Thiopental Sodium for injection USP 1000mg Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT

Thiopental Sodium for Injection USP 500mg Taj Pharma
Thiopental Sodium for injection USP 1000mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

   a) Each vial contains:
   Thiopental Sodium USP……………………500mg
   Excipient…………………..………………q.s.

   b) Each vial contains:
   Thiopental Sodium USP…………………..1000mg
   Excipient…………………..………………q.s.

   Thiopental sodium and sodium carbonate (equivalent to 470mg / 930mg thiopental sodium)

Excipient with known effect:

Each vial of 500mg / 1000mg contains 53 mg (2.3 mmol) sodium/vial.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for solution for injection

Yellowish-white powder

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Intravenous anaesthesia.

Induction of general anaesthesia and also as an adjunct to provide hypnosis during balanced anaesthesia with other anaesthetic agents, including analgesics and muscle relaxants.

As an adjunct for control of refractory convulsive disorders of various aetiology, including those caused by local anaesthetics.

Reducing the intracranial pressure in patients with increased intracranial pressure, if controlled ventilation is provided.

4.2 Posology and method of administration

Posology

Using of thiopental is reserved only for health care personnel trained in anaesthesiology. A person qualified in the use of anesthetics should be constantly available during the administration of the medicinal product.

After continuous administration of thiopental the effect duration is prolonged, personnel qualified in the use of anesthetics should be constantly available during the administration of the medicinal product.

A normal adult dose for induction of anaesthesia is 4-6 mg/kg body weight, but the individual response to the drug is so varied that there can be no fixed dosage. The drug should be titrated against patient requirements as governed by age, sex, body weight and the patient’s general condition. The dose should usually be reduced and carefully titrated in patients with a poor general condition. Younger patients require relatively larger doses than middle-aged and elderly persons; the latter metabolize the drug more slowly. Pre-puberty requirements are the same for both sexes, but adult females require less than adult males. Dose is usually proportional to body weight and obese patients require a larger dose than relatively lean persons of the same weight.

Test Dose

It is advisable to inject a small intravenous ”test” dose of 25 to 75 mg (1 to 3 ml of a 2.5% solution) to assess tolerance or unusual sensitivity to thiopental and pausing to observe patient reaction for at least 60 seconds. If unexpectedly deep anesthesia develops or if respiratory depression occurs, consider these possibilities:

1. The patient may be unusually sensitive to thiopental.
2. The solution may be more concentrated than had been assumed.
3. The patient may have received too much premedication.

If the test dose results in local or regional pain, extravasal or intraarterial administration should be suspected (see section 4.4.).

Use in Anesthesia

Moderately slow induction can usually be accomplished in a healthy female or male adult weighing 60-80 kg by injection of 50 to 75 mg of thiopental at intervals of 20 to 40 seconds, depending on the reaction of the patient. Once anesthesia is established, additional injections of 25 to 50 mg can be given whenever the patient moves. Slow injection is recommended to minimize respiratory depression and the possibility of overdosage.

The smallest dose consistent with attaining the surgical objective is the desired goal. Momentary apnea following each injection is typical, and progressive decrease in the amplitude of respiration appears with increasing dosage. Pulse remains normal or increases slightly and returns to normal.

Muscles usually relax about 30 seconds after unconsciousness is attained, but this may be masked if a skeletal muscle relaxant is used.

The tone of jaw muscles is a fairly reliable index. The pupils may dilate but later contract.

Sensitivity to light is not usually lost until a level of anesthesia deep enough to permit surgery is attained. Nystagmus and divergent strabismus are characteristic during early stages, but at the level of surgical anesthesia, the eyes are central and fixed. Corneal and conjunctival reflexes disappear during surgical anesthesia.

When thiopental is used as the sole anesthetic agent, the desired level of anesthesia can be maintained by injection of small repeated doses as needed or by using a continuous intravenous infusion with a 0.2% or 0.4% concentration (see section 6.6). For information on preparation of solutions see section 6.6.

With continuous infusion, the depth of anesthesia is controlled by adjusting the rate of infusion.

Paediatric population

The doses are recommended for healthy paediatric population, and doses may have to be adjusted depending on for example concomitant illness, preanesthesia.

