Otipax is indicated in infants above 6 months of age, children and adults for the local symptomatic treatment of certain painful conditions of the middle ear with intact tympanic membrane:

-           congestive acute otitis media,

-           flu otitis so-called phlyctenular viral otitis,

-           barotrauma otitis.

Posology:

4 drops in the auditory meatus, 2 or 3 times a day in the painful ear

Method of administration:

Auricular route.

In order to avoid unpleasant contact of the cold solution with the ear, warm the container between the hands before use.

-         Dropper bottle: instill the drops in the auditory meatus by applying gentle pressure to the soft part of the dropper in the painful ear.

Warnings

As a precautionary measure, ensure that the tympanic membrane is intact before any administration.

If there is tympanic destruction, intra-auricular administration may bring the product into contact with the structures of the middle ear, with adverse effects upon them.

This medicine contains an active ingredient which may give a positive result in the anti-doping tests.

Precautions

Limit treatment duration to 10 days. Management must be reviewed after that time.

The data available to date do not suggest the possibility of clinically significant interactions.

Pregnancy category B. Reproduction studies have been performed in mouse and rat embryos and have revealed no evidence of impaired fertility or harm to the foetus due to OTIPAX. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.  

Lactation

In the normal conditions of use, phenazone and lidocain are not excreted in human milk. Otipax can be used during breast-feeding

Otipax has no influence on the ability to drive and use machines.

The side effects which have been reported are classified after by system-organ class and by frequency defined as: very common (>1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100), rare (> 1/10,000, < 1/1,000) and very rare (< 1/10,000).

To report any side effect(s):

National Pharmacovigilance and Drug Safety Centre (NPC)

o   Fax: +966-11-205-7662

o   Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

o   Toll free phone: 8002490000

o   E-mail: npc.drug@sfda.gov.sa

o   Website: www.sfda.gov.sa/npc

Not applicable.

Pharmacotherapeutic group: S, Sensory organs, ATC code: S02 DA30

Phenazone: pyrazolone derivative with analgesic and anti-inflammatory properties.

Lidocaine: local anesthetic of the amide group.

Skin resorption of any of the components was not studied. It is almost absent.

There is no systemic passage of this solution unless there is an eardrum breach

Otipax is not toxic in single administration by oral or intraperitoneal route in mice and rats. Therefore, OTIPAX can be administered without risk of accident owing to any toxic effect of the drug.

Neither local intolerance nor disturbance in general health of young rats has been observed.

All the active ingredients and the excipients are included in the Pharmacopoeias, and the route of administration and the low dosage make unlikely any systemic penetration.

Therefore, tests for teratogenicity have not to be carried out.

Sodium thiosulphate, ethanol, glycerol and purified water.

Not applicable.

Store below 30°C.

Do not use for more than 10 days after opening.

Bottle (yellow glass type III) of 15 ml (containing 16 g of solution) closed by a stopper (LDPE) with a seal (LDPE) and a dropper (PE/vinyl acetate) and a stopper (LDPE). Box of 1 bottle.

No requirement.