GABAPENTIN capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Gabapentin Capsules, USP are indicated for: - Management of postherpetic neuralgia in adults - Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Gabapentin, during pregnancy. Encourage women who are taking Gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of Gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fe
Product summary:
Product: 71335-1323 NDC: 71335-1323-1 30 CAPSULE in a BOTTLE NDC: 71335-1323-2 90 CAPSULE in a BOTTLE Product: 71335-1375 NDC: 71335-1375-1 90 CAPSULE in a BOTTLE NDC: 71335-1375-2 28 CAPSULE in a BOTTLE NDC: 71335-1375-3 30 CAPSULE in a BOTTLE NDC: 71335-1375-4 60 CAPSULE in a BOTTLE NDC: 71335-1375-5 120 CAPSULE in a BOTTLE NDC: 71335-1375-6 84 CAPSULE in a BOTTLE Product: 71335-1497 NDC: 71335-1497-1 90 CAPSULE in a BOTTLE NDC: 71335-1497-2 28 CAPSULE in a BOTTLE NDC: 71335-1497-3 120 CAPSULE in a BOTTLE NDC: 71335-1497-4 30 CAPSULE in a BOTTLE NDC: 71335-1497-5 60 CAPSULE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
71335-1323-1, 71335-1323-2, 71335-1375-1, 71335-1375-2, 71335-1375-3, 71335-1375-4, 71335-1375-5, 71335-1375-6, 71335-1497-1, 71335-1497-2, 71335-1497-3, 71335-1497-4, 71335-1497-5

Bryant Ranch Prepack

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MEDICATION GUIDE

Gabapentin (GAB-a-PEN-tin) Capsules, USP 100 mg, 300 mg and 400 mg Rx Only

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.Suicidal Thoughts. 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:

thoughts about suicide or dying

attempts to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks

trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood

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

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

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.

2. 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.

3. Gabapentin Capsules may cause a serious or life-threatening allergic reactions that may affect your skin or

other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop

Gabapentin Capsules. You may or may not have a rash with an allergic reaction caused by Gabapentin

Capsules. Call a healthcare provider right away if you have any of the following symptoms:

skin rash

hives

difficulty breathing

fever

swollen glands that do not go away

swelling of your face, lips, throat, or tongue

yellowing of your skin or of 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 is Gabapentin Capsules?

Gabapentin Capsule is 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 with seizures.

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

have diabetes

are pregnant or plan to become pregnant. It is not known if Gabapentin 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.

Pregnancy Registry: 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 .

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter

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.

Take Gabapentin capsules with water.

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.

If you take too much Gabapentin, call your healthcare provider or your local Poison Control Center right

away at 1-800-222-1222.

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 affects you. Gabapentin Capsules can slow your thinking and motor skills.

What are the possible side effects of Gabapentin Capsules?

Gabapentin Capsules may cause serious side effects including:

See “What is the most important information I should know about Gabapentin Capsules?”

problems driving while using Gabapentin Capsules. See “What I should avoid while taking

Gabapentin Capsules?”

sleepiness and dizziness, which could increase the occurrence of accidental injury, including falls

The most common side effects of Gabapentin Capsules include:

lack of coordination

viral infection

feeling drowsy

feeling tired

fever

jerky movements

difficulty with speaking

nausea and vomiting

tremor

difficulty with coordination

double vision

unusual eye movement

swelling, usually of legs and feet

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 68°F to 77°F (20°C to 25°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 go to http://www.acihealthcareusa.com or call 1-754-702-5116

What are the ingredients in Gabapentin Capsules ?

Active ingredient: gabapentin

Inactive ingredients in the capsules: Pregelatinized maize starch, and talc and Ingredients of Imprinting

Ink( Black SW-9049) are Black Iron Oxide NF (E 172), Butyl Alcohol NF, Dehydrated Alcohol USP,

Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia

Soution NF.

The 100-mg capsule shell also contains: gelatin and titanium dioxide.

The 300-mg capsule shell also contains: gelatin, titanium dioxide, black iron oxide, red iron oxide and yellow

iron oxide.

The 400-mg capsule shell also contains: gelatin, titanium dioxide, black iron oxide, red iron oxide and yellow

iron oxide.

Trademarks are the property of their respective owners.

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

This product’s label may have been updated. For current full prescribing information, please visit

www.acihealthcareusa.com

Manufactured By

Strides Pharma Science Limited

Unit – II, R.S.No.32, 33 & 34, PIMS Road,

Periyakalapet, Puducherry - 605 014, India.