The suggested paediatric dosage categories are only indicative of required doses. Actual dosing must be individualized and titrated to effect based on age, maturity and the general condition of the paediatric patient.

Use in convulsive states

75 mg to 125 mg (3mls to 5mls of a 2.5% w/v solution) should be given as soon as possible after the convulsion begins. Further doses may be required to control convulsions following the use of a local anaesthetic. Other regimens, such as the use of intravenous or rectal diazepam, may be used to control convulsive states.

Paediatric population

Intravenously 2 mg/kg initially and then individually titrated until satisfactorily clinical effect has been established. A maximum dose of 5 mg/kg/h should not be exceeded.

Use in neurological patients with raised intracranial pressure

Intermittent bolus injections of 1.5 to 3mg/kg of bodyweight may be given to reduce elevations of intracranial pressure if controlled ventilation is provided.

Paediatric population

The safety of thiopental in paediatric populations to treat raised intracranial pressure has not yet been established.

Hepatic impairment

Reduced dose should be used in patients with hepatic impairment (see section 4.4).

Renal impairment

Thiopental should be used with caution in patients with renal impairment (see section 4.4).

Method of administration

This medicinal product must only be administered by the intravenous route. Care should be taken to ensure intravenous administration (see section 4.4). For instructions on dilution of the medicinal product before administration, see section 6.6. Infusion should only be given through a central venous catheter.

4.3 Contraindications

Hypersensitivity to barbiturates or to any of the excipients listed in section 6.1.
Thiopental is contra-indicated in respiratory obstruction, acute asthma, severe shock and dystrophia myotonica. Administration of any barbiturate is contra-indicated in porphyria.

4.4 Special warnings and precautions for use

Thiopental may cause addiction.

Keep endotracheal intubation equipment, oxygen and resuscitative equipment readily available.

Caution must be taken in patients with increased intracranial pressure or asthma.

If used under these conditions reduce dosage and administer slowly.

Use in neurological patients with raised intracranial pressure

Thiopental has been associated with reports of severe or refractory hypokalaemia during infusion; severe rebound hyperkalaemia may occur after cessation of thiopental infusion. The potential for rebound hyperkalaemia should be taken into account when stopping thiopental therapy.

Caution must be taken in patients with potential airway compromise, such as conditions involving inflammation in the mouth, jaw and throat.

Cardiorespiratory depression

Thiopental sodium causes respiratory depression and a reduction in cardiac output and may precipitate acute circulatory failure in patients with cardiovascular disease, particularly constrictive pericarditis. Care should also be exercised with severe cardiovascular diseases, severe respiratory diseases and hypertension of various aetiology.

When particular caution is required

Special care is needed in administering thiopental sodium to patients with the following conditions:- hypovolaemia, severe haemorrhage, burns, cardiovascular disease, myasthenia gravis, adrenocortical insufficiency (even when controlled by cortisone), cachexia, raised intracranial pressure and raised blood urea.

Dose reduction required

Reduced doses are recommended in shock, dehydration, severe anaemia, hyperkalaemia, toxaemia, metabolic disorders e.g. thyrotoxicosis, myxoedema and diabetes.

Increased doses

Increased doses may be necessary in patients who have either a habituation or addiction to alcohol or drugs of abuse. Under these circumstances it is recommended that supplementary analgesic agents are used.

Hepatic impairment

Thiopental sodium is metabolized primarily by the liver so doses should be reduced in patients with hepatic impairment.

Renal impairment

Barbiturate anaesthetics should be used with caution in severe renal disease. Reduced doses are also indicated in the elderly and in patients who have been premedicated with narcotic analgesics.

Use in underlying disease

Patients taking long-term medications such as aspirin, oral anticoagulants, oestrogens, MAOIs and lithium may need to adjust the dose or stop therapy prior to elective surgery. Patients with diabetes or hypertension may need to adjust their therapy before anaesthesia (see section 4.5).

Thiopental concentrations less than 2.0 % can cause hemolysis.

