Lundbeck Llc

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Lundbeck Llc Drugs

Fentanyl Citrate Lozeng...

Fentanyl Citrate Lozenge

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 Dose50 mg/kg/day   Maximum Dose150 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)].
Lotemax

Lotemax

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 Dose50 mg/kg/day Maximum Dose150 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)].
Onfi

Onfi

2.1 Dosing Information

A daily dose of ONFI greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability. Each dose in Table 1 (e.g. 5 to 20 mg in ≤30 kg weight group) has been shown to be effective, although effectiveness increases with increasing dose [see Clinical Studies (14)]. Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state.
Table 1. Recommended Total Daily Dosing by Weight Group ≤30 kg Body Weight >30 kg Body Weight Starting Dose 5 mg 10 mg Starting Day 7 10 mg 20 mg Starting Day 14 20 mg 40 mg
2.2 Gradual Withdrawal

As with all antiepileptic drugs and benzodiazepines, withdraw ONFI gradually. Taper by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued [see Warnings and Precautions (5.3)].

2.3 Important Administration Instructions

Instruct patients to read the "Instructions for Use" carefully for complete directions on how to properly dose and administer ONFI oral suspension.

ONFI Tablet Oral AdministrationONFI tablets can be taken with or without food.ONFI tablets can be administered whole, broken in half along the score, or crushed and mixed in applesauce.

ONFI Oral Suspension Oral AdministrationONFI oral suspension can be taken with or without food [see Clinical Pharmacology (12.3)].

Shake ONFI Oral Suspension well before every administration. When administering the oral suspension, use only the oral dosing syringe provided with the product. Each carton includes two syringes, but only one syringe should be used for dosing. The second oral syringe is reserved as a replacement in case the first syringe is damaged or lost. Insert the provided adapter firmly into the neck of the bottle before first use and keep the adapter in place for the duration of the usage of the bottle. To withdraw the dose, insert the dosing syringe into the adapter and invert the bottle then slowly pull back the plunger to prescribed dose. After removing the syringe from the bottle adapter, slowly squirt ONFI Oral Suspension into the corner of the patient's mouth. Replace the cap after each use. The cap fits over the adapter when the adapter is properly placed. See ONFI Oral Suspension "Instructions for Use" for complete instruction on how to properly dose and administer the ONFI Oral Suspension.

2.4 Dosage Adjustments in Geriatric Patients

Plasma concentrations at any given dose are generally higher in the elderly: proceed slowly with dose escalation. The starting dose should be 5 mg/day for all elderly patients. Then titrate elderly patients according to weight, but to half the dose presented in Table 1, as tolerated. If necessary and based upon clinical response, an additional titration to the maximum dose (20 mg/day or 40 mg/day, depending on weight) may be started on day 21 [see Use in Specific Populations (8.5)].

2.5 Dosage Adjustments in CYP2C19 Poor Metabolizers

In CYP2C19 poor metabolizers, levels of N-desmethylclobazam, clobazam's active metabolite, will be increased. Therefore, in patients known to be CYP2C19 poor metabolizers, the starting dose should be 5 mg/day and dose titration should proceed slowly according to weight, but to half the dose presented in Table 1, as tolerated. If necessary and based upon clinical response, an additional titration to the maximum dose (20 mg/day or 40 mg/day, depending on the weight group) may be started on day 21 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.5)].

2.6 Patients with Renal Impairment

No dose adjustment is required for patients with mild and moderate renal impairment. There is no experience with ONFI in patients with severe renal impairment or end stage renal disease (ESRD). It is not known if clobazam or its active metabolite, N-desmethylclobazam, is dialyzable [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.7 Dosage Adjustments in Patients with Hepatic Impairment

ONFI is hepatically metabolized; however, there are limited data to characterize the effect of hepatic impairment on the pharmacokinetics of ONFI. For this reason, proceed slowly with dosing escalations. For patients with mild to moderate hepatic impairment (Child-Pugh score 5-9), the starting dose should be 5 mg/day in both weight groups. Then titrate patients according to weight, but to half the dose presented in Table 1, as tolerated. If necessary and based upon clinical response, start an additional titration on day 21 to the maximum dose (20 mg/day or 40 mg/day, depending on the weight group). There is inadequate information about metabolism of ONFI in patients with severe hepatic impairment. Therefore no dosing recommendation in those patients can be given [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)].
Northera

Northera

2.1 Dosing Information

The recommended starting dose of NORTHERA is 100 mg, taken orally three times daily: upon arising in the morning, at midday, and in the late afternoon at least 3 hours prior to bedtime (to reduce the potential for supine hypertension during sleep). Administer NORTHERA consistently, either with food or without food. Take NORTHERA capsule whole. Titrate to symptomatic response, in increments of 100 mg three times daily every 24 to 48 hours up to a maximum dose of 600 mg three times daily (i.e., a maximum total daily dose of 1,800 mg).

Monitor supine blood pressure prior to initiating NORTHERA and after increasing the dose.

Patients who miss a dose of NORTHERA should take their next scheduled dose.

Lundbeck Llc

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