Distributed by:

ACI Healthcare USA, Inc.

10100 W. Sample Road, Suite 406

Coral Springs, FL 33065

1039335

Revised: 08/2019

®Trademarks are the property of their respective owners

Revised: 5/2020

Document Id: 238d05d6-6c7d-49c7-b7fb-d4c73370d1bc

34391-3

Set id: bb87b2ea-4c7d-4194-bc48-ec16b1e9d96a

Version: 4

Effective Time: 20200522

Bryant Ranch Prepack

GABAPENTIN- gabapentin capsule

Bryant Ranch Prepack

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and

effectively. See full prescribing information for GABAPENTIN CAPSULES.

GABAPENTIN Capsules, for oral use

Initial U.S. Approval:1993

INDICATIONS AND USAGE

Gabapentin Capsules, USP are indicated for

Postherpetic neuralgia in adults (1)

Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and

pediatric patients 3 years and older with epilepsy (1)

DOSAGE AND ADMINISTRATION

Postherpetic Neuralgia (2.1)

Dose can be titrated up as needed to a dose of 1800 mg/day

Day 1: Single 300 mg dose

Day 2: 600 mg/day (i.e., 300 mg two times a day)

Day 3: 900 mg/day (i.e., 300 mg three times a day)

Epilepsy with Partial Onset Seizures (2.2)

Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three

times daily

Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses;

recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended

dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is

reached by upward titration over a period of approximately 3 days

Dose should be adjusted in patients with reduced renal function (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

Capsules: 100 mg, 300 mg, and 400 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to gabapentin or its ingredients (4)

WARNINGS AND PRECAUTIONS

Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative

etiology is not be established (5.1)

Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately (5.2)

Driving impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient

experience to assess whether their ability to drive or operate heavy machinery will be impaired (5.3,5.4)

Increased seizure frequency may occur in patients with seizure disorders if Gabapentin is abruptly discontinued (5.5)

Suicidal Behavior and Ideation: Monitor for suicidal thoughts / behavior (5.6)

Neuropsychiatric Adverse Reactions in Children 3-12 Years of Age: Monitor for such events (5.7)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were:

Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema (6.1)

Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus (6.1)

Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact ACI HealthcareUSA, Inc. at 1-888-802-1213 or

www.acihealthcareusa.com or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Concentrations increased by morphine; may need dose adjustment (5.4,7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm (8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMlNlSTRATION

2.1 Dosage for Postherpetic Neuralgia

2.2 Dosage for Epilepsy with Partial Onset Seizures

2.3 Dosage Adjustment in Patients with Renal Impairment

2.4 Dosage in Elderly

2.5 Administration Information

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

5.2 Anaphylaxis and Angioedema

5.3 Effects on Driving and Operating Heavy Machinery

5.4 Somnolence/Sedation and Dizziness

5.5 Withdrawal Precipitated Seizure, Status Epilepticus

5.6 Suicidal Behavior and Ideation

5.7 Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age)

5.8 Tumorigenic Potential

5.9 Sudden and Unexplained Death in Patients with Epilepsy

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Other Antiepileptic Drugs

7.2 Opioids

7.3 Maalox

(aluminum hydroxide, magnesium hydroxide)

7.4 Drug/Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Postherpetic Neuralgia

14.2 Epilepsy for Partial Onset Seizures (Adjunctive Therapy)

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Gabapentin Capsules, USP are indicated for:

Management of postherpetic neuralgia in adults

Adjunctive therapy in the treatment of partial onset seizures, with and without secondary

generalization, in adults and pediatric patients 3 years and older with epilepsy

2 DOSAGE AND ADMlNlSTRATION

2.1 Dosage for Postherpetic Neuralgia

In adults with postherpetic neuralgia, Gabapentin may be initiated on Day 1 as a single 300 mg dose, on

Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day).

The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg

three times a day). 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; however, in these clinical

studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated

2.2 Dosage for Epilepsy with Partial Onset Seizures

Patients 12 years of age and above

The starting dose is 300 mg three times a day. The recommended maintenance dose of Gabapentin is

300 mg to 600 mg three times a 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. Administer Gabapentin three times a day using

300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours.

Pediatric Patients Age 3 to 11 years

The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the

recommended maintenance dose reached by upward titration over a period of approximately 3 days. The

recommended maintenance dose of Gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in

three divided doses. The recommended maintenance dose of Gabapentin in patients 5 to 11 years of age

is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the

capsule formulations. 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.

