{"adverse_reactions":["ADVERSE REACTIONS Nausea, vomiting, headache, confusion, and disorientation may occur. Occurrences of syncope, gastric discomfort, lethargy, vertigo, thirst, dizziness, hiccups, hypernatremia, hyperosmolarity, irritability, rash and light-headedness have been reported."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the potential of these effects."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Isosorbide is rapidly absorbed after oral administration. It is essentially nonmetabolized, and in the circulation, it contributes to the tonicity of the blood until it is eliminated by the kidney unchanged. While in the blood, isosorbide acts as an osmotic agent to promote redistribution of water toward the circulation with ultimate elimination in the urine. The physical action of ISMOTIC is similar to that of other osmotic drugs."],"contraindications":["CONTRAINDICATIONS Well-established anuria Severe dehydration Frank or impending acute pulmonary edema Severe cardiac decompensation Hypersensitivity to any component of this preparation"],"description":["DESCRIPTION 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 C 6 H 10 O 4 represented by the structure:"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 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"],"dosage_and_administration_table":["
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
"],"effective_time":"20060323","general_precautions":["General For oral use only – not for injection. Repetitive doses should be used with caution particularly in patients with diseases associated with salt retention. Ensure that patient’s bladder has been emptied prior to surgery."],"how_supplied":["HOW SUPPLIED Disposable plastic bottles of 220 mL (100 gm of isosorbide/220 mL) for oral use only. NDC 0065-0034-08 Storage: Store at 15°-30°C (59°-86°F). CAUTION: Federal ( USA) law prohibits dispensing without prescription. Mfd. for : Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Mfd. by: ALCON (Puerto Rico) INC. Humacao, Puerto Rico 00791 USA July 1997 Printed in USA 249165-0797"],"id":"80ECF847-19AB-AB43-07B1-CB1D5C6B9C92","indications_and_usage":["INDICATIONS AND USAGE 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."],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in breast milk, caution should be exercised when isosorbide is administered to a nursing mother."],"openfda":{},"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS General For oral use only – not for injection. Repetitive doses should be used with caution particularly in patients with diseases associated with salt retention. Ensure that patient’s bladder has been emptied prior to surgery. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the potential of these effects. Pregnancy Pregnancy Category B Reproduction (fertility and teratology) studies have been performed in rats at doses approximately 5 times the recommended initial human dose of 1.5 gm/kg body weight and have revealed no evidence of impaired fertility or harm to the fetus due to isosorbide. Teratology studies have been performed with rabbits and rats given daily oral doses of isosorbide at 6.5 and 10 times, respectively, the recommended initial human dose during organogenesis without evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in breast milk, caution should be exercised when isosorbide is administered to a nursing mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"pregnancy":["Pregnancy Pregnancy Category B Reproduction (fertility and teratology) studies have been performed in rats at doses approximately 5 times the recommended initial human dose of 1.5 gm/kg body weight and have revealed no evidence of impaired fertility or harm to the fetus due to isosorbide. Teratology studies have been performed with rabbits and rats given daily oral doses of isosorbide at 6.5 and 10 times, respectively, the recommended initial human dose during organogenesis without evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used during pregnancy only if clearly needed."],"set_id":"f305b18b-8506-4414-87a1-10aa3b76a691","spl_unclassified_section":["ISMOTIC isosorbide isosorbide isosorbide alcohol caramel crème de menthe malic acid potassium citrate potassium sorbate saccharin calcium sodium citrate sorbitol solution vanilla concentrate imitation #20 potassium hydroxide water"],"version":"1","warnings":["WARNINGS 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."]}