Vyvanse

Vyvanse Manufacturers

• Physicians Total Care, Inc.
  

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  Vyvanse | Physicians Total Care, Inc.

  

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  Dosage should be individualized according to the therapeutic needs and response of the patient. Vyvanse should be administered at the lowest effective dosage.

  In patients who are either starting treatment for the first time or switching from another medication, 30 mg once daily in the morning is the recommended dose. If the decision is made in the judgment of the clinician to increase the dose beyond 30 mg/day, daily dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals. The maximum recommended dose is 70 mg/day; doses greater than 70 mg/day of Vyvanse have not been studied. Vyvanse has not been studied in children under 6 years of age.

  Vyvanse should be taken in the morning. Afternoon doses should be avoided because of the potential for insomnia.

  Vyvanse may be taken with or without food.

  Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

  Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.

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• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

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  Vyvanse | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

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  2.1 General Instructions for Use

  Vyvanse should be taken in the morning with or without food.  Afternoon doses should be avoided because of the potential for insomnia.

  Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water.  The solution should be consumed immediately and should not be stored.  The dose of a single capsule should not be divided.  The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

  2.2 Initiation Treatment

  The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above.  Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day; Doses greater than 70 mg/day have not been studied.

  Dosage should be individualized according to the therapeutic needs and response of the patient.  Vyvanse should be administered at the lowest effective dosage.  The least amount of Vyvanse feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

  2.3 Maintenance/Extended Treatment

  It is generally agreed that pharmacological treatment of ADHD may be needed for extended periods.  The benefit of maintaining adult patients (ages 18-55 years) with ADHD on Vyvanse was demonstrated in a controlled randomized withdrawal trial [see Clinical Studies (14)].  Subjects assigned to Vyvanse in the randomized withdrawal phase continued on the same dose used to confirm response in the open-label phase.

  The physician who elects to use Vyvanse for extended periods should periodically re-evaluate the long-term usefulness of Vyvanse for the individual patient.  Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.

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• Shire Llc
  

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  Vyvanse | Abbvie Inc.

  

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  2.1 General Administration Recommendations

  KALETRA tablets may be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed. KALETRA oral solution must be taken with food.

  2.2 Dosage Recommendations in Adults

  Considerations in Determining KALETRA Once Daily vs. Twice Daily Dosing Regimen:

  KALETRA can be given as once daily or twice daily dosing regimen in patients with less than three lopinavir resistance-associated substitutions. KALETRA must be given as twice daily dosing regimen in patients with three or more resistance-associated substitutions. Table 1 includes the recommended once daily dosing regimen and Tables 2 and 3 include the recommended twice daily dosing regimen.

  KALETRA once daily dosing regimen is not recommended in:

  Adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Microbiology (12.4)]. In combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7.3)]. In combination with efavirenz, nevirapine, or nelfinavir [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)]. In pregnant women [see Dosage and Administration (2.4), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

  The dose of KALETRA must be increased when administered in combination with efavirenz, nevirapine or nelfinavir.

  Table 3 outlines the dosage recommendations for twice daily dosing when KALETRA is taken in combination with efavirenz, nevirapine or nelfinavir.

  Table 1. Recommended Dosage in Adults- KALETRA Once Daily Regimen KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day 200/50 mg Tablet 4 tablets orally once daily 800/200 mg 400/100 mg Oral Solution 10 mL orally once daily 800/200 mg Table 2. Recommended Dosage in Adults - KALETRA Twice Daily Regimen KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day 200/50 mg Tablet 2 tablets orally twice daily 800/200 mg 400/100 mg Oral Solution 5 mL orally twice daily 800/200 mg Table 3. Recommended Dosage in Adults - KALETRA Twice Daily Regimen in Combination with Efavirenz, Nevirapine, or Nelfinavir KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day 200/50 mg Tablet and 100/25 mg Tablet 2 KALETRA 200/50 mg tablets and
  1 KALETRA 100/25 mg tablet orally twice daily 1000/250 mg 400/100 mg Oral Solution 6.5 mL orally twice daily 1000/250 mg 2.3 Dosage Recommendations in Pediatric Patients

  KALETRA tablets and oral solution should not be administered once daily in pediatric patients < 18 years of age. The dose of the oral solution should be administered using a calibrated dosing syringe.

  Before prescribing KALETRA 100/25 mg tablets, children should be assessed for the ability to swallow intact tablets. If a child is unable to reliably swallow a KALETRA tablet, the KALETRA oral solution formulation should be prescribed.

