Fentanyl Citrate Lozenge

Fentanyl Citrate Lozenge Manufacturers

• Physicians Total Care, Inc.
  

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  Fentanyl Citrate Lozenge | Physicians Total Care, Inc.

  

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  As with all opioids, the safety of patients using such products is dependent on health care professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

  2.1 Initial Dose

  Individually titrate OTFC to a dose that provides adequate analgesia and minimizes side effects. The initial dose of OTFC to treat episodes of breakthrough cancer pain is always 200 mcg. The OTFC unit should be consumed over 15 minutes. Patients should be prescribed an initial titration supply of six 200 mcg OTFC units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose to prevent confusion and possible overdose.

  2.2 Dose Titration

  From this initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single OTFC dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Patients should record their use of OTFC over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.

  In cases where the breakthrough pain episode is not relieved 15 minutes after completion of the OTFC unit (30 minutes after the start of the unit), patients may take ONLY ONE additional dose of the same strength for that episode.  Thus, patients should take a maximum of two doses of OTFC for any breakthrough pain episode.

  Patients must wait at least 4 hours before treating another episode of breakthrough pain with OTFC.  To reduce the risk of overdosing during titration, patients should have only one strength of OTFC available at any one time.

  2.3 Maintenance Dosing

  Once titrated to an effective dose, patients should generally use ONLY ONE OTFC unit of the appropriate strength per breakthrough pain episode.

  On those occasions when the breakthrough pain episode is not relieved 15 minutes after completion of the OTFC unit, patient may take ONLY ONE additional dose using the same strength for that episode.

  Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with OTFC. Once a successful dose has been found (i.e., an average episode is treated with a single unit), patients should limit consumption to four or fewer units per day.

  Dosage adjustment of OTFC may be required in some patients in order to continue to provide adequate relief of breakthrough pain.

  Generally, the OTFC dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.

  If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated.

  2.4 Administration of OTFC

  Open the blister package with scissors immediately prior to product use. The patient should place the OTFC unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle. The OTFC unit should be sucked, not chewed. A unit dose of OTFC, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when consumed as directed [see Clinical Pharmacology (12.3)].

  The OTFC unit should be consumed over a 15-minute period. Longer or shorter consumption times may produce less efficacy than reported in OTFC clinical trials. If signs of excessive opioid effects appear before the unit is consumed, remove the drug matrix from the patient’s mouth immediately and decrease future doses.

  2.5 Discontinuation of OTFC

  For patients requiring discontinuation of opioids, a gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.

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• Cima Laboratories, Inc.
  

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  Fentanyl Citrate Lozenge | 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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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Fentanyl Citrate Lozenge | Lake Erie Medical Dba Quality Care Products Llc

  

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  Healthcare professionals who prescribe OTFC on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of OTFC [see WARNINGS AND PRECAUTIONS (5.10)].

  As with all opioids, the safety of patients using such products is dependent on healthcare professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

  2.1 Initial Dose

  Individually titrate Oral Transmucosal Fentanyl Citrate (OTFC) to a dose that provides adequate analgesia and minimizes side effects. The initial dose of OTFC to treat episodes of breakthrough cancer pain is always 200 mcg. The OTFC unit should be consumed over 15 minutes. Patients should be prescribed an initial titration supply of six 200 mcg OTFC units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose to prevent confusion and possible overdose.

  2.2 Dose Titration

  From this initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single OTFC dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Patients should record their use of OTFC over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.

  In cases where the breakthrough pain episode is not relieved 15 minutes after completion of the OTFC unit (30 minutes after the start of the unit), patients may take ONLY ONE additional dose of the same strength for that episode. Thus, patients should take a maximum of two doses of OTFC for any breakthrough pain episode.

  Patients must wait at least 4 hours before treating another episode of breakthrough pain with OTFC. To reduce the risk of overdosing during titration, patients should have only one strength of OTFC available at any one time.

  * Available dosage strengths include: 200, 400, 600, 800, 1200, and 1600 mcg.

  2.3 Maintenance Dosing 

  Once titrated to an effective dose, patients should generally use ONLY ONE Oral Transmucosal Fentanyl Citrate (OTFC) unit of the appropriate strength per breakthrough pain episode.

