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.
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.
Inactives: Edetate Disodium 0.015%, Sodium Chloride; Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.2 to 5.8 during its shelf life), and Purified Water. The osmolality of Paremyd® is approximately 307 mOsm/L.
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.
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. 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.
Paremyd® (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25% 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