Product image of Otalgan (Procaine Hydrochloride, Phenazone) supplied by GNH India

Otalgan

Active Ingredient:
Procaine Hydrochloride, Phenazone
Origin:
EU

Otalgan (Procaine Hydrochloride, Phenazone)

Procaine hydrochloride, the active ingredient in Otalgan, is a local anesthetic and non‑steroidal anti‑inflammatory drug (NSAID) presented as a combination formulation for otic use. It is used to relieve pain and inflammation in the ear, particularly in conditions such as otitis media and external ear irritation.

GNH India supplies Otalgan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Swiss Pharma Gmbh

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Indications & Clinical Uses

Otalgan combines a local anesthetic and an NSAID to address ear‑related pain and inflammation. It is indicated for several ear conditions where both analgesia and anti‑inflammatory action are needed.

  • Otitis media: reduces pain and inflammation in the middle ear.
  • Otitis externa: alleviates discomfort and swelling of the external auditory canal.
  • Post‑procedural ear pain: provides symptomatic relief after ear examinations or minor surgical interventions.

How It Works

  • Procaine hydrochloride blocks voltage‑gated sodium channels in peripheral nerves, preventing the initiation and propagation of nerve impulses and producing local anesthesia. Phenazone (antipyrine) inhibits cyclooxygenase enzymes, decreasing prostaglandin synthesis and thereby reducing inflammation and pain at the site of application.

Side Effects

Adverse reactions may occur following otic administration of Otalgan. Monitoring for both common and less frequent events is recommended.

Common Side Effects

  • Ear itching: mild pruritus in the treated ear.
  • Ear fullness: sensation of blockage or pressure.
  • Temporary hearing change: mild, reversible alteration in hearing acuity.
  • Local redness: mild erythema of the ear canal skin.

Serious or Rare Side Effects

  • Allergic reaction: rash, swelling, or hives indicating hypersensitivity.
  • Otitis media exacerbation: worsening infection symptoms.
  • Persistent vertigo: ongoing dizziness after application.
  • Severe ototoxicity: rare loss of hearing requiring medical assessment.

Precautions & Warnings

When using Otalgan, consider the following safety measures to minimize risks and ensure effective therapy.

  • Contraindication: avoid use in patients with known hypersensitivity to procaine, phenazone or any formulation excipients.
  • Ear integrity: do not apply if the tympanic membrane is perforated unless specifically directed by a clinician.
  • Pediatric use: exercise caution and follow professional guidance for children.
  • Concomitant otic medications: assess potential additive effects before combining with other ear drops.
  • Pregnancy and lactation: use only if the benefit outweighs potential risk, under medical supervision.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light in the original container.

Avoid Interactions

Otalgan may interact with other medicines applied to the ear or systemic agents that affect bleeding or hypersensitivity.

Major Interactions (Avoid)

  • Systemic NSAIDs: concurrent use may increase risk of gastrointestinal bleeding.
  • Aminoglycoside ear drops: combined ototoxic potential.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: monitor for any signs of otic bleeding.
  • Other local anesthetics: cumulative nerve‑blocking effect may enhance local anesthesia.
  • Corticosteroid ear preparations: assess for altered drug absorption.
  • Alcohol: may increase systemic exposure to phenazone metabolites.

Frequently Asked Questions

Otalgan is formulated for otic use to relieve pain and inflammation associated with ear conditions such as otitis media, otitis externa, and post‑procedural ear discomfort. The combination of a local anesthetic and an NSAID provides both symptomatic analgesia and anti‑inflammatory effects directly at the site of application.

Procaine hydrochloride acts as a local anesthetic by blocking voltage‑gated sodium channels on peripheral nerve fibers, which stops the initiation and transmission of pain signals. This effect is confined to the area where the drop is applied, producing rapid relief of ear pain.

The dosage of Otalgan is determined by the prescribing clinician based on the patient’s age, the specific ear condition, and the severity of symptoms. Healthcare professionals set the number of drops, frequency, and duration of treatment according to clinical guidelines.

Otalgan should be used in pregnancy or while breastfeeding only if the potential benefit justifies any possible risk to the fetus or infant. The decision must be made by a qualified healthcare provider who can evaluate the individual’s clinical situation.

To order Otalgan, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with single‑component ear drops, Otalgan offers a dual mechanism—local anesthesia from procaine and anti‑inflammatory action from phenazone—providing broader symptom control. Alternatives may contain only a steroid or only an anesthetic, which might not address both pain and inflammation simultaneously.

Otalgan should be stored at ambient temperature, preferably below 25 °C. Keep the container tightly closed, protect it from moisture and direct sunlight, and store it in its original packaging to maintain stability.

Otalgan is applied as ear drops. The patient or caregiver gently pulls the ear’s pinna upward and backward (or downward for children), instills the prescribed number of drops into the ear canal, and remains lying down for a few minutes to allow the solution to coat the ear surface.

Serious risks, though rare, include allergic reactions such as rash, swelling or hives, and ototoxicity that could lead to hearing loss. Any signs of severe dizziness, worsening ear infection, or systemic hypersensitivity require immediate medical evaluation.

Individuals with known hypersensitivity to procaine, phenazone, or any excipients in the formulation should avoid Otalgan. It is also contraindicated in patients with a perforated tympanic membrane unless specifically directed by a clinician, and it should be used with caution in children and pregnant or lactating women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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