2.3 Dosage Adjustment in Patients with Renal Impairment

Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing

hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in

each indication):

TABLE 1. Gabapentin Dosage Based on Renal Function

Sections or subsections omitted from the full prescribing information are not listed.

TID = Three times a day; BID = Two times a day; QD = Single daily dose

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

100 to 300

100 QD

125 QD

150 QD

200 QD

300 QD

Post-Hemodialysis Supplemental Dose (mg)

Hemodialysis

Creatinine clearance (CLCr) is diffcult to measure in outpatients. In patients with stable renal function,

creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:

The use of Gabapentin in patients less than 12 years of age with compromised renal function has not

been studied.

2.4 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.

2.5 Administration Information

Administer Gabapentin orally with or without food.

Gabapentin capsules should be swallowed whole with water.

If the Gabapentin 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).

3 DOSAGE FORMS AND STRENGTHS

Capsules:

100 mg: Hard gelatin capsules with white opaque body with white opaque cap, imprinted with

“AHD” on cap and “100” on body in black ink and filled with white to off-white powder.

300 mg: Hard gelatin capsules with yellow opaque body with caramel opaque cap, imprinted with

“AHD” on cap and “300” on body in black ink and filled with white to off-white powder.

400 mg: Hard gelatin capsules with orange opaque body with caramel opaque cap, imprinted with

“AHD” on cap and “400” on body in black ink and filled with white to off-white powder.

4 CONTRAINDICATIONS

Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its

ingredients.

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)

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.

5 WARNINGS AND PRECAUTIONS

5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan

Hypers ens itivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan

hypersensitivity, has occurred with Gabapentin. Some of these reactions have been fatal or life-

threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or

lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis,

hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.

Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not

noted here may be involved.

It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy,

may be present even though rash is not evident. If such signs or symptoms are present, the patient should

be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or

symptoms cannot be established.

5.2 Anaphylaxis and Angioedema

Gabapentin can cause anaphylaxis and angioedema after the first dose or at any time during treatment.

Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat,

and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue

Gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis

or angioedema.

5.3 Effects on Driving and Operating Heavy Machinery

Patients taking Gabapentin should not drive until they have gained sufficient experience to assess

whether Gabapentin impairs their ability to drive. Driving performance studies conducted with a

prodrug of gabapentin (gabapentin enacarbil tablet, extended-release) indicate that gabapentin may cause

significant driving impairment. Prescribers and patients should be aware that patients’ ability to assess

their own driving competence, as well as their ability to assess the degree of somnolence caused by

Gabapentin, can be imperfect. The duration of driving impairment after starting therapy with Gabapentin

is unknown. Whether the impairment is related to somnolence [see Warnings and Precautions (5.4)] or

other effects of Gabapentin is unknown.

Moreover, because Gabapentin causes somnolence and dizziness [see Warnings and Precautions (5.4)],

patients should be advised not to operate complex machinery until they have gained sufficient

experience on Gabapentin to assess whether Gabapentin impairs their ability to perform such tasks.

5.4 Somnolence/Sedation and Dizziness

During the controlled epilepsy trials in patients older than 12 years of age receiving doses of

Gabapentin up to 1800 mg daily, somnolence, dizziness, and ataxia were reported at a greater rate in

patients receiving Gabapentin compared to placebo: i.e., 19% in drug versus 9% in placebo for

somnolence, 17% in drug versus 7% in placebo for dizziness, and 13% in drug versus 6% in placebo

for ataxia. In these trials somnolence, ataxia and fatigue were common adverse reactions leading to

discontinuation of Gabapentin in patients older than 12 years of age, with 1.2%, 0.8% and 0.6%

discontinuing for these events, respectively.

During the controlled trials in patients with post-herpetic neuralgia, somnolence, and dizziness were

reported at a greater rate compared to placebo in patients receiving Gabapentin, in dosages up to 3600

mg per day: i.e., 21% in Gabapentin-treated patients versus 5% in placebo-treated patients for

somnolence and 28% in Gabapentin-treated patients versus 8% in placebo-treated patients for dizziness.

Dizziness and somnolence were among the most common adverse reactions leading to discontinuation of

Gabapentin.

Patients should be carefully observed for signs of central nervous system (CNS) depression, such as

somnolence and sedation, when Gabapentin is used with other drugs with sedative properties because of

potential synergy. In addition, patients who require concomitant treatment with morphine may experience

increases in gabapentin concentrations and may require dose adjustment [see Drug Interactions (7.2)].

5.5 Withdrawal Precipitated Seizure, Status Epilepticus

Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure

frequency.

