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LIDOCAINE HYDROCHLORIDE/PHENYLEPHRINE HYDROCHLORIDE is a brand name for Lidocaine (also known as Lignocaine). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is indicated in adults and children 12 years of age and older for the following: • Preparation of the nasal mucosa for surgery. • Aid in removal of foreign bodies from the nose. • Topical anaesthesia of the pharynx prior to direct or indirect laryngoscopy. • Topical anaesthesia and local…
Verbatim from this product's MHRA label. Tap a section to expand.
The product is for use by Healthcare Professionals (HCPs) in a clinical setting. 5 mg of Phenylephrine hydrochloride. Each spray measures 130 microlitres.
Posology Adults and children 12 years and older:
The recommended dose is up to a maximum of 8 sprays in total as 4 sprays per nostril or 8 sprays to the throat. Wait 10 minutes after administration before inserting an endoscope or conducting a procedure.
Children aged under 12 years:
Not recommended. Route of administration: nasal or pharyngeal. 6.
Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1 000; <1/100); rare (≥1/10 000; <1/1 000); very rare (<1/10 000); frequency not known (cannot be estimated from the available data).
Psychiatric disorders:
Not known: Nervousness, disorientation.
Nervous system disorders:
Not known: Tremor, numbness.
Eye disorders:
Not known: Mydriasis.
Ear and labyrinth disorders:
Not known: Tinnitus.
Cardiac disorders:
Not known: Palpitations, dizziness.
Vascular disorders:
Not known: Hypertension.
Gastrointestinal disorders:
Common: Transient bitter taste in mouth (lasting one to two minutes), nausea, vomiting. 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 (CNS) 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.
Eating and drinking: the use of topical anaesthetic agents in the oral cavity and upper airway tissues may interfere with swallowing and thus enhance the danger of aspiration of food and drink. For this reason, food or drink should not be ingested within 2 hours of using local anaesthetics in the mouth area.
Numbness of the tongue or buccal mucosa may increase the risk of trauma from hot drinks or biting. Patients with cardiovascular diseases. This medicinal product should be given with caution to patients with cardiovascular disease, especially those suffering from hypertension, severe bradycardia, conduction disturbances or severe digitalis intoxication.
5mmHg diastolic) lasting for 10 minutes after the administration of this medication to healthy individuals. This must be taken into account if this medication is given to hypertensive patients. Patients with impaired kidney and liver function.
Lidocaine is metabolised in the liver and must be given with caution to patients with hepatic insufficiency. Metabolites of lidocaine may accumulate in patients with renal impairment. General precautions: genetic predisposition to malignant hyperthermia and pre- existing abnormal neurological conditions.
Lidocaine and phenylephrine should be administered with caution to patients taking β-adrenergic blocking agents (see section below headed ‘Interaction with other medicinal products and other forms of interaction’) and those with cardiovascular disease, diabetes mellitus, hypertension or hyperthyroidism, hypoxia, hypercapnia and porphyria.
Lidocaine and phenylephrine should be used with caution in patients with traumatized mucosa and/or sepsis in the region of the proposed application. Lidocaine and phenylephrine should also be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function and in severe shock.
1 • Hypersensitivity to other local anaesthetics of the amide type and to other sympathomimetic agents • Pregnancy and breast-feeding • Children under the age of 12 years • Hypovolaemia, hypertension, acute ischaemic heart disease and complete heart block • Thyrotoxicosis • Glaucoma • Urinary retention
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 vasodilation 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, angina 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. Prolonged mydriasis (pupillary dilatation) can result from systemic absorption of phenylephrine. Mydriasis may precipitate acute angle closure glaucoma in patients with narrow angles; this is a medical emergency characterised by eye pain and blurred vision that can lead to central retinal vein thrombosis.
4). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
e. orally and topically (nasal, aural and eye preparations). Sympathomimetic-containing products should be used with great care in patients suffering from angina. Mydriasis (prolonged dilation of the pupils of the eye) has been reported with phenylephrine.
8). Special precaution should be taken to avoid spraying in the eye.