Extravascular infiltration:

Extravascular injection should be avoided. Care should be taken to insure that the needle is within the lumen of the vein before intravenous injection of this medicinal product. Extravascular injection may cause chemical irritation of the tissues varying from slight tenderness to venospasm, extensive necrosis, severe pain and sloughing. This is due primarily to the high alkaline pH (10 to 11) of clinical concentrations of the drug. If extravasation occurs, the local irritant effects can be reduced by injection of 1% lidocaine locally to relieve pain and enhance vasodilatation. Local application of heat also may help to increase local circulation and removal of the infiltrate (see section 4.8).

Intra-arterial injection:

Intra-arterial injection can occur inadvertently, especially if an aberrant superficial artery is present at the medial aspect of the antecubital fossa. The area selected for intravenous injection of the drug should be palpated for detection of an underlying pulsating vessel. Accidental intra-arterial injection may cause arteriospasm and severe pain along the course of the artery with blanching of the arm and fingers. Appropriate corrective measures should be instituted promptly to avoid possible development of gangrene. Methods suggested for dealing with this complication vary with the severity of symptoms (see section 4.8).

The following have been suggested (controlling investigations are missing):

1. Dilute the medicinal product by removing the tourniquet and any restrictive garments.
2. Leave the intravenous cannula in place, if possible.
3. Inject the artery with a dilute solution of papaverine, or lidocaine, to inhibit smooth muscle spasm.
4. If necessary, perform sympathetic block of the brachial plexus and/or stellate ganglion to relieve pain and assist in opening collateral circulation. Papaverine can be injected into the subclavian artery, if desired.
5. Unless otherwise contraindicated, treat with heparin to prevent thrombus formation.
6. Consider local infiltration of an alpha-adrenergic blocking agent such as phentolamine into the vasospastic area.
7. Provide additional symptomatic treatment as required.

This medicinal product contains 106 mg sodium per vial for 1g and 53mg per vial for 500mg / 1000mg. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

Thiopental sodium has been shown to interact with sulphafurazole. Reduced initial doses may be required to achieve adequate anaesthesia, but repeat doses may also be necessary to maintain anaesthesia.

Gastrointestinal drugs: Metoclopramide and droperidol reduce the dose of thiopental sodium required to induce anaesthesia.

The use of anaesthetics with other CNS depressant drugs such as those used for premedication may produce synergistic effects on the CNS and, in some cases, a smaller dose of general anaesthetic should be used. Bradycardia occurring during anaesthetic induction with thiopental has been reported in patients also receiving fentanyl.

Benzodiazepines: Midazolam potentiates the anaesthetic effects of thiopental sodium.

Probenecid: Pretreatment with probenecid has been shown to potentiate thiopental sodium anaesthesia.

Angiotensin-II receptor antagonists: Enhanced hypotensive effect when general anaesthetics given with angiotensin-II receptor antagonists.

Antibacterials: General anaesthetics possibly potentiate hepatotoxicity of isoniazid; effects of thiopental sodium enhanced by sulphonamides; hypersensitivity-like reactions can occur when general anaesthetics given with intravenous vancomycin.

Antidepressants: Increased risk of arrhythmias and hypotension when general anaesthetics given with tricyclic antidepressants. Hypotension and hypertension has been seen with MAOIs.

Antipsychotics: Patients being treated with phenothiazine antipsychotics may experience increased hypotension. Some phenothiazines, especially promethazine, may also increase the incidence of excitatory phenomena produced by barbiturate anaesthetics; cyclizine may possibly have a similar effect. The sedative properties may be also potentiated by thiopental sodium.

Diazoxide: Enhanced hypotensive effect when general anaesthetics given with diazoxide.

Diuretics: Enhanced hypotensive effect when general anaesthetics given with diuretics.

Methyldopa: enhanced hypotensive effect when general anaesthetics given with methyldopa.

Moxonidine: Enhanced hypotensive effect when general anaesthetics given with moxonidine

Nitrates: Enhanced hypotensive effect when general anaesthetics given with nitrates.

Vasodilator antihypertensives: Enhanced hypotensive effect when general anaesthetics given with hydralazine, minoxidil or nitroprusside.

It should be noted that thiopental will interact with beta-blockers and calcium antagonists causing a fall in blood pressure.

