Prilocaine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 27, 2026🚩 Report this page

Prilocaine

Amides

Sold as PRILOTEKAL · CITANEST WITH OCTAPRESSIN…

GB MHRA

Drug class: Amides
Availability: See label
Markets covered: 1
Products on record: 10

Overview

Prilocaine is an active pharmaceutical ingredient in the Amides group (N01BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	10	March 27, 2026

GBUnited Kingdom· MHRA

10 products

Uses

GBOfficial regulatory label· revised October 10, 2025[1]

Oraqix is indicated in adults for localised anaesthesia in periodontal pockets for diagnostic and treatment procedures such as probing, scaling and/or root planing.

How to take

Drug interactions

Known interactions involving Prilocaine. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL046900033 · revised October 10, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised October 10, 2025[1]

The most frequent adverse events in all clinical trials were local reactions in the oral cavity. The frequency and type of reactions were very similar for Oraqix and placebo. For patients exposed to Oraqix and the placebo, 15% reported adverse events of mild intensity.
For both groups, 4% reported adverse events of moderate intensity. The local reactions reported, such as soreness, ulceration, irritation and redness, represent a pattern of symptoms normally found after scaling and root planing therapy.
Similar symptoms may also be associated with periodontal disease. Table 1. e. symptoms in the oral cavity 2 includes complaints of bad or bitter taste lasting for up to 4 hours after Oraqix administration 3 Allergic reactions have been reported in the postmarketing period.
Most often the reactions manifest as skin rashes, gingival redness and swelling. Occasionally, severe reactions including laryngeal edema and anaphylactoid reactions have occurred. 2 for additional information) causing cyanosis. Methaemoglobinaemia was not reported during clinical studies with Oraqix.

GBOfficial regulatory label· Warnings and precautions· revised October 10, 2025[1]

Oraqix must not be injected. Oraqix should be used with caution in patients with severe impairment of renal or hepatic function. With short-term treatment it is unlikely that either lidocaine, prilocaine or their respective metabolites will accumulate significantly.
g. grade II and III AV block, pronounced bradycardia). Similarly, it should be used with caution in patients who are in remission from porphyria or who are asymptomatic carriers of the mutated genes that are responsible for the development of porphyria.
2 Pharmacokinetics). The use of Oraqix in children and adolescents has not been assessed. Isolated cases of methaemoglobinaemia in children using the combination of lidocaine and prilocaine in other medicinal products have been reported.
Care should be taken not to allow Oraqix to come in contact with the eyes as it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, immediately rinse the eye in water or sodium chloride solution and protect it until sensation returns.
When Oraqix is used, the patient should be aware that its use may be accompanied by a block of all sensations in the treated area and, if inadvertently spread may induce numbness of the oral mucosa. Care should be taken to avoid excess Oraqix gel from spreading to the oro-pharyngeal mucosa.
The patient should avoid inadvertent trauma to the treated area, exposure to extreme hot or cold temperatures and refrain from eating and drinking until complete sensation has returned. Oraqix should not be applied to ulcerative lesions or during acute infections of the oral cavity.
Persons applying or removing the gel should ensure that contact is avoided in order to prevent the development of hypersensitivity. This product contains an active ingredient that may interfere with tests for substances prohibited in sportswomen and sportsmen.
This may make them falsely positive.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drug interactions

Drugs in the same class

Sources & citations