Lotemax

Lotemax Manufacturers

• Physicians Total Care, Inc.
  

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  Lotemax | Physicians Total Care, Inc.

  

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  SHAKE VIGOROUSLY BEFORE USING.

  Steroid Responsive Disease Treatment: Apply one to two drops of LOTEMAX into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (See PRECAUTIONS).

  Post-Operative Inflammation: Apply one to two drops of LOTEMAX into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

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• Bausch & Lomb Incorporated
  

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  Lotemax | Lundbeck Llc

  

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  2.1       Important Dosing Instructions 

  SABRIL is given orally with or without food. The SABRIL dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution). Patients with impaired renal function require dose adjustment [see Dosage and Administration (2.4)]. 

  SABRIL tablets and powder for oral solution are bioequivalent. Either tablet or powder can be used for CPS. Powder for oral solution should be used for IS; tablets should not be used for IS because of difficulty in the administration of tablets to infants and young children.

  SABRIL powder for oral solution should be mixed with water prior to administration.

  If using SABRIL powder for oral solution, physicians should review and discuss the Medication Guide and instructions for mixing and giving SABRIL with the patient or caregiver(s). Physicians should confirm that patients or caregiver(s) understand how to mix SABRIL powder with water and administer the correct daily dose. Empty the entire contents of each 500 mg packet into a clean cup, and dissolve in 10 mL of cold or room temperature water per packet (see Table 2). Administer the resulting solution using the 10 mL oral syringe supplied with the medication. The concentration of the final solution is 50 mg/mL. Discard the resulting solution if it is not clear (or free of particles) and colorless. Each individual dose should be prepared and used immediately. Discard any unused portion of the solution after administering the correct dose.

  Monitoring of SABRIL plasma concentrations to optimize therapy is not helpful.

  If a decision is made to discontinue SABRIL, the dose should be gradually reduced [see Warnings and Precautions (5.6)].

  2.2       Refractory Complex Partial Seizures

  Adults (Patients 17 Years of Age and Older)
  Treatment should be initiated at 1000 mg/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals depending on response. The recommended dose of SABRIL in adults is 3000 mg/day (1500 mg twice daily).  A 6000 mg/day dose has not been shown to confer additional benefit compared to the 3000 mg/day dose and is associated with an increased incidence of adverse events.

  In controlled clinical studies in adults with complex partial seizures, SABRIL was tapered by decreasing the daily dose 1000 mg/day on a weekly basis until discontinued [see Warnings and Precautions (5.6)].

  Pediatric (Patients 10 to 16 Years of Age)
  Treatment is based on body weight as shown in Table 1. Treatment should be initiated at a total daily dose of 500 mg/day (250 mg twice daily) and may be increased weekly in 500 mg/day increments to a total maintenance dose of 2000 mg/day (1000 mg twice daily). Patients weighing more than 60 kg should be dosed according to adult recommendations. 

  Table 1. Pediatric CPS Dosing Recommendations     Body Weight
  [kg]   Total Daily*
  Starting Dose
  [mg/day]   Total Daily*
  Maintenance Dose†
  [mg/day]   25 to 60††   500   2000

  *Administered in two divided doses.
  †Maintenance dose is based on 3000 mg/day adult-equivalent dose
  †† Patients weighing more than 60 kg should be dosed according to adult recommendations

  In a controlled study in pediatric patients with complex partial seizures, SABRIL was tapered by decreasing the daily dose by one third every week for three weeks [see Warnings and Precautions (5.6)].

  2.3       Infantile Spasms

  The initial daily dosing is 50 mg/kg/day given in two divided doses (25 mg/kg twice daily); subsequent dosing can be titrated by 25 mg/kg/day to 50 mg/kg/day increments every 3 days, up to a maximum of 150 mg/kg/day given in 2 divided doses (75 mg/kg twice daily) [see Use in Specific Populations (8.4)].

  Table 2 below describes how many packets and how many milliliters (mL) of water will be needed to prepare each individual dose. The concentration after reconstitution is 50 mg/mL.

  Table 2. Number of SABRIL Packets and mL of Water Needed for Each Individual Dose     Individual Dose [mg]
  [Given Twice Daily]    Total Number of
  SABRIL Packets    Total mL of Water
  Required for Dissolving    0 to 500    1 Packet    10 mL    501 to 1000    2 Packets    20 mL    1001 to 1500    3 Packets    30 mL

  Table 3 provides the volume of the 50 mg/mL dosing solution that should be administered as individual doses in infants of various weights.

