Cumberland Pharmaceuticals Inc.

Cumberland Pharmaceuticals Inc. Drugs

• Kristalose
  

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  Kristalose

  

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  The usual adult dosage is 10 g to 20 g of lactulose daily. The dose may be increased to 40 g daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement.

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• Acetadote
  

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  Acetadote

  

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  The total dose of Acetadote is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).

  2.1 Administration Instructions (Three–Bag Method: Loading, Second and Third Dose)

  Dosing for Patients who weigh 5 kg to 20 kg (Table 1):

  Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr

  Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs

  Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs

  Table 1. Three Bag Method Dosage Guide by Weight in Patients 5 kg to 20 kg

  *Acetadote is compatible with the following diluents; 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

  BodyWeight (kg) Bag 1 (loading dose):150 mg/kg in 3 mL/kg of diluent* infused over 1 hour Bag 2 (second dose)50 mg/kg in 7mL/kg of diluent* infused over 4 hours Bag 3 (third dose)100 mg/kg diluted in 14 mL/kg of diluent* infused over 16 hours Acetadote Total Dose Diluentvolume Acetadote Total Dose Diluentvolume Acetadote Total Dose Diluentvolume 5 kg 750 mg 15 mL 250 mg 35 mL 500 mg 70 mL 10 kg 1,500 mg 30 mL 500 mg 70 mL 1,000 mg 140mL 15 kg 2,250 mg 45 mL 750 mg 105mL 1,500 mg 210mL 20 kg 3,000 mg 60 mL 1,000mg 140mL 2,000 mg 280mL

  See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

  Dosing for patients who weigh 21 kg to 40 kg (Table 2):

  Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr

  Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs

  Third Dose: 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs

  Table 2. Three Bag Method Dosage Guide by Weight in Patients 21 kg to 40 kg

  *Acetadote is compatible with the following diluents; 5% Dextrose in Water 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

  BodyWeight (kg) Bag 1 (loading dose):150 mg/kg in 100 mL of diluent* infused over 1 hr Bag 2 (second dose)50 mg/kg in 250 mL of diluent* infused over 4 hrs Bag 3 (third dose)100 mg/kg in 500 mL of diluent* infused over 16 hrs AcetadoteTotal Dose (mg) AcetadoteTotal Dose (mg) AcetadoteTotal Dose (mg) 21 kg 3,150 mg 1,050 mg 2,100 mg 30 kg 4,500 mg 1,500 mg 3,000 mg 40 kg 6,000 mg 2,000 mg 4,000 mg

  See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.

  Dosing for patients who weigh 41 kg to 100 kg (Table 3):

  Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr

  Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs

  Third Dose: 100 mg/kg diluted in 1000 mL of diluent* administered over 16 hrs

  Table 3. Three Bag Method Dosage Guide by Weight in Patients 41 kg to 100 kg

  *Acetadote is compatible with the following diluents; 5% Dextrose 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

  BodyWeight (kg) Bag 1 (loading dose):150 mg/kg diluted in 200 mL of diluent* infused over 1 hr Bag 2 (second dose):50 mg/kg diluted in 500 mL of diluent* infused over 4 hrs Bag 3 (third dose):100 mg/kg diluted in 1000 mL of diluent* infused over 16 hrs Acetadote Total Dose (mg) Acetadote Total Dose (mg) Acetadote Total Dose (mg) 41 kg 6,150 mg 2,050 mg 4,100 mg 50 kg 7,500 mg 2,500 mg 5,000 mg 60 kg 9,000 mg 3,000 mg 6,000 mg 70 kg 10,500 mg 3,500 mg 7,000 mg 80 kg 12,000 mg 4,000 mg 8,000 mg 90 kg 13,500 mg 4,500 mg 9,000 mg 100 kg 15,000 mg 5,000 mg 10,000 mg

  Patients Weighing More Than 100 kg

  No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of Acetadote recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours (See Table 3).

  Continued Therapy beyond 21 Hours

  While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged, in such cases consideration should be given to the need for continued infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.

  2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

  The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. [see Dosage and Administration (2)].

  As Acetadote is hyperosmolar (2600 mOsmol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.

  Table 4. Acetadote Concentration and Osmolarity

  *Osmolarity should be adjusted to a physiologically safe level, (generally not less than 150mOsmol/L in children).

  Acetadote Concentration (mg/mL) Osmolarity in ½ Normal Saline Osmolarity in D5W Osmolarity in Sterile Water for Injection 7 mg/mL 245 mOsmol/L 343 mOsmol/L 91 mOsmol/L* 24 mg/m/L 466 mOsmol/L 564 mOsmol/L 312 mOsmol/L

  Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.

  Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.

  Note: The color of Acetadote may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.

  2.3 Renal Impairment

  No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

  2.4 Hepatic Impairment

  Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.

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• Caldolor
  

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  Caldolor

  

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  Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. After observing the response to initial therapy with Caldolor, the dose and frequency should be adjusted to suit an individual patient's needs. Do not exceed 3200 mg total daily dose.

  To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Caldolor.

  2.1 Analgesia (Pain)

  Administer 400 mg to 800 mg intravenously every 6 hours as necessary. Infusion time must be no less than 30 minutes.

  2.2 Antipyretic (Fever)

  Administer 400 mg intravenously, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. Infusion time must be no less than 30 minutes.

  2.3 Preparation and Administration

  Caldolor must be diluted prior to intravenous infusion. Dilute to a final concentration of 4 mg/mL or less. Appropriate diluents include 0.9% Sodium Chloride Injection USP (normal saline), 5% Dextrose Injection USP (D5W), or Lactated Ringers Solution.

  800 mg dose: Dilute 8 mL of Caldolor in no less than 200 mL of diluent. 400 mg dose: Dilute 4 mL of Caldolor in no less than 100 mL of diluent.

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particulates are observed, the solution should not be used.

  Diluted solutions are stable for up to 24 hours at ambient temperature (approximately 20 to 25° C) and room lighting.

  Infusion time must be no less than 30 minutes.

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