Europe — EMA
Otipax (Phenazone, Lidocaine Hydrochloride)
Phenazone, the active ingredient in Otipax, is an analgesic and local anesthetic presented as a topical ear formulation for auricular use.
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What is Phenazone, Lidocaine Hydrochloride?
Phenazone, the active ingredient in Otipax, is an analgesic and local anesthetic presented as a topical ear formulation for auricular use. It relieves pain and discomfort associated with ear conditions in adults and children. GNH USA supplies Otipax as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Otipax as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Phenazone, Lidocaine Hydrochloride used for?
Otipax combines phenazone and lidocaine to provide symptomatic relief in ear‑related conditions. It is used for: - Otitis media: reduces pain and pressure in the middle ear. - External ear canal irritation: eases discomfort from minor abrasions or inflammation. - Post‑procedural ear discomfort: alleviates pain after otoscopic examinations or minor ear surgeries. - Earwax removal procedures: minimizes pain during mechanical removal of cerumen. - Acute otitis externa: helps control pain associated with swimmer’s ear. - Ear pain in children: provides age‑appropriate analgesia for mild ear discomfort.
What are the side effects of Phenazone, Lidocaine Hydrochloride?
Otipax may cause adverse reactions at the site of application or systemically.
Common Side Effects: - Mild burning or stinging sensation in the ear. - Transient itching or mild erythema of the external canal. - Temporary tinnitus or ringing sensation. - Minor dizziness following application.
Serious or Rare Side Effects: - Allergic contact dermatitis with swelling or rash. - Severe ototoxicity presenting as hearing loss. - Persistent vertigo or balance disturbances. - Systemic hypersensitivity reactions such as urticaria or anaphylaxis.
What precautions apply to Phenazone, Lidocaine Hydrochloride?
Before using Otipax, consider the following safety measures: - Assess for ear perforation: avoid use if tympanic membrane is ruptured. - Check for known hypersensitivity: discontinue if allergic reaction occurs. - Use with caution in children under six months: consult a healthcare professional. - Avoid concurrent use with other otic anesthetics: reduce risk of cumulative toxicity. - Do not apply to infected or inflamed ear canals without medical advice. - Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.
What does Phenazone, Lidocaine Hydrochloride interact with?
Otipax may interact with other medications applied to the ear or systemic agents that affect hearing.
Major Interactions (Avoid): - Concurrent otic aminoglycoside antibiotics: increased risk of ototoxicity. - Systemic quinidine or quinine: potential additive cardiac effects.
Moderate Interactions (Monitor Closely): - Other topical anesthetics: cumulative local anesthetic effect. - Anticoagulant therapy: heightened risk of ear bleeding if trauma occurs. - CYP 3‑4



