Affordable Pharmaceuticals, Llc

Affordable Pharmaceuticals, Llc Drugs

• Nizatidine Solution
  

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  Nizatidine Solution

  

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  Active Duodenal Ulcer—The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

  Maintenance of Healed Duodenal Ulcer—The recommended oral dosage for adults is 150 mg once daily at bedtime.

  Gastroesophageal Reflux Disease—The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

  Active Benign Gastric Ulcer—The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

  Each mL of Nizatidine Oral Solution contains 15 mg of nizatidine. In adults, Nizatidine Oral Solution may be substituted for any of the above indications using equivalent doses of the oral solution.

  Pediatric Dosing—Each mL of oral solution contains 15 mg of nizatidine. Nizatidine Oral Solution is indicated for pediatric patients 12 years of age or older. For pediatric patients 12 years of age and older, the dosage of nizatidine is 150 mg b.i.d. (2 tsp, b.i.d.)

  The following dosage recommendations are provided:

  Erosive Esophagitis—For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

  Gastroesophageal Reflux Disease—For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

  Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency— The dose for patients with renal dys function should be reduced as follows:

  Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Creatine Clearance Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Creatine Clearance Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

  Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  Based on the pharmacokinetic data in elderly patients with renal impairment, pediatric patients with creatinine clearances less than 50 mL/min should have their dose of nizatidine reduced accordingly. The clinical effects of this dose reduction in pediatric patients with renal failure have not been evaluated.

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• Peg-3350 And Electrolyt...
  

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  Peg-3350 And Electrolytes

  

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  2.1 Dosage Overview

  PEG-3350 and Electrolytes for Oral Solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted PEG-3350 and Electrolytes for Oral Solution solution contains: 236 grams of polyethylene glycol (PEG) 3350, 22.74 grams sodium sulfate (anhydrous), 6.74 grams of sodium bicarbonate, 5.86 grams of sodium chloride, and 2.97 grams of potassium chloride. PEG-3350 and Electrolytes for Oral Solution is also available with pineapple flavor.

  2.2 Administration Instructions Prior to Dosage

  On the day prior to the colonoscopy, instruct patients to:

  Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. Early in the evening prior to colonoscopy, fill the supplied container containing the PEG-3350 and Electrolytes for Oral Solution powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

  2.3 Dosage

  The following is the recommended dose of reconstituted PEG-3350 and Electrolytes for Oral Solution solution for adults. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

  Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) 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. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).

  The first bowel movements should occur approximately one hour after the start of PEG-3350 and Electrolytes for Oral Solution administration. Continue drinking until the watery stool is clear and free of solid matter.

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• Peg-3350
  

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  Peg-3350

  

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  2.1 Dosage Overview

  PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution may be used with or without one of the supplied flavor packs.

  2.2 Administration Instructions Prior to Dosage

  On the day prior to the colonoscopy, instruct patients to:

  Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. If adding a PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon-lime, orange or pineapple) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution flavor packs are for use only in combination with the contents of the accompanying 4 liter container. Early in the evening prior to colonoscopy, fill the supplied container containing the PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

  2.3 Dosage

  The following is the recommended dose of reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

  Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) 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. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour). Pediatric Patients > 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour.

  The first bowel movements should occur approximately one hour after the start of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution administration. Continue drinking until the watery stool is clear and free of solid matter.

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• Peg-3350
  

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  Peg-3350

  

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  2.1 Dosage Overview

  PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution may be used with or without one of the supplied flavor packs.

  2.2 Administration Instructions Prior to Dosage

  On the day prior to the colonoscopy, instruct patients to:

  Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. If adding a PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon-lime, orange or pineapple) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution flavor packs are for use only in combination with the contents of the accompanying 4 liter container. Early in the evening prior to colonoscopy, fill the supplied container containing the PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

  2.3 Dosage

  The following is the recommended dose of reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

  Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) 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. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour). Pediatric Patients > 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour.

  The first bowel movements should occur approximately one hour after the start of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution administration. Continue drinking until the watery stool is clear and free of solid matter.

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