ACE inhibitors: enhanced hypotensive effect when general anaesthetics given with ACE inhibitors.

Adrenergic neuron blockers: Enhanced hypotensive effect when general anaesthetics given with adrenergic neurone blockers.

Alpha-blockers: Enhanced hypotensive effect when general anaesthetics given with alpha-blockers.

Herbal medicines: Animal data suggest valerian and St John’s Wort may prolong the effect of thiopental sodium.

Analgesics: Pretreatment with aspirin has been shown to potentiate thiopental sodium anaesthesia. Opioid analgesics can potentiate the respiratory depressant effect of barbiturate anaesthetics and the dose of anaesthetic may need to be reduced. The analgesic effect of pethidine can be reduced by thiopental sodium.

Opioids potentiate the respiratory depressive effect. The effect is enhanced by alcohol, hypnotics, central acting muscle relaxants, anxiolytics, antipsycotics and antihistamines.

Thiopental interacts with opioid analgesics (decreased sensibility to pain) and sufentanile (decrease dose dependently the need of barbiturates at induction of anaesthesia. Increased doses may be necessary in patients with alcohol- or narcotics misuse.

Pharmacokinetic interactions

Concomitant use of barbiturates and quetiapine may result in a reduced serum concentration of quetiapine.

Barbiturates increase by enzyme induction the elimination of androgens, some antiepileptics, felodipin, glucocorticoids, metronidazole, peroral anticoagulants and estrogen and thereby decrease the plasma concentration of these substances.

Barbiturates inhibit the hypoglycaemic effect of peroral antidiabetics (sulfonyl-urine substances).

Barbiturates inhibit the effect of bronchodilators (aminophylline).

4.6 Fertility, pregnancy and lactation

Pregnancy

It has been shown that thiopental can be used without adverse effects during pregnancy. However, when considering use of thiopental the clinician should only use the drug when the expected benefits outweigh any potential risks.

Breast-feeding

Thiopental readily crosses the placental barrier and also appears in breast milk. Animal reproduction studies have not been conducted with thiopental. Therefore, breast-feeding should be temporarily suspended (for at least 12 hours) or breast milk expressed before the induction of anaesthesia.

Fertility

There are no data on the effect of thiopental on human fertility.

4.7 Effects on ability to drive and use machines

This medicinal product has major influence on the ability to drive and use machines. Even though the recovery after use of this medicinal product is rapid; post-operative vertigo, disorientation and sedation may be prolonged and out-patients given thiopental should therefore be advised not to drive or use machinery especially within the first 24 to 36 hours.

4.8 Undesirable effects

The frequencies of adverse events are ranked according to the following:

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), not known (cannot be estimated from the available data).

Immune hemolytic anemia with renal failure and paralysis of nervus radialis have been reported in rare cases. Reactions which may be caused by the diluent, preparation – or solving technique or by administration of prepared solutions with thiopental sodium include fever, venous thrombosis or phlebitis at the injection site, and events after extravasal injection.

Laryngeal spasm may occur, together with coughing or sneezing, during the induction procedure. For this reason it is not advised to use thiopental sodium alone for peroral endoscopy.

Excessive doses are associated with hypothermia and profound cerebral impairment.

Postoperative vomiting is infrequent, but shivering may occur and there may be persistent drowsiness, confusion and amnesia.

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.

4.9 Overdose

Overdosage may occur from too rapid or repeated injections. Too rapid injection may be followed by an alarming fall in blood pressure and shock. Apnea may occur in connection with too excessive or too rapid injections. Also laryngospasm, coughing and other respiratory difficulties may occur, but may also be a sign of under dosing (reflex induced).

In the event of suspected or apparent overdosage, the drug should be discontinued. A patent airway should be secured. Oxygenation and ventilation should be monitored and supported as needed. The circulation should be monitored and supported as needed.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmaceutical group: General anesthetics This medicinal product is a thiobarbiturate with rapid onset for intravenous administration. Thiopental induces hypnosis and anesthesia, but not analgesia. Hypnosis is produced within 30 to 40 seconds. Recovery is within 30 minutes after adequate induction dose. Repeated injections give a prolonged anesthesia because of entry into fatty tissue.

