Each ml of drops or 1 gm of ointment contains:
- Gentamicin (as sulphate) 3 mg.
- Prednisolone acetate 10 mg (drops) or 6 mg(oint.)
Apigent-P® eye or ear drops and ointment contain a combination of an antibiotic (gentamicin sulphate) and a corticosteroid (prednisolone acetate)
Gentamicin sulphate, an aminoglycoside, is a bactericidal agent against many strains of ram negative microorganisms as; Neisseria species, Moraxella, Escherichia coli, Pseudomonas aeruginosa and Serratia marcescens and some Gram positive organisms as; Staphylococcus species and Streptococcus species.
Prednisolone acetate, a corticosteriod, is an anti- inflammatory antiallergic agent indicated for steroid-responsive inflammatory conditions of palpebral and bulbar conjunctiva, cornea and anterior segment of the eye and that of the external ear canal and /or middle ear (e.g. suppurative otitis media)
Generally, this combination is used for conditions which corticosteriod is indicated, and a bacterial infection or a risk bacterial infection exits
Eye: Inflammatory conditions of conjunctiva, cornea and anterior segment of the eye where steroid use is accepted to obtain a diminution of edema and inflammation.
Eye: Chronic anterior uveitis and corneal injury from chemicals, radiations or foreign bodies.
Ear: Lesions in the external ear canal, such as acute or chronic otitis externa, eczematoid dermatitis, seborrheic dermatitis and contact dermatitis infected with microorganisms.
Ear: Chronic suppurative otitis media
1-Hypersensitivity to any of the ingredients or to other corticosteroids
2-Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella and also mycobacterial infection of the eye and fungal diseases of the ocular structures
3-Viral infections of the ear.
Ocular irritation and punctate keratitis have been associated with the use of drops. Renewal of the medication should be made only by a physician. Intraocular pressure should be routinely monitored
Should not be prescribed for undiagnosed red eyes, which may be caused by herpes simplex virus
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration
If inflammation or pain of the eye persist longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician
Do not use the same bottle for simultaneous eye and ear infections to avoid contamination and/or cross infection.
Contamination of the solution may occur if the dropper touches any surface
Safety for children less than 6 years has not been established
Use during pregnancy only if potential benefit outweighs potential risk
Dosage and Administration
N.B.Shake well before use.
Drops – For the Eye
Instill 1-2 drops into the conjunctival sac 2-4 times daily.
During the initial 24-48 hours; the dosing frequency may be increased, if necessary, up to 1 drop every hour or as directed by the physician.
Ointment – For the Eye
Apply either at night (if eye drops were used during the day), or 3-4 times daily if ointment is being used alone, or as directed by the physician.
Drops – For the Ear
Instill 3-4 drops 3-4 times daily or as directed by the physician.
Ointment – For the Ear
Apply the ointment directly into the external ear 3 times daily or pack the aural canal with gauze wick filled with the ointment or as directed by the physician.
- Drops: Dropper bottles of 5 ml sterile suspension.
- Ointment: Sterile tubes of 5 gm.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: S02AA14