Cholografin Meglumine label

Cholografin Meglumine

Cholografin Meglumine Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.

History

There is currently no drug history available for this drug.

Other Information

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure

Figure

Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride.

Molecular Formula: C9H13NO2.HCl

Molecular Weight: 203.67 g/mol

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

Cholografin Meglumine Manufacturers

  • Bracco Diagnostics Inc.
    Cholografin Meglumine | Akorn, Inc.
    No Recall

    Cholografin Meglumine | Akorn, Inc.

    Cholografin Meglumine | Akorn, Inc.
    2.1 General Dosing Recommendations

    In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.

    In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.

    2.2 Dosing in Pediatric Patients Less Than 1 Year of Age

    In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.