FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
- With repeated doses, consideration should be given to maintenance of adequate fluid and electrolyte balance.
- If urinary output continues to decrease, the patient’s clinical status should be closely reviewed. Accumulation of ISMOTIC may result in overexpansion of the extracellular fluid.
Legal Issues
There is currently no legal information available for this drug.
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
For the short-term reduction of intraocular pressure. May be used prior to and after intraocular surgery. May be used to interrupt an acute attack of glaucoma.
History
There is currently no drug history available for this drug.
Other Information
ISMOTIC® is a 45% w/v solution of isosorbide in a vanilla-mint flavored vehicle. ISMOTIC is a caramel colored aqueous solution that is chemically stable at room temperature.
Each mL contains:
Isosorbide 45% w/v (Isosorbide Concentrate 60.6%), Alcohol 0.3% w/v, Caramel, Creme de Menthe, Malic Acid, Potassium Citrate, Potassium Sorbate, Saccharin Calcium, Sodium Citrate, Sorbitol Solution, Vanilla Concentrate Imitation #20, Potassium Hydroxide (to adjust pH), and Purified Water.
DM-00
Typical analysis of electrolyte content:
4.6 meq. of Sodium/220 mL ISMOTIC Solution
0.9 meq. of Potassium/220 mL ISMOTIC Solution
Isosorbide, the osmotic agent in ISMOTIC, is a dihydric alcohol with the formula C6H10O4 represented by the structure:
Sources
Ismotic Manufacturers
-
Alcon Laboratories, Inc.
Ismotic | Alcon Laboratories, Inc.
The recommended initial dose of isosorbide is 1.5 gm/kg body weight (equivalent to 1.5 mL /lb. of body weight). The onset of action is usually within 30 minutes while the maximum effect is expected at 1 to 1 1/2 hours. The useful dose range is 1 to 3 gm/kg body weight and the drug effect will persist up to 5 to 6 hours. Use two to four times a day as indicated. Palatability may be improved if the medication is poured over cracked ice and sipped.
RECOMMENDED DOSAGES ARE:
POUNDS MILLILITERS POUNDS MILLILITERS 100 150 155 235 105 155 160 240 110 165 165 250 115 170 170 255 120 180 175 265 125 190 180 270 130 195 185 280 135 205 190 285 140 210 195 295 145 220 200 300 150 225
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