MYDFRIN 2.5% w/v Ophthalmic solution Ref.[27535] Active ingredients: Phenylephrine

Ordinarily, any mydriatric, including phenylephrine hydrochloride, is contraindicated in patients with glaucoma, since it may occasionally raise intraocular pressure. However, when temporary dilatation of the pupil may free adhesions or when vasoconstriction of the ciliary body vascular may lower intraocular tension, these advantages may temporarily outweigh the danger from coincident dilatation of the pupil.

MYDFRIN should be used with caution in children, the elderly and in patients with sympathetic denervation (e.g. patients with insulin dependent diabetes, orthostatic hypotension, hypertension, hyperthyroidism).

Systemic absorption may be enhanced when applying MYDFRIN to an instrumented, traumatized, diseased or postsurgical eye or adnexa, or to patients with suppressed lacrimation as during anesthesia.

Studies have not been performed to evaluate the effect of ocular administration of MYDFRIN on fertility.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and may result in a decrease in systemic adverse reactions.

To prevent pain, a drop of suitable topical anesthetic may be applied before using MYDFRIN.

MYDFRIN contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MYDFRIN and wait at least 15 minutes before re-insertion.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.

Pregnant Women

There are no or limited amount of data from the use of MYDFRIN in pregnant women. However, there is data with the systemic use of phenylephrine that suggest risk. MYDFRIN is not recommended during pregnancy.

Nursing Women

It is not known whether phenylephrine or its metabolites are excreted into 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 MYDFRIN therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Pediatrics

The use in preterm and newborn infants is not recommended unless clearly necessary. Full-term, but especially low birth weight and premature infants, may be an increased risk for systemic adverse reactions including transient increases in blood pressure. The infant should be monitored after instillation, and routines to adequately deal with emergency situations should be in place. The lowest possible dose should be used. Instillation of more than one drop per eye must be avoided.

The lowest dose necessary to produce the desired effect should always be used in children.

Parents should be warned not to get MYDFRIN in their children’s mouth or cheeks and to wash their hands and the child’s hands or cheeks following administration.

Geriatrics

Rebound miosis has been reported in elderly persons one day after receiving phenylephrine HCl ophthalmic solutions, and reinstallation of the drug produced a reduction in mydriasis. This may be of clinical importance in dilatation of the pupils of elderly subjects prior to retinal detachment or cataract surgery. Due to a strong action of the drug on the dilator muscle, elderly individuals may also develop transient pigment floaters in the aqueous humor 40 to 45 minutes following the administration of phenylephrine hydrochloride ophthalmic solution. The appearance may be similar to anterior uveitis or to a microscopic hyphema.

Cardiac disorders: blood pressure increased, tachycardia;

Eye disorders: conjunctivitis, eye irritation, eye pain, ocular hyperemia;

Immune system disorders: hypersensitivity;

Nervous system disorders: dizziness;

Respiratory, thoracic and mediastinal disorders: pulmonary edema;

Skin and subcutaneous tissue disorders: dermatitis contact.

Systemic toxicity can result from topical application of sympathicomimetic drugs; headache, blood pressure elevation, extrasystoles, tachycardia, syncope and cerebrovascular accidents have been reported.

MYDFRIN should be used with caution, if at all, in patients taking monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, certain antihypertensive agents (e.g. guanethidine, reserpine, and non-selective beta blockers, such as propranolol), or systemic atropine.

As with other adrenergic drugs, when MYDFRIN is administered simultaneously with, or up to 21-days after, administration of MAOIs, careful supervision and adjustment of dosages are required since exaggerated adrenergic effects may result.

The pressor response of adrenergic agents may also be potentiated by tricyclic antidepressants and certain antihypertensive agents.

Concomitant use of phenylephrine and systemic atropine may enhance the pressor effects and induce tachycardia in some patients, especially infants.

Phenylephrine may potentiate the cardiovascular depressant effects of potent inhalation anesthetic agents.