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Therapeutic Category
- OPHTHALMOLOGICAL DRUGS
- MYDRIATICS
- Pharmaceutical Form : Eye Drops
- Composition : Phenylephrine HCl 100 mg / 1 ml
- Active Substance : Phenylephrine HCl
INDICATIONS
FRINOMED 10% is recommended for use as a decongestant and vasoconstrictor and for pupil dilation in uveitis (posterior synechiae). Wide angle glaucoma, prior to surgery, refraction, ophthalmoscopic examination, and diagnostic procedures.
CONTRAINDICATIONS:
Ophthalmic solutions of phenylephrine hydrochloride are contraindicated in persons with narrow angle glaucoma (and in those individuals who are hypersensitive to phenylephrine or to any of the components of the product.)
FRINOMED 10% is contraindicated in infants and in patients with aneurysms.
WARNINGS:
There have been rare reports associating the use of FRINOMED 10% with the development of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions.
These episodes have usually occurred in elderly patients with pre-existing cardiovascular diseases.
PRECAUTIONS:
General:
Exceeding recommended dosages or applying FRINOMED 10% Ophthalmic Solution to the traumatized, diseased or post-surgical eye or adnexa or to patients with suppressed lacrimation, as during anesthesia, any result in the absorption of sufficient quantities of phenylephrine to produce a systemic vasopressor response.
A significant elevation in blood pressure is rare but has been reported following conjunctional instillation of recommended doses of FRINOMED 10% Solution
Caution, therefore, should be exercised in administering the FRINOMED 10% solution to children of low body weight, the elderly, and patients with insulin-dependent diabetes, hypertension, hyperthyroidism, generalized arteriosclerosis, or cardiovascular disease.
Ordinarily, any mydriatic, including phenylephrine hydrochloride, is contraindicated in patients with glaucoma, since it may occasionally raise intraocular pressure.
Due to a strong action of the drug on the dilator muscle, older individuals may also develop transient pigment floaters in the aqueous humor 30 to 45 minutes following the administration of Phenylephrine Hydrochloride Ophthalmic Solutions. The appearance may be similar to anterior uveitis or a microscopic hyphema.
To prevent pain, a drop of suitable topical anesthetic may be applied before using the 10% ophthalmic solution.
Pregnancy Category C
FRINOMED 10% should be given to a pregnant woman only if clearly needed
Nursing mothers:
It is not known whether this drug is excreted in milk, many are. Caution should be exercised when phenylephrine Hydrochloride Ophthalmic solution is administered to a nursing woman.
DRUG INTERACTIONS:
As with all other adrenergic drugs, when FRINOMED 10% is administered simultaneously with, or up to 21 days after, administration of monoamine oxidase (MAO) inhibitors, careful supervision and adjustment of dosages are required since exaggerated adrenergic effects may occur.
The pressor response of adrenergic agents may also be potentiated by tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa, and atropine-like drugs
DOSES
Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.
Vasoconstriction and Pupil Dilation:
FRINOMED 10% is especially useful when rapid and powerful dilation of the pupil and reduction of congestion in the capillary bed are desired.
A drop of suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the FRINOMED 10% on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use to the topical anesthetic.
Uveitis: Posterior Synechiae:
FRINOMED 10% may be used in patients with uveitis when synechiae are present or may develop.
The formulation of synechiae may be prevented by the used of the 10% ophthalmic solution and atropine to produce wide dilation of the pupil.
To free recently formed posterior synechiae, 1 drop of the 10% ophthalmic solution may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary.
In the interim, hot compresses should be applied for five or ten minutes three times a day, with 1 drop of a 1% or 2% solution of atropine sulfate before and after each series of compresses.
Glaucoma:
In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of the 10% ophthalmic solution on the upper surface of the cornea. This treatment may be repeated as often as necessary.
Phenylephrine hydrochloride may be used with miotics in patients with wide angle glaucoma.
Surgery:
When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, the 10% ophthalmic solutions may be applied topically from 30-60 minutes before the operation.
STORAGE CONDITIONS
Store between (15-30) °C, away from light
PACKAGING:
Bottle of 5 – 10 ml