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Side Effects & Adverse Reactions
Contains Sodium Bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
For topical ophthalmic use only. As with all other adrenergic drugs, when administered simultaneously, or up to 21 days other administration of monoamine oxidase (MAO) inhibitors, 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.
There have been rare reports associating the use of phenylephrine hydrochloride 10 percent ophthalmic solutions with the development of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infractions. These episodes, some ending fatally, have usually occurred in elderly patients with preexisting cardiovascular diseases.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
As an ophthalmic decongestant and vasoconstrictor and for pupil dilation in uveitis (posterior synechiae), wide angle glaucoma, prior to surgery, refraction, ophthalmoscopic examination and diagnostic procedures.
There is currently no drug history available for this drug.
Phenylephrine Hydrochloride Ophthalmic Solution, is a non-irritating, sterile solution containing sympathomimetic agent producing vasoconstrictor and mydriatic effects. Phenylephrine Hydrochloride is a synthetic sympathomimetic and adrenergic compound structurally similar to epinephrine and ephedrine. A prompt, short acting mydriatic, it causes little or no cycloplegia or irritation. The active ingredient is represented by the chemical structural formula:
Molecular Weight: 203.67
Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride [R]-.
Each mL Contains:
ACTIVE: Phenylephrine Hydrochloride, 25 mg (2.5%); INACTIVES: Boric Acid, Edetate Disodium, Purified Water, Sodium Bisulfite, Sodium Borate. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0-7.5). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.