  KALETRA oral solution should not be administered to neonates before a postmenstrual age (first day of the mother’s last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days has been attained [see Warnings and Precautions (5.2)].

  KALETRA oral solution contains 42.4% (v/v) alcohol and 15.3% (w/v) propylene glycol. Special attention should be given to accurate calculation of the dosage of KALETRA, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors, and overdose. This is especially important for infants and young children. Total amounts of alcohol and propylene glycol from all medicines that are to be given to pediatric patients 14 days to 6 months of age should be taken into account in order to avoid toxicity from these excipients [see Warnings and Precautions (5.2) and Overdosage (10)].

  Pediatric Dosage Calculations

  Calculate the appropriate dose of KALETRA for each individual pediatric patient based on body weight (kg) or body surface area (BSA) to avoid underdosing or exceeding the recommended adult dose.

  Body surface area (BSA) can be calculated as follows:

  The KALETRA dose can be calculated based on weight or BSA:

  Based on Weight:

  Patient Weight (kg) × Prescribed lopinavir dose (mg/kg) = Administered lopinavir dose (mg)

  Based on BSA:

  Patient BSA (m2) × Prescribed lopinavir dose (mg/m2) = Administered lopinavir dose (mg)

  If KALETRA oral solution is used, the volume (mL) of KALETRA solution can be determined as follows:

  Volume of KALETRA solution (mL) = Administered lopinavir dose (mg) ÷ 80 (mg/mL)

  Dosage Recommendation in Pediatric Patients 14 Days to 6 Months:

  In pediatric patients 14 days to 6 months of age, the recommended dosage of lopinavir/ritonavir using KALETRA oral solution is 16/4 mg/kg or 300/75 mg/m2 twice daily. Prescribers should calculate the appropriate dose based on body weight or body surface area. Table 4 summarizes the recommended daily dosing regimen for pediatric patients 14 days to 6 months.

  It is recommended that KALETRA not be administered in combination with efavirenz, nevirapine, or nelfinavir in patients < 6 months of age.

  Table 4. Recommended KALETRA Oral Daily Dosage in Pediatric Patients 14 days to 6 months Patient Age Based on Weight (mg/kg) Based on BSA (mg/m2) Frequency 14 days to 6 months 16/4 300/75 Given twice daily

  Dosage Recommendation in Pediatric Patients 6 Months to 18 Years:

  Without Concomitant Efavirenz, Nevirapine, or Nelfinavir

  Dosing recommendations using oral solution

  In children 6 months to 18 years of age, the recommended dosage of lopinavir/ritonavir using KALETRA oral solution without concomitant efavirenz, nevirapine, or nelfinavir is 230/57.5 mg/m2 given twice daily, not to exceed the recommended adult dose (400/100 mg [5 mL] twice daily). If weight-based dosing is preferred, the recommended dosage of lopinavir/ritonavir for patients < 15 kg is 12/3 mg/kg given twice daily and the dosage for patients ≥ 15 kg to 40 kg is 10/2.5 mg/kg given twice daily. Table 5 summarizes the recommended daily dosing regimen for pediatric patients 6 months to 18 years.

  Table 5. Recommended KALETRA Oral Daily Dosage in Pediatric Patients 6 months to 18 years Patient Age Based on Weight (mg/kg) Based on BSA (mg/m2) Frequency 6 months to 18 years <15 kg 12/3 230/57.5 Given twice daily ≥15 kg to 40 kg 10/2.5

  Dosing recommendations using tablets

  Table 6 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for KALETRA tablets.

  Table 6. Pediatric Dosing Recommendations for Patients 6 Months to 18 Years of Age Based on Body Weight or Body Surface Area for KALETRA Tablets Without Concomitant Efavirenz, Nevirapine, or Nelfinavir Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily 15 to 25 ≥0.6 to < 0.9 2 >25 to 35 ≥0.9 to < 1.4 3 >35 ≥1.4 4 (or two 200/50 mg tablets) * KALETRA oral solution is available for children with a BSA less than 0.6 m2 or those who are unable to reliably swallow a tablet.

  Concomitant Therapy: Efavirenz, Nevirapine, or Nelfinavir

  Dosing recommendations using oral solution

  A dose increase of KALETRA to 300/75 mg/m2 using KALETRA oral solution is needed when co-administered with efavirenz, nevirapine, or nelfinavir in children (both treatment-naïve and treatment-experienced) 6 months to 18 years of age, not to exceed the recommended adult dose (533/133 mg [6.5 mL] twice daily). If weight-based dosing is preferred, the recommended dosage for patients <15 kg is 13/3.25 mg/kg given twice daily and the dosage for patients >15 kg to 45 kg is 11/2.75 mg/kg given twice daily.

