GABAPENTIN- gabapentin tablet, coated

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

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Active ingredient:
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Gabapentin is 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 fetal skeletal an
Product summary:
Product: 50090-4445 NDC: 50090-4445-0 90 TABLET, COATED in a BOTTLE NDC: 50090-4445-1 60 TABLET, COATED in a BOTTLE NDC: 50090-4445-2 30 TABLET, COATED in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-4445-0, 50090-4445-1, 50090-4445-2

GABAPENTIN- gabapentin tablet, coated

A-S Medication Solutions

----------

MEDICATION GUIDE

Gabapentin Tablets, USP

(GA-ba-PEN-tin)

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

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

Stopping gabapentin tablets suddenly can cause serious problems.

Gabapentin tablets can cause serious side effects including:

Suicidal Thoughts. Like other antiepileptic drugs, gabapentin tablets 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 tablets without first talking to a healthcare provider.

Stopping gabapentin tablets 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.

Changes in behavior and thinking - Using gabapentin tablets in children 3 to 12 years of age can cause

emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school

performance, and hyperactivity.

Gabapentin tablets may cause 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 tablets. You may or may not have a rash with an allergic reaction caused by gabapentin

tablets.

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 tablets.

What are gabapentin tablets?

Gabapentin tablets 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 with seizures.

Who should not take gabapentin tablets?

Do not take gabapentin tablets if you are allergic to gabapentin or any of the other ingredients in gabapentin

tablets. See the end of this Medication Guide for a complete list of ingredients in gabapentin tablets.

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

Before taking gabapentin tablets, 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 tablets. You

and your healthcare provider will decide if you should take gabapentin tablets while you are pregnant.

Pregnancy Registry: If you become pregnant while taking gabapentin tablets, 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 tablets.

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

medicines, vitamins, and herbal supplements.

Taking gabapentin tablets 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 tablets?

Take gabapentin tablets exactly as prescribed. Your healthcare provider will tell you how much

gabapentin tablets to take.

Do not change your dose of gabapentin tablets without talking to your healthcare provider.

If you take gabapentin tablets and break a tablet in half, the unused half of the tablet should be

taken at your next scheduled dose. Half tablets not used within 28 days of breaking should be

thrown away.

Gabapentin tablets 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 tablets.

If you take too much gabapentin tablets, call your healthcare provider or your local Poison Control Center

right away at 1-800-222-1222.

What should I avoid while taking gabapentin tablets?

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin

tablets without first talking with your healthcare provider. Taking gabapentin tablets 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 tablets affect you. Gabapentin tablets can slow your thinking and motor skills.

What are the possible side effects of gabapentin tablets?

Gabapentin tablets may cause serious side effects including:

See "What is the most important information I should know about gabapentin tablets?"

problems driving while using gabapentin tablets. See "What I should avoid while taking gabapentin

tablets?"

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

The most common side effects of gabapentin tablets include:

lack of coordination

viral infection

feeling drowsy

nausea and vomiting

difficulty with speaking

tremor

swelling, usually of legs and

feet

feeling tired

fever

jerky movements

difficulty with coordination

double vision

unusual eye movement

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 tablets. 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 tablets?

Store gabapentin tablets at 20° to 25°C (68° to 77°F).

Gabapentin tablets come in a child-resistant package.

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

General information about the safe and effective use of gabapentin tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

gabapentin tablets for a condition for which it was not prescribed. Do not give gabapentin tablets 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 tablets. If you would

like more information, talk with your healthcare provider. You can ask your healthcare provider or

pharmacist for information about gabapentin tablets that was written for healthcare professionals.

For more information contact TAGI Pharma, Inc. at 1-855-225-8244.

What are the ingredients in gabapentin tablets?

Active ingredient: gabapentin

Inactive ingredients in the tablets: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol,

talc and titanium dioxide.

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

Revised: 8/2019

Document Id: b759bab0-4b3e-40fe-af4d-a0f04fc01973

34391-3

Set id: af076d4c-9bdc-4bea-ad13-62800aea9f74

Version: 1

Effective Time: 20190827

A-S Medication Solutions

GABAPENTIN- gabapentin tablet, coated

A-S Medication Solutions

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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

effectively. See full prescribing information for GABAPENTIN TABLETS.

GABAPENTIN tablets, for oral use

Initial U.S. Approval: 1993

INDICATIONS AND USAGE

Gabapentin is 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 1,800 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

Tablets: 600 mg, and 800 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 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 to 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 TAGI Pharma, Inc. at 1-855-225-8244 or FDA at 1-800-

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: 8/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

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 is 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 ADMINISTRATION

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 1,800 mg/day (600 mg

three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1,800

mg/day to 3,600 mg/day with comparable effects across the dose range; however, in these clinical

studies, the additional benefit of using doses greater than 1,800 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 2,400 mg/day have been well tolerated in long-term

clinical studies. Doses of 3,600 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

600 mg or 800 mg tablets. 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

oral solution, capsule, or tablet, or using combinations of these 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

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

each indication):

TABLE 1. Gabapentin Dosage Based on Renal Function

Renal Function

Creatinine Clearance

(mL/min)

Total Daily Dose Range

(mg/day)

Dosage Regimen

(mg)

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

≥ 60

900 to 3,600

300 TID 400 TID 600 TID 800 TID

1,200

> 30 to 59

400 to 1,400

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 difficult to measure in outpatients. In patients with stable renal function,

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

CLCr =

[140 – age (years) ] × weight (kg)

72 × serum creatinine (mg/dL)

( × 0.85 for female patients)

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.

Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablet in order to

administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used

within 28 days of dividing the scored tablet should be discarded.

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

Gabapentin Tablets USP, 600 mg are white, elliptical, film-coated scored tablets debossed "O|E" on

one side and "600" on the other side

Gabapentin Tablets USP, 800 mg are white, elliptical, film-coated scored tablets debossed "O|E" on

one side and "800" on the other side

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.

4 CONTRAINDICATIONS

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

ingredients.

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 1,800 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 3,600

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) versus 0.5% in patients

receiving placebo (2 of 378). Among the 2,074 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 to 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

1,000 Patients

Drug Patients with

Events Per 1,000

Patients

Relative Risk:

Incidence of Events

in Drug Patients /

Incidence in Placebo

Risk Difference:

Additional Drug

Patients with Events

Per 1,000 Patients

Patients

Per 1,000 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) versus 1.3% (placebo-treated

patients); hostility 5.2% versus 1.3%; hyperkinesia 4.7% versus 2.9%; and thought disorder 1.7% versus

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 2,085 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 2,203 epilepsy patients treated (2,103 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 Warnings and Precautions (5.4)]

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

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

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

Precautions (5.7)]

Sudden and Unexplained Death in Patients with Epilepsy [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 2,074 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

Reported as blurred vision

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

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

Weight Increase

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

*

*

Plus background antiepileptic drug therapy

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

men and women treated with gabapentin. The incidence of adverse reactions increased slightly with

increasing age in patients treated with either gabapentin or placebo. Because only 3% of patients

(28/921) in placebo-controlled studies were identified as nonwhite (black or other), there are

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

Table 5 lists adverse reactions that occurred in at least 2% of gabapentin-treated patients, age 3 to 12

years of age with epilepsy participating in placebo-controlled trials, and which were numerically more

common in the gabapentin group.

TABLE 5. Adverse Reactions in a Placebo-Controlled

Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12

Years

Gabapentin

N = 119

%

Placebo

N = 128

%

Body as a Whole

Viral Infection

Fever

Increased Weight

Fatigue

Digestive System

Nausea and/or Vomiting

Nervous System

Somnolence

Hostility

Emotional Lability

Dizziness

Hyperkinesia

Respiratory System

Bronchitis

Respiratory Infection

Other reactions in more than 2% of pediatric patients 3 to 12 years of age but equally or more frequent

in the placebo group included: pharyngitis, upper respiratory infection, headache, rhinitis, convulsions,

diarrhea, anorexia, coughing, and otitis media.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of gabapentin. Because

these reactions are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary disorders: jaundice

Investigations: elevated creatine kinase, elevated liver function tests

Amblyopia was often described as blurred vision.

*

*

Plus background antiepileptic drug therapy

Metabolism and nutrition disorders: hyponatremia

Musculoskeletal and connective tissue disorder: rhabdomyolysis

Nervous system disorders: movement disorder

Psychiatric disorders: agitation

Reproductive system and breast disorders: breast enlargement, changes in libido, ejaculation disorders

and anorgasmia

Skin and subcutaneous tissue disorders: angioedema [see Warnings and Precautions (5.2)], erythema

multiforme, Stevens-Johnson syndrome.

Adverse reactions following the abrupt discontinuation of gabapentin have also been reported. The

most frequently reported reactions were anxiety, insomnia, nausea, pain, and sweating.

7 DRUG INTERACTIONS

7.1 Other Antiepileptic Drugs

Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly

coadministered antiepileptic drugs [see Clinical Pharmacology (12.3)].

7.2 Opioids

Hydrocodone

Coadministration of gabapentin with hydrocodone decreases hydrocodone exposure [see Clinical

Pharmacology (12.3)]. The potential for alteration in hydrocodone exposure and effect should be

considered when gabapentin is started or discontinued in a patient taking hydrocodone.

Morphine

When gabapentin is administered with morphine, patients should be observed for signs of CNS

depression, such as somnolence, sedation and respiratory depression [see Clinical Pharmacology (12.3)].

7.3 Maalox

(aluminum hydroxide, magnesium hydroxide)

The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid

(Maalox

) containing magnesium and aluminum hydroxides. It is recommended that gabapentin be taken

at least 2 hours following Maalox administration [see Clinical Pharmacology (12.3)].

7.4 Drug/Laboratory Test Interactions

Because false positive readings were reported with the Ames N-Multistix SG dipstick test for urinary

protein when gabapentin was added to other antiepileptic drugs, the more specific sulfosalicylic acid

precipitation procedure is recommended to determine the presence of urine protein.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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

fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to

pregnant animals at doses similar to or lower than those used clinically [see Data].

