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ISOPTO® Atropine 1% Ophthalmic solution

ISOPTO® Atropine 1% Ophthalmic solution  top of page

[Package insert]


Indications
ISOPTO® Atropine 1% is indicated for:

1.1 MYDRIASIS
1.2 CYCLOPLEGIA
1.3 PENALIZATION OF THE HEALTHY EYE IN THE TREATMENT OF AMBLYOPIA

Dosing:
2.1 In individuals from three (3) months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time.

2.2 In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed.


Precautions/Warnings
:
WARNINGS AND PRECAUTIONS
5.1 PHOTOPHOBIA AND BLURRED VISION
Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.

5.2 ELEVATION OF BLOOD PRESSURE
Elevation in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, 1%.

5.3 INCREASED ADVERSE DRUG REACTION SUSCEPTIBILITY WITH CERTAIN CENTRAL NERVOUS SYSTEM CONDITIONS
Individuals with Down syndrome, spastic paralysis, or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary, and gastrointestinal toxicity from systemic absorption of atropine.

Supplied:
ISOPTO® Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows:

5 mL filled in 8-mL bottles NDC 0065-0303-55
15 mL filled in 15-mL bottles NDC 0065-0303-15
Storage: Store ISOPTO® Atropine 1% at 2–25°C (36–77°F).

Efficacy:
CLINICAL STUDIES
Topical administration of ISOPTO® Atropine 1% results in mydriasis and/or cycloplegia, with efficacy demonstrated in both adults and children. The maximum effect for mydriasis is achieved in about 30–40 minutes after administration, with recovery after approximately 7–10 days. The maximum effect for cycloplegia is achieved within 60–180 minutes after administration, with recovery after approximately 7–12 days.

DESCRIPTION
ISOPTO® Atropine 1% is a sterile topical ophthalmic solution. Each mL of ISOPTO® Atropine 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine.

MECHANISM OF ACTION
Atropine acts as a competitive antagonist of the parasympathetic (and sympathetic) acetylcholine muscarinic receptors. Topical atropine on the eye induces mydriasis by inhibiting contraction of the circular pupillary sphincter muscle normally stimulated by acetylcholine. This inhibition allows the countering radial pupillary dilator muscle to contract which results in dilation of the pupil. Additionally, atropine induces cycloplegia by paralysis of the ciliary muscle which controls accommodation while viewing objects.



Cyclopentolate Hydrochloride Ophthalmic Solution 0.5%

Cyclopentolate Hydrochloride Ophthalmic Solution 0.5%  top of page

[Package insert]


Indications
Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

Dosing:
Adults: Instill one or two drops of 0.5% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days.
Children: Instill one or two drops of 0.5% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% solution if necessary.
Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.

Precautions/Warnings
:
WARNINGS
FOR TOPICAL APPLICATION IN THE EYE. NOT FOR INJECTION. This preparation may cause CNS disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of 0.5% Cyclopentolate hydrochloride solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation.

Mydriatics may produce a transient elevation of intraocular pressure.

PRECAUTIONS
General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination.

See Insert.

Supplied:
Cyclopentolate Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in multiple–dose plastic Boston Round Natural LDPE bottle with a 15 mm LLDPE dropper-tip and 15 mm polypropylene red cap.

NDC 17478-096-15 15 mL fill/15 mL bottle

Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Efficacy:
DESCRIPTION
Cyclopentolate Hydrochloride Ophthalmic Solution, USP is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use.

CLINICAL PHARMACOLOGY
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing papillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.



Homatropine hydrobromide Ophthalmic solution 5%

Homatropine hydrobromide Ophthalmic solution 5%  top of page

[Package insert]


Indications
A moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. For pre and postoperative states when mydriasis is required. Use as an optical aid in some cases of axial lens opacities.

CONTRAINDICATIONS:
Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g. narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.

Dosing:
For refraction, instill one or two drops topically in the eye(s). May be repeated in five or ten minutes if necessary. For uveitis, instill one or two drops topically up to every three to four hours. Individuals with heavily pigmented irides may require larger doses.

Precautions/Warnings
:
WARNING:
For topical use only – not for injection. Risk-benefit should be considered when the following medical problems exist: keratoconus (Homatropine may produce fixed dilated pupil); Down’s syndrome, children with brain damage and the elderly (increased susceptibility). In infants and small children, use with extreme caution. Excessive use in pediatric patients or certain individuals with a history of susceptibility to belladonna alkaloids may produce systemic symptoms of homatropine poisoning (see overdose section).

