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Halothane BP (250ml)
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory.

Composition

Each 250 ml bottle contains:

  • Halothane BP - 250 ml
  • Thymol BP - 0.01 % w/w

Presentation

Halothane BP (RS) 2-bromo-2-chloro-1.1.1 trifluoroethane stabilised with thymol 0.01 % w/w is a colourless volatile liquid.

Indications

'Halothane' is a volatile anaesthetic which is suitable for the induction and maintenance of anaesthesia for all types of surgery and in patients of all ages.

Dosage and Method of Administration

A number of anaesthetic vaporisers specially designed for use with 'Halothane' are available. Open, semi-open, semi-closed and closed circuit systems have all been used with good results.

Adults (lncludlng the elderly): For induction of anesthesia in the adult patient a concentration of 2-4% 'Halothane' in oxygen or oxygen/nitrous oxide may be used. Maintenance - 0.5 - 2% 'Halothane' in oxygen or oxygen/nitrous oxide is usually adequate.

Children: Induction - a concentration of 1.5 - 2% 'Halothane' in oxygen or oxygeNnitrous oxide is used. Maintenance - 0.5 - 2% is usually adequate.

Contra-Indications

'Halothane' is contra-indicated in patients with previous history of malignant hyperpyrexia or those susceptible to malignant hyperpyrexia. The appearance of unexplained jaundice and pyrexia following exposure to 'Halothane' should be regarded as a contra-indication to its later use.

Warnings and Precautions for Use

As 'Halothane' causes relaxation of the uterine muscle it is advisable that anaesthesia be maintained at the lightest plane possible during obstetric operations. Obstetric use, especially high concentrations, may result in post partum haemorrhage.

The role of 'Halothane' in liver damage occasionally observed after anaesthesia has not been definitely established. However, as such cases appear more frequently after repeated anaesthetic administration, the appearance of unexplained jaundice and pyrexia following exposure to 'Halothane' should be regarded as a contra-indication to its later use. Repeated exposure within a period of three months should be avoided in all patients. 'Halothane' is a potent cerebral vasodilator. Increase in cerebral blood flow and / orintracranial pressure may be observed during anesthesia with 'Halothane'. These may be more marked in the presence of intracranial Space-occupying lesions. The use of moderate hyperventilatlon during neurosurgery is recommended to counteract the rise in intracranial pressure which may occur with 'Halothane'.

Malignant hyperpyrexia has been reported in some patients receiving `Halothane', more commonly when co-administered with suxamethonium. This syndrome occurs with other anaesthetic agents and may respond to intravenous dantrolene sodium. During the induction of anesthesia with 'Halothane' a moderate fall in blood pressure commonly occurs (Halothane lowers arterial blood pressure in a dose dependent manner). The blood pressure tends to rise when the vapour concentration is reduced to maintenance levels, but it usually remains steady below the pre-operative level. However if necessary, intravenous doses of methoxamine (5 mg are usually adequate) can be given to counteract the fall in blood pressure.

Anaesthesia with 'Halothane' may be associated with bradycardia, which may augment its hypotensive effect. The intravenous administration if an anticholinergistic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to be predominant or when 'Halothane' is used in conjugation with other agents likely to cause bradycardia. Cardiac arrhythmias have been reported during anaesthesia with 'Halothane'.

Caution is required with regard to the administration of 'Halothane to patients with phaeochromocytoma, as it is possible that this may lead to an increased likelihood of intraoperative arrhythmias. 'Halothane' may cause respiratory depression, particularly at higher concentrations. It is advisable to ensure adequate room ventilation when volatile agents such as 'Halothzne' are used. Halothane causes relaxation of the skeletal smooth muscles. Caution is required when using 'Halothane' in patients with myasthenia gravis or those co-administered aminoglycoside antibiotics.

