Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

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(GA ba PEN tin)

Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Seizure Disorders

Management (in combination with other anticonvulsants) of partial seizures with or without secondary generalization in adults and children >12 years of age.

Management (in combination with other anticonvulsants) of partial seizures in children 3–12 years of age.

Neuropathic Pain

Management of postherpetic neuralgia in adults.

Treatment of pain associated with diabetic neuropathy†. 40% of patients who receive gabapentin for pain associated with diabetic neuropathy obtain good pain relief.

Some evidence of benefit for the relief of chronic neurogenic pain† in a variety of conditions including trigeminal neuralgia†, pain and control of paroxysmal symptoms of multiple sclerosis†, complex regional pain syndromes†, HIV-related peripheral neuropathy†, and neuropathic pain associated with cancer†. Also has been used in the treatment of restless legs syndrome†. Additional study needed to further elucidate precise role in the management of these conditions.

Vasomotor Symptoms

Has been used for the management of vasomotor symptoms (e.g., hot flashes) in women with breast cancer†.

Has been used for the management of vasomotor symptoms (e.g., hot flashes) associated with menopause†.

Dosage and Administration

General

Seizure Disorders

  • Monitoring of plasma gabapentin concentrations is not necessary to optimize therapy. Because addition of gabapentin to existing anticonvulsant therapy does not appreciably alter steady-state plasma concentrations of concomitantly administered anticonvulsants, additional monitoring of plasma concentrations of anticonvulsants generally is not necessary. (See Specific Drugs under Interactions.)
  • Discontinuance of gabapentin and/or addition of an alternative anticonvulsant drug to therapy should be done gradually over ≥1 week.

Administration

Oral Administration

Administer orally without regard to meals.

If Neurontin® film-coated scored tablets containing 600 or 800 mg of gabapentin are to be used in patients requiring a 300- or 400-mg dose, divide the tablet in half to allow administration of the appropriate dose. Instruct patients to take one-half tablet and to use the remaining half-tablet for the next dose. Half-tablets that are not used within several days should be discarded.

Seizure Disorders

Administer orally 3 times daily. The interval between doses in this schedule should not exceed 12 hours.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Pediatric Patients

Seizure Disorders

Partial Seizures
Oral

Children 3–12 years of age: Initially, 10–15 mg/kg daily in 3 divided doses. Maintenance dosage of 40 mg/kg daily in 3 divided doses for children 3 or 4 years of age and 25–35 mg/kg daily in 3 divided doses for children 5–12 years of age.

Children >12 years of age: Initially, 300 mg 3 times daily. Maintenance dosage of 900 mg to 1.8 g daily in 3 divided doses.

Adults

Seizure Disorders

Partial Seizures
Oral

Initially, 300 mg 3 times daily. Maintenance dosage of 900 mg to 1.8 g daily in 3 divided doses.

Neuropathic Pain

Postherpetic Neuralgia
Oral

300 mg on the first day, 300 mg twice daily on the second day, and 300 mg 3 times daily on the third day. Increase dosage as needed for relief of pain up to a total daily dosage of 1.8 g in 3 divided doses. No evidence of additional benefit with dosages >1.8 g daily.

Diabetic Neuropathy
Oral

Dosages of 900 mg to 3.6 g daily have been used; however, pain relief generally observed in patients receiving dosages >1.8 g daily.

Vasomotor Symptoms

Oral

300 mg 3 times daily has been effective; higher dosages may provide additional benefit.†

Prescribing Limits

Pediatric Patients

Children 3–12 years of age: Dosages up to 50 mg/kg daily in divided doses have been tolerated as adjunctive therapy in the management of partial seizures.

Children >12 years of age: Dosage of 3.6 g daily has been tolerated as adjunctive therapy in the management of partial seizures.

Adults

Dosage of 3.6 g daily has been tolerated as adjunctive therapy in the management of partial seizures.

Special Populations

Dosage in Renal Impairment

Not studied in children <12 years of age with renal impairment.

In adults and children ≥12 years of age, base dosage on measured or estimated Clcr:

Dosage for Adults and Children ≤12 Years of Age with Renal Impairment
Clcr (mL/min) Total Daily Dosage (mg/day) Dosage Regimen
≥60 900–3600 300 –1200 mg 3 times daily
30–59 400–1400 200 –700 mg twice daily
15–29 200–700 200 –700 mg once daily
15a 100–300 100 –300 mg once daily
ESRD patients undergoing hemodialysis 125–350 mgb

aIn patients with Clcr <15 mL/min, reduce dosage proportionally (e.g., a patient with a Clcr of 7.5 mL/min should receive one-half the dosage that a patient with a Clcr of 15 mL/min should receive).

bGive maintenance doses based on Clcr, with supplemental doses (125–350 mg) given after each 4-hour hemodialysis session.

Geriatric Patients

Select dosage carefully, usually initiating therapy at the low end of the dosage range. Adjust dosage based on Clcr.

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