Gabapentin: Package Insert and Label Information (Page 4 of 5)

DRUG ABUSE AND DEPENDENCE

The abuse and dependence potential of Gabapentin Capsules has not been evaluated in human studies.

OVERDOSAGE

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdoses of Gabapentin Capsules up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. All patients recovered with supportive care.

Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

DOSAGE AND ADMINISTRATION

Gabapentin Capsules is given orally with or without food.

If Gabapentin Capsules dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).

Postherpetic Neuralgia

In adults with postherpetic neuralgia, Gabapentin Capsules therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Epilepsy

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

Patients >12 years of age: The effective dose of Gabapentin Capsules is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours.

Pediatric Patients Age 3–12 years: The starting dose should range from 10 to 15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of Gabapentin Capsules in patients 5 years of age and older is 25 to 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) (see CLINICAL PHARMACOLOGY, Pediatrics.) Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor gabapentin plasma concentrations to optimize Gabapentin Capsules therapy. Further, because there are no significant pharmacokinetic interactions among Gabapentin Capsules and other commonly used antiepileptic drugs, the addition of Gabapentin Capsules does not alter the plasma levels of these drugs appreciably.

If Gabapentin Capsules is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage in Renal Impairment

Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr ) can be reasonably well estimated using the equation of Cockcroft and Gault:

for females CCr =(0.85)(140-age)(weight)/[(72)(SCr )]for males CCr =(140-age)(weight)/[(72)(SCr )]

where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.

Dosage adjustment in patients ≥ 12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).

Table 6. Gabapentin Capsules Dosage Based on Renal Function.

Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg)
≥60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID
>30 to 59 400 to 1400 200 BID 300 BID 400 BID 500 BID 700 BID
>15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD
15a 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis 125b 150b 200b 250b 350b
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

The use of Gabapentin Capsules in patients <12 years of age with compromised renal function has not been studied.

Dosage in Elderly

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

HOW SUPPLIED

Buff-Buff, opaque hard gelatin capsules printed with “IP 102” on both cap and body. They are available as follows:

35356-708-30

35356-708-60

35356-708-90

35356-708-01

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 10-2011

MEDICATION GUIDE

Gabapentin Capsules, USP

Read the Medication Guide before you start taking gabapentin capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about gabapentin capsules?

Do not stop taking gabapentin capsules without first talking to your healthcare provider.

Stopping gabapentin capsules suddenly can cause serious problems.

Gabapentin capsules can cause serious side effects including:

  1. Like other antiepileptic drugs, gabapentin capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

    Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  2. thoughts about suicide or dying
  3. attempts to commit suicide
  4. new or worse depression
  5. new or worse anxiety
  6. feeling agitated or restless
  7. panic attacks
  8. trouble sleeping (insomnia)
  9. new or worse irritability
  10. acting aggressive, being angry, or violent
  11. acting on dangerous impulses
  12. an extreme increase in activity and talking (mania)
  13. other unusual changes in behavior or mood

    How can I watch for early symptoms of suicidal thoughts and actions?

  14. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  15. Keep all follow-up visits with your healthcare provider as scheduled.

    Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    Do not stop taking gabapentin capsules without first talking to a healthcare provider.

    • Stopping gabapentin capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

    Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

  16. Changes in behavior and thinking – Using gabapentin capsules in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.
  17. Gabapentin capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop gabapentin capsules. Call a healthcare provider right away if you have any of the following symptoms:
    • skin rash
    • hives
    • fever
    • swollen glands that do not go away
    • swelling of your lip and tongue
    • yellowing of your skin or the whites of the eyes
    • unusual bruising or bleeding
    • severe fatigue or weakness
    • unexpected muscle pain
    • frequent infections

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin capsules.

What are gabapentin capsules?

Gabapentin capsules are a prescription medicine used to treat:

Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
Partial seizures when taken together with other medicines in adults and children 3 years of age and older.

Who should not take gabapentin capsules?

Do not take gabapentin capsules if you are allergic to gabapentin or any of the other ingredients in gabapentin capsules. See the end of this Medication Guide for a complete list of ingredients in gabapentin capsules.

What should I tell my healthcare provider before taking gabapentin capsules?

Before taking gabapentin capsules, tell your healthcare provider if you:

have or have had kidney problems or are on hemodialysis
have or have had depression, mood problems, or suicidal thoughts or behavior
are pregnant or plan to become pregnant. It is not known if gabapentin capsules can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin capsules. You and your healthcare provider will decide if you should take gabapentin capsules while you are pregnant.
  • If you become pregnant while taking gabapentin capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
are breast-feeding or plan to breast-feed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking gabapentin capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take gabapentin capsules?

Take gabapentin capsules exactly as prescribed. Your healthcare provider will tell you how much gabapentin capsules to take.
  • Do not change your dose of gabapentin capsules without talking to your healthcare provider. While taking gabapentin capsules, always swallow them whole with plenty of water.
Gabapentin capsules can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox® , Mylanta® , Gelusil® , Gaviscon® , or Di-Gel® , you should wait at least 2 hours before taking your next dose of gabapentin capsules.
If you take too much gabapentin capsules, call your healthcare provider or your local Poison Control Center right away.

What should I avoid while taking gabapentin capsules?

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin capsules affect you. Gabapentin capsules can slow your thinking and motor skills.

What are the possible side effects of gabapentin capsules?

See “What is the most important information I should know about gabapentin capsules?”
The most common side effects of gabapentin capsules include:
dizziness • difficulty with speaking
lack of coordination • temporary loss of memory (amnesia)
viral infection • tremor
feeling drowsy • difficulty with coordination
feeling tired • double vision
fever • unusual eye movement
jerky movements

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of gabapentin capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store gabapentin capsules?

Store Gabapentin Capsules between 59°F to 86°F (15°C to 30°C).

Keep gabapentin capsules and all medicines out of the reach of children.

General information about the safe and effective use of gabapentin capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin capsules for a condition for which it was not prescribed. Do not give gabapentin capsules to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about gabapentin capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin capsules that was written for healthcare professionals.

For more information about gabapentin capsules, go to http://www.amneal.com. For medical inquiries or to report side effects regarding gabapentin capsules, please call 1-877-835-5472.

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin

Inactive ingredients in the capsules: magnesium stearate, pregelatinized starch, starch and talc.

The 100-mg capsule shell contains: gelatin, sodium lauryl sulfate and titanium dioxide.

The 300-mg capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow.

The 400-mg capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No. 6, and FD&C Blue No. 1.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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