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of

major birth defects and miscarriage for the indicated population is unknown.

Data

Animal data

When pregnant mice received oral doses of gabapentin (500, 1,000, or 3,000 mg/kg/day) during the

period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was

observed at the two highest doses. The no-effect dose for embryofetal developmental toxicity in mice

(500 mg/kg/day) is less than the maximum recommended human dose (MRHD) of 3,600 mg/kg on a body

surface area (mg/m ) basis.

In studies in which rats received oral doses of gabapentin (500 to 2,000 mg/kg/day) during pregnancy,

adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis)

were observed at all doses. The lowest dose tested is similar to the MRHD on a mg/m basis.

When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in

embryofetal mortality was observed at all doses tested (60, 300, or 1,500 mg/kg). The lowest dose

tested is less than the MRHD on a mg/m basis.

In a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to

neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to

the last trimester of pregnancy in humans). Gabapentin caused a marked decrease in neuronal synapse

formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic

repair. Gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-

activated calcium channels, a receptor involved in neuronal synaptogenesis. The clinical significance of

these findings is unknown.

8.2 Lactation

Risk Summary

Gabapentin is secreted in human milk following oral administration. The effects on the breastfed infant

and on milk production are unknown. The developmental and health benefits of breastfeeding should be

considered along with the mother's clinical need for gabapentin and any potential adverse effects on the

breastfed infant from gabapentin or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients

have not been established.

Safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients

below the age of 3 years has not been established [see Clinical Studies (14.2)].

8.5 Geriatric Use

The total number of patients treated with gabapentin in controlled clinical trials in patients with

postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were

75 years of age and older. There was a larger treatment effect in patients 75 years of age and older

compared to younger patients who received the same dosage. Since gabapentin is almost exclusively

eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a

eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a

consequence of increased gabapentin exposure for a given dose that results from an age-related

decrease in renal function. However, other factors cannot be excluded. The types and incidence of

adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended

to increase in incidence with age.

Clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and

over to determine whether they responded differently from younger subjects. Other reported clinical

experience has not identified differences in responses between the elderly and younger patients. In

general, dose selection for an elderly patient should be cautious, usually starting at the low end of the

dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of

concomitant disease or other drug therapy. This drug is known to be substantially excreted by the

kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal

function. 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 [see Dosage and Administration (2.4), Adverse Reactions (6), and Clinical Pharmacology (12.3)].

8.6 Renal Impairment

Dosage adjustment in adult patients with compromised renal function is necessary [see Dosage and

Administration (2.3) and Clinical Pharmacology (12.3)]. Pediatric patients with renal insufficiency have

not been studied.

Dosage adjustment in patients undergoing hemodialysis is necessary [see Dosage and Administration

(2.3) and Clinical Pharmacology (12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Gabapentin is not a scheduled drug.

9.2 Abuse

Gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1

receptor sites. A small number of postmarketing cases report gabapentin misuse and abuse. These

individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the

individuals described in these reports had a history of poly-substance abuse or used gabapentin to

relieve symptoms of withdrawal from other substances. When prescribing gabapentin carefully evaluate

patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or

abuse (e.g., development of tolerance, self-dose escalation, and drug-seeking behavior).

9.3 Dependence

There are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after

discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug

is not approved. Such symptoms included agitation, disorientation and confusion after suddenly

discontinuing gabapentin that resolved after restarting gabapentin. Most of these individuals had a

history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other

substances. The dependence and abuse potential of gabapentin has not been evaluated in human studies.

10 OVERDOSAGE

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as

8,000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation,

hypoactivity, or excitation. Acute oral overdoses of gabapentin 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. Coma, resolving with dialysis, has been reported in patients

with chronic renal failure who were treated with gabapentin. 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. If

overexposure occurs, call your poison control center at 1-800-222-1222.

11 DESCRIPTION

The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-

(aminomethyl) cyclohexaneacetic acid.

The molecular formula of gabapentin is C H NO and the molecular weight is 171.24. The structural

formula of gabapentin is:

Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely

soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-

octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.

Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive

ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium

dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The precise mechanisms by which gabapentin produces its analgesic and antiepileptic action are

unknown. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA)

but has no effect on GABA binding, uptake, or degradation. In vitro studies have shown that gabapentin

binds with high-affinity to the α2δ subunit of voltage-activated calcium channels; however, the

relationship of this binding to the therapeutic effects of gabapentin is unknown.

12.3 Pharmacokinetics

All pharmacological actions following gabapentin administration are due to the activity of the parent

compound; gabapentin is not appreciably metabolized in humans.

Oral Bioavailability

Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases.

Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900, 1,200,

2,400, 3,600, and 4,800 mg/day given in 3 divided doses, respectively. Food has only a slight effect on

the rate and extent of absorption of gabapentin (14% increase in AUC and C

Distribution

Less than 3% of gabapentin circulates bound to plasma protein. The apparent volume of distribution of

gabapentin after 150 mg intravenous administration is 58 ± 6 L (mean ± SD). In patients with epilepsy,

steady-state predose (C

) concentrations of gabapentin in cerebrospinal fluid were approximately

20% of the corresponding plasma concentrations.

