Rxpak Division Of Mckesson Corporation

Rxpak Division Of Mckesson Corporation Drugs

• Klor-con
  

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  Klor-con

  

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  The usual dietary potassium intake by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more of potassium from the total body store.

  Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

  Each Klor-Con® Extended-release Tablet provides 8 mEq or 10 mEq of potassium chloride.

  Klor-Con® Extended-release Tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).

  NOTE: Klor-Con® Extended-release Tablets must be swallowed whole and never crushed, chewed, or sucked.

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• Pacerone
  

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  Pacerone

  

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  BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, PACERONE® TABLETS SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.

  In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of Pacerone® Tablets has not been determined. Because of the food effect on absorption, Pacerone® Tablets should be administered consistently with regard to meals (see "CLINICAL PHARMACOLOGY"). Individual patient titration is suggested according to the following guidelines:

  For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia: Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of Pacerone® Tablets in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardia usually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats.

  Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see "PRECAUTIONS, Drug Interactions").

  Upon starting Pacerone® Tablets therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see section on "Drug Interactions"). When adequate arrhythmia control is achieved, or if side effects become prominent, Pacerone® Tablets dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see "CLINICAL PHARMACOLOGY, Monitoring Effectiveness"). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Pacerone® Tablets may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenance dose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings and/or programmed electrical stimulation, and by patient tolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity (see "CLINICAL PHARMACOLOGY").

  The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient's arrhythmia and response to therapy.

  When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

  Loading Dose (Daily) Adjustment and Maintenance Dose (Daily)

  VentricularArrhythmias

  1 to 3 weeks

  ~1 month

  usualmaintenance

  800 to 1,600 mg

  600 to 800 mg

  400 mg

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• Keppra
  

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  Keppra

  

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  2.1 Important Administration Instructions

  KEPPRA is given orally with or without food. The KEPPRA dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution, in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  KEPPRA tablets should be swallowed whole. KEPPRA tablets should not be chewed or crushed.

  2.2 Partial Onset Seizures

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)], a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month to < 6 Months

  Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For KEPPRA tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For KEPPRA tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  KEPPRA Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  Total daily dose (mL/day) =  

  Daily dose (mg/kg/day) × patient weight (kg)

  -----------------------------------------

  100 mg/mL

  2.3 Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

  2.5 Adult Patients with Impaired Renal Function

  KEPPRA dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr=  

  [140-age (years)] × weight (kg)

   

  -----------------------------------------   (× 0.85 for female patients)

  72 × serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2)=  

    CLcr (mL/min)

   

  ----------------------------   × 1.73

    BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73m2) Dosage (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended.

  Normal

  > 80

  500 to 1,500

  Every 12 hours

  Mild

  50 – 80

  500 to 1,000

  Every 12 hours

  Moderate

  30 – 50

  250 to 750

  Every 12 hours

  Severe

  < 30

  250 to 500

  Every 12 hours

  ESRD patients using dialysis

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  500 to 1,000*

  Every 24 hours*

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• Keppra Xr
  

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  Keppra Xr

  

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  KEPPRA XR is administered once daily.

  Treatment should be initiated with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended once daily dose of 3000 mg.

  2.1 Adult Patients with Impaired Renal Function

  KEPPRA XR dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr=

  [140-age (years)] × weight (kg)

  (× 0.85 for female patients)

  72 × serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m2)=

  CLcr (mL/min)

  × 1.73

  BSA subject (m2)

  Table 1: Dosing Adjustment Regimen For Adult Patients With Impaired Renal Function Group Creatinine Clearance (mL/min/1.73m2) Dosage (mg) Frequency

  Normal

  > 80

  1000 to 3000

  Every 24 hours

  Mild

  50 – 80

  1000 to 2000

  Every 24 hours

  Moderate

  30 – 50

  500 to 1500

  Every 24 hours

  Severe

  < 30

  500 to 1000

  Every 24 hours

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• Donnatal
  

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  Donnatal

  

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  The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a

  minimum of adverse effects.

  Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity

  of symptoms.

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• Albenza
  

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  Albenza

  

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  Dosing of ALBENZA will vary, depending upon which of the following parasitic infections is being treated. In young children, the tablets should be crushed or chewed and swallowed with a drink of water.

   Indication

   Patient Weight

   Dose

   Duration

   Hydatid Disease

   60 kg or greater

   400 mg twice daily, with meals

   28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles

   less than 60 kg

   15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

  NOTE: When administering ALBENZA in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when 3 courses of therapy have been given.

   Neurocysticercosis

   60 kg or greater

   400 mg twice daily, with meals

   8 to 30 days

   less than 60 kg

   15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

  Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment.

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• Ativan
  

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  Ativan

  

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  Ativan (lorazepam) is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.

  The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.

  For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.

  For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.

  For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.

  The dosage of Ativan (lorazepam) should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.

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