10ML

Dexnova

Dexamethasone Sodium Phosphate Ophthalmic Solution USP

PRESERVATIVE FREE

Inflammatory conditions of the anterior segment of the eye, such as marginal keratitis, stromal oedema in keratitis, anterior uveitis, episcleritis (if NSAIDs are contraindicated or insufficient), scleritis, acute phase of severe allergic conjunctivitis not responding to standard therapy.

Composition:

Dexamethasone Sodium Phosphate IP
Eq. to Dexamethasone Phosphate 0.1% w/v
Sterile Aqueous Base IP Q.s.

Preservative:

This product is preservative free.

Therapeutic Indications:

Posology and Method of Administration:

Ophthalmic use.

Posology

Adults (including the elderly):
The usual dose in adults including the elderly is 1 drop, 4 to 6 times daily.

In severe conditions, the treatment can be used more frequently at first (1 drop every hour) and then reduced to 1 drop every 4 hours as the eye inflammation subsides. Dexamethasone sodium phosphate dosage should be progressively reduced.

Use in children and adolescents:
Use of Dexamethasone Sodium Phosphate Ophthalmic solution in children and adolescents must be restricted.

No data on safety and efficacy is available for children aged under 2 years.

Contraindications:

Hypersensitivity to the active substance or any of the excipients.

Use is contra-indicated in herpes simplex and other viral diseases of the cornea and conjunctiva, fungal disease, ocular tuberculosis, untreated purulent infections, patients with a history of acute epithelial herpes simplex keratitis or hypersensitivity to any component of the preparation.

Storage:

Keep in cool dry place. Protect from light.
Keep out of reach of children.
Prescription only medicine.

Presentation:

10 ml LDPE bottle, packed in a carton along with insert.

For topical ophthalmic use only. Not for injection into the eye.

Care should be taken to ensure that the eye is not infected before Dexamethasone Sodium Phosphate Ophthalmic are used.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.

Caution is also necessary when used in conjunction with antiviral therapy in the treatment of stromal keratitis or uvetis and use of periodic slit-lamp microscopy.

Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. In such cases antibiotic therapy is mandatory. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs, and corticosteroids therapy should be discontinued if fungal infection occurs.

This medicinal product contains phosphates which may lead to corneal deposits or corneal opacity when topically administered. It should be used with caution in patients presenting with compromised cornea and in instances where the patient is receiving polypharmacy with other phosphate containing eye medications.

Topical corticosteroids should not be used for longer than one week except under ophthalmic supervision. Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity, visual field defects and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure and the lens should be checked routinely and frequently, particularly in patients with a history or presence of glaucoma. The dose of anti-glaucoma medication may need to be adjusted in these patients. Prolonged use may also increase the hazard of secondary ocular infections. Topical ophthalmic corticosteroids may slow corneal wound healing.

Contact lenses should not be worn during treatment with corticosteroid eye drops due to increased risk of infection.

Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

In children, long-term, continuous corticosteroid therapy should be avoided due to possible adrenal suppression.

Interaction with Other Medicinal Products and Other Forms of Interaction:

The risk of increased intraocular pressure associated with prolonged corticosteroid therapy may be more likely to occur with concomitant use of anticholinergics, especially atropine and related compounds, in patients predisposed to acute angle closure.

The risk of corneal deposits or corneal opacity may be more likely to occur in patients presenting with compromised cornea and receiving polypharmacy with other phosphate containing eye medications.

The following drug interactions are possible, but are unlikely to be of clinical significance, following the use of Dexamethasone Sodium Phosphate Ophthalmic in the eye:

The therapeutic efficacy of dexamethasone may be reduced by phenytoin, phenobarbitone, ephedrine and rifampicin.

Glucocorticoids may increase the need for salicylates as plasma salicylate clearance is increased.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Fertility, Pregnancy and Lactation:

Pregnancy
There are no or limited amount of data from the use of dexamethasone eye drops in pregnant women. Studies in animals have shown that topically applied steroids can be absorbed systemically and can cause abnormalities of foetal development in pregnant animals. Although the relevance of these findings to human beings has not been established, the use of Dexamethasone Sodium Phosphate Ophthalmic during pregnancy should be avoided.

Breast-feeding mothers
Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether dexamethasone is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from dexamethasone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Effects on Ability to Drive and Use Machines:

Dexamethasone Sodium Phosphate Ophthalmic Solution has no or negligible influence on the ability to drive and use machines however instillation of eye drops may cause transient blurring of vision. Warn patients not to drive or operate hazardous machinery until vision is clear.

Overdose:

Overdose is unlikely to occur as Dexamethasone Sodium Phosphate Ophthalmic Solution are single-dose units. Excess Dexamethasone Sodium Phosphate Ophthalmic Solution may be wiped away with a clean tissue.

Presentation:

10 ml LDPE bottle, packed in a carton along with insert.