Fanatrex

Gabapentin is a prescription medication used to treat adults with nerve pain caused by shingles. Shingles is a painful rash that is caused by the varicella-zoster virus, the virus that also causes chickenpox. Gabapentin is also used in combination with other medications to treat partial seizures. Gabapentin belongs to a group of drugs called anticonvulsants, which help treat seizures by decreasing abnormal excitement in the brain. It also works by altering the way the body senses pain.

This medication comes in tablet, capsule, and oral (by mouth) solution forms and is taken up to 3 times a day, with or without food. The capsules are taken with a full glass of water.

Common side effects of gabapentin include lack of coordination, dizziness, and drowsiness. Do not drive a car or operate heavy machinery until you know how this medication affects you.

Fanatrex is part of the drug class:

• Other antiepileptics

Postherpetic Neuralgia:

In adults with postherpetic neuralgia, gabapentin therapy may be started as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided twice daily), and 900 mg/day on Day 3 (divided three times daily). The dose can be increased as needed for pain relief to a daily dose of 1800 mg (divided three times daily). Additional benefit of using doses greater than 1800 mg/day was not shown.

Epilepsy:

Gabapentin is recommended for as add-on therapy in patients 3 years of age and older. Effectiveness in children below the age of 3 years has not been established.

Patients >12 years of age:

The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day). The starting dose is 300 mg three times a day. If necessary, the dose may be increased to three times a day up to 1800 mg/day. The maximum time between doses in the three times daily schedule should not exceed 12 hours.

Pediatric Patients Age 3–12 years:

The starting dose should range from 10–15 mg/kg/day in 3 divided doses, and the dose can be increased gradually over approximately 3 days.

• The effective dose of gabapentin in patients 5 years of age and older is 25–35 mg/kg/day and given in divided doses (three times a day).
• The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day).

The maximum time interval between doses should not exceed 12 hours.

Kidney Dysfunction:

Dosing is also based on the functional status of your kidneys.

Stopping gabapentin:

If gabapentin is stopped and/or a different anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

NDC 43093-105-01

Rx only

FusePaq™

Fanatrex™

(gabapentin 25 mg/mL, in oral suspension - kit)


FusePaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practices (cGMP).


Description:


This kit contains active and inactive bulk materials to prepare 420 mL of a gabapentin oral suspension containing 25 mg/mL gabapentin.  This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.


Contents:

• 10.5 g gabapentin, USP
• 420 mL oral suspension vehicle (water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, sodium benzoate, potassium sorbate, dibasic sodium phosphate)
• Disposable funnel
• Press-in bottle adaptor for oral dispenser
• Oral dispenser
• Instructions

Suggested Preparation
Gabapentin, 25 mg/mL oral suspension

1    Remove and Inspect the Contents of the Kit

Remove kit contents. Ensure that seals are present and intact on the gabapentin and oral suspension vehicle bottles. If the seals are not intact, do not use the kit.

2    Prepare for Mixing

Wear gloves and eye protection during mixing operations. Remove the seal from the oral suspension bottle. Break the seal and remove the cap from the gabapentin bottle.

3    Transfer Gabapentin to the Suspension Bottle

Uncap the suspension bottle. Using the included funnel, carefully transfer the gabapentin powder to the suspension bottle. Cap the suspension bottle and mix thoroughly by inverting and shaking until all contents are dissolved. Uncap the suspension bottle. Pour a small amount of the mixed suspension back into the gabapentin bottle. Cap the gabapentin bottle and shake to ensure that all residual gabapentin has been dissolved. Pour the liquid through the funnel into the suspension bottle. Discard the funnel and gabapentin powder bottle.

4    Complete the Mixing Process

Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Mix well by inverting repeatedly several times. Visually ensure that all contents are dissolved.

5    Re-label the Suspension

Label the mixed suspension as required for prescription products. Ensure that the original oral suspension vehicle label is removed or obscured, since the original label is no longer accurate once the suspension is prepared.

Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the mixed suspension between 15-30°C (59-86°F). The mixed suspension is stable for at least eight weeks, based upon real-time and accelerated stability studies.

Each lot of suspension vehicle is tested to meet microbial limits per USP Microbial Limit Test <61>. In addition, the suspension vehicle formulation has passed the USP <51> Antimicrobial Effectiveness Test.

An oral dispenser is provided in the kit and may be used to facilitate delivery of the suspension.

U.S. Patents Pending

Manufactured by:
Fusion Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012

CS75-A1 rev 0

For patients greater than or equal to 12 years:
-CrCl greater than 60 mL/min: 300 to 1200 mg orally 3 times a day
-CrCl 30 to 59 mL/min: 200 to 700 mg orally daily; increase to 600 mg as needed
-CrCl 15 to less than 29 mL/min: 200 to 700 mg orally once a day
-CrCl 15 mL/min: 100 to 300 mg orally every other day
-CrCl less than 15 mL/minute: Reduce daily dose in proportion to CrCl based on dose for CrCl 15 mL/minute (e.g., for a CrCl of 7.5 mL/min, reduce the daily dose by one-half to 50 to 150 mg/day)
-Hemodialysis: Dose based on CrCl plus a single supplemental dose of 125 to 350 mg given after each 4 hours of hemodialysis
-Use of this drug in patients less than 12 years of age with compromised renal function has not been studied.

