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

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Capsules • 100 mg: White hard gelatin capsules imprinted “216” on body with blue ink. • 300 mg: Yellow hard gelatin capsules imprinted “215” on body with blue ink. • 400 mg: Orange hard gelatin capsules imprinted “214” on body with blue ink.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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) ] • Respiratory Depression [see Warnings and Precautions (5.7) ] • Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.8) ] • Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.10) ]

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

9 DRUG ABUSE AND DEPENDENCE

DRUG ABUSE AND DEPENDENCE SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin have been reported. Symptoms have included double vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy, and diarrhea. Fatal respiratory depression has been reported with gabapentin overdose, alone and in combination with other CNS depressants. Gabapentin can be removed by hemodialysis. If overexposure occurs, call your poison control center at 1-800-222-1222.

11 DESCRIPTION

DESCRIPTION SECTION

The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 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 capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Gabapentin Capsules USP are supplied as follows: 100 mg capsules: White hard gelatin capsules imprinted “216” on body with blue ink, available in: Overbagged with 10 capsules per bag, NDC 55154-8194-0 300 mg capsules: Yellow hard gelatin capsules imprinted “215” on body with blue ink, available in: Overbagged with 10 capsules per bag, NDC 55154-8195-0 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Storage Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Administration Information Inform patients that gabapentin capsules are taken orally with or without food. 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 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) ] . Respiratory Depression Inform patients about the risk of respiratory depression. Include information that the risk is greatest for those using concomitant CNS depressants (such as opioid analgesics) or those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions (5.7) ]. 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) ] . Trademarks are the property of their respective owners. PACKAGING INFORMATION American Health Packaging unit dose blisters contain drug product from Ascend Laboratories, LLC Distributed by: American Health Packaging Columbus, OH 43217 Distributed By: Cardinal Health Dublin, OH 43017 L57032690224 L57032770724 8458001/0925

MEDICATION GUIDE

SPL MEDGUIDE SECTION

8458001/0925 Gabapentin Capsules USP (GA ba PEN tin) What is the most important information I should know about gabapentin? Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems. Gabapentin can cause serious side effects including: 1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin 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 without first talking to a healthcare provider. • Stopping gabapentin suddenly can cause serious problems. Stopping a seizure medicine suddenly in a person 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 in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, changes in school performance, restlessness, and hyperactivity. 3. Gabapentin 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. You may or may not have a rash with an allergic reaction caused by gabapentin. 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. 4. Serious breathing problems. Serious breathing problems can happen when gabapentin is taken with other medicines (such as opioid pain medicines) that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Call your healthcare provider or get medical help right away if you have any of the following symptoms: • feel short of breath • feel very tired • dizziness • breathing slower than normal • confusion • headache Be sure that your caregiver or family members know which symptoms may be serious so they can call your healthcare provider or get medical help if you are unable to seek treatment on your own. Your healthcare provider may lower your dose or stop your treatment with gabapentin if you have serious breathing problems. What is gabapentin? Gabapentin 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. It is not known if gabapentin is safe and effective to treat: • children with pain from damaged nerves from a painful rash caused by the chicken pox virus. • partial seizures in children under 3 years of age. Do not take gabapentin if you: • are allergic to gabapentin or any of the other ingredients in gabapentin. See the end of this Medication Guide for a complete list of ingredients in gabapentin. Do not take gabapentin if you: • are allergic to gabapentin or any of the other ingredients in gabapentin. See the end of this Medication Guide for a complete list of ingredients in gabapentin. Before taking gabapentin, tell your healthcare provider about all of your medical conditions including 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 a history of drug abuse. • have diabetes • have breathing problems • 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. You and your healthcare provider will decide if you should take gabapentin while you are pregnant. o Pregnancy Registry: If you become pregnant while taking gabapentin, 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 visiting http://www.aedpregnancyregistry.org/ . • are breastfeeding or plan to breastfeed. 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. Especially tell your healthcare provider if you take: • any opioid pain medicine such as morphine, hydrocodone, oxycodone, or buprenorphine. • any medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem), or any medicines that make you sleepy. You may have a higher chance for dizziness, sleepiness, or breathing problems if these medicines are taken with gabapentin. Taking gabapentin 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? • Take gabapentin exactly as prescribed. Your healthcare provider will tell you how much gabapentin to take. o Do not change your dose of gabapentin without talking to your healthcare provider. o Gabapentin can be taken with or without food. o Swallow gabapentin capsules whole 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. • In case of overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org . What should I avoid while taking gabapentin? • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking with your healthcare provider. Taking gabapentin 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 affects you. Gabapentin can slow your thinking and motor skills. What are the possible side effects of gabapentin? Gabapentin may cause serious side effects including: See “What is the most important information I should know about gabapentin?” • problems driving while using g...

Package/Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-8194-0 GABAPENTIN CAPSULES, USP 100 mg 10 CAPSULES

Package/Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-8195-0 GABAPENTIN CAPSULES, USP 300 mg 10 CAPSULES