  Table 3. Infant Dosing Table   Weight
  [kg]  Starting Dose
  50 mg/kg/day  Maximum Dose
  150 mg/kg/day    3    1.5 mL twice daily    4.5 mL twice daily    4    2 mL twice daily    6 mL twice daily    5    2.5 mL twice daily    7.5 mL twice daily    6    3 mL twice daily    9 mL twice daily    7    3.5 mL twice daily    10.5 mL twice daily    8    4 mL twice daily    12 mL twice daily    9    4.5 mL twice daily    13.5 mL twice daily    10    5 mL twice daily    15 mL twice daily    11    5.5 mL twice daily    16.5 mL twice daily    12    6 mL twice daily    18 mL twice daily    13    6.5 mL twice daily    19.5 mL twice daily    14    7 mL twice daily    21 mL twice daily    15    7.5 mL twice daily    22.5 mL twice daily    16    8 mL twice daily    24 mL twice daily 

  In a controlled clinical study in patients with infantile spasms, SABRIL was tapered by decreasing the daily dose at a rate of 25 mg/kg to 50 mg/kg every 3 to 4 days [see Warnings and Precautions (5.6)].

  2.4       Patients with Renal Impairment

  SABRIL is primarily eliminated through the kidney.

  Infants
  Information about how to adjust the dose in infants with renal impairment is unavailable.

  Adult and pediatric patients 10 years and older

  Mild renal impairment (CLcr >50 to 80 mL/min): dose should be decreased by 25% Moderate renal impairment (CLcr >30 to 50 mL/min): dose should be decreased by 50% Severe renal impairment (CLcr >10 to 30 mL/min): dose should be decreased by 75%.

  CLcr in mL/min may be estimated from serum creatinine (mg/dL) using the following formulas:

  Patients 10 to <12 years old:  CLcr (mL/min/1.73 m2) = (K × Ht) / Scr

                                              height (Ht) in cm; serum creatinine (Scr) in mg/dL
                                              K (proportionality constant): Female Child (<12 years):  K=0.55;
                                              Male Child (<12 years):  K=0.70

  Adult and pediatric patients 12 years or older: CLcr (mL/min) = [140-age (years)] × weight (kg) / [72 × serum creatinine (mg/dL)] (×0.85 for female patients)

  The effect of dialysis on SABRIL clearance has not been adequately studied [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)].

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• Bausch & Lomb Incorporated
  

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  Lotemax | Bausch & Lomb Incorporated

  

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  SHAKE VIGOROUSLY BEFORE USING.

  Steroid Responsive Disease Treatment: Apply one to two drops of LOTEMAX into the conjunctival sac of the affected eye four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (See PRECAUTIONS).

  Post-Operative Inflammation: Apply one to two drops of LOTEMAX into the conjunctival sac of the operated eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

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• Bausch & Lomb Incorporated
  

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  Lotemax | Par Pharmaceutical, Inc.

  

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  The recommended starting adult dose for all cholestyramine for oral suspension powdered products (Cholestyramine for Oral Suspension USP and Cholestyramine for Oral Suspension USP, Light) is one packet or one level scoopful once or twice a day. The recommended maintenance dose for all cholestyramine for oral suspension powdered products is 2 to 4 packets or scoopfuls daily (8-16 grams anhydrous cholestyramine resin) divided into two doses. Four grams of anhydrous cholestyramine resin is contained in each measured dose of Cholestyramine as follows:

  Cholestyramine for Oral Suspension USP

  9 grams

  Cholestyramine for Oral Suspension USP, Light

  5 grams

  It is recommended that increases in dose be gradual with periodic assessment of lipid/lipoprotein levels at intervals of not less than 4 weeks. The maximum recommended daily dose is six packets or scoopfuls of cholestyramine for oral suspension (24 grams of anhydrous cholestyramine resin). The suggested time of administration is at mealtime but may be modified to avoid interference with absorption of other medications. Although the recommended dosing schedule is twice daily, cholestyramine for oral suspension may be administered in 1 to 6 doses per day.

  Cholestyramine should not be taken in its dry form. Always mix Cholestyramine with water or other fluids before ingesting. See Preparation Instructions.

  Concomitant Therapy

  Preliminary evidence suggests that the lipid-lowering effects of Cholestyramine on total and LDL-cholesterol are enhanced when combined with a HMG-CoA reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin, and fluvastatin. Additive effects on LDL-cholesterol are also seen with combined nicotinic acid/Cholestyramine therapy. See the Drug Interactions subsection of the PRECAUTIONS section for recommendations on administering concomitant therapy.

  PREPARATION

  The color of Cholestyramine may vary somewhat from batch to batch but this variation does not affect the performance of the product. Place the contents of one single-dose packet or one level scoopful of Cholestyramine in a glass or cup. Add an amount of water or other non-carbonated beverage of your choice depending on the product being used:

  Product Formula

  Amount of Water or other Non-Carbonated Liquid

  Cholestyramine for Oral Suspension USP

  2-6 ounces per dose

  Cholestyramine for Oral Suspension USP, Light

  2-6 ounces per dose

  Stir to a uniform consistency and drink.

  Cholestyramine may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

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