LIDOCAINE HCL

5mg of Phenylephrine Hydrochloride . Prime the pump dispenser by activating the pump 3 times. The pump dispenser will deliver a dose volume of 130μl in each spray. 65mg of Phenylephrine Hydrochloride .

Adults, and Children over 12 years:

Up to a maximum of 8 sprays in total. Children below 12 years of age Not recommended

The lidocaine and phenylephrine topical solution may interfere with swallowing, and numbness of the tongue or buccal mucosa may increase the danger of biting trauma. g. g. phenylephrine) may produce systemic adverse effects as a result of the raised plasma concentrations which ensue when the rate of absorption into the circulation exceeds the rate of breakdown, for example, by absorption of large amounts through mucous membranes or damaged skin or from highly vascular areas.

Possible Systemic Effects due to Lidocaine The systemic toxicity of local anaesthetics mainly involves the central nervous system and the cardiovascular system. Excitation of the CNS may be manifested by restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions.

Numbness of the tongue and perioral region may appear as an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation resulting in hypotension and bradycardia; arrhythmias and cardiac arrest may occur.

Some local anaesthetics cause methaemoglobinaemia. Possible Systemic Effects due to Phenylephrine. Sympathomimetics may produce a wide range of adverse effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system.

These effects are mediated via the various types of adrenergic receptor, and the adverse effects of an individual drug depend to some extent upon its relative agonist activity on these different types of receptor at a given dose. Central effects of sympathomimetic agents include fear, anxiety, nervousness, restlessness, tremors, insomnia, confusion, irritability, psychotic states and epileptiform convulsions.

Appetite may be reduced and nausea and vomiting may occur. Effects on the cardiovascular system are complex. Stimulation of alpha-adrenergic receptors produced vasoconstriction with resultant hypertension. This vasoconstriction is sometimes sufficiently severe to produce gangrene when sympathomimetics are infiltrated into the digits.

The rise of blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of β1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest: hypotension with dizziness and fainting, and flushing, may occur.

An increased incidence of sudden death, sometimes attributed to the induction of ventricular arrhythmias, has been associated with the excessive use of sympathomimetic agents in aerosol form; although the association has been questioned by some authorities, it is important to avoid excessive doses.

Other effects that may occur with sympathomimetic agents include difficulty in micturition, particularly in the case of prostatic hypertrophy, and urinary retention, dyspnoea, weakness, altered metabolism, sweating, hyperpyrexia and hypersalivation.

Headache is also common. 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.

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Lidocaine and phenylephrine topical solution should be administered with caution to patients taking β-adrenergic blocking agents (see section below headed ‘Interactions with other Medicaments and other forms of Interaction’,) and those with cardiovascular disease, diabetes mellitus, hypertension or hyperthyroidism, hypoxia, hypercapnia and porphyria.

Lidocaine and phenylephrine topical solution should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application. Lidocaine and phenylephrine topical solution should also be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function and in severe shock.

Oral topical anaesthesia may interfere with swallowing, and numbness of the tongue or buccal mucosa may increase the danger of biting trauma. e. orally and topically (nasal, aural and eye preparations) Sympathomimetic-containing products should be used with great care in patients suffering from angina.

1. Lidocaine and phenylephrine topical solution should not be administered to those who are pregnant or breast-feeding. Hypovolaemia, hypertension, acute ischaemic heart disease and complete heart block. Thyrotoxicosis, glaucoma or urinary retention.

Patients receiving other sympathomimetic drugs. Lidocaine and phenylephrine topical solution should not be given to patients taking monoamine oxidase inhibitors or within 2 weeks of their use. (see also 'Interactions' below).