Elimination

Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin

is not appreciably metabolized in humans.

Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing.

Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to

creatinine clearance. In elderly patients, and in patients with impaired renal function, gabapentin plasma

clearance is reduced. Gabapentin can be removed from plasma by hemodialysis.

Specific Populations

Age

The effect of age was studied in subjects 20 to 80 years of age. Apparent oral clearance (CL/F) of

gabapentin decreased as age increased, from about 225 mL/min in those under 30 years of age to about

125 mL/min in those over 70 years of age. Renal clearance (CLr) and CLr adjusted for body surface

area also declined with age; however, the decline in the renal clearance of gabapentin with age can

largely be explained by the decline in renal function [see Dosage and Administration (2.4) and Use in

Specific Populations (8.5)].

Gender

Although no formal study has been conducted to compare the pharmacokinetics of gabapentin in men and

women, it appears that the pharmacokinetic parameters for males and females are similar and there are no

significant gender differences.

Race

Pharmacokinetic differences due to race have not been studied. Because gabapentin is primarily renally

excreted and there are no important racial differences in creatinine clearance, pharmacokinetic

differences due to race are not expected.

Pediatric

Gabapentin pharmacokinetics were determined in 48 pediatric subjects between the ages of 1 month and

12 years following a dose of approximately 10 mg/kg. Peak plasma concentrations were similar across

the entire age group and occurred 2 to 3 hours postdose. In general, pediatric subjects between 1 month

and < 5 years of age achieved approximately 30% lower exposure (AUC) than that observed in those 5

years of age and older. Accordingly, oral clearance normalized per body weight was higher in the

younger children. Apparent oral clearance of gabapentin was directly proportional to creatinine

clearance. Gabapentin elimination half-life averaged 4.7 hours and was similar across the age groups

studied.

A population pharmacokinetic analysis was performed in 253 pediatric subjects between 1 month and 13

years of age. Patients received 10 to 65 mg/kg/day given three times a day. Apparent oral clearance

(CL/F) was directly proportional to creatinine clearance and this relationship was similar following a

single dose and at steady-state. Higher oral clearance values were observed in children < 5 years of

age compared to those observed in children 5 years of age and older, when normalized per body

weight. The clearance was highly variable in infants < 1 year of age. The normalized CL/F values

observed in pediatric patients 5 years of age and older were consistent with values observed in adults

after a single dose. The oral volume of distribution normalized per body weight was constant across the

age range.

These pharmacokinetic data indicate that the effective daily dose in pediatric patients with epilepsy ages

3 and 4 years should be 40 mg/kg/day to achieve average plasma concentrations similar to those

achieved in patients 5 years of age and older receiving gabapentin at 30 mg/kg/day [see Dosage and

Administration (2.2)].

Adult Patients with Renal Impairment

Subjects (N = 60) with renal impairment (mean creatinine clearance ranging from 13 to 114 mL/min)

were administered single 400 mg oral doses of gabapentin. The mean gabapentin half-life ranged from

about 6.5 hours (patients with creatinine clearance > 60 mL/min) to 52 hours (creatinine clearance < 30

mL/min) and gabapentin renal clearance from about 90 mL/min (> 60 mL/min group) to about 10 mL/min

(< 30 mL/min). Mean plasma clearance (CL/F) decreased from approximately 190 mL/min to 20 mL/min

[see Dosage and Administration (2.3) and Use in Specific Populations (8.6)]. Pediatric patients with renal

insufficiency have not been studied.

Hemodialysis

In a study in anuric adult subjects (N = 11), the apparent elimination half-life of gabapentin on

nondialysis days was about 132 hours; during dialysis the apparent half-life of gabapentin was reduced

to 3.8 hours. Hemodialysis thus has a significant effect on gabapentin elimination in anuric subjects [see

Dosage and Administration (2.3) and Use in Specific Populations (8.6)].

Hepatic Disease

Because gabapentin is not metabolized, no study was performed in patients with hepatic impairment.

Drug Interactions

In Vitro Studies

In vitro studies were conducted to investigate the potential of gabapentin to inhibit the major

cytochrome P450 enzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and

CYP3A4) that mediate drug and xenobiotic metabolism using isoform selective marker substrates

and human liver microsomal preparations. Only at the highest concentration tested (171 mcg/mL; 1

mM) was a slight degree of inhibition (14% to 30%) of isoform CYP2A6 observed. No inhibition

of any of the other isoforms tested was observed at gabapentin concentrations up to 171 mcg/mL

(approximately 15 times the C

at 3,600 mg/day).

In Vivo Studies

The drug interaction data described in this section were obtained from studies involving healthy

adults and adult patients with epilepsy.