  On those occasions when the breakthrough pain episode is not relieved 15 minutes after completion of the OTFC unit, patient may take ONLY ONE additional dose using the same strength for that episode.

  Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with OTFC. Once a successful dose has been found (i.e., an average episode is treated with a single unit), patients should limit consumption to four or fewer units per day.

  Dosage adjustment of OTFC may be required in some patients in order to continue to provide adequate relief of breakthrough pain.

  Generally, the OTFC dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.

  If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated.

  2.4 Administration of OTFC

  Open the blister package with scissors immediately prior to product use. The patient should place the Oral Transmucosal Fentanyl Citrate (OTFC) unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle. The OTFC unit should be sucked, not chewed. A unit dose of OTFC, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when consumed as directed [ see Clinical Pharmacology (12.3)].

  The OTFC unit should be consumed over a 15-minute period. Longer or shorter consumption times may produce less efficacy than reported in OTFC clinical trials. If signs of excessive opioid effects appear before the unit is consumed, remove the drug matrix from the patient’s mouth immediately and decrease future doses.

  2.5 Discontinuation of OTFC

  For patients requiring discontinuation of opioids, a gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.

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• Par Pharmaceutical Inc.
  

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  Fentanyl Citrate Lozenge | Par Pharmaceutical Inc.

  

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  Healthcare professionals who prescribe OTFC on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of OTFC [see WARNINGS AND PRECAUTIONS (5.10)].

  As with all opioids, the safety of patients using such products is dependent on healthcare professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

  2.1 Initial Dose

  Individually titrate Oral Transmucosal Fentanyl Citrate (OTFC) to a dose that provides adequate analgesia and minimizes side effects. The initial dose of OTFC to treat episodes of breakthrough cancer pain is always 200 mcg. The OTFC unit should be consumed over 15 minutes. Patients should be prescribed an initial titration supply of six 200 mcg OTFC units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose to prevent confusion and possible overdose.

  2.2 Dose Titration

  From this initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single OTFC dosage unit per breakthrough cancer pain episode. If signs of excessive opioid effects appear before the unit is consumed, the dosage unit should be removed from the patient’s mouth immediately, disposed of properly, and subsequent doses should be decreased. Patients should record their use of OTFC over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted.

  In cases where the breakthrough pain episode is not relieved 15 minutes after completion of the OTFC unit (30 minutes after the start of the unit), patients may take ONLY ONE additional dose of the same strength for that episode. Thus, patients should take a maximum of two doses of OTFC for any breakthrough pain episode.

  Patients must wait at least 4 hours before treating another episode of breakthrough pain with OTFC. To reduce the risk of overdosing during titration, patients should have only one strength of OTFC available at any one time.

  * Available dosage strengths include: 200, 400, 600, 800, 1200, and 1600 mcg.

  2.3 Maintenance Dosing 

  Once titrated to an effective dose, patients should generally use ONLY ONE Oral Transmucosal Fentanyl Citrate (OTFC) unit of the appropriate strength per breakthrough pain episode.

  On those occasions when the breakthrough pain episode is not relieved 15 minutes after completion of the OTFC unit, patient may take ONLY ONE additional dose using the same strength for that episode.

  Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with OTFC. Once a successful dose has been found (i.e., an average episode is treated with a single unit), patients should limit consumption to four or fewer units per day.

  Dosage adjustment of OTFC may be required in some patients in order to continue to provide adequate relief of breakthrough pain.

  Generally, the OTFC dose should be increased only when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.

  If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated.

  2.4 Administration of OTFC

  Open the blister package with scissors immediately prior to product use. The patient should place the Oral Transmucosal Fentanyl Citrate (OTFC) unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle. The OTFC unit should be sucked, not chewed. A unit dose of OTFC, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when consumed as directed [ see Clinical Pharmacology (12.3)].

  The OTFC unit should be consumed over a 15-minute period. Longer or shorter consumption times may produce less efficacy than reported in OTFC clinical trials. If signs of excessive opioid effects appear before the unit is consumed, remove the drug matrix from the patient’s mouth immediately and decrease future doses.

  2.5 Discontinuation of OTFC

  For patients requiring discontinuation of opioids, a gradual downward titration is recommended because it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.

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