In the placebo-controlled epilepsy studies in patients >12 years of age, the incidence of status

epilepticus in patients receiving Gabapentin was 0.6% (3 of 543) vs. 0.5% in patients receiving placebo

(2 of 378). Among the 2074 patients >12 years of age treated with Gabapentin across all epilepsy

studies (controlled and uncontrolled), 31 (1.5%) had status epilepticus. Of these, 14 patients had no prior

history of status epilepticus either before treatment or while on other medications. Because adequate

historical data are not available, it is impossible to say whether or not treatment with Gabapentin is

associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar

population not treated with Gabapentin.

5.6 Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Gabapentin, increase the risk of suicidal thoughts or behavior in

patients taking these drugs for any indication. Patients treated with any AED for any indication should be

monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any

unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different

AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted

Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to

placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate

of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24%

among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal

thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in

the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about

drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week

after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because

most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or

behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.

The finding of increased risk with AEDs of varying mechanisms of action and across a range of

indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary

substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative

risk by indication for all evaluated AEDs.

TABLE 2 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

Indication

Placebo

Patients

with Events

Per 1000

Patients

Drug

Patients

with Events

Per 1000

Patients

Relative Risk:

Incidence of

Events in

Drug Patients/

Incidence in

Placebo

Patients

Risk

Difference:

Additional

Drug Patients

with Events

Per 1000

Patients

Epilepsy

Psychiatric

Other

Total

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in

clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the

epilepsy and psychiatric indications.

Anyone considering prescribing Gabapentin or any other AED must balance the risk of suicidal

thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which

AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of

suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the

prescriber needs to consider whether the emergence of these symptoms in any given patient may be

related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal

thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of

the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of

suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported

immediately to healthcare providers.

5.7 Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age)

Gabapentin use in pediatric patients with epilepsy 3 to 12 years of age is associated with the occurrence

of CNS related adverse reactions. The most significant of these can be classified into the following

categories: 1) emotional lability (primarily behavioral problems),2) hostility, including aggressive

behaviors, 3) thought disorder, including concentration problems and change in school performance,

and 4) hyperkinesia (primarily restlessness and hyperactivity). Among the gabapentin-treated patients,

most of the reactions were mild to moderate in intensity.

In controlled clinical epilepsy trials in pediatric patients 3 to 12 years of age, the incidence of these

adverse reactions was: emotional lability 6% (gabapentin-treated patients) vs. 1.3% (placebo-treated

patients); hostility 5.2% vs. 1.3%; hyperkinesia 4.7% vs. 2.9%; and thought disorder 1.7% vs. 0%. One

of these reactions, a report of hostility, was considered serious. Discontinuation of gabapentin treatment

occurred in 1.3% of patients reporting emotional lability and hyperkinesia and 0.9% of gabapentin-

treated patients reporting hostility and thought disorder. One placebo-treated patient (0.4%) withdrew

due to emotional lability.

5.8 Tumorigenic Potential

In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in

rats [see Nonclinical Toxicology (13.1)]. The clinical significance of this finding is unknown. Clinical

experience during gabapentin’s premarketing development provides no direct means to assess its

potential for inducing tumors in humans.

In clinical studies in adjunctive therapy in epilepsy comprising 2085 patient-years of exposure in

patients >12 years of age, new tumors were reported in 10 patients (2 breast, 3 brain, 2 lung, 1 adrenal, 1

non-Hodgkin’s lymphoma, 1 endometrial carcinoma in situ), and preexisting tumors worsened in 11

patients (9 brain, 1 breast, 1 prostate) during or up to 2 years following discontinuation of Gabapentin..

Without knowledge of the background incidence and recurrence in a similar population not treated with

Gabapentin, it is impossible to know whether the incidence seen in this cohort is or is not affected by

treatment.

5.9 Sudden and Unexplained Death in Patients with Epilepsy

During the course of premarketing development of Gabapentin, 8 sudden and unexplained deaths were

recorded among a cohort of 2203 epilepsy patients treated (2103 patient-years of exposure) with

Gabapentin.