Thiopental is a short-acting substituted barbiturate that is more lipid soluble than other groups of barbiturates. The drug reversibly depresses the activity of all excitable tissues. The CNS is particularly sensitive and normally a general anaesthesia can be achieved with thiopental sodium without significant effects on peripheral tissues.

Thiopental sodium acts through the CNS with particular activity in the mesencephalic reticular activating system. The barbiturates exert different effects on synaptic transmission, mostly those dependent on GABA. Autonomic ganglia of the peripheral nervous system are also depressed.

5.2 Pharmacokinetic properties

Following intravenous administration, unconsciousness occurs within 30 seconds and will be continued for 20 to 30 minutes after a single dose. Rapid uptake occurs to most vascular areas of the brain followed by redistribution into other tissues.

Thiopental is almost completely metabolized and only approximately 0.3 % is excreted unchanged in the urine. Thiopental is extremely fat soluble and is largely metabolized in the liver but is slowly excreted from lipid depot and is very slowly transformed. During one hour 10-15 % is metabolized, mainly in the liver. The half-life of the distribution phase after a single intravenous dose is 2-4 hours and the half-life of the elimination phase is 9-11 hours. The plasma protein binding is 80-90% at therapeutic concentration level.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None

6.2 Incompatibilities

This medicine must not be mixed with other medicinal products except those mentioned in section 6.6.

The solutions prepared with THIOPENTAL are strongly alkaline and are not compatible with volume replacement solutions and acidic anaesthetic adjuvant solutions, since precipitation and clogging of the injection needle may occur. Similarly, chemical changes in the added solution cannot be ruled out.

6.3 Shelf life

3 years

Shelf-life after reconstitution

Chemical and physical in-use stability has been demonstrated for 9 hours below 25°C and 24 hours at 2°C to 8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

For single use after reconstitution. Discard any remainder after use.

6.5 Nature and contents of container

20 mL vials made from colourless type III glass with a rubber stopper, aluminium seal and a polypropylene flip-off cap.

Pack size: 1, 10, 25 and 50 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Solutions should be prepared aseptically with one of the three following diluents:

– Sterile Water for Injection (according Ph.Eur.),

– solution for infusion of sodium chloride (9 mg/ml),

– 5% dextrose solution for infusion.

Clinical concentrations used for intermittent intravenous administration vary between 2.0% and 5.0%.

A 2.0% or 2.5% solution is most commonly used. A 3.4% concentration in sterile water for injection is isotonic; concentrations less than 2.0% in this diluent are not used because they cause hemolysis. For continuous intravenous drip administration, concentrations of 0.2% or 0.4% are used. Solutions may be prepared by adding thiopental to 5% water solution of dextrose or to 0.9% solution of sodium chloride.

CALCULATIONS FOR VARIOUS CONCENTRATIONS

Since this medicinal product contains no added bacteriostatic agent, extreme care in preparation and handling should be exercised at all times to prevent the introduction of microbial contaminants.

Solutions should be freshly prepared and used promptly; when reconstituted for administration to several patients; unused portions should be discarded after 24 hours. Sterilization by vapour should not be attempted.

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

7. MANUFACTURED IN INDIA BY:

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

THIOPENTAL SODIUM FOR INJECTION USP 500MG / 1000MG
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

WHAT IS IN THIS LEAFLET:

1. What Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma is and what it is used for
2. What you need to know before Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma is given
3. How Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma is given
4. Possible side effects
5. How to store Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma
6. Contents of the pack and other information

   1. WHAT THIOPENTAL SODIUM FOR INJECTION USP 500MG/100ML TAJ PHARMA IS AND WHAT IT IS USED FOR

Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma contains the active ingredient thiopental sodium (as thiopental sodium and sodium carbonate) which is also known as thiopentone sodium. It is an anaesthetic agent, which may be given:

• as a general anaesthetic or to make you sleepy before using another anaesthetic agent
• before using agents to prevent pain or to relax muscles
• to control fits
• to reduce intracranial pressure.

This injection is usually given to you by a doctor directly into a vein.