Phenytoin

In a single (400 mg) and multiple dose (400 mg three times a day) study of gabapentin in epileptic

patients (N = 8) maintained on phenytoin monotherapy for at least 2 months, gabapentin had no effect

on the steady-state trough plasma concentrations of phenytoin and phenytoin had no effect on

gabapentin pharmacokinetics.

Carbamazepine

Steady-state trough plasma carbamazepine and carbamazepine 10, 11 epoxide concentrations were

not affected by concomitant gabapentin (400 mg three times a day; N = 12) administration. Likewise,

gabapentin pharmacokinetics were unaltered by carbamazepine administration.

Valproic Acid

The mean steady-state trough serum valproic acid concentrations prior to and during concomitant

gabapentin administration (400 mg three times a day; N = 17) were not different and neither were

gabapentin pharmacokinetic parameters affected by valproic acid.

Phenobarbital

Estimates of steady-state pharmacokinetic parameters for phenobarbital or gabapentin (300 mg three

times a day; N = 12) are identical whether the drugs are administered alone or together.

Naproxen

Coadministration (N = 18) of naproxen sodium capsules (250 mg) with gabapentin (125 mg) appears

to increase the amount of gabapentin absorbed by 12% to 15%. Gabapentin had no effect on naproxen

pharmacokinetic parameters. These doses are lower than the therapeutic doses for both drugs. The

magnitude of interaction within the recommended dose ranges of either drug is not known.

Hydrocodone

Coadministration of gabapentin (125 to 500 mg; N = 48) decreases hydrocodone (10 mg; N = 50)

and AUC values in a dose-dependent manner relative to administration of hydrocodone alone;

and AUC values are 3% to 4% lower, respectively, after administration of 125 mg gabapentin

and 21% to 22% lower, respectively, after administration of 500 mg gabapentin. The mechanism for

this interaction is unknown. Hydrocodone increases gabapentin AUC values by 14%. The magnitude

of interaction at other doses is not known.

Morphine

A literature article reported that when a 60 mg controlled-release morphine capsule was

administered 2 hours prior to a 600 mg gabapentin capsule (N = 12), mean gabapentin AUC

increased by 44% compared to gabapentin administered without morphine. Morphine

pharmacokinetic parameter values were not affected by administration of gabapentin 2 hours after

morphine. The magnitude of interaction at other doses is not known.

Cimetidine

In the presence of cimetidine at 300 mg four times a day (N = 12), the mean apparent oral clearance

of gabapentin fell by 14% and creatinine clearance fell by 10%. Thus, cimetidine appeared to alter

the renal excretion of both gabapentin and creatinine, an endogenous marker of renal function. This

small decrease in excretion of gabapentin by cimetidine is not expected to be of clinical importance.

The effect of gabapentin on cimetidine was not evaluated.

Oral Contraceptive

Based on AUC and half-life, multiple-dose pharmacokinetic profiles of norethindrone and ethinyl

estradiol following administration of tablets containing 2.5 mg of norethindrone acetate and 50 mcg

of ethinyl estradiol were similar with and without coadministration of gabapentin (400 mg three

times a day; N = 13). The C

of norethindrone was 13% higher when it was coadministered with

gabapentin; this interaction is not expected to be of clinical importance.

Antacid (Maalox

) (aluminum hydroxide, magnesium hydroxide)

Antacid (Maalox

) containing magnesium and aluminum hydroxides reduced the mean bioavailability

of gabapentin (N = 16) by about 20%. This decrease in bioavailability was about 10% when

gabapentin was administered 2 hours after Maalox.

Probenecid

Probenecid is a blocker of renal tubular secretion. Gabapentin pharmacokinetic parameters without

and with probenecid were comparable. This indicates that gabapentin does not undergo renal tubular

secretion by the pathway that is blocked by probenecid.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Gabapentin was administered orally to mice and rats in 2-year carcinogenicity studies. No evidence of

drug-related carcinogenicity was observed in mice treated at doses up to 2,000 mg/kg/day. At 2,000

mg/kg, the plasma gabapentin exposure (AUC) in mice was approximately 2 times that in humans at the

MRHD of 3,600 mg/day. In rats, increases in the incidence of pancreatic acinar cell adenoma and

carcinoma were found in male rats receiving the highest dose (2,000 mg/kg), but not at doses of 250 or

1,000 mg/kg/day. At 1,000 mg/kg, the plasma gabapentin exposure (AUC) in rats was approximately 5

times that in humans at the MRHD. Studies designed to investigate the mechanism of gabapentin-induced

pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic

acinar cells in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity. It is not

known whether gabapentin has the ability to increase cell proliferation in other cell types or in other

species, including humans.

Mutagenesis

Gabapentin did not demonstrate mutagenic or genotoxic potential in in vitro (Ames test, HGPRT forward

mutation assay in Chinese hamster lung cells) and in vivo (chromosomal aberration and micronucleus test

in Chinese hamster bone marrow, mouse micronucleus, unscheduled DNA synthesis in rat hepatocytes)

®

assays.

Impairment of Fertility

No adverse effects on fertility or reproduction were observed in rats at doses up to 2,000 mg/kg. At

2,000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 8 times that in humans at

the MRHD.