Some of these could represent seizure-related deaths in which the seizure was not observed, e.g., at

night. This represents an incidence of 0.0038 deaths per patient-year. Although this rate exceeds that

expected in a healthy population matched for age and sex, it is within the range of estimates for the

incidence of sudden unexplained deaths in patients with epilepsy not receiving Gabapentin.(ranging from

0.0005 for the general population of epileptics to 0.003 for a clinical trial population similar to that in

the Gabapentin program, to 0.005 for patients with refractory epilepsy). Consequently, whether these

figures are reassuring or raise further concern depends on comparability of the populations reported

upon to the Gabapentin cohort and the accuracy of the estimates provided.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

[see Warnings and Precautions (5.1)]

Anaphylaxis and Angioedema [see Warnings and Precautions (5.2)]

Somnolence/Sedation and Dizziness [see see Warnings and Precautions (5.4)]

Withdrawal Precipitated Seizure, Status Epilepticus [see see Warnings and Precautions (5.5)]

Suicidal Behavior and Ideation [see see Warnings and Precautions (5.6)]

Neuropsychiatric Adverse Reactions (Pediatric Patients 3-12 Years of Age) [see see Warnings and

Precautions (5.7)]

Sudden and Unexplained Death in Patients with Epilepsy [see see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

Postherpetic Neuralgia

The most common adverse reactions associated with the use of Gabapentin in adults, not seen at an

equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral

edema.

In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received Gabapentin

and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction.

The adverse reactions that most frequently led to withdrawal in Gabapentin-treated patients were

dizziness, somnolence, and nausea.

Table 3 lists adverse reactions that occurred in at least 1% of Gabapentin-treated patients with

postherpetic neuralgia participating in placebo-controlled trials and that were numerically more

frequent in the Gabapentin group than in the placebo group.

TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia

Gabapentin

N=336

Placebo

N=227

Body as a Whole

Asthenia

Infection

Accidental injury

Digestive System

Diarrhea

Dry mouth

Constipation

Nausea

Vomiting

Metabolic and Nutritional Disorders

Peripheral edema

Weight gain

Hyperglycemia

Nervous System

Dizziness

Somnolence

Ataxia

Abnormal thinking

Abnormal gait

Incoordination

Respiratory System

Pharyngitis

Special Senses

Amblyopia

Conjunctivitis

Diplopia

Otitis media

Other reactions in more than 1% of patients but equally or more frequent in the placebo group included

pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome.

There were no clinically important differences between men and women in the types and incidence of

adverse reactions. Because there were few patients whose race was reported as other than white, there

are insufficient data to support a statement regarding the distribution of adverse reactions by race.

Epilepsy with Partial Onset Seizures (Adjunctive Therapy)

The most common adverse reactions with Gabapentin in combination with other antiepileptic drugs in

patients >12 years of age, not seen at an equivalent frequency among placebo-treated patients, were

somnolence, dizziness, ataxia, fatigue, and nystagmus.

The most common adverse reactions with Gabapentin in combination with other antiepileptic drugs in

pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients,

were viral infection, fever, nausea and/or vomiting, somnolence, and hostility [see Warnings and

Precautions (5.7) ].

Approximately 7% of the 2074 patients >12 years of age and approximately 7% of the 449 pediatric

patients 3 to 12 years of age who received Gabapentin in premarketing clinical trials discontinued

treatment because of an adverse reaction. The adverse reactions most commonly associated with

withdrawal in patients >12 years of age were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea

and/or vomiting (0.6%), and dizziness (0.6%). The adverse reactions most commonly associated with

withdrawal in pediatric patients were emotional lability (1.6%), hostility (1.3%), and hyperkinesia

(1.1%).

Table 4 lists adverse reactions that occurred in at least 1% of Gabapentin-treated patients >12 years of

age with epilepsy participating in placebo-controlled trials and were numerically more common in the

Reported as blurred vision

Gabapentin group. In these studies, either Gabapentin or placebo was added to the patient’s current

antiepileptic drug therapy.

TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients

>12 years of age

Gabapentin

N=543

Placebo

N=378

Body As A Whole

Fatigue

Increased Weight

Back Pain

Peripheral Edema

Cardiovascular

Vasodilatation

Digestive System

Dyspepsia

Dry Mouth or Throat

Constipation

Dental Abnormalities

Nervous System

Somnolence

Dizziness

Ataxia

Nystagmus

Tremor

Dysarthria

Amnesia

Depression

Abnormal thinking

Abnormal coordination

Respiratory System

Pharyngitis

Coughing

Skin and Appendages

Abrasion

Urogenital System

Impotence

Special Senses

Diplopia

Amblyopia

Among the adverse reactions occurring at an incidence of at least 10% in Gabapentin-treated patients,

somnolence and ataxia appeared to exhibit a positive dose-response relationship.

The overall incidence of adverse reactions and the types of adverse reactions seen were similar among

Plus background antiepileptic drug therapy

Amblyopia was often described as blurred vision.

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