Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Combined drug with local anesthetic and anti-inflammatory effects .
Phenazone is a non-steroidal anti-inflammatory drug, an analgesic with anti-inflammatory action. Blocks cyclooxygenase and inhibits prostaglandin synthesis.
Lidocaine is a local anesthetic. It disrupts the conduction of pain impulses due to antagonism with sodium and calcium in the nerve fiber membrane. A successful combination of two active substances promotes rapid analgesic action, increases its intensity and duration. The drug stimulates the liquefaction of mucus and its removal from the middle ear cavity through the Eustachian tube and eardrum.
Pharmacokinetics
If the integrity of the eardrum is preserved, it does not penetrate the body.
Indications for use
- otitis media in the catarrhal ;
- otitis barotraumatic;
- otitis media after the flu.
Registration number:
P N011568/01
Trade name
Otipax®
International nonproprietary or generic name
Lidocaine + phenazone
Dosage form
Ear drops
Compound
1 g of solution contains: Active ingredients: lidocaine hydrochloride 10 mg, phenazone 40 mg; Excipients: sodium thiosulfate 1 mg, ethanol 221.8 mg, glycerol 709 mg, water 18.2 mg.
Description
A clear, colorless or yellowish solution with the odor of alcohol.
Pharmacotherapeutic group
Local anti-inflammatory, analgesic antiseptic. ATX code: S02DA30
Pharmacological properties
Pharmacodynamics
Phenazone has anti-inflammatory and analgesic effects. Lidocaine has a local anesthetic effect.
Pharmacokinetics
The drug does not penetrate the body if the eardrum is intact.
Indications for use
Local symptomatic treatment and pain relief in children from birth and adults with otitis media with an intact eardrum, including:
- acute exudative otitis media;
- otitis as a complication after influenza, exudative viral otitis;
- barotraumatic otitis
Contraindications
- Hypersensitivity to the components of the drug;
- Perforation of the eardrum (including those of infectious or traumatic origin)
Carefully
It is necessary to ensure the integrity of the eardrum before starting to use the drug. If the drug is used with a perforated eardrum, the drug may come into contact with the organs of the middle ear and lead to complications.
Use during pregnancy and breastfeeding
If the eardrum is intact and the drug is used correctly, the likelihood of active substances entering the systemic circulation is extremely low. In this regard, in the absence of contraindications, the use of Otipax® by pregnant women and women during breastfeeding is possible.
Directions for use and doses
Otipax® is used in children from birth and adults topically, by instilling 4 drops into the external auditory canal on the affected side 2-3 times a day. To avoid contact of the cold solution with the auricle, the bottle should be warmed in the palms before use. The duration of treatment with Otipax® is no more than 10 days, after which the prescribed treatment should be reconsidered.
Side effect
There is a risk of local allergic reactions, irritation and hyperemia of the ear canal. Please notify your doctor of all cases of undesirable reactions not listed in the instructions.
Overdose
No cases of drug overdose have been reported.
Interaction with other drugs
There is no information about clinically significant interactions with other drugs and (or) foods.
special instructions
In order to prevent complications, before starting the use of the drug Otipax®, it is recommended to consult an otolaryngologist to exclude perforation of the eardrum. If the symptoms of the disease worsen or there is no improvement, a second consultation with a doctor is necessary after 2-3 days of treatment. When using the drug for the first time or resuming treatment, no special actions are required. There are no additional or special actions when skipping one or more doses of the drug, or when discontinuing it. Athletes must take into account that the drug Otipax® contains an active substance that can give a positive result during doping control. No special precautions are required when disposing of unused drugs.
Impact on the ability to drive vehicles and machinery
Otipax® does not affect the ability to drive vehicles and machines.
Release form
Ear drops, 10 mg/g + 40 mg/g. 16 g each in an amber glass bottle with a screw cap and a dropper, packed in a PVC/paper blister, placed in a cardboard box with attached instructions for medical use. It is possible to have a first opening control.
Best before date
3 years. After opening the bottle, the drug should be used within 1 month. Do not use after the expiration date stated on the package.
Storage conditions
At a temperature not exceeding 30 oC. Keep out of the reach of children!
Vacation conditions
Available without a prescription.
Manufacturer:
Biocode, France Registered address: 7, Avenue Gallienie, 94250 Gentilly, France
Manufacturer's address:
1, Avenue Blaise Pascal, 60000 Beauvais, France.
You can obtain additional information about the drug, as well as send your complaints and information about adverse events to the following address in Russia:
LLC "BIOCODEX" 119049, Moscow, per. Yakimansky, 6, building 1 Tel. Fax E-mail Internet address: www.biocodex.ru
Otipax for children
In childhood, an infection from the nasopharynx often enters the middle ear and causes otitis media. The safest drug for catarrhal otitis is Otipax for children, which has anti-inflammatory and analgesic effects.
In addition to catarrhal otitis, it is used for ear congestion ( eustachitis ) in children, for external otitis, some forms of purulent otitis and after removal of foreign bodies. They are used in children to relieve pain in the preperforative stage of otitis media , starting in infancy.
Instructions for Otipax for children
The drops are preheated to 38-40 °C. It is better to instill drops onto a turunda made of cotton wool or gauze inserted into the ear. Children under one year old use 1-2 drops, from 1 to 2 years old - 3 drops, children of preschool age and schoolchildren - 4 drops 3 times a day.