  Dosing recommendations using tablets

  Table 7 provides the dosing recommendations for pediatric patients 6 months to 18 years of age based on body weight or body surface area for KALETRA tablets when given in combination with efavirenz, nevirapine, or nelfinavir.

  Table 7. Pediatric Dosing Recommendations for Patients 6 Months to 18 Years of Age Based on Body Weight or Body Surface Area for KALETRA Tablets With Concomitant Efavirenz†, Nevirapine, or Nelfinavir† Body Weight (kg) Body Surface Area (m2)* Recommended number of
  100/25 mg Tablets Twice Daily 15 to 20 ≥0.6 to < 0.8 2 >20 to 30 ≥0.8 to < 1.2 3 >30 to 45 ≥1.2 to <1.7 4 (or two 200/50 mg tablets) >45 ≥1.7 5 [see Dosage and Administration (2.2)] * KALETRA oral solution is available for children with a BSA less than 0.6 m2 or those who are unable to reliably swallow a tablet.
  † Please refer to the individual product labels for appropriate dosing in children. 2.4 Dosage Recommendations in Pregnancy

  Administer 400/100 mg of KALETRA twice daily in pregnant patients with no documented lopinavir-associated resistance substitutions. Once daily KALETRA dosing is not recommended in pregnancy [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

  There are insufficient data to recommend dosing in pregnant women with any documented lopinavir-associated resistance substitutions. No dosage adjustment of KALETRA is required for patients during the postpartum period. Avoid use of KALETRA oral solution in pregnant women [see Use in Specific Populations (8.1)]. 2.1 General Administration Recommendations

  KALETRA tablets may be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed. KALETRA oral solution must be taken with food.

  2.2 Dosage Recommendations in Adults

  Considerations in Determining KALETRA Once Daily vs. Twice Daily Dosing Regimen:

  KALETRA can be given as once daily or twice daily dosing regimen in patients with less than three lopinavir resistance-associated substitutions. KALETRA must be given as twice daily dosing regimen in patients with three or more resistance-associated substitutions. Table 1 includes the recommended once daily dosing regimen and Tables 2 and 3 include the recommended twice daily dosing regimen.

  KALETRA once daily dosing regimen is not recommended in:

  Adult patients with three or more of the following lopinavir resistance-associated substitutions: L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V [see Microbiology (12.4)]. In combination with carbamazepine, phenobarbital, or phenytoin [see Drug Interactions (7.3)]. In combination with efavirenz, nevirapine, or nelfinavir [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)]. In pregnant women [see Dosage and Administration (2.4), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

  The dose of KALETRA must be increased when administered in combination with efavirenz, nevirapine or nelfinavir.

  Table 3 outlines the dosage recommendations for twice daily dosing when KALETRA is taken in combination with efavirenz, nevirapine or nelfinavir.

  Table 1. Recommended Dosage in Adults- KALETRA Once Daily Regimen KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day 200/50 mg Tablet 4 tablets orally once daily 800/200 mg 400/100 mg Oral Solution 10 mL orally once daily 800/200 mg Table 2. Recommended Dosage in Adults - KALETRA Twice Daily Regimen KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day 200/50 mg Tablet 2 tablets orally twice daily 800/200 mg 400/100 mg Oral Solution 5 mL orally twice daily 800/200 mg Table 3. Recommended Dosage in Adults - KALETRA Twice Daily Regimen in Combination with Efavirenz, Nevirapine, or Nelfinavir KALETRA Dosage Form Recommended Dosage Total KALETRA Dosage per Day 200/50 mg Tablet and 100/25 mg Tablet 2 KALETRA 200/50 mg tablets and
  1 KALETRA 100/25 mg tablet orally twice daily 1000/250 mg 400/100 mg Oral Solution 6.5 mL orally twice daily 1000/250 mg 2.4 Dosage Recommendations in Pregnancy

  Administer 400/100 mg of KALETRA twice daily in pregnant patients with no documented lopinavir-associated resistance substitutions. Once daily KALETRA dosing is not recommended in pregnancy [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

  There are insufficient data to recommend dosing in pregnant women with any documented lopinavir-associated resistance substitutions. No dosage adjustment of KALETRA is required for patients during the postpartum period. Avoid use of KALETRA oral solution in pregnant women [see Use in Specific Populations (8.1)].

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