Interactions with other medicaments and other forms of interaction

'Halothane' augments the action of non depolarising muscle relaxants and the muscle relaxant effects of aminoglycosides. 'Halothane' may augment the hypotension caused by the ganglionic blocking effect of tubocuraine. Caution should be exercised during the administration of adrenaline to patients anaesthetised with 'Halothane'as arrhythmias may be precipitated. For this reason the dose of adrenaline should be restricted and an antiarrhythmic administered as appropriate. Caution should also be applied for other sympathomimetics, and for aminophylline, Theophylline and tricyclic antidepressants, which may also precipitate arrhythmias

Pregnancy and Lactation

Pregnancy: Data from animal experiments have indicated that 'Halothane' may have teratogenic potential in some species. Although these findings cannot be directly related to man, it would be prudent to avoid general anaesthesia with inhalation agents during early pregnancy, except where such use is essential.

Lactation: There are no well controlled studies with ' Halothane' in lactating women. 'Halothane' has been detected in breast milk of lactating women, but the effects of 'Halothane on breast fed neonates have not been established. However' Halothane' has been in wide use for over 30 years without apparent ill consequence.

Effect on ability to drive and use machinery

Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some time after general anaesthesia.

Possible adverse reactions

Bradycardia and/or hypotension may occur during 'Halothane' anaesthesia. Hypertension may occur particularly during induction. Shivering may be observed during recovery from anaesthesia, especially if-the patient's in cool surroundings. Post-operative nausea and vomiting may occur after 'Halothane' anaesthesia. Anaesthesia with 'Halothane' may be followed by damage. However, As such cases appear more frequently after repeated anaesthetic administration, the appearance of unexplained jaundice and pyrexia following exposure to 'Halothane' should be regarded as contra-indication to its later use. Repeat exposure within a period of three months should be avoided.

Overdosage

There is no specific antidote. Treatment should be aimed at maintaining respiratory function (by moving the patient to fresh air or inserting an airway with respiratory support) and cardlovascular function. Cases of internal ingestion must be treated symptomatically.

Pharmacological Properties

Phermecodynsmlc Properties: When inhaled, Halothane' is absorbed through the alveoli into the bloodstream. In the bloodstream 'Halothane' circulates through the body to the principle site of action, the brain. Here, 'Halothane' causes a progressive depression of the central nervous system beginning with the higher centres (cerebral cortex) and spreading to the vital centres of the medulla. This depression is reversible. However, its mode of action, like all anaesthetic agents, is unknown. 'Halothane' may cause bronchodilation. Bronchial relaxation is usually dose-related and may be due to blockage of pathways, causing bronchial constriction or depression of bronchial muscular tone.

'Halothane' causes reversible, dose-related decline in renal blood flow, glomerularfifteration rate and urinary flow. 'Halothane' may be absorbed by the rubber used in some anaesthetic circuits. The rubber/gas partition coefficient at 20°C is 120.

Phamracoklnetic Properties:

'Halothane' has a relatively low solubility in blood and therefore alveoli blood concentration equilibrate rapidly. The triexponential decline in 'Halothane' blood concentration following the end of administration is thought to represent distribution into three compartments; the vessel rich group (brain/heart/ liver), the musculature and adipose tissue. Approximately 80% of the inhaled 'Halothane' is eliminated unchanged by the Iungs. The remaining 20% is metabolised in the liver by oxidative and under hypoxic conditions, reductive pathways. The main metabolites are trifluoroacetic acid, bromide and chloride salts (via the oxidative abnormalities of liver function or more rarely liver Pathway) and fluoride salts (via the reductive pathway). The concentration of metabolites peak at l0 hours postoperatively and are eliminated by renal excretion during the following week.

Incompatibilities

None known.

Special Precautions for Storage

Bottles of 'Halothane' must be securely closed and stored below 25°C protected from light. 'Halothane' must be kept in the original contanier until immediately prior to its use.

Instructions for use/handling

Whilst in the liquid phase, 'Halothane must not be emergency diluted or contaminated. However, in the vapour phase it may be administered together with or a mixture of nitrous oxide and oxygen. Avoid accidental inhalation. Use under well ventilated condition. Keep concentration in air as low as possible.

 
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