Gabapentin by Central Packaging / Central Packaging, LLC GABAPENTIN capsule

Gabapentin by

Drug Labeling and Warnings

Gabapentin by is a Prescription medication manufactured, distributed, or labeled by Central Packaging, Central Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Postherpetic neuralgia

Management of postherpetic neuralgia (PHN) in adults.

Seizures, focal (partial) onset (immediate release only)

As adjunctive therapy in the treatment of focal (partial) seizures with and without secondary generalization in adults and pediatric patients ≥3 years of age with epilepsy.

MEDICATION GUIDE

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

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

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

4. Serious breathing problems. Serious breathing problems can occur when gabapentin capsules are taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting gabapentin capsules or when the dose is increased. Get help right away if breathing problems occur.

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
have breathing problems
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.

Pregnancy Registry: If you become pregnant while taking gabapentin capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

are breast-feeding or plan to breast-feed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules.

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 oxycodone), 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 capsules.

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 to take.

Do not change your dose of gabapentin capsules without talking to your healthcare provider.
Take gabapentin capsules with 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, 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 affect 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 drowsy
viral infection
nausea and vomiting
difficulty with speaking
jerky movements
tremor
difficulty with coordination
swelling, usually of legs and feet
double vision
feeling tired
unusual eye movement
fever

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 20° to 25°C (68° to 77°F).

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

General information about the safe and effective use of gabapentin capsules

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

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

For more information, call Northstar Rx LLC at 1-800-206-7821.

What are the ingredients in gabapentin capsules?

Active ingredient: gabapentin

Inactive ingredients: corn starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains yellow iron oxide and 400 mg also contains yellow iron oxide and red iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac.

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

* All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Medication Guides available at www.northstarrxllc.com/products or call 1-800-206-7821.

Manufactured for: Northstar Rx LLC
Memphis, TN 38141.

Manufactured by: Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80175-0662(NDC:16714-662)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	300 mg

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	D;03
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80175-0662-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078787	01/31/2008

Labeler - Central Packaging (117617671)

Establishment
Name	Address	ID/FEI	Business Operations
Central Packaging, LLC		117617671	repack(80175-0662)