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GARASONE™ Ophthalmic/Otic Preparations
Schering
Betamethasone Sodium Phosphate - Gentamicin Sulfate
Topical Corticosteroid - Antibiotic
 
Action And Clinical Pharmacology: The anti-inflammatory activity of betamethasone is combined with the broad spectrum bactericidal activity of gentamicin. Betamethasone inhibits the inflammatory response of the eye and ear to irritating agents of a mechanical, chemical or immunological nature, while gentamicin is active in vitro against a wide variety of pathogenic gram-negative and gram-positive bacteria. tag_IndicationsIndications

Indications And Clinical Uses: Ophthalmic: In ocular inflammation, when concurrent use of an antimicrobial is judged necessary: e.g., staphylococcal blepharoconjunctivitis. For the treatment of non-purulent bacterial infections of the anterior segment of the eye due to organisms sensitive to gentamicin and when the anti-inflammatory action of betamethasone sodium phosphate is indicated, as in allergic vernal and phlyctenular conjunctivitis; non-purulent blepharitis; interstitial sclerosing post-operative keratitis; superficial chemical and thermal burns of the cornea. In stubborn cases of anterior segment eye disease or in deep-seated ocular diseases, systemic therapy may be required. However, in these diseases Garasone solution may be used as adjunctive therapy.

Otic: For the treatment of lesions in the external ear canal, such as acute otitis externa, eczematoid-dermatitis, seborrheic dermatitis and contact dermatitis secondarily infected with susceptible organisms.

Contra-Indications: Those individuals who have shown hypersensitivity to any of its components and to other aminoglycosides or to other corticosteroids.

Ophthalmic: In epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva, mycobacterial infections of the eye, trachoma, fungal diseases of ocular structures.

Use of corticosteroid/antibiotic combinations is contraindicated after removal of a corneal foreign body or in the presence of acute local viral lesions, e.g. herpes, and in patients with absent or perforated tympanic membranes. As with all ophthalmic products containing benzalkonium chloride, patients are advised not to wear soft contact lenses during treatment with Garasone ophthalmic/otic solution.

Manufacturers' Warnings In Clinical States: Prolonged ophthalmic use of Garasone preparations may result in increased intraocular pressure in some individuals. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored. In diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical preparations containing corticosteroids. Protracted use of topical corticosteroids in the eye may result in the development of posterior subcapsular cataracts. Acute anterior uveitis may occur in susceptible individuals, primarily blacks.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Although corticosteroids are contraindicated in acute viral infection of the cornea caused by herpes simplex, there may be occasion to employ steroids in the healing stage to prevent scarring; however, this must only be done with great caution and close observation. In patients with a history of herpetic infection of the cornea, reactivation of the disease may occur with the use of topical ophthalmic or otic corticosteroids.

The use of steroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Precautions: During long-term use of preparations containing corticosteroids, the possibility of fungal infection must be considered, especially in the presence of a persistent corneal ulceration that fails to respond to conventional therapy. By reducing inflammation, steroids may mask the symptoms of serious ocular disease or that due to organisms resistant to gentamicin.

In ophthalmic use, intraocular pressure should be checked frequently (see Warnings). Slit-lamp examination should be done for dendritic keratitis.

If irritation occurs, hypersensitivity to a component of the preparation is a possibility and use of the product should be discontinued. Cross-allergenicity among aminoglycosides and corticosteroids has been demonstrated (see Contraindications).

To avoid possible contamination, do not touch the tip of dropper or tube to any surface. Do not allow dispenser tip to touch the surface of the eye.

It is not advisable to treat bacterial corneal ulcers, which may be due to P. aeruginosa, with a combination antibiotic-anti-inflammatory product as initial therapy. It is prudent to use an anti-infective agent alone initially. For ulcers caused by Pseudomonas, Garamycin ophthalmic ointment would be indicated. If the infection responds to the anti-infective treatment, then the addition of an anti-inflammatory agent to minimize the fibrous reaction and scarring of the cornea is suggested.

Clinical studies have shown that microorganisms previously sensitive to gentamicin have become resistant during therapy. Although this has occurred infrequently, the possibility should nevertheless be considered. There is evidence that cross resistance between gentamicin and other aminoglycoside antibiotics may occur since bacteria made resistant to aminoglycoside antibiotics artificially in the laboratory are also resistant to gentamicin. However, gentamicin may be active against clinical isolates of bacteria resistant to other aminoglycosides. Conversely, organisms resistant to gentamicin may be sensitive to other aminoglycoside antibiotics.

Pregnancy: Safety of topical corticosteroid/antibiotic preparations during pregnancy has not been established.

Lactation: Since it is not known whether the components of Garasone are excreted in the human milk, caution should be exercised when administering to a nursing woman.

Children: Safety and effectiveness in children below the age of 8 years have not been established.

Adverse Reactions: Ophthalmic: Adverse reactions reported include: increased ocular pressure; ocular hypersensitivity manifested by increased ocular hyperemia, edema and burning sensation.

Adverse reactions reported with other steroid-anti-infective combinations include: allergic sensitization due to the antibiotic component; elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing due to the steroid component.

Corticosteroid-containing preparations can also cause anterior uveitis or perforation of the globe. Mydriasis, defects in visual acuity and visual fields, loss of accommodation and ptosis have also been reported.

Otic: The possibility of ototoxicity should be kept in mind and the patient monitored accordingly.

Symptoms And Treatment Of Overdose: Symptoms: Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency. A single overdosage of gentamycin would not be expected to produce symptoms. tag_Treatment

Treatment: Appropriate symptomatic treatment of corticosteroid overdosage is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.

Dosage And Administration: Ophthalmic/Otic Solution: Ophthalmic: Instill 2 drops into the conjunctival sac of the affected eye 3 or 4 times daily. During the acute stage, 2 drops may be administered every 2 hours.

Otic: Thoroughly clean the ear canal of cerumen and debris. Instill 3 or 4 drops into the affected ear 3 times daily or as directed by the physician. The patient should lie with the affected ear turned upward; instill the solution and let the patient remain in this position for several minutes to insure penetration of the medication into the ear canal. If preferred, a cotton wick may be inserted into the canal and then saturated with the solution. The wick should be kept moist by adding further solution every 4 hours. The wick should be replaced once every 24 hours.

Ophthalmic Ointment: Apply a thin film to the affected area 3 or 4 times per day. When a favorable response is observed, the number of daily applications may be reduced. The ointment form is also indicated for application at bedtime in conjunction with daytime use of the drops.

Improvement usually occurs within 48 hours, with clearing of the signs and symptoms usually within 2 weeks. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.

Availability And Storage: Ophthalmic/Otic Solution: Each mL of sterile aqueous solution contains: gentamicin (as sulfate USP) 3 mg and betamethasone 1.0 mg (as sodium phosphate USP). Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, sodium borate, sodium chloride, sodium citrate dihydrate, sodium phosphate dibasic and sodium phosphate monobasic. Dropper bottles of 7.5 mL. Store between 2 and 30°C.

Ophthalmic Ointment: Each g of sterile ointment contains: gentamicin (as sulfate USP) 3 mg and betamethasone 1.0 mg (as sodium phosphate USP). Nonmedicinal ingredients: mineral oil and white petrolatum. Tubes of 3.5 g. Store between 2 and 30°C.