Otomidone 25mg/ml + 28.8mg/ml Ear Drops Solution 10ml

Otomidone Gocce Auricolari Fenazone / Procaina Cloridrato 10ml
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Manufacturer
SIT LABORATORIO FARMAC.
SKU
007312010
Active principle
FENAZONE/PROCAINA CLORIDRATO
NAME
OTOMIDONE

PHARMACOTHERAPEUTIC CATEGORY
Otologicals.

ACTIVE PRINCIPLES
Phenazone 2.50 g / 100 ml and procaine hydrochloride 2.88 g / 100 ml.

EXCIPIENTS
Excipient: glycerol.

INDICATIONS
Pain reliever in simple inflammations of the ear canal.

CONTRAINDICATIONS / SECONDARY EFFECT
Myasthenia gravis, hypersensitivity and idiosyncrasy to procaine or phenazone. Perforation of the eardrum of infectious or traumatic origin.

DOSAGE
After careful cleaning of the ear canal with dry cotton, instill 3-4 drops in the ear canal, making sure that the patient's auricle is in a horizontal position. Remain in this position for at least 5 minutes. Repeat the instillation of the medication every hour until the pain subsides. Thereafter for 1-2 days, medicate every 2-3 hours. After instillation, close the ear canal with a cotton swab or better still with a strip of edged gauze. It can also be used lukewarm by heating the vial in a water bath before use. Elderly patients should adhere to the minimum dosages indicated above.

STORAGE
No special storage precautions.

WARNINGS
The products for topical application can give rise to phenomena of sensitization or irritation: in this case, stop the treatment. Do not extend the administration of the drug beyond ten days. In the presence of local lesions, the possibility of systemic effects from increased absorption of procaine and phenazone should be kept in mind. As a precautionary measure, before administering the product make sure of the integrity of the eardrum membrane. The container of this medicine is made of latex rubber. It can cause severe allergic reactions.

INTERACTIONS
They are not known.

SIDE EFFECTS
The use of phenazone, albeit systemically, has been associated with a high risk of agranulocytosis; this drug, as well as procaine, can cause allergic reactions in sensitized subjects and, following absorption, also anaphylactic manifestations. In case of perforation of the eardrum the product, in contact with the structure of the middle ear can cause side effects at this level.

PREGNANCY AND BREASTFEEDING
In pregnant women, the product must be administered under direct control and only in cases of actual need.