GABAPENTIN: Package Insert and Label Information (Page 6 of 6)

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.

HOW SUPPLIED

Gabapentin Tablets USP, 600 mg are available as white, oval shaped tablets, debossed

Company Logo

“4443”, with a partial score on one side and “600” on the other side containing 600 mg gabapentin USP packaged in bottles of 100, 500 and 1000 tablets and unit-dose boxes of 100 tablets.

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. J 8/2011

MEDICATION GUIDE

GABAPENTIN (GA-ba-PEN’-tin) TABLETS USP

Read the Medication Guide before you start taking gabapentin 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? 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. 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 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 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 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. You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop gabapentin. Call a healthcare provider right away if you have any of the following symptoms:

  • skin rash
  • hives
  • fever
  • swollen glands that do not go away
  • swelling of your lip and 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.

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.

Who should not take 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.

What should I tell my healthcare provider before taking gabapentin?

Before taking gabapentin, 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
  • 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 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.

  • 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 non-prescription medicines, vitamins, and herbal supplements.

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.

    -Do not change your dose of gabapentin without talking to your healthcare provider. If you break a tablet in half the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within several days of breaking should be thrown away.

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

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?

  • See “What is the most important information I should know about gabapentin?”
  • The most common side effects of gabapentin include:
  • dizziness
  • lack of coordination
  • viral infection
  • feeling drowsy
  • feeling tired
  • fever
  • jerky movements
  • difficulty with speaking
  • temporary loss of memory (amnesia)
  • tremor
  • 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. 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?

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

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

General information about the safe and effective use of gabapentin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin for a condition for which it was not prescribed. Do not give gabapentin 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. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin that was written for healthcare professionals.

For more information about gabapentin, or to report side effects regarding gabapentin, please call Teva Pharmaceuticals Medical Affairs at 1-888-838-2872.

What are the ingredients in gabapentin? Active ingredient: gabapentin USP

Inactive ingredients: lactose monohydrate, microcrystalline cellulose and polyethylene glycol.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 8/2011

All trademarks are the property of their respective owners.

PRINCIPAL DISPLAY PANEL

Gabapentin Tablets USP 600mg Label
(click image for full-size original)

Gabapentin 600mg Tablets

GABAPENTIN Tablets USP 600 mg

PHARMACIST: Dispense the accompanying

Medication Guide to each patient.

Rx only

TEVA

GABAPENTIN
gabapentin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42549-537(NDC:0093-4443)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 600 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code 4443;600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42549-537-02 112 TABLET (TABLET) in 1 BOTTLE None
2 NDC:42549-537-28 28 TABLET (TABLET) in 1 BOTTLE None
3 NDC:42549-537-30 30 TABLET (TABLET) in 1 BOTTLE None
4 NDC:42549-537-56 56 TABLET (TABLET) in 1 BOTTLE None
5 NDC:42549-537-60 60 TABLET (TABLET) in 1 BOTTLE None
6 NDC:42549-537-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076017 06/09/2009
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc. (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLC 786036330 relabel, repack

Revised: 01/2012 STAT Rx USA LLC

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