After instillation, you need to seal the ear canal with cotton wool, lubricated with Vaseline - the drug will not evaporate and its effectiveness will be higher. A one-time use of the drug gives a short-term effect, so its course use is necessary. The anti-inflammatory effect is observed on days 2–3.
Adverse reactions and overdose
After using the medication, undesirable reactions may occur, namely the appearance of an allergy at the site of use of the drug, the symptoms of which are a burning sensation, peeling of the skin, and redness.
If such signs appear, you should stop treatment and inform your doctor.
The drug is characterized by low adsorption. That is why, if the specified dose is observed, cases of overdose are not permissible. If you neglect the instructions, side reactions may appear in a more pronounced form.
Otipax's analogs
Level 4 ATC code matches:
Antipyrine
Otinum
Otirelax
The pharmacy chain widely offers drops for topical use for otitis media. Structural analogues are Folicap and Otirelax , similar in action to Sofradex , Otinum , Anauran , Uniflox , Tsipromed , Garazon , Polydexa .
The price of Otipax analogues differs significantly. Thus, Otirelax 15 ml can be purchased for 100-200 rubles, Sofradex 5 ml for 190-500 rubles. The cost of Otinum 10 ml is 170-300 rubles, Anaurana 25 ml is 270-470 rubles.
Which is better: Otipax or Otinum?
Otinum has anti-inflammatory and moderate local anesthetic effects. The difference between the two drugs is the active substance: Otinum contains choline salicylate , a derivative of salicylic acid, and there is no anesthetic, so the analgesic effect is not so pronounced. If it enters the middle ear, ototoxicity occurs. Used in children from 1 year of age. Manufacturer ICN Polfa Rzeszow (Poland)
Anauran or Otipax - which is better?
Anauran contains the local anesthetic lidocaine and the antibiotics polymyxin and neomycin . From the point of view of the anti-inflammatory effect, this drug is stronger, however, the presence of ototoxic antibiotics is a contraindication to their use in case of perforation of the eardrum. The drug is effective for external and otitis media before perforation occurs. Has no age restrictions. Manufacturer: Zambon SPA (Italy).
Sofradex or Otipax - which is better?
Sofradex contains two antibiotics ( framycetin and gramicidin ) and the glucocorticoid dexamethasone . In terms of the strength of its anti-inflammatory effect, it is superior to the drug described. Glucocorticoids are not ototoxic, but antibiotics are otoxic. Drops are intended for the treatment of otitis without compromising the integrity of the eardrum. Of course, only a doctor can determine this during examination, and accordingly, recommend this or that drug. Used in children from 7 years of age. Manufacturer: Aventis Pharma (India).
Otirelax or Otipax - which is better?
Otirelax is a structural analogue of Otipax (their composition is the same) and the same effect. The difference is that the latter is an original drug, and Otirelax is a generic produced by Rompharm Company SRL (Romania).
Otofa or Otipax - which is better?
Otofa combines a pronounced antibacterial effect and the absence of ototoxic action. The active substance is rifamycin , which is not an ototoxic antibiotic and these drops can be used in the perforated stage. In this regard, this drug has an advantage, since all the drugs described above (Sofradex, Otinum, Otipax, Anauran) have a main contraindication - perforation of the eardrum .
Contraindications
People who have perforated eardrums or have increased susceptibility to the constituent components should avoid taking the drug. If there are ear injuries, then taking medication can only worsen the situation.
It is also not recommended for athletes to take before the start of competitions, since the elements present in the composition may show a positive response when tested for doping.
Particular caution should be taken when taking the medicine during pregnancy and breastfeeding.
Reviews about Otipax
Otipax drops act on the inflamed eardrum, reducing its tension and swelling, which cause pain. For otitis media, it is important that ear drops have a pronounced analgesic effect, since the main symptom of otitis media is pain. Otipax ear drops have a rapid analgesic effect, which is very important for children. The local anesthetic lidocaine helps reduce pain after 5 minutes, and complete disappearance after 20–30 minutes. They are prescribed on the first day of the disease to relieve pain.
Reviews about Otipax drops are only positive. Everyone notes a quick and long-lasting (2-3 hours) analgesic effect. The important thing is that the drops can be used for 6 months after you open the bottle and can be used by the whole family, including infants.
These ear drops were used not only for otitis of a bacterial nature, but also for barotraumatic otitis that occurs in children during flights.
- “... We always take these drops with us on vacation. After the flight, my son’s ears often hurt, and otitis occurs when diving.”
Many parents report that the drug was prescribed to their children, in whom ARVI is often complicated by otitis media, for the purpose of its prevention. At the first signs of respiratory infections and runny nose, drops in the nose and drops in the ears were prescribed.
Otipax price, where to buy
You can buy it in many pharmacies, since Russia, Ukraine, and Belarus have registered this drug.
How much does 1 bottle of the drug cost at the pharmacy? The cost in pharmacies in Russian cities is approximately the same. In Moscow you can buy it for 190 - 270 rubles. The price of Otipax ear drops in Voronezh ranges from 200 to 280 rubles; in St. Petersburg you can buy drops for children for 200-270 rubles.
The Ukrainian pharmacy chain (Kyiv, Kharkov, Dnepropetrovsk) offers these ear drops for 90-120 hryvnia.
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