14 CLINICAL STUDIES

14.1 Postherpetic Neuralgia

Gabapentin was evaluated for the management of postherpetic neuralgia (PHN) in two randomized,

double-blind, placebo-controlled, multicenter studies. The intent-to-treat (ITT) population consisted of

a total of 563 patients with pain for more than 3 months after healing of the herpes zoster skin rash

(Table 6).

TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients

Study

Study Duration

Gabapentin

(mg/day)

Target

Dos e

Patients Receiving

Gabapentin

Patients Receiving

Placebo

8 weeks

3,600

7 weeks

1,800, 2,400

Total

Each study included a 7- or 8-week double-blind phase (3 or 4 weeks of titration and 4 weeks of fixed

dose). Patients initiated treatment with titration to a maximum of 900 mg/day gabapentin over 3 days.

Dosages were then to be titrated in 600 to 1,200 mg/day increments at 3- to 7-day intervals to the target

dose over 3 to 4 weeks. Patients recorded their pain in a daily diary using an 11-point numeric pain

rating scale ranging from 0 (no pain) to 10 (worst possible pain). A mean pain score during baseline of

at least 4 was required for randomization. Analyses were conducted using the ITT population (all

randomized patients who received at least one dose of study medication).

Both studies demonstrated efficacy compared to placebo at all doses tested.

The reduction in weekly mean pain scores was seen by Week 1 in both studies, and were maintained to

the end of treatment. Comparable treatment effects were observed in all active treatment arms.

Pharmacokinetic/pharmacodynamic modeling provided confirmatory evidence of efficacy across all

doses. Figures 1 and 2 show pain intensity scores over time for Studies 1 and 2.

Figure 1. Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 1

*

Gven in 3 divided doses (TID)

Figure 2. Weekly Mean Pain Scores (Observed Cases in ITT Population): Study 2

The proportion of responders (those patients reporting at least 50% improvement in endpoint pain score

compared to baseline) was calculated for each study (Figure 3).

Figure 3. Proportion of Responders (patients with ≥ 50% reduction in pain score) at Endpoint:

Controlled PHN Studies

14.2 Epilepsy for Partial Onset Seizures (Adjunctive Therapy)

The effectiveness of gabapentin as adjunctive therapy (added to other antiepileptic drugs) was

established in multicenter placebo-controlled, double-blind, parallel-group clinical trials in adult and

pediatric patients (3 years and older) with refractory partial seizures.

Evidence of effectiveness was obtained in three trials conducted in 705 patients (age 12 years and

above) and one trial conducted in 247 pediatric patients (3 to 12 years of age). The patients enrolled had

a history of at least 4 partial seizures per month in spite of receiving one or more antiepileptic drugs at

therapeutic levels and were observed on their established antiepileptic drug regimen during a 12-week

baseline period (6 weeks in the study of pediatric patients). In patients continuing to have at least 2 (or 4

in some studies) seizures per month, gabapentin or placebo was then added on to the existing therapy

during a 12-week treatment period.

Effectiveness was assessed primarily on the basis of the percent of patients with a 50% or greater

reduction in seizure frequency from baseline to treatment (the "responder rate") and a derived measure

called response ratio, a measure of change defined as (T - B)/(T + B), in which B is the patient's

baseline seizure frequency and T is the patient's seizure frequency during treatment. Response ratio is

distributed within the range -1 to +1. A zero value indicates no change while complete elimination of

seizures would give a value of -1; increased seizure rates would give positive values. A response ratio

of -0.33 corresponds to a 50% reduction in seizure frequency. The results given below are for all

partial seizures in the intent-to-treat (all patients who received any doses of treatment) population in

each study, unless otherwise indicated.

One study compared gabapentin 1,200 mg/day, in three divided doses with placebo. Responder rate was

23% (14/61) in the gabapentin group and 9% (6/66) in the placebo group; the difference between groups

was statistically significant. Response ratio was also better in the gabapentin group (-0.199) than in the

placebo group (-0.044), a difference that also achieved statistical significance.

A second study compared primarily gabapentin 1,200 mg/day, in three divided doses (N = 101), with

placebo (N = 98). Additional smaller gabapentin dosage groups (600 mg/day, N = 53; 1,800 mg/day, N

= 54) were also studied for information regarding dose response. Responder rate was higher in the

gabapentin 1,200 mg/day group (16%) than in the placebo group (8%), but the difference was not

statistically significant. The responder rate at 600 mg (17%) was also not significantly higher than in the

placebo, but the responder rate in the 1,800 mg group (26%) was statistically significantly superior to

the placebo rate. Response ratio was better in the gabapentin 1,200 mg/day group (-0.103) than in the

placebo group (-0.022); but this difference was also not statistically significant (p = 0.224). A better

response was seen in the gabapentin 600 mg/day group (-0.105) and 1,800 mg/day group (-0.222) than in

the 1,200 mg/day group, with the 1,800 mg/day group achieving statistical significance compared to the

placebo group.

A third study compared gabapentin 900 mg/day, in three divided doses (N = 111) and placebo (N = 109).