The dose of gabapentin available under the trade name GRALISE (R) should be adjusted in patients with reduced renal function. Patients with reduced renal function should initiate GRALISE (R) at a daily dose of 300 mg. Daily dosing in patients with reduced renal function should be individualized based on tolerability and desired clinical benefit. GRALISE (R) should be titrated following the schedule outlined below:
Hemodialysis: Not recommended
CrCl less than 30 mL/min: Not recommended
CrCl 30 to 60 mL/min: 600 to 1800 mg orally with the evening meal
CrCl greater than or equal to 60 mL/min: 1800 mg orally with the evening meal

The dose of gabapentin enacarbil available under the trade name HORIZANT (R) should be adjusted in patients with reduced renal function as follows:
RESTLESS LEGS SYNDROME:
-CrCl less than 15 mL/min on hemodialysis: Not recommended
-CrCl less than 15 mL/min: 300 mg orally every other day
-CrCl 15 to 29 mL/min: 300 mg orally once a day
-CrCl 30 to 59 mL/min: Start at 300 mg orally daily and increase to 600 mg as needed
-CrCl greater than or equal to 60 mL/min: 600 mg orally once a day
POSTHERPETIC NEURALGIA:
-CrCl less than 15 mL/min on hemodialysis: 300 mg orally following every dialysis; increase to 600 mg orally following every dialysis if needed
-CrCl less than 15 mL/min: 300 mg orally every other day in the AM; increase to 300 mg orally once daily in the AM if needed
-CrCl 15 to 29 mL/min: 300 mg orally in the morning on day 1 and day 3 of therapy, then 300 mg once a day in the morning; may increase to 300 mg orally 2 times a day if needed; when tapering: if taking 300 mg orally 2 times a day, reduce to 300 mg orally once a day in the AM for 1 week; if taking 300 mg orally once a day no taper is needed
-CrCl 30 to 59 mL/min: 300 mg orally in the AM for 3 days, then 300 mg orally 2 times a day; increase to 600 mg orally 2 times a day as needed; when tapering: reduce current maintenance dose to once daily in the AM for 1 week
-CrCl greater than or equal to 60 mL/min: 600 mg orally in the morning for 3 days, then 600 mg orally 2 times a day thereafter; when tapering: 600 mg orally in the AM for 1 week

Data not available

For patients greater than or equal to 12 years:
-CrCl greater than 60 mL/min: 300 to 1200 mg orally 3 times a day
-CrCl 30 to 59 mL/min: 200 to 700 mg orally daily; increase to 600 mg as needed
-CrCl 15 to less than 29 mL/min: 200 to 700 mg orally once a day
-CrCl 15 mL/min: 100 to 300 mg orally every other day
-CrCl less than 15 mL/minute: Reduce daily dose in proportion to CrCl based on dose for CrCl 15 mL/minute (e.g., for a CrCl of 7.5 mL/min, reduce the daily dose by one-half to 50 to 150 mg/day)
-Hemodialysis: Dose based on CrCl plus a single supplemental dose of 125 to 350 mg given after each 4 hours of hemodialysis
-Use of this drug in patients less than 12 years of age with compromised renal function has not been studied.

The dose of gabapentin available under the trade name GRALISE (R) should be adjusted in patients with reduced renal function. Patients with reduced renal function should initiate GRALISE (R) at a daily dose of 300 mg. Daily dosing in patients with reduced renal function should be individualized based on tolerability and desired clinical benefit. GRALISE (R) should be titrated following the schedule outlined below:
Hemodialysis: Not recommended
CrCl less than 30 mL/min: Not recommended
CrCl 30 to 60 mL/min: 600 to 1800 mg orally with the evening meal
CrCl greater than or equal to 60 mL/min: 1800 mg orally with the evening meal

The dose of gabapentin enacarbil available under the trade name HORIZANT (R) should be adjusted in patients with reduced renal function as follows:
RESTLESS LEGS SYNDROME:
-CrCl less than 15 mL/min on hemodialysis: Not recommended
-CrCl less than 15 mL/min: 300 mg orally every other day
-CrCl 15 to 29 mL/min: 300 mg orally once a day
-CrCl 30 to 59 mL/min: Start at 300 mg orally daily and increase to 600 mg as needed
-CrCl greater than or equal to 60 mL/min: 600 mg orally once a day
POSTHERPETIC NEURALGIA:
-CrCl less than 15 mL/min on hemodialysis: 300 mg orally following every dialysis; increase to 600 mg orally following every dialysis if needed
-CrCl less than 15 mL/min: 300 mg orally every other day in the AM; increase to 300 mg orally once daily in the AM if needed
-CrCl 15 to 29 mL/min: 300 mg orally in the morning on day 1 and day 3 of therapy, then 300 mg once a day in the morning; may increase to 300 mg orally 2 times a day if needed; when tapering: if taking 300 mg orally 2 times a day, reduce to 300 mg orally once a day in the AM for 1 week; if taking 300 mg orally once a day no taper is needed
-CrCl 30 to 59 mL/min: 300 mg orally in the AM for 3 days, then 300 mg orally 2 times a day; increase to 600 mg orally 2 times a day as needed; when tapering: reduce current maintenance dose to once daily in the AM for 1 week
-CrCl greater than or equal to 60 mL/min: 600 mg orally in the morning for 3 days, then 600 mg orally 2 times a day thereafter; when tapering: 600 mg orally in the AM for 1 week

Administration advice:
-This drug may be given with or without food.
-Tablets should be swallowed whole and should not be cut, crushed, or chewed.
-Gabapentin enacarbil available under the trade name Horizant (R) should be taken with food.
-Gabapentin available under the trade name Gralise (R) should be taken with food with the evening meal.
-Gabapentin available under the trade names Gralise (R) and Horizant (R) should be swallowed whole, not crushed, split, or chewed.

General:
Horizant (R) and Gralise (R) are not interchangeable with other gabapentin products because of differing pharmacokinetic profiles.
-If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.
-Gabapentin available under the trade names Gralise (R) or Horizant (R) are not interchangeable with each other or with other gabapentin products.

Benefit should outweigh risk. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown. -Limited information indicates that maternal doses up to 2.1 g daily produce relatively low levels in infant serum. -Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.