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Neo-Synephrine

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Neo-Synephrine

Neo-Synephrine

WARNINGS

There have been rare reports associating the use of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) 10 percent ophthalmic solutions with the development of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions. These episodes, some ending fatally, have usually occurred in elderly patients with preexisting cardiovascular diseases.

PRECAUTIONS

Exceeding recommended dosages or applying NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride ophthalmic solutions to the instrumented, traumatized, diseased or postsurgical eye or adnexa, or to patients with suppressed lacrimation, as during anesthesia, may 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 conjunctival instillation of recommended doses of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) 10 percent ophthalmic solutions. Caution, therefore, should be exercised in administering the 10 percent solutions to children of low body weight, the elderly, and patients with insulin-dependent diabetes, hypertension, hyperthyroidism, generalized arteriosclerosis, or cardiovascular disease. The posttreatment blood pressure of these patients, and any patients who develop symptoms, should be carefully monitored.

Ordinarily, any mydriatic, including NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) 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 intrinsic vessels may lower intraocular tension, these advantages may temporarily outweigh the danger from coincident dilatation of the pupil.

Rebound miosis has been reported in older persons one day after receiving NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride ophthalmic solutions, and reinstillation of the drug produced a reduction in mydriasis. This may be of clinical importance in dilating the pupils of older subjects prior to retinal detachment or cataract surgery.

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 NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride ophthalmic solutions. The appearance may be similar to anterior uveitis or to a microscopic hyphema.

To prevent pain, a drop of suitable topical anesthetic may be applied before using the 10 percent ophthalmic solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been done to evaluate the potential of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) in these areas.

Pregnancy Category C: Animal reproduction studies have not been conducted with NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) . It is also not known whether NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) 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 NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride ophthalmic solution is administered to a nursing woman.

Pediatric Use: NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions are contraindicated in infants. (See CONTRAINDICATIONS.) For use in older children see DOSAGE AND ADMINISTRATION.

Exceeding recommended dosages or applying NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride ophthalmic solutions to the instrumented, traumatized, diseased or postsurgical eye or adnexa, or to patients with suppressed lacrimation, as during anesthesia, may result in the absorption of sufficient quantities of phenylephrine to produce a systemic vasopressor response.

The hypertensive effects of phenylephrine may be treated with an alpha-adrenergic blocking agent such as phentolamine mesylate, 5 mg to 10 mg intravenously, repeated as necessary.

The oral LD50 of phenylephrine in the rat: 350 mg/kg, in the mouse: 120 mg/kg.

Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.

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