Monograph: |
Glycerin
Indications: Edema, corneal
DESCRIPTION:
Glycerin is 1,2,3-propanetriol: CH2OH-CHOH-CH2OH.
It is a clear, colorless, viscous liquid. Ophthalgan is a sterile glycerin ophthalmic solution.
CLINICAL PHARMACOLOGY:
Glycerin ophthalmic solution is used only for topical application to the cornea. By virtue of its osmotic action, it promptly reduces edema and causes clearing of corneal haze. The action of glycerin is transient, and it is, therefore, used primarily for diagnostic purposes.
INDICATIONS AND USAGE:
Glycerin is indicated to clear an edematous cornea in order to facilitate ophthalmoscopic and gonioscopic examination especially in acute glaucoma, bullous keratitis, Fuchs's endothelial dystrophy, and so forth. In gonioscopy of an edematous cornea, additional glycerin may be used as the lubricant. A local anesthetic should be instilled shortly before use of glycerin.
CONTRAINDICATIONS:
Hypersensitivity to the active or inactive ingredients.
PRECAUTIONS:
Because glycerin is an irritant and may cause pain, a local anesthetic should be instilled shortly before its use.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: No long-term studies in animals or humans have been conducted.
Pregnancy Category C: Animal reproduction studies have not been conducted with glycerin. It is also not known whether glycerin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glycerin 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 glycerin is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children have not been established.
ADVERSE REACTIONS:
Some pain and/or irritation may occur upon instillation.
DOSAGE AND ADMINISTRATION:
One or two drops prior to examination. In gonioscopy of an edematous cornea, additional glycerin may be used as the lubricant.
DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.
(Glycerin contains not more than 1.0% water. Chlorobutanol (chloral derivative) 0.55% is incorporated as preservative. The pH of this solution may differ from that specified in the U.S.P.)
|