2. WHAT YOU NEED TO KNOW BEFORE THIOPENTAL SODIUM FOR INJECTION USP 500MG/100ML TAJ PHARMA IS GIVEN

You MUST NOT be given Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma if you:

• are allergicto thiopental sodium or have had reactions to thiopental or to other barbiturates (such as some anaesthetics)
• have any respiratory abnormalities(including difficulty in breathing), such as an obstruction in your lungs or in the tubes leading to them
• have acute asthma(short term asthma)
• are in severe shock
• have myotonic dystrophy– a muscular disease
• have the condition known as porphyria– a metabolic disorder.

If any of these apply to you, tell the doctor or nurse, they will usually decide to use another medicine instead.

Take special care with Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma

Tell your doctor before you are given thiopental if you have any of the following, as your dose may need to be adjusted:

• heart diseaseor circulatory problems, as these can suddenly be made more severe by thiopental
• severe anaemia, blood pressure problems (high blood pressure orlow blood pressure), raised blood potassium, increased blood urea, bacterial infection in the blood, severe bleeding
• liver or kidney disease
• increased pressure in the brain
• muscle weaknessor degeneration (such as myasthenia gravis or muscular dystrophies)
• thyroid glandproblems
• diabetes
• dehydration, malnutritionor wasting
• underproduction of steroid hormones by the adrenal gland(even when controlled by cortisone)
• a metabolic disordercaused by an underactive thyroid gland (a reduced dose may be required)
• asthma
• burns
• shock
• hypovolaemia– a low level of fluids in the body
• are elderly(a reduced dose may be required)
• are taking opioid analgesics– strong pain relievers.
• are on a sodium controlled diet, as this product contains 53.5mg sodium per vial.

Taking other medicines

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

The following medicines can affect, or be affected by, this injection and may need to be adjusted before or after receiving this injection:

• antibiotics (used to treat infections), such as vancomycin, isoniazid and sulphonamides
• sulphafurazole (an antibiotic) – smaller doses of thiopental given more frequently may be required
• antihypertensives (used to treat high blood pressure or heart problems), such as ACE inhibitors, angiotensin-II receptor antagonists, alpha blockers, beta-blockers, calcium antagonists, diuretics, vasodilating anti-hypertensives, alpha adrenergic neurone blockers
• nitrates (used to treat angina)
• antidepressants (used to treat depression), such as monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants
• benzodiazepines, such as midazolam, to treat anxiety
• lithium (used to treat mania, manic depressive illness or depression)
• analgesics (used to treat pain) such as aspirin
• opioid analgesics (strong pain relievers) such as morphine, fentanyl and pethidine
• phenothiazines (used to treat psychosis and nausea) such as promethazine
• drugs that have an effect on the gastrointestinal tract (gut), such as metoclopramide or droperidol
• drugs that have an effect on the central nervous system (CNS)
• cyclizine (used to treat dizziness, nausea and vomiting)
• drugs to treat high blood pressure, such as diazoxide, methyldopa, moxonidine, hydralazine, minoxidil and nitroprusside
• probenecid (used to treat gout and high uric acid in the blood)
• oral anticoagulants (used to thin your blood)
• oestrogens (oral contraceptives or hormone replacement therapy)
• herbal medicines, such as Valerian or St John’s Wort.

Thiopental sodium with alcohol

The effect of alcohol may be increased in the period after treatment with thiopental sodium (for at least the first 24 hours).

Pregnancy and breast-feeding

Breast-feeding should be temporarily stopped or breast milk expressed before being given Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma.

If you are pregnant or breast feeding, think you may be pregnant or are planning to become pregnant, your doctor will consider the risks and benefits of giving Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma to you.

Driving and using machines

You may experience dizziness (vertigo), disorientation and sedation; these will wear off quite quickly. Do not drive or operate machinery, especially during the first 24 to 36 hours after the injection.

3. HOW THIOPENTAL SODIUM FOR INJECTION USP 500MG/100ML TAJ PHARMA IS GIVEN

This injection is usually given to you directly into a vein by a doctor, but can be given via a drip into a vein.

