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Topical otic analgesic Pregnancy: In case of intact tympanic membrane, systemic absorption is unlikely. If the recommended dosage (4 drops two or three times daily) and therapy duration (should not exceed 7 days) are observed, the product can be administered during pregnancy and breast-feeding, if necessary. Women during pregnancy or breast-feeding should consult their doctor or pharmacist before using it. There is limited pharmacokinetic information available; it is not known if the active substances pass into breast milk or cross the placenta.

Phenazone with lidocaine

Brand names: Otocalm

Phenazone with lidocaine ear drops combine an analgesic and a local anaesthetic for the symptomatic relief of pain in acute otitis media with an intact eardrum.

Adult dose

Dose: 4 drops into the affected ear, for local symptomatic relief of pain in middle-ear disease without tympanic perforation (acute congestive otitis media, viral bullous otitis, barotraumatic otitis)
Route: Auricular - instilled into the external auditory canal of the affected ear
Frequency: Two or three times daily
VERBATIM UK SPC §4.2 (Otigo 40 mg/10 mg per g ear drops, solution): 'Instil 4 drops two or three times daily into the external auditory canal of the affected ear, slightly pressing the elastic part of the dropper. Taking into account that Otigo acts locally, dosage adjustments based on age are not necessary. Otigo is suitable for use both in adults and children. Duration of treatment If symptoms do not improve within 7 days or worsen rapidly or significantly at any time, the therapy should be re-evaluated. Method of administration For auricular use only. To avoid the unpleasant contact of the ear with the cold solution, warm the vial before use between your hands.' §4.6 also states the therapy duration 'should not exceed 7 days'. STRENGTH, §2: '1 g of solution contains: phenazone 40 mg lidocaine hydrochloride 10 mg'. §4.1: 'local symptomatic treatment and relief of pain in the following diseases of the middle ear without tympanic perforation: - acute, congestive otitis media; - otitis in influenza, the so called viral bullous otitis; - barotraumatic otitis.' §4.3: contraindicated in 'Infectious or traumatic perforation of the tympanic membrane'. The SPC prints no maximum daily dose beyond 'two or three times daily', so none is given. §4.8 (undesirable effects) is not present in the bundle, so the side-effect list is limited to §4.4.

Paediatric dose

Dose: 4 drops into the affected ear
Route: Auricular - instilled into the external auditory canal of the affected ear
Frequency: Two or three times daily
THE LABEL'S OWN STATEMENT, NOT SCALED. VERBATIM §4.2: 'Taking into account that Otigo acts locally, dosage adjustments based on age are not necessary. Otigo is suitable for use both in adults and children.' The SPC gives no age band and no neonatal dose; none is implied. §4.4 cautions about methaemoglobinaemia in susceptible patients, 'including infants under 3 months of age'. Verify any under-18 dose against a children's formulary before use.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients
  • Infectious or traumatic perforation of the tympanic membrane

Side effects

  • Methaemoglobinaemia has been reported following topical use of local anaesthetics (§4.4)
  • If the tympanic membrane is perforated, contact with middle-ear structures risks ototoxicity (§4.4)

Interactions

  • No interaction studies have been performed

Monitoring

  • Check for perforation of the tympanic membrane before starting treatment (including the presence of a myringotomy)
  • Stop treatment and seek medical advice if ear discharge develops during treatment, which may indicate perforation
  • Re-evaluate therapy if symptoms do not improve within 7 days or worsen rapidly or significantly at any time
  • Caution in patients susceptible to methaemoglobinaemia, including infants under 3 months of age and patients with haemoglobinopathies or G6PD deficiency

Clinical monograph

How it works

Lidocaine blocks neuronal sodium channels to produce local anaesthesia, while phenazone provides additional analgesic and anti-inflammatory action within the ear canal.

Prescribing in practice

  • It must not be used if the tympanic membrane is perforated.
  • It relieves pain only and does not treat the underlying infection, which may still require separate management.
  • Local irritation of the ear canal may occur.

Monitoring

No formal monitoring is required; review if ear pain persists, worsens, or is accompanied by discharge.

Counselling the patient

  • These drops ease pain but do not cure the infection itself.
  • Do not use if you have or suspect a hole in the eardrum.
  • Seek review if pain continues or you notice fluid draining from the ear.

Evidence & guidelines

Use reflects its established role in symptomatic relief of ear pain in otitis media with an intact eardrum; see current prescribing references.

Reference: NICE NG91; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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