An additional gabapentin 1,200 mg/day dosage group (N = 52) provided dose-response data. A

statistically significant difference in responder rate was seen in the gabapentin 900 mg/day group (22%)

compared to that in the placebo group (10%). Response ratio was also statistically significantly

superior in the gabapentin 900 mg/day group (-0.119) compared to that in the placebo group (-0.027), as

was response ratio in 1,200 mg/day gabapentin (-0.184) compared to placebo.

Analyses were also performed in each study to examine the effect of gabapentin on preventing

secondarily generalized tonic-clonic seizures. Patients who experienced a secondarily generalized

tonic-clonic seizure in either the baseline or in the treatment period in all three placebo-controlled

studies were included in these analyses. There were several response ratio comparisons that showed a

statistically significant advantage for gabapentin compared to placebo and favorable trends for almost

all comparisons.

Analysis of responder rate using combined data from all three studies and all doses (N = 162,

gabapentin; N = 89, placebo) also showed a significant advantage for gabapentin over placebo in

reducing the frequency of secondarily generalized tonic-clonic seizures.

In two of the three controlled studies, more than one dose of gabapentin was used. Within each study,

the results did not show a consistently increased response to dose. However, looking across studies, a

trend toward increasing efficacy with increasing dose is evident (see Figure 4).

Figure 4. Responder Rate in Patients Receiving Gabapentin Expressed as a Difference from

Placebo by Dose and Study: Adjunctive Therapy Studies in Patients ≥ 12 Years of Age with

Partial Seizures

In the figure, treatment effect magnitude, measured on the Y axis in terms of the difference in the

proportion of gabapentin and placebo-assigned patients attaining a 50% or greater reduction in seizure

frequency from baseline, is plotted against the daily dose of gabapentin administered (X axis).

frequency from baseline, is plotted against the daily dose of gabapentin administered (X axis).

Although no formal analysis by gender has been performed, estimates of response (Response Ratio)

derived from clinical trials (398 men, 307 women) indicate no important gender differences exist. There

was no consistent pattern indicating that age had any effect on the response to gabapentin. There were

insufficient numbers of patients of races other than Caucasian to permit a comparison of efficacy among

racial groups.

A fourth study in pediatric patients age 3 to 12 years compared 25 to 35 mg/kg/day gabapentin (N = 118)

with placebo (N = 127). For all partial seizures in the intent-to-treat population, the response ratio was

statistically significantly better for the gabapentin group (-0.146) than for the placebo group (-0.079).

For the same population, the responder rate for gabapentin (21%) was not significantly different from

placebo (18%).

A study in pediatric patients age 1 month to 3 years compared 40 mg/kg/day gabapentin (N = 38) with

placebo (N = 38) in patients who were receiving at least one marketed antiepileptic drug and had at least

one partial seizure during the screening period (within 2 weeks prior to baseline). Patients had up to 48

hours of baseline and up to 72 hours of double-blind video EEG monitoring to record and count the

occurrence of seizures. There were no statistically significant differences between treatments in either

the response ratio or responder rate.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4445

NDC: 50090-4445-0 90 TABLET, COATED in a BOTTLE

NDC: 50090-4445-1 60 TABLET, COATED in a BOTTLE

NDC: 50090-4445-2 30 TABLET, COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration Information

Inform patients that gabapentin is taken orally with or without food. Inform patients that, should they

divide the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the

unused half-tablet as the next dose. Advise patients to discard half-tablets not used within 28 days of

dividing the scored tablet.

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

Prior to initiation of treatment with gabapentin, instruct patients that a rash or other signs or symptoms of

hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the

patient should report any such occurrence to a physician immediately [see Warnings and Precautions

(5.1)].

Anaphylaxis and Angioedema

Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of

anaphylaxis or angioedema [see Warnings and Precautions (5.2)].

Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery

Advise patients that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS

depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although

patients' ability to determine their level of impairment can be unreliable, advise them neither to drive a

car nor to operate other complex machinery until they have gained sufficient experience on gabapentin

to gauge whether or not it affects their mental and/or motor performance adversely. Inform patients that

it is not known how long this effect lasts [see Warnings and Precautions (5.3) and Warnings and

it is not known how long this effect lasts [see Warnings and Precautions (5.3) and Warnings and

Precautions (5.4)].

Suicidal Thinking and Behavior

Counsel the patient, their caregivers, and families that AEDs, including gabapentin, may increase the

risk of suicidal thoughts and behavior. Advise patients of the need to be alert for the emergence or

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

suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients to report behaviors of

concern immediately to healthcare providers [see Warnings and Precautions (5.6)].

Use in Pregnancy

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during

therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy

[see Use in Specific Populations (8.1) and (8.2)].

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry

is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients

can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1)].

The brands listed are the registered trademarks of their respective owners.

Manufactured by:

CSPC Ouyi Pharmaceutical Co., Ltd.

Shijiazhuang, Hebei, China, 052160

Manufactured for:

TAGI Pharma, Inc.