If thiopental is accidentally injected into an artery instead of a vein, it can cause damage to your tissues. Your doctor should treat these effects (a similar problem can occur if thiopental leaks from the vein into surrounding tissue). If you feel severe pain near where the drug was injected tell the doctor or nurse immediately so that treatment can be started quickly.

Dose

The sterile powder is made into a solution and must not be mixed with other acidic injections.

This solution should be discarded after 7 hours.

The dosage will be adjusted according to your age, sex, and weight as well as your response to the drug.

Anaesthesia:

Adults: 100mg – 150mg, injected over 10 to 15 seconds.

Elderly: as for adults, although smaller doses may be required.

Children: the calculated dose will usually be 2 to 7mg/kg.

You will normally feel the effects within 30 seconds and be asleep within one minute. Further small doses will be given to you as necessary (you will normally be asleep during this process).

Convulsions (fits):

75mg to 125mg, given as soon as possible after the convulsion begins. Further doses may be required and your doctor will decide the best dose to give.

Neurological patients with raised intracranial pressure: Intermittent injections of 1.5 to 3mg/kg.

Reduced doses may be needed if you have:

• liver disease (including jaundice), shock, dehydration, severe anaemia, high blood level of potassium, infection in your blood
• myxoedema (a metabolic disorder caused by an underactive thyroid gland).
• received morphine or similar medicines before you are given thiopental
• received a medicine called sulfafurazole – your doctor may need to give you smaller and more frequent doses of thiopental.

Increased doses may be needed if you:

• are a heavy and frequent drinker of alcohol
• regularly take non-prescribed drugs.

The dose of thiopental may need to be increased or given with another medicine to increase its effect.

If you are given more thiopental than you should

This product will be given to you under medical supervision, it is therefore unlikely that you will be given too much. However, if you feel unwell you should tell your doctor immediately. Symptoms could be: rapid shallow breathing or feeling faint or dizzy.

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

4. POSSIBLE SIDE EFFECTS

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

Tell your doctor right away if you notice any of the following symptoms – you may need urgent medical treatment:

Difficulty breathing, wheezing, rash, itching, hives, dizziness, difficulty swallowing, and swelling of the face, lips, tongue or throat, or any other allergic reaction. This could be a severe allergic reaction (frequency not known, cannot be estimated from the available data).

When it is injected, thiopental can cause the following (frequencies not known):

• coughing, sneezing or spasm of the airways; difficulty in breathing
• fall in blood pressure – often seen when thiopental is first given
• drowsiness, nausea with or without vomiting, anorexia (poor appetite), malaise (general sense of unwellness), fatigue, dizziness, headache
• delirium (sudden severe confusion)
• shivering, low body temperature and severely reduced brain function can occur with excessive doses of thiopental.

Other effects include (frequencies not known):

• confusion, amnesia (loss or disruption of memory)
• reduced pumping action of the heart or irregular heartbeats
• low blood pressure or other circulatory effects
• thiopental has been associated with reports of decreased potassium blood levels during infusion and increased potassium blood levels after stopping thiopental infusion.
• tissue damage if the injection leaks into surrounding tissue. If you experience severe pain at the site of injection, inform your doctor immediately.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THIOPENTAL SODIUM FOR INJECTION USP 500MG/100ML TAJ PHARMA

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

Before reconstitution:

Do not store above 25°C. Keep in outer carton.

After reconstitution:

This product contains no preservatives and should be used immediately. If the solution is stored, keep it upright and store between 2°C and 8°C. The reconstituted solution must be used within 7 hours. Use once following reconstitution and discard any residue.

Do not use this medicine if you notice that the solution is discoloured.

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

6. FURTHER INFORMATION

What Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma contains

a) Each vial contains:
Thiopental Sodium USP……………………500mg
Excipient…………………..………………q.s.

b) Each vial contains:
Thiopental Sodium USP…………………..1000mg
Excipient…………………..………………q.s.

What Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma looks like and contents of the pack

The product is a dry, yellow-white powder contained in a glass vial with a rubber closure. Each vial contains 500mg thiopental sodium (as thiopental sodium and sodium carbonate).

Thiopental Sodium for Injection USP 500mg/100ml Taj Pharma is packed in 1, 10 or 25 glass vials.

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