2 Treatment of acute toxicity

If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately and CNS symptoms (convulsion, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsant drugs.

If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.

If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, chronotropic and or inotropic agents should be considered. Children should be given doses commensurate with age and weight.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Accidental intravascular injections of local anaesthetics may cause immediate (within seconds to a few minutes) systemic toxic reactions. In the event of overdose, systemic toxicity appears later (15–60 minutes after injection) due to the slower increase in local anaesthetic blood concentration (see section 4.8.1 and 4.8.2).

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group

Lidocaine is a local anaesthetic of the amide type. At high doses lidocaine has a quinidine like action on the myocardium i.e. cardiac depressant. All local anaesthetics stimulate the CNS and may produce anxiety, restlessness and tremors.

5.2 Pharmacokinetic properties

Lidocaine is readily absorbed from the gastro-intestinal tract, from mucous membranes and through damaged skin. It is rapidly absorbed from injection sites including muscle.

Elimination half-life is 2 hours.

Lidocaine undergoes first pass metabolism in the liver.

Less than 10% of a dose is excreted unchanged via the kidneys.

The speed of onset and duration of action of lidocaine are increased by the addition of a vasoconstrictor and absorption into the site of injection is reduced.

5.3 Preclinical safety data

Lidocaine and adrenaline are well-established active ingredients.

In animal studies, the signs and symptoms of toxicity noted after high doses of lidocaine are the results of the effects on the central nervous and cardiovascular systems. No drug related adverse effects were seen in the reproduction toxicity studies, neither did lidocaine show any mutagenic potential in either in vitro or in vivo mutagenicity tests. Cancer studies have not been performed with lidocaine, due to the area and duration of therapeutic use for this drug.

Genotoxicity tests with lidocaine showed no evidence of mutagenic potential. A metabolite of lidocaine, 2,6-dimethylaniline, showed weak evidence of activity in some genotoxicity tests. The metabolite 2,6-dimethylaniline has been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride, sodium metabisulphite, methylparahydroxybenzoate, sodium hydroxide, hydrochloric acid and water for injections.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Two years.

Use within 3 days of first opening.

6.4 Special precautions for storage

Store between 2°C and 8°C.

6.5 Nature and contents of container

Multiple dose vial – 20 ml.

6.6 Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

  1. 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

PACKAGE LEAFLET: INFORMATION FOR THE USER

LIDOCAINE AND ADRENALINE INJECTION BP
1% W/V / 2% W/V
TAJ PHARMA

lidocaine, adrenaline (epinephrine)

Read all of this leaflet carefully before this medicine is given to you 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 or nurse.
  • If you get any side effects, talk to your doctor or nurse. See section 4.

WHAT IS IN THIS LEAFLET:

  1. What Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline is and what it is used for
  2. What you need to know before Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline is given to you
  3. How Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline is given to you
  4. Possible side effects
  5. How to store Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline
  6. Contents of the pack and other information1. WHAT LIDOCAINE AND ADRENALINE INJECTION BP 1% W/V / 2% W/V TAJ PHARMA WITH ADRENALINE IS AND WHAT IT IS USED FOR

The name of your medicine is ‘Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma 1% with adrenaline (epinephrine) 1:200,000’ or ‘Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma 2% with adrenaline (epinephrine) 1:200,000’. It is referred to as ‘Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline’ in the rest of this leaflet.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline is used to numb (anaesthetise) part of the body for surgical operations or to provide pain relief.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma 1% with adrenaline is used in adults and children above 1 year of age to:

  • numb (anaesthetise) the area of the body where surgery is to be performed.
  • provide pain relief in labour, after surgery or after acute injury.
  • treat certain types of chronic pain.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma 2% with adrenaline is used in adults and children above 12 years to:

  • numb (anaesthetise) the area of the body where surgery is to be performed.
  • provide pain relief in labour, after surgery or after acute injury.
  • treat certain types of chronic pain.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline contains two different medicines: lidocaine and adrenaline (epinephrine). Each of these works in a different way.

  • Lidocaine belongs to a group of medicines called local anaesthetics. These medicines numb (anaesthetise) parts of the body.
  • Adrenaline (epinephrine) belongs to a group of medicines called vasoconstrictors. These medicines make the blood vessels where the injection is given narrower. This means you will bleed less and the effects of the medicine will last longer.
  1. WHAT YOU NEED TO KNOW BEFORE LIDOCAINE AND ADRENALINE INJECTION BP 1% W/V / 2% W/V TAJ PHARMA WITH ADRENALINE IS GIVEN TO YOU

You must not be given Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline:

  • if you are allergic to lidocaine, adrenaline or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to any other local anaesthetics.

You must not be given Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given it.

Warnings and precautions

Talk to your doctor or nurse before using Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline, if you:

  • have high blood pressure or heart problems such as a slow heart beat.
  • have been told that you have hypovolaemia (decreased volume of blood).
  • have liver or kidney problems.
  • have difficulty breathing.
  • have epilepsy.
  • have diabetes.
  • have thyroid problems.
  • have ever had a stroke.
  • have an infection or inflammation at the site where the injection is to be given.
  • have ever been told that you have a rare disease of the blood pigment called ‘porphyria’ or anyone in your family has it.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline.

Other medicines and Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline can affect the way some medicines work and some medicines can have an effect on Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline.