PRECAUTIONS:
To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after installation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Excessive topical use of this drug can potentially lead to a confusional state characterized by delirium, agitation, and rarely coma. This state is more apt to occur in the pediatric and geriatric age groups. The specific anti-dote for this systemic anticholinergic syndrome is injectable physostigmine salicylate.

Supplied:
5mL size in a white plastic bottle
5mL - NDC 59390-192-05

STORAGE:
Store at 15° - 30°C (59°- 86°F).

Efficacy:
DESCRIPTION:
Homatropine hydrobromide 5% is an anticholinergic prepared as a sterile topical ophthalmic solution.

CLINICAL PHARMACOLOGY:
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).



NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution)

NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution)  top of page

[Package insert]


Indications
NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride is recommended for use as a decongestant and vasoconstrictor and for pupil dilatation in uveitis (posterior synechiae), wide angle glaucoma, prior to surgery, refraction, ophthalmoscopic examination, and diagnostic procedures.

Dosing:
DOSAGE AND ADMINISTRATION
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 DILATATION
NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions are especially useful when rapid and powerful dilatation of the pupil and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of the NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions 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 of the topical anesthetic.

UVEITIS: POSTERIOR SYNECHIAE
NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent ophthalmic solutions may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of the 10 percent ophthalmic solutions and atropine to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, 1 drop of the 10 percent ophthalmic solutions 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 percent 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 percent ophthalmic solutions on the upper surface of the cornea. This treatment may be repeated as often as necessary.

NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride may be used with miotics in patients with wide angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure. Hence, there may be marked improvement in visual acuity after using NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride in conjunction with miotic drugs.

SURGERY
When a short-acting mydriatic is needed for wide dilatation of the pupil before intraocular surgery, the 10 percent ophthalmic solutions or 2.5 percent ophthalmic solution may be applied topically from 30 to 60 minutes before the operation.

REFRACTION
Prior to determination of refractive errors, NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be used effectively with homatropine hydrobromide, atropine sulfate, or a combination of homatropine and cocaine hydrochloride.

For adults, a drop of the preferred cycloplegic is placed in each eye, followed in five minutes by 1 drop of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in ten minutes by another drop of the cycloplegic. In 50 to 60 minutes, the eyes are ready for refraction.

For children, a drop of atropine sulfate 1 percent is placed in each eye, followed in 10 to 15 minutes by 1 drop of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution and in five to ten minutes by a second drop of atropine sulfate 1 percent. In one to two hours, the eyes are ready for refraction.

For a “one application method,” NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution may be combined with a cycloplegic to elicit synergistic action. The additive effect varies depending on the patient. Therefore, when using a “one application method,” it may be desirable to increase the concentration of the cycloplegic.

OPHTHALMOSCOPIC EXAMINATION
One drop of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent ophthalmic solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilatation lasts from one to three hours.

DIAGNOSTIC PROCEDURES
Provocative Test for Angle Block in Patients with Glaucoma: The 2.5 percent ophthalmic solution may be used as a provocative test when latent increased intraocular pressure is suspected. Tension is measured before application of NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride and again after dilatation. A 3 to 5 mm of mercury rise in pressure suggests the presence of angle block in patients with glaucoma; however, failure to obtain such a rise does not preclude the presence of glaucoma from other causes.

Shadow Test (Retinoscopy): When dilatation of the pupil without cycloplegic action is desired for the shadow test, the 2.5 percent ophthalmic solution may be used alone.

Blanching Test: One or 2 drops of the 2.5 percent ophthalmic solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iritis.


Precautions/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.

Supplied:
In Mono-Drop ® plastic dropper bottle: Low surface tension solutions
2.5 percent ophthalmic solution - NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 2.5 percent in a sterile, isotonic, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, boric acid, and, as antiseptic preservative, benzalkonium chloride, NF, 1:7500. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 15 mL (NDC 0024-1358-01).

10 percent ophthalmic solution- NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, low surface tension vehicle with sodium phosphate, sodium biphosphate, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1359-01).

Viscous solution

10 percent ophthalmic solution- NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride 10 percent in a sterile, buffered, viscous vehicle with sodium phosphate, sodium biphosphate, methylcellulose, and, as antiseptic preservative, benzalkonium chloride 1:10,000. The pH is adjusted with phosphoric acid or sodium hydroxide. Bottles of 5 mL (NDC 0024-1362-01).

Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature]

Manufactured for Sanofi-Synthelabo Inc. New York, NY 10016 by Abbott Laboratories North Chicago, IL 60064. Revised September 1999. FDA revision date: n/a

Efficacy:
NEO-SYNEPHRINE hydrochloride, brand of phenylephrine hydrochloride ophthalmic solution, is a sterile solution used as a vasoconstrictor and mydriatic for use in ophthalmology.

NEO-SYNEPHRINE (phenylephrine hydrochloride ophthalmic solution) hydrochloride is a synthetic sympathomimetic compound structurally similar to epinephrine and ephedrine.



Cyclomydril® - cyclopentolate 0.2% / phenylephrine 1%

Cyclomydril® - cyclopentolate 0.2% / phenylephrine 1%  top of page

[Package insert]


Indications
For the production of mydriasis.

Dosing:
Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.


Precautions/Warnings
:
WARNINGS
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. The use of this combination may have an adverse effect on individuals suffering from cardiovascular disease, hypertension, and hyperthyroidism, and it may cause CNS disturbances. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. Observe infants closely for at least 30 minutes.

Mydriatics may produce a transient elevation of intraocular pressure.

PRECAUTIONS
GENERAL
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma. The effect of long-term use of this preparation has not been established, therefore, it should be restricted to short-term use.

Supplied:
2 mL and 5 mL in plastic DROP-TAINER® dispensers.

2 mL NDC 0065-0359-02
5 mL NDC 0065-0359-05

Efficacy:
Cyclopentolate hydrochloride is an anticholinergic drug and Phenylephrine hydrochloride is an adrenergic drug. This combination induces mydriasis that is greater than that of either drug alone at its respective concentration. The concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

Drug Description
CYCLOMYDRIL® (cyclopentolate hydrochloride 0.2% and phenylephrine hydrochloride 1% ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution.

 



Tropicamide 0.5% , 1% (Mydriacyl ®) ophthalmic solution

Tropicamide 0.5% , 1% (Mydriacyl ®) ophthalmic solution  top of page

[Package insert]


Indications
For mydriasis and cycloplegia for diagnostic procedures.

Dosing:
For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

Precautions/Warnings
:
WARNINGS
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION.

This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Remove contact lenses before using.

PRECAUTIONS
GENERAL
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.

Supplied:
3 mL and 15 mL in plastic DROP-TAINER® dispensers.

0.5% - 15 mL: NDC 0998-0354-15
1% - 3 mL: NDC 0065-0355-03
15 mL: NDC 0998-0355-15

Efficacy:
Description:
MYDRIACYL® (tropicamide ophthalmic solution, USP) is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths.
Tropicamide 0.5% , 1% (Mydriacyl ®) ophthalmic solution

Active: tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives : sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH range 4.0 - 5.8.

CLINICAL PHARMACOLOGY
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

 



PAREMYD® (hydroxyamphetamine Hydrobromide 1% and tropicamide 0.25%)

PAREMYD® (hydroxyamphetamine Hydrobromide 1% and tropicamide 0.25%)  top of page

[Package insert]


Indications

PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) Solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired. PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) provides clinically significant mydriasis with partial cycloplegia.

Dosing:
One to two drops in the conjunctival sac. The onset of action with PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) Solution occurs within 15 minutes followed by maximum effect within 60 minutes. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours. Mydriasis will reverse spontaneously with time, typically in 6 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.


Precautions/Warnings
:

Warnings & Precautions
WARNINGS
For topical ophthalmic use only; not for injection. There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma. This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children, or the aged. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs.

PRECAUTIONS
GENERAL
Patients with hypertension, hyperthyroidism, diabetes, or cardiac disease (i.e., arrhythmias or chronic ischemic heart disease) should be monitored after instillation. The elderly and others in whom glaucoma or increased intraocular pressure may be encountered following administration of PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) Solution should also be monitored closely. To avoid inducing angle-closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No studies have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) .

PREGNANCY
Pregnancy Category C: Animal reproduction studies have not been conducted with PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) . It is also not known whether PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) is administered to a nursing woman.

PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established. PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. (See WARNINGS.) Keep this and all medications out of the reach of children.

GERIATRIC USE
No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Supplied:
PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% as a 15 mL solution in a 15 mL opaque white, low density polyethylene bottle with a natural low density polyethylene dropper tip and a red polypropylene cap. 15 mL - NDC 17478-704-12

Note: Protect from light. Store between 15° C to 25° C (59° F to 77° F).


Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Ophthalmic – Mydriatics & Cycloplegics