Domina

Composition:

Each 1 ml sterile ophthalmic suspension contains 1mg dexamethasone and 10000 IU polymyxin B sulphate and neomycin sulphate equivalent to 3.5 mg neomycin.

Excipient:

Sodium Chloride, Hydroxy propyl Methyl cellulose, Polysorbate, Benzalkonium Chloride, Hydrochloric acid, Sodium hydroxide, Purified water.

Mechanism of action:

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of this ophthalmic suspension in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Indications:

Maxidom is indicated in the following cases:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitis’s is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The particular anti-infective drug in this ophthalmic Suspension is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophiles influenzae, Klebsiella species, Neisseria species, and Pseudomonas aeruginosa.
This ophthalmic Suspension does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumonia.

Contraindications:

This ophthalmic Suspension is contraindication in these cases:

Hypersensitivity to active substances or to any of the excipients. or to other corticosteroids.
in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Warnings and precautions:

This ophthalmic Suspension is not for injection. It should never be injected subconjunctival, nor should it be directly introduced into the anterior chamber of the eye.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
Prolonged use of corticosteroids may lead to:
glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision
posterior subcapsular cataract formation.
suppress the host immune response and thus increase the hazard of secondary ocular infections.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.
Prolonged use of topical anti-bacterial agents may give rise to overgrowth of non-susceptible organisms including fungi.
If this ophthalmic suspension is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored. Steroids should be used with caution in the presence of glaucoma. IOP should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Products containing neomycin sulfate may cause cutaneous sensitization. Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of the product, treatment should be discontinued.
If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.
To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface.
The use of this bottle by more than one person may spread infection
Keep bottle tightly closed when not in use.
Keep out of reach of children.

Pregnancy:

This ophthalmic Suspension should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

Breast-feeding:

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when this ophthalmic Suspension is administered to a nursing woman.

Side effects:

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination.

Reactions occurring most often from the presence of the anti-infective ingredient are:

allergic sensitizations

The reactions due to the corticosteroid component are:

elevation of IOP with possible development of glaucoma, infrequent optic nerve damage, posterior subcapsular cataract formation, delayed wound healing.

corticosteroid containing preparations have also been reported to cause:

Perforation of the globe, Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia.

Additional adverse reactions identified from post marketing use include:

Ulcerative keratitis, headache, Stevens-Johnson syndrome

The following additional adverse reactions have been reported with dexamethasone :

Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

Dosage and administrations:

Shake the bottle well before use
One to two drops in the conjunctival sac(s).
In severe disease: drops may be used hourly, being tapered to discontinuation as the inflammation subsides.
In mild disease: drops may be used up to four to six times daily.
Not more than 20ml should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in warnings above.
This ophthalmic suspension Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

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