ℹ️ Compiled from public regulatory records · Last regulator revision: September 1, 2025🚩 Report this page

Procaine

Active ingredient · 3 therapeutic classes

GB MHRA

Drug class: Local Anesthetics
Availability: See label
Markets covered: 1
Products on record: 1

C05ADLocal Anesthetics N01BAEsters Of Aminobenzoic Acid S01HALocal Anesthetics

Overview

Procaine is an active pharmaceutical ingredient in the Local Anesthetics group (C05AD). 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	1	September 1, 2025

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised September 1, 2025[1]

OtoAkut is indicated for the local symptomatic treatment of pain in the external auditory canal, namely for external ear infections and acute otitis media. It should only be used if the tympanic membran (eardrum) is intact.

How to take

Drug interactions

Known interactions involving Procaine. 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) · PL150110040 · revised September 1, 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.

Procaine: Uses, Side Effects, Dosage - Drugvu

Side effects & warnings

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

Adverse reactions are listed below by system organ class and frequency.
Very rare (<1/10,000):
Immune system disorders: Hypersensitivity reactions such as skin reactions or nettle rash 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.

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

Before the beginning of treatment with the medicinal product, it is recommended to check if there is perforation of the tympanic membrane. If the tympanic membrane is perforated, intra-auricular administration may lead to contact of the product with middle ear structures and cause undesirable effects in these tissues.
The product should not be used in the presence of a perforated tympanic membrane, which would include the presence of a myringotomy, in case of penetration of the active substances into the middle ear, risking ototoxicity. The patient should be advised that treatment should be stopped, and medical advice sought, if ear discharge develops during the course of treatment, which may indicate perforation.
If symptoms do not improve within 2 days or worsen rapidly or significantly at any time, the therapy should be re-evaluated. Methemoglobinemia has been reported following the topical use of local anaesthetics. Caution should be exercised in patients who are susceptible to methemoglobinemia, including infants under 3 months of age and patients with haemoglobinopathies or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Patients should be advised to avoid letting OtoAkut come into contact with eyes or nose. If contact occurs, the eyes or nose should be rinsed out immediately with plenty of water. If orally ingested by mistake, local numbness of the tongue and oral cavity may occur.
This may lead to difficulty in swallowing. In this case the oral cavity should be rinsed out immediately with plenty of water and medical advice should be searched. Paediatric population A medical examination is required before using this medicinal product in children under the age of 3 years.
g. contact dermatitis), or irritation to the eyes and mucous membranes.

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