Indications of Candistin 0.3%+1%+0.025%+2%
This ear drop is indicated for the treatment of superficial bacterial and fungal infections of the external auditory canal and the middle ear, caused by organisms susceptible to the action of Ofloxacin and Clotrimazole.
This ear drop Clear, pyrogen free, preservative free otic solution. Each ml contains-
Ofloxacin BP 3 mg
Clotrimazole BP 10 mg
Beclomethasone Dipropionate BP 0.25 mg
Lidocaine Hydrochloride BP 20 mg.
Other ophthalmic preparations
Ofloxacin is a bactericidal drug. It act by inhibiting the enzyme DNA gyrase (Topoisomerase 2) and Topoisomerase 4.DNA gyrase helps in the formation of a highly condensed three dimensional structure of the DNA by its nicking and closing activity and also by introducing negative supercoil in to the DNA double helix. Ofloxacin inhibits DNA gyrase which results in abnormal linkage between opened DNA and gyrase and negative supercoiling is also impaired. This will inhibits transcription of DNA in to RNA and subsequent protein synthesis.Clotrimazole is fungicidal or fungistatic depending on the drug concentrations. It inhibits the conversion of Lanosterol to 14 demethyl Lanosterol by inhibiting the cytochromeP450 enzyme 14 alpha demethylase and impair ergosterol synthesis which is an essential constituent of cell membrane. Inhibition of ergosterol synthesis will alter the membrane permeability of the susceptible fungus and kill or inhibit them.Beclomethasone: The drug exerts its pharmacological action by penetrating and binding to cytoplasmic receptor protein and causes a structural change in steroid receptor complex. This structural change allows it`s migration in to the nucleus and then binding to specific sites on the DNA which leads to transcription of specific m-RNA and which ultimately regulates protein synthesis. It exerts highly selective glucocorticoid action. It stimulates the enzymes needed to decrease the inflammatory response. The drug exerts anti-inflammatory and immunosuppressant actions as follows: - 1) Induce lipocortins in macrophages, endothelium, and fibroblasts which inhibits Phospholipase A2 and thus decreases the production of Prostaglandins, leukotrienes (LT), and platelet activating factor, 2) Causes negative regulation of genes for cytokines in macrophages, endothelial cells and lymphocytes and thus decreases the production of interleukins (IL-1, IL-2, IL-3, IL-6), TNF-alpha, GM-CSF (granulocyte macrophage colony stimulating factor), Gama interferon and suppresses fibroblast proliferation and T-lymphocyte functions and interferes chemo taxis. 3) Decreases the production of acute phase reactants from macrophages and endothelial cells and interferes complement function. 4) Decreases the production of ELAM-1(Endothelial leukocyte adhesion molecule-1) and ICAM-1(intracellular adhesion molecule-1) in endothelial cells. 5) Inhibit IgE mediated histamine and LT-C4 release from basophiles and the effects of antigen-antibody reaction is not mediated 6) Reduces the production of collagenase and stromolysin and thus prevents tissue destruction.Lidocaine is a local anesthetic which works by blocking pain signals from the nerves to brain to decrease pain sensation.
Dosage & Administration of Candistin 0.3%+1%+0.025%+2%
Adults & Children: Apply 3-5 drops of Ear Drops into the affected ear, 3-4 times a day for 7 to 14 days.
Dosage of Candistin 0.3%+1%+0.025%+2%
Adults & Children: Instill 2-5 drops three to four times daily into the affected ear for 7-14 days.
Otitis Externa with intact tympanic membrane: From age 06 months & older.
Chronic Suppurative Otitis Media with perforated tympanic membrane: 12 years & older.
Instruction to use: To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe up & backward in case of adults and children older than 3 years. In case of pediatric patients gently pull the ear lobe down & backward.
This ear drop is contraindicated in patients with sensitive to Ofloxacin or other quinolone, or to any of the components of this medications. It is contra-indicated in viral infections of the ear.
Side Effects of Candistin 0.3%+1%+0.025%+2%
The systemic side-effects are not common with this ear drops. The following adverse reactions may be observed when using this product: itching, burning, irritation, dryness, earache, headache, vertigo, dizziness, redness, folliculitis, hypertrichosis, acne form eruptions and hypopigmentation.
Precautions & Warnings
If a favorable response does not occur in one week, discontinue the use of this preparation and obtain cultures to guide further treatment.
As with other anti-infective preparations, prolonged use may result in overgrowth of nonsusceptible organisms.
If local irritation or sensitization occurs, discontinue this preparation and institute appropriate therapy.
If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
Not for Ophthalmic use. Not for injection.
Keep away from light and moisture, store below 25°C.
Anti-fungal or anti-bacterial ear drops
Mode Of Action
It is a combination of an antibacterial, an antifungal, an anti-inflammatory and a topical local anesthetic agent. This ear drop has been specially formulated to maintain the natural environment of the external ear canal.Ofloxacin is a fluoroquinolone that has a broad spectrum of activity against otic pathogens without ototoxicity. Hence Ofloxacin is preferred to Aminoglycosides for any application within the middle ear space. Ofloxacin exerts antibacterial activity by inhibiting DNA gyrase of bacteria. Ofloxacin has been shown to be active against the following organisms responsible for otic infections: Gram-positive: Staphylococcus aureus, Streptococcus pneumoniae. Gram-negative: Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa.Clotrimazole is a synthetic imidazole derivative, which is a broad-spectrum antifungal agent that exerts fungicidal activity against fungi responsible for superficial mycotic infections affecting the outer or middle ear including Candida, Microsporum & Trichophyton. Clotrimazole inhibits Cytochrome P-450 synthesis of Ergosterol, which decreases fungal cell wall integrity thus inhibits fungal growth. Clotrimazole also has activity against certain bacteria such as Streptococci and Staphylococci. The antibacterial effect of Clotrimazole is advantageous to treat mixed bacterial-fungal infections.Beclomethasone Dipropionate is a potent steroid as compared with other topical corticosteroids. Beclomethasone like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators.Lidocaine Hydrochloride is a topical local anesthetic which helps to reduce pain and stinging in the ear.
Safety during pregnancy or lactation has not been established. It is not known whether the active substances pass into breast milk when applied topically. Therefore, the potential benefit of this product during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.