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

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Zydus Pharmaceuticals (USA) Inc. as follows:
(600 mg/ 100 UD) NDC 60687-507-01 packaged from NDC 68382-204
(800 mg/ 100 UD) NDC 60687-518-01 packaged from NDC 68382-20

Distributed by:
American Health Packaging
Columbus, OH 43217

8450701/0920

MEDICATION GUIDE

8450701/0920

GABAPENTIN (gab” a pen’ tin) Tablets, USP

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. 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.

2. 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.

3. 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. 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 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 tablets 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. 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 tablets.

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 affects 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).

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.

Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

What are the ingredients in gabapentin tablets?
Active ingredient: Gabapentin, USP
Inactive ingredients: copovidone, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, poloxamer, povidone and talc.

® All trademarks are the property of their respective owners.

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

Distributed by:
American Health Packaging Columbus, OH 43217

8450701/0920

Package/Label Display Panel – Carton – 600 mg

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

NDC 60687- 507 -01

Gabapentin
Tablets, USP

600 mg

100 Tablets (10 x 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-coated Tablet Contains:
Gabapentin, USP…………………………………………… 600 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 68382-204, Zydus Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

750701 0450701/0819

Package/Label Display Panel – Blister – 600 mg

600 mg Gabapentin Tablet Blister
(click image for full-size original)

Gabapentin Tablet, USP

600 mg

Package/Label Display Panel – Carton – 800 mg

800 mg Gabapentin Tablets Carton
(click image for full-size original)

NDC 60687- 518 -01

Gabapentin
Tablets, USP

800 mg

100 Tablets (10 x 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-coated Tablet Contains:
Gabapentin, USP…………………………………………… 800 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

The drug product contained in this package is from
NDC # 68382-205, Zydus Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

751801 0451801/0819

Package/Label Display Panel – Blister – 800 mg

800 mg Gabapentin Tablet Blister
(click image for full-size original)

Gabapentin Tablet, USP

800 mg

GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-507(NDC:68382-204)
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
COPOVIDONE K25-31
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
POLOXAMER 407
POVIDONE, UNSPECIFIED
TALC
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 17mm
Flavor Imprint Code ZE;72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-507-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-507-11)
1 NDC:60687-507-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-507-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078926 12/16/2019
GABAPENTIN gabapentin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-518(NDC:68382-205)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 800 mg
Inactive Ingredients
Ingredient Name Strength
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
POLOXAMER 407
POVIDONE, UNSPECIFIED
TALC
COPOVIDONE K25-31
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 20mm
Flavor Imprint Code ZE;71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-518-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-518-11)
1 NDC:60687-518-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-518-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078926 12/16/2019
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-507), repack (60687-518)

Revised: 12/2020 American Health Packaging

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