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ANESTADENT is a brand name for Articaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Local or local-regional anesthesia in dentistry and dental surgical procedures in patients at least 4 years old.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The smallest possible volume of solution which will lead to an effective anaesthesia should be used. Adults The quantity to be injected will be adjusted as a function of the extent of the intervention. As a general rule, one to three cartridges per session.
The dose should not exceed 7 mg of articaine hydrochloride per kilogram of body weight. Paediatric population Articaine hydrochloride/Epinephrine NewLine Pharma should not be used in children aged below 4 years because of safety and efficacy concerns.
The quantity to be injected depends on the age and the weight of the child as well as the type of intervention to be performed. 125 mL of anaesthetic solution) per kilogram of body weight. 33 Elderly Reduce to one-half the dose used for adults.
Method of administration Local or regional intraoral submucosal injection. The injection rate must not exceed 1 mL of solution per minute
Undesirable effects may result from overdose, due in particular to accidental intravascular injection or in cases of abnormal absorption, such as in inflamed or highly vascularised tissues. The following frequencies are used for the description of the occurrence of adverse reactions: 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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Undesirable effects due to articaine:
Metabolism and nutrition disorders: Rare Metabolism increase Nervous system disorders: Rare Metallic flavour, tinnitus, disorientation, tremors, excitatory reactions, vertigo, midryasis, paraesthesia (of lips, tongue), mandibular spasm and convulsions.
Eye disorders:
Rare During and immediately after anaesthesia rare transient eye disorders may occur (diplopia) Cardiac disorders: Rare Bradycardia with myocardial depression, arrhythmia Vascular disorders: Rare Hypotension, hypertension Respiratory, thoracic and mediastinal disorders: Rare Tachypnea, broncodilatation Gastrointestinal disorders: Rare Nausea, vomiting Skin and subcutaneous tissue disorders: Very rare Cutaneous rashes, pruritus, urticaria General disorders and administration site conditions: Very rare: Allergic reactions (bronchospasm, oedema of the larynx up to cardiorespiratory collapse from anaphylactic shock) Rare: increase in body temperature Undesirable effects due to adrenaline: Cardiac disorders: Rare Arrhythmia Vascular disorders: Rare Hypertension (severe in patients suffering from hypertension and hyperthyroidism) Gastrointestinal disorders: Rare Vomiting General disorders and administration site conditions: Rare Heat sensation, sweating, headache, anxiety, retrosternal and pharyngeal pain.
01 mg/mL of adrenaline (epinephrine). Be aware of a risk of local necrosis in hypertensive or diabetic subjects. Risk of self-biting under anesthesia: various bite wounds (lips, cheeks, mucosa, and tongue); warn the patient to avoid chewing gum or food for as long as the insensitivity persists.
g. in patients receiving anticoagulants); - patients with cholinesterase deficiency, as a prolonged and possibly pronounced drug effect can be expected; - epilepsy. Due to the presence of adrenaline, precautions and monitoring should be increased in the case of: - rhythm disorders, except bradycardia; - severe cardiovascular diseases such as unstable angina, recent myocardial infarction, recent coronary artery bypass surgery, coronary heart disease, congestive heart failure; - severe arterial hypertension; - uncontrolled or poorly controlled hypertension; - hyperthyroidism; - diabetes mellitus.
In the case of serious liver failure, it may be necessary to reduce the doses of articaine due to the principally hepatic metabolism of local anesthetics with amide function. e. essentially ‘sodium- free’. Due to the presence of sodium metabisulphite, it may rarely cause severe hypersensitivity reactions and bronchospasm.
Overdose of the medicinal product should be avoided and two maximal doses of the drug should be administered with a minimum interval of 24 hours. 8), usual precautions for nerve-block anaesthesia should be observed. Food intake should only commence after the anaesthetic effect has worn off.
1 - Known allergy or hypersensitivity to other local anaesthetics of the amide type
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients with cardiovascular diseases may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may result. The product contains sodium metabisulphite: this substance may cause allergic-type reactions and severe asthmatic episodes in certain susceptible people and in particular in asthmatic patients.
Due to the content of both articaine and adrenaline, the following undesirable effects can occur: Nervous System disorders: Very rare (< 1/10,000): Persistent hypoesthesia and gustatory loss after mandibular or inferior alveolar nerve blocks 2 weeks delayed onset of facial nerve paralysis has been described with articaine/adrenaline, the event still occur 6 months later.
In some cases, an incorrect injection may cause severe ischemia and necrosis. Lesions to nerves, hyposensitivity and alterations of taste, may occur after an incorrect injection or in case of patient with particular conditions. 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 the MHRA Yellow Card in the Google Play or Apple App Store).