Paremyd

What is Paremyd and how is it used?

Paremyd is a prescription medicine used to treat the symptoms of Mydriasis/Cycloplegia. Paremyd may be used alone or with other medications.

Paremyd belongs to a class of drugs called Cycloplegics/Mydriatics.

It is not known if Paremyd is safe and effective in children.

What are the possible side effects of Paremyd?

Paremyd may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• blurred vision,
• chest pain or pressure,
• confusion,
• dizziness,
• lightheadedness,
• fast, slow, or irregular heartbeat,
• nausea,
• pain or discomfort in the arms, jaw, back, or neck,
• shortness of breath,
• sudden sweating,
• tiredness,
• weakness,
• agitation,
• anxiety,
• cold or clammy skin,
• pale skin,
• cough,
• difficulty swallowing,
• eye pain,
• failure to recognize people,
• irritability,
• itching,
• hyperactivity,
• restlessness,
• loss of consciousness,
• loss of vision,
• mood or mental changes,
• nervousness,
• nightmares,
• pounding heartbeats,
• hallucinations,
• skin rash,
• tightness in the chest,
• tremor,
• unusual behavior,
• disorientation,
• wheezing,
• bloating,
• blurred vision,
• diarrhea,
• enlarged pupils,
• fainting,
• gas,
• headache,
• heartburn,
• indigestion,
• loss of appetite,
• nausea,
• nervousness,
• pounding in the ears,
• stomach pain,
• sweating, and
• vomiting

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Paremyd include:

• change in ability to see color,
• difficulty seeing at night,
• dry mouth,
• headache,
• increased sensitivity of the eyes to sunlight,
• muscle stiffness or tightness, and
• temporary stinging in the eyes

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Paremyd. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) sterile ophthalmic solution is a topical mydriatic combination product for ophthalmic use.

INDICATIONS

PAREMYD^® Solution is indicated for mydriasis in routine diagnostic procedures and in conditions where short-term pupil dilation is desired.

PAREMYD^® provides clinically significant mydriasis with partial cycloplegia.

DOSAGE AND ADMINISTRATION

One to two drops in the conjunctival sac. The onset of action with PAREMYD^® 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.

HOW SUPPLIED

PAREMYD^® (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

Storage

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

Manufactured by: Akorn, Inc. Lake Forest, IL 60045 PM00N. Revised Jun 2016

SIDE EFFECTS

Increased intraocular pressure has been reported following use of mydriatics. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, allergic reactions, nausea, vomiting, pallor and muscle rigidity have been reported with the use of tropicamide and/or hydroxyamphetamine hydrobromide, and thus may occur with PAREMYD^® Solution. Central nervous system disturbances have also been reported. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs.

Rare but serious cardiovascular events, including death due to myocardial infarction, ventricular fibrillation and significant hypotensive episodes have occurred shortly following PAREMYD^® instillation.

DRUG INTERACTIONS

No Information Provided

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 cardio-respiratory 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^® 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^®.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with PAREMYD^®. It is also not known whether PAREMYD^® can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. PAREMYD^® 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^® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. PAREMYD^® may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory 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 or effectiveness have been observed between elderly and younger patients.

OVERDOSE

Ocular overdosage will cause dilation of the pupils. Systemic overdosage or ingestion of large doses may result in hypertension, cardiac arrhythmias, sub-sternal discomfort, headache, sweating, nausea, vomiting and gastrointestinal irritation. Patients with systemic overdosage should be carefully monitored and treated symptomatically.

CONTRAINDICATIONS

PAREMYD^® Solution should not be used in patients with angle-closure glaucoma or in those with narrow angles in whom dilation of the pupil may precipitate an attack of angle-closure glaucoma. This product is also contraindicated in patients who are hypersensitive to any of its components.

CLINICAL PHARMACOLOGY

PAREMYD^® Solution combines the effects of the adrenergic agent, hydroxyamphetamine hydrobromide, and the anticholinergic agent, tropicamide.

Hydroxyamphetamine hydrobromide is an indirectly-acting sympathomimetic agent which, when applied topically to the eye, causes the release of endogenous norepinephrine from intact adrenergic nerve terminals resulting in mydriasis. Since hydroxyamphetamine hydrobromide has little or no direct activity on the receptor site, dilation does not usually occur if there is damage to the presynaptic nerve terminal, e.g., Horner's Syndrome. However, it is not known whether damage to the presynaptic nerve terminal will influence the extent of mydriasis produced by PAREMYD^®. Hydroxyamphetamine hydrobromide has minimal cycloplegic action.

Tropicamide is a parasympatholytic agent which, when applied topically to the eye, blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle. Tropicamide produces short-duration mydriasis. Although cycloplegia occurs with higher doses of tropicamide, there is evidence with 0.25% tropicamide that full cycloplegia does not occur.

Since both these agents act on different effector sites, their simultaneous use produces an additive mydriatic effect. PAREMYD^® provides diminished pupil responsiveness to light, facilitating ophthalmoscopy. The onset of action with PAREMYD^® occurs within 15 minutes, followed by maximum effect within 60 minutes after instillation of one drop. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours, with recovery beginning at approximately 90 minutes and with complete recovery occurring in most patients in 6 to 8 hours. However, in some cases complete recovery may take up to 24 hours. Effectiveness may differ slightly in patients with light and dark irides, with those patients with light irides experiencing a slightly greater mydriasis.

PATIENT INFORMATION

Patients should be advised not to touch the dropper tip to any surface since this may contaminate the solution. Patients should be advised to use caution when driving or engaging in other hazardous activities while pupils are dilated. Patients may experience photophobia and/or blurred vision and should protect their eyes in bright illumination when pupils are dilated. 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.