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

16 HOW SUPPLIED/STORAGE AND HANDLING

Gabapentin Capsules, USP are supplied as follows:

100 mg capsules;
White/White colored, size ‘3’ hard gelatin capsules with “103” printed on body of capsule containing white to off white granular powder; available in:
Bottles of 100: NDC 42582-114-10
Bottles of 500: NDC 42582-114-18

300 mg capsules;
Yellow/Yellow colored, size ‘1’ hard gelatin capsules with “104” printed on body of capsule containing white to off white granular powder; available in:
Bottles of 100: NDC 42582-115-10
Bottles of 500: NDC 42582-115-18

400 mg capsules;
Orange/ Orange colored, size ‘0’ hard gelatin capsules with “105” printed on body of capsule containing white to off white granular powder; available in:
Bottles of 100: NDC 42582-116-10
Bottles of 500: NDC 42582-116-18

Store gabapentin capsules at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

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 capsules, 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 capsules 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 capsules 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 capsules 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 capsules, 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 (8.3)].

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)].

Rx only

Manufactured for:
Bi-Coastal Pharma International LLC
1161 Broad Street
Shrewbury, NJ 07702

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa-403 722, India

MEDICATION GUIDE

Gabapentin (GAB a PEN tin) Capsules

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

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

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

Stopping gabapentin capsules suddenly can cause serious problems.

Gabapentin capsules can cause serious side effects including:

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

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

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

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

• Pay attention to any changes, especially sudden changes, in mood, behaviors,
thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried
about symptoms.

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

• Stopping gabapentin capsules suddenly can cause serious problems.
Stopping a seizure medicine suddenly in a patient who has epilepsy can
cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If
you have suicidal thoughts or actions, your healthcare provider may check for
other causes.

2. Changes in behavior and thinking — Using gabapentin capsules in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

3. Gabapentin capsules may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin capsules. You may or may not have a rash with an allergic reaction caused by gabapentin capsules. Call a healthcare provider right away if you have any of the following symptoms:

• skin rash
• hives
• difficulty breathing
• fever
• swollen glands that do not go away
• swelling of your face, lips, throat or tongue
• yellowing of your skin or of the whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

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

What are gabapentin capsules?
Gabapentin capsules are a prescription medicine used to treat:

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

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

What should I tell my healthcare provider before taking gabapentin capsules? Before taking gabapentin capsules, tell your healthcare provider if you:

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

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

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

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

How should I take gabapentin capsules?

• Take gabapentin capsules exactly as prescribed. Your healthcare provider will tell you how much gabapentin capsules to take.

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

o Take gabapentin capsules with plenty of water.

• Gabapentin capsules can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox®, Mylanta®, Gelusil®, Gaviscon® , or Di-Gel®, you should wait at least 2 hours before taking your next dose of gabapentin capsules.

If you take too much gabapentin capsules, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.

What should I avoid while taking gabapentin capsules?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin capsules affects you. Gabapentin capsules can slow your thinking and motor skills.

What are the possible side effects of gabapentin capsules?

Gabapentin capsules may cause serious side effects including:

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

problems driving while using gabapentin capsules. See “What I should avoid while taking gabapentin capsules?”

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

The most common side effects of gabapentin capsules include:

• lack of coordination • feeling tired

• viral infection • fever

• feeling drowsy • jerky movements

• nausea and vomiting • difficulty with coordination

• difficulty with speaking • double vision

• tremor • unusual eye movement

• swelling, usually of legs and feet

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

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

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

How should I store gabapentin capsules?

• Store gabapentin capsules between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of gabapentin capsules

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

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

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin, USP

Inactive ingredients in the capsules: lactose monohydrate, corn starch, and talc.

The 100 mg capsule shell contains gelatin and titanium dioxide.

The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide.

The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue No. 2, propylene glycol and shellac.

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

Rx only

Manufactured for:
Bi-Coastal Pharma International LLC
1161 Broad Street
Shrewbury, NJ 07702

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa-403 722, India

NDC 42582-114-10
Bi-Coastal Pharma International LLC
Gabapentin
Capsules, USP
100 mg
PHARMACIST: Dispense the Medication
Guide provided separetely to each patient.Rx Only 100 Capsules

image description
(click image for full-size original)

NDC 42582-115-10
Bi-Coastal Pharma International LLC
Gabapentin
Capsules, USP
300 mg
PHARMACIST: Dispense the Medication
Guide provided separetely to each patient.Rx Only 100 Capsules

image description
(click image for full-size original)

NDC 42582-116-10
Bi-Coastal Pharma International LLC
Gabapentin
Capsules, USP
400 mg
PHARMACIST: Dispense the Medication
Guide provided separetely to each patient.Rx Only 100 Capsules

image description
(click image for full-size original)
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42582-114-10 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:42582-114-18 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 04/13/2016
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42582-115-10 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:42582-115-18 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 04/13/2016
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42582-116-10 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:42582-116-18 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090007 04/13/2016
Labeler — Bi-Coastal Pharma International LLC (078397428)

Revised: 04/2016 Bi-Coastal Pharma International LLC

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