Gabapentin (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

600 mg tablets:

White to off -White, film-coated, oval-shaped tablets, scored on both the sides and debossed with “NT”and “150” on one side.
55700-815-30

55700-815-60

55700-815-90

800 mg tablets:

White to off -White, film-coated, oval-shaped tablets, scored on both the sides and debossed with “NT”and “151” on one side.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 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 tablet is taken orally with or without food. Inform patients that, should they divide the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Advise patients to discard half-tablets not used within 28 days of dividing the scored tablet.

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 tablets and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.2)]

Dizziness and Somnolence Effects on Driving and Operating Heavy Machinery
Advise patients that gabapentin tablets 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 tablets 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)].

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)].

This product’s label may have been updated. For full prescribing information, please visit www.acihealthcareusa.com.

Made in INDIA
PON/DRUGS/16 13 4193

Distributed by:
ACI Healthcare USA, Inc.
10100 W. Sample Road, Suite 406
Coral Springs, FL 33065

Revised: 08/2019

Trademarks are the property of their respective owners.

MEDICATION GUIDE

GABAPENTIN (GAB-a-PEN-tin)
Tablets, USP 600 mg and 800 mg
Rx Only

Read the Medication Guide before you start taking gabapentin tablets 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 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 a 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 tablets. You may or may not have a rash with an allergic reaction caused by gabapentin tablets. 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 is gabapentin tablet?
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 tablets 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.

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

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.

For more information go to http://www.acihealthcareusa.com or call 1-754-702-5116.

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

Inactive ingredients in the tablets: copovidone, hydroxyl propyl cellulose, magnesium stearate, mannitol, poloxamer, talc, low-substituted
hydroxypropyl cellulose and and opadry II (white). Opadry II (white) contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc.

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

This product’s label may have been updated. For current full prescribing information, please visit www.acihealthcareusa.com

Made in INDIA
PON/DRUGS/16 13 4193

Distributed by:
ACI Healthcare USA, Inc.
10100 W. Sample Road, Suite 406 Coral Springs, FL 33065

Revised: 08/2019

Trademarks are the property of their respective owners.

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