In particular, tell your doctor if you are taking any of the following medicines:

  • Other local anaesthetics.
  • Other medicines that contain adrenaline.
  • Halothane (a general anaesthetic).
  • Medicines used to treat an uneven heart beat (arrhythmia) such as amiodarone.
  • Beta-blockers medicines such as propranolol.
  • Butyrophenone medicines for sickness, such as domperidone.
  • Other butyrophenone medicines for mental problems, such as haloperidol.
  • Phenothiazine medicines for mental problems, such as chlorpromazine.
  • Medicines for depression such as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
  • Medicines that induce labour.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline

Driving and using machines

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline may make you feel sleepy and affect the speed of your reactions. After you have been given Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline, you should not drive or use tools or machines until the next day.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline contains sodium, methyl hydroxybenzoate and sodium metabisulphite

  • Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline contains 2.49 mg of sodium per millilitre (ml), equivalent to 49.8 mg per 20 ml. To be taken into consideration by patients on a controlled sodium diet.
  • Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline contains methyl hydroxybenzoate (E218). This may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
  • Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline contains sodium metabisulphite. This may rarely cause severe hypersensitivity reactions and bronchospasm.
  1. HOW LIDOCAINE AND ADRENALINE INJECTION BP 1% W/V / 2% W/V TAJ PHARMA WITH ADRENALINE IS GIVEN TO YOU

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline will be given to you by a doctor. It will be given to you as an injection. The dose that your doctor gives you will depend on the type of pain relief that you need. It will also depend on your body size, age, physical condition and the part of your body that the medicine is being injected into. You will be given the smallest dose possible to produce the required effect.

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline will usually be given near the part of the body to be operated on. It stops the nerves from being able to pass pain messages to the brain. It will stop you feeling pain. It will start to work a few minutes after being injected and will slowly wear off when the medical procedure is over.

If you have been given too much Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline

Serious side effects from getting too much Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline are usually as follows:

  • Feeling dizzy or light-headed.
  • Numbness of the lips and around the mouth.
  • Numbness of the tongue.
  • Hearing problems.
  • Problems with your sight (vision).

To reduce the risk of serious side effects, your doctor will stop giving you Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline, tell your doctor immediately.

More serious side effects from being given too much Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline include problems with your speech, irrational behaviour, twitching of your muscles, fits (seizures), effects on your heart and blood vessels, loss of consciousness, coma and stopping breathing for a short while (apnoea).

  1. POSSIBLE SIDE EFFECTS

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

If you suffer from any of the following symptoms seek immediate medical attention:

  • Severe allergic reactions;signs may include sudden onset of swelling of your face, lips, tongue or throat which may make it difficult to swallow, severe or sudden swelling of your hands, feet and ankles, difficulty breathing (you may find it more difficult to breathe or your breathing may stop) or severe itching of the skin (with raised lumps).
  • Nerve damage;signs may include gradual onset of numbness, prickling or tingling and/or muscle weakness in your feet or hands, which can spread upward into your legs and arms.
  • Arachnoiditis (inflammation of a membrane that surrounds the spinal cord);signs may include a stinging or burning pain in the lower back or legs and tingling, numbness or weakness in the legs.

If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor immediately:

Common (may affect up to 1 in 10 people)

  • Low blood pressure. This might make you feel dizzy or light-headed.
  • High blood pressure.
  • Feeling sick (nausea) or being sick (vomiting).
  • Pins and needles.
  • Feeling dizzy.
  • Slow heartbeat.

Uncommon (may affect up to 1 in 100 people)

  • Ringing in the ears (tinnitus) or being sensitive to sound.
  • Difficulty in speaking.
  • Numbness of the tongue or around the mouth.
  • Fits (seizures).
  • Feeling sleepy.
  • Blurred vision.

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

  • Uneven heart beat (arrhythmias).
  • Double vision.

Possible side effects seen with other local anaesthetics which might also be caused by Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline include:

  • Damaged nerves which may cause permanent problems.

Other possible side effects:

  • Numbness where the injection is given. This will go away slowly.

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.

  1. HOW TO STORE LIDOCAINE AND ADRENALINE INJECTION BP 1% W/V / 2% W/V TAJ PHARMA WITH ADRENALINE
  • 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 vial and container after EXP. The expiry date refers to the last day of that month.
  • Store between 2 and 8°C in a fridge.
  • Your doctor or the hospital will normally store Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline and they are responsible for the quality of the product when it has been opened if it is not used immediately. They are also responsible for disposing of any unused Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma with adrenaline correctly.
  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma contains|

a) Each ml of solution for injection contains:
Lidocaine hydrochloride
monohydrate equivalent to
lidocaine hydrochloride BP…………10mg
Adrenaline (epinephrine) as the acid tartrate………………………………….5mg

b) Each ml of solution for injection contains:
Lidocaine hydrochloride
monohydrate equivalent to
lidocaine hydrochloride BP…………10mg
Adrenaline (epinephrine) as the acid tartrate………………………………….5mg

The other ingredients are sodium chloride, sodium metabisulphite, methyl hydroxybenzoate, sodium hydroxide, hydrochloric acid and water for injections.

What Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma 1% and 2% with adrenaline (epinephrine) 1:200,000 looks like and contents of the pack

Lidocaine and Adrenaline Injection BP 1% w/v / 2% w/v Taj Pharma 1% and 2% with adrenaline (epinephrine) 1:200,000 is a solution for injection. It comes in multi-dose vials of 20 ml.

  1. 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