Prescription Drugs

CLINICAL PHARMACOLOGY GaviLyte-G induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.

CLINICAL PHARMACOLOGY GaviLyte-C with flavor pack cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance.

GaviLyte™ -G (PEG-3350 (236g) and Electrolytes For Oral Solution, USP) DESCRIPTION GaviLyte-G is a white powder in a 4 liter jug tor reconstitution, containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride. When dissolved in water to a volume of 4 liters, GaviLyfe-G (PEG-3350 (236g) and Electrolytes for Oral Solution, USP) is an isosmotic solution, for oral administration, having a mildly salty taste. GaviLyte-G is administered orally or via nasogastric tube as a gastrointestinal lavage.

GaviLyte™-C with Flavor Pack (PEG-3350 (240 g) and Electrolytes for Oral Solution, USP) with Flavor Pack For Gastrointestinal Lavage DESCRIPTION GaviLyte-C with flavor pack is a white, colon lavage preparation provided as water-soluble components for solution. This preparation with lemon flavor pack added delivers the following, in grams per liter: Polyethylene glycol 3350-------- 60.00 Sodium chloride----------------- 1.46 Potassium Chloride --------------0.745 Sodium bicarbonate------------- 1.68 Sodium sulfate -------------------5.68 Flavor ingredients ----------------0.500 When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is an isosmotic solution, for oral administration, having mild salty taste. This preparation can be used without the flavor pack and is administered orally or via nasogastric tube. Each lemon flavor pack (2 g) contains natural lemon flavor powder, saccharin sodium, maltodextrin,

INDICATIONS GaviLyte-G is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination. DOSAGE AND ADMINISTRATION The recommended dose for adults is 4 liters of GaviLyte-G solution prior to gastrointestinal examination, as ingestion of this dose produces a satisfactory preparation in over 95% of patients. Ideally, the patients should fast for approximately three or four hours priorto GaviLyte-G administration, but in no case should solid food be given for at least two hours before the solution is given. GaviLyte-G is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Oral administration is at a rate of 240 mL (8oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric tube administration is at the rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour). The first bowel movement should occur approximately one hour after the start of GaviLyte-G administration. Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer GaviLyte-G on the evening before the examination, particularly if the patient is to have a barium enema Preparation Of The solution GaviLyte-G is prepared by filing the container to the 4 liter mark with water and shaking vigorously several times to ensure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before admin istration. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion. HOW SUPPLIED GaviLyte-G is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has the attached lemon flavor pack, in powdered form, for the addition of the flavor packet by the pharmacist priorto dispensing. Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g and lemon flavor pack 2 g (optional). When made up to 4 liters volume with water, the solution contains PEG-335017.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L Storage Store in sealed container at 59°-86°F. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused potion, NDC 43386-090-19 Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: GAVIS Pharmaceuticals, LLC., Somerset, NJ 08873. Revised: 2012

INDICATIONS GaviLyte-C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. DOSAGE AND ADMINISTRATION GaviLyte-C with flavor pack can be administered orally or by nasogastric tube. Patients should fast at least 3 hours priorto administration. A one hour waiting period after the appearance of clear liquid stool should be allowed Rriorto examination to complete bowel evacuation, No foods except clear liquids should be permitted priorto examination after GaviLyte-C with flavor pack administration. Oral The recommended adult oral dose is 240 mL (8fl. Oz.) every 10 minutes (see PATIENT INFORMATION). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 to 4 liters. Nasogastric Tube GaviLyte-C with flavor pack is administered at the rate of 20 to 30 mL per minute (1.2 to 1.8 L/hour). Preparation Of GaviLyte-C with flavor pack Sglution This preparation can be used with or without the lemon flavor pack. To add flavor, tear open lemon flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. SHAKE WELL to incorporate flavoring into the powder. Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.) Note: If not using flavor pack, omit steps one and two, above. HOW SUPPLIED GaviLyte-C with flavor pack is supplied in 4 liter bottles with an attached lemon flavor pack. Each 4 liter bottle contains polyethylene glycol-3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate {anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution. GaviLyte-C with flavor pack 4 liter : NDC 43386-060-19 Store at 20° to 25°C (68° TO 77°F): excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION. Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873, USA. Distributed by: GAVIS Pharmaceuticals, LLC., Somerset, NJ 08873, USA. RevISED: Aug 2012

PATIENT INFORMATION GaviLyte-G produces a watery stool which cleanses the bowel before examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking GaviLyte-G. Drink 240 mL (8oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of GaviLyte-G administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort ordistention occur, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters and it is best to drink all of the solution. Any unused solution should be discarded.

PATIENT INFORMATION GaviLyte-C with flavor pack produces a watery stool which cleanses the bowel prior to examination. For best results, no solid food should be ingested during the 3 to 4 hour period prior to the initiation of GaviLyte-C with flavor pack administration. In no case should solid foods be eaten within 2 hours of drinking GaviLyte-C with flavor pack. The rate of administration is 240 mL (8 fl. oz.) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of GaviLyte-C with flavor pack administration. Administration of GaviLyte-C with flavor pack should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3 to 4 liters (3 to 4 quarts), although more or less may be required in some patients. The unused portion should be discarded.

OVERDOSE No information provided. CONTRAINDICATIONS GaviLyte-G is contraindicated in patients known to be hypersensitive to any of the components. GaviLyte-G is contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus.

OVERDOSE No information provided. CONTRAINDICATIONS GaviLyte-C with flavor pack is contraindicated in patients known to be hypersensitive to any of the components. GaviLyte-C with flavor pack is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

SIDE EFFECTS Nausea, abdominal dullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GaviLyte-G. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper Gl bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG. DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of GaviLyte-G may be flushed from the gastrointestinal tract and not absorbed.

SIDE EFFECTS Nausea, abdominal fullness and bloating are the most common adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported, which may represent allergic reactions. DRUG INTERACTIONS Oral medication administered within one hour of start of administration of GaviLyte-C with flavor pack may be flushed from the gastrointestinal tract and not absorbed.

WARNINGS The lemon flavor pack is for use only in combination with the contents of the accompanying 4 liter container. No additional ingredients, e.g. flavorings, should be added to the solution. GaviLyte-G should be used with caution in patients with severe ulcerative colitis. PRECAUTIONS General Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of GaviLyte-G, especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. It gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of GaviLyte-G. Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenic and reproductive studies with animals have not been performed. Pregnancy Category C Animal reproduction studies have not been conducted with GaviLyte-G. It is also not known whether GaviLyte-G can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-G should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in children have not been established.

WARNINGS Flavor pack is for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. GaviLyte-C with flavor pack should be used with caution in patients with severe ulcerative colitis. PRECAUTIONS General Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of GaviLyte-C with flavor pack, especially if it is administered via nasogastric tube. If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of GaviLyte-C with flavor pack. Carcinogenesis, Mutagenesis, Impairment Of Fertility Studies to evaluate carcinogenic or mutagenic potential or potential to adversely affect male or female fertility have not been performed. Pregnancy Category C Animal reproduction studies have not been conducted with GaviLyte-C with flavor pack, and it is not known whether GaviLyte-C with flavor pack can affect reproductive capacity or harm the fetus when administered to a pregnant patient GaviLyte-C with flavor pack should be given to a pregnant patient only if clearly needed. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper Gl bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrate on chest X-ray after vomiting and aspirating PEG.