South Beloit, IL 61080

MEDICATION GUIDE

Gabapentin Tablets, USP

(GA-ba-PEN-tin)

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

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

Stopping gabapentin tablets suddenly can cause serious problems.

Gabapentin tablets can cause serious side effects including:

1.

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

Suicidal Thoughts. Like other antiepileptic drugs, gabapentin tablets may cause suicidal

thoughts or actions in a very small number of people, about 1 in 500.

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 tablets without first talking to a healthcare provider.

Stopping gabapentin tablets 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.

3.

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 tablets.

What are gabapentin tablets?

Gabapentin tablets 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 with seizures.

Who should not take gabapentin tablets?

Do not take gabapentin tablets if you are allergic to gabapentin or any of the other ingredients in

gabapentin tablets. See the end of this Medication Guide for a complete list of ingredients in gabapentin

tablets.

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

Before taking gabapentin tablets, 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.

Changes in behavior and thinking - Using gabapentin tablets in children 3 to 12 years of age can

cause emotional changes, aggressive behavior, problems with concentration, restlessness,

changes in school performance, and hyperactivity.

Gabapentin tablets may cause 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 tablets. You may or may not have a rash with an allergic reaction

caused by gabapentin tablets.

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

Tell your healthcare provider right away if you become pregnant while taking gabapentin tablets.

You and your healthcare provider will decide if you should take gabapentin tablets while you are

pregnant.

Pregnancy Registry: If you become pregnant while taking gabapentin tablets, 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 tablets.

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

counter medicines, vitamins, and herbal supplements.

Taking gabapentin tablets 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 tablets?

Take gabapentin tablets exactly as prescribed. Your healthcare provider will tell you how much

gabapentin tablets to take.

Do not change your dose of gabapentin tablets without talking to your healthcare provider.

If you take gabapentin tablets and break a tablet in half, the unused half of the tablet should be

taken at your next scheduled dose. Half tablets not used within 28 days of breaking should be

thrown away.

Gabapentin tablets 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 tablets.

If you take too much gabapentin tablets, call your healthcare provider or your local Poison Control

Center right away at 1-800-222-1222.

What should I avoid while taking gabapentin tablets?

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin

tablets without first talking with your healthcare provider. Taking gabapentin tablets 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 tablets affect you. Gabapentin tablets can slow your thinking and motor skills.

What are the possible side effects of gabapentin tablets?

Gabapentin tablets may cause serious side effects including:

See "What is the most important information I should know about gabapentin tablets?"

problems driving while using gabapentin tablets. See "What I should avoid while taking gabapentin

tablets?"

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

The most common side effects of gabapentin tablets include:

lack of coordination

viral infection

feeling drowsy

nausea and vomiting

difficulty with speaking

tremor

feeling tired

fever

jerky movements

difficulty with coordination

double vision

unusual eye movement

swelling, usually of legs and

feet

unusual eye movement

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 tablets. 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 tablets?

Store gabapentin tablets at 20° to 25°C (68° to 77°F).

Gabapentin tablets come in a child-resistant package.

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

General information about the safe and effective use of gabapentin tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use gabapentin tablets for a condition for which it was not prescribed. Do not give gabapentin tablets 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 tablets. If you

would like more information, talk with your healthcare provider. You can ask your healthcare provider

or pharmacist for information about gabapentin tablets that was written for healthcare professionals.

For more information contact TAGI Pharma, Inc. at 1-855-225-8244.

What are the ingredients in gabapentin tablets?

Active ingredient: gabapentin

Inactive ingredients in the tablets: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl

alcohol,

talc and titanium dioxide.

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

The brands listed are the registered trademarks of their respective owners.

Manufactured by:

CSPC Ouyi Pharmaceutical Co., Ltd.

Shijiazhuang, Hebei, China, 052160

Manufactured for:

TAGI Pharma, Inc.

South Beloit, IL 61080

Revised: 3/2019

Gabapentin

GABAPENTIN

gabapentin tablet, coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 0 9 0 -4445(NDC:51224-0 21)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GABAPENTIN (UNII: 6 CW7F3G59 X) (GABAPENTIN - UNII:6 CW7F3G59 X)

GABAPENTIN

6 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Co po vido ne K2 5-3 1 (UNII: D9 C330 MD8 B)

Ma g nesium Stea ra te (UNII: 70 0 9 7M6 I30 )

Po lyethylene g lyco l, unspecified (UNII: 3WJQ0 SDW1A)

Po lyvinyl a lco ho l, unspecified (UNII: 532B59 J9 9 0 )

sta rch, co rn (UNII: O8 232NY3SJ)

Ta lc (UNII: 7SEV7J4R1U)

Tita nium dio xide (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

2 pieces

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

O ;E;6 0 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

A-S Medication Solutions

1

NDC:50 0 9 0 -4445-0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

2

NDC:50 0 9 0 -4445-1

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

3

NDC:50 0 9 0 -4445-2

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 70 57

0 5/0 1/20 19

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -4445) , REPACK(50 0 9 0 -4445)

Revised: 8/2019

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