Ofloxacin, Beclomethasone and Clotrimazole Ear Drops

Trade Name :
Liotic

Composition :
Each ml contains:
Ofloxacin IP 0.3% w/v, Beclomethasone Dipropionate IP 0.025% w/v + Clotrimazole IP 1% w/v + Glycerin IP 2% v/v + Propylene Glycol IP q.s.

Dosage Form :
Ear Drops

Dosage and Method of Administration :
NOT FOR OPHTHALMIC USE.NOT FOR INJECTION.
FOR EXTERNAL USE ONLY.
apply 3-5 drops of Ear Drops into the affected ear.
To apply, tilt head so the ear faces up and gently pull the ear lobe backward and upward in case of adults and children older than 3 years.
Apply 3-5 drops of Ear Drops into the ear.
Keep head tilted for about 5 minutes to allow the drops to penetrate lower into the ear canal.
Follow these instructions 3-4 times a day for 7 to 14 days.

Indications :
LIOTIC can be used for the treatment of superficial bacterial and fungal infections of the external auditory canal and middle ear, caused by organisms susceptible to the action of Ofloxacin and Clotrimazole.

Pharmacological Properties :

LIOTIC Ear Drops provides an antibacterial and antifungal action along with an anti-inflammatory agent. It may be used to prevent or treat ear infections. Along with the treatment it also maintains the natural environment of the external ear canal.

Ofloxacin is a fluoroquinolone that has a broad spectrum of activity against otic pathogens but lacks the capacity for ototoxicity. Hence ofloxacin is preferred to aminoglycosides for any application within the middle ear space. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial enzyme that is essential in DNA replication, repair, deactivation and transcription.

Ofloxacin has been shown to be active against the following organisms responsible clinically for liotic infections:
Gram-positive: Staphylococcus aureus Streptococcus pneumoniae
Gram-negative: Escherichia coli Haemophilus influenza Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa

Clotrimazole is a synthetic imidazole derivative. Clotrimazole, a synthetic imidazole derivative is a broad-spectrum antifungal agent that has fungicidal activity against fungi responsible for superficial mycotic infections affecting the outer or middle ear including Candida, Microsporum, and Trichophyton. Clotrimazole inhibits fungal cytochrome P-450 synthesis of ergosterol, which decreases fungal cell wall integrity. By inhibiting the biosynthesis of ergosterol for fungal cytoplasmic membrane, clotrimazole inhibits fungal growth. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. Clotrimazole also has activity against certain gram-positive bacteria such as Streptococci and Staphylococci. It is the most widely used topical azole. Its antibacterial effect is advantageous in treating mixed bacterial-fungal infections.

Beclomethasone like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. Corticosteroids like Beclomethasone are thought to act by the induction of phospholipase A2 inhibitory proteins, 2 collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting their release from the common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Beclomethasone Dipropionate 0.025 % is a potent steroid as compared with other topical corticosteroids. Beclomethasone Dipropionate is often used in conjunction with acetic acid to reduce inflammation when infection is present.

Glycerin acts as a carrier for the other ingredients. It soothes and moisturizes the skin. Glycerin also softens cerumen due to its water-retaining and emollient properties.

The Propylene glycol which acts as a base is an inert, non-irritant and viscous vehicle. It softens the cerumen and ensures prolonged contact of the active ingredients with the surface of the ear canal.

Warnings and Precautions :
NOT FOR OPHTHALMIC USE.
NOT FOR INJECTION.
Serious and occasionally fatal hypersensitivity reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. If an allergic reaction to Otiflox Ear Drops is suspected, stop the medication. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Precautions :
If a favourable response does not occur in one week, discontinue the use of this preparation and obtain cultures to guide further treatment.
If local irritation or sensitization occurs, discontinue this preparation and institute appropriate therapy.
Use of corticosteroids, depending on dose and duration may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.
Secondary Infection: The development of secondary infection has occurred after use of combination containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term application of steroids. The possibility of fugal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Contraindications :
Patients sensitive to Ofloxacin or other quinolones, or to any of the components of this medication
Viral infections of the ear

Shelf Life :
2 Years

Packaging Information :
Product is packed in a 5 ml plastic bottle with a plastic nozzle pre sterilized and plastic cap.

Storage and Handling Instructions :
Store at room temperature. Protect from light.