GABAPENTIN

Main information

  • Trade name:
  • GABAPENTIN - gabapentin capsule
  • Composition:
  • GABAPENTIN 300 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GABAPENTIN - gabapentin capsule
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Gabapentin is  indicated for: - Management of postherpetic neuralgia in adults - Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.  Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http:/ / www.aedpregnancyregistry.org/ . Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal
  • Product summary:
  • Product: 50090-0895 NDC: 50090-0895-0 100 CAPSULE in a BOTTLE NDC: 50090-0895-5 240 CAPSULE in a BOTTLE

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 50090-0895-0, 50090-0895-1, 50090-0895-2, 50090-0895-3, 50090-0895-4, 50090-0895-5
  • Last update:
  • 26-05-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

GABAPENTIN - gabapentin capsule

A-S Medication Solutions

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MEDICATION GUIDE

Gabapentin Capsules, USP

Gabapentin Tablets, USP

(GA ba PEN tin)

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. Suicidal Thoughts. 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 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.

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 with seizures.

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

have diabetes

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.

Pregnancy Registry: 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 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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-

counter 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 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.

Take gabapentin capsules with water.

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.

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?

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?

Gabapentin may cause serious side effects including:

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

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

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

The most common side effects of gabapentin 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. 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 capsules and 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, call 1-800-818-4555.

What are the ingredients in gabapentin?

Active ingredient: gabapentin

Inactive ingredients in the capsules: calcium carbonate, calcium sulfate dihydrate, glyceryl behenate, and

pregelatinized maize starch. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate,

yellow iron oxide (300 mg and 400 mg) and red iron oxide (400 mg). The imprinting ink contains shellac,

dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black

iron oxide, potassium hydroxide, and purified water.

Inactive ingredients in the tablets: glyceryl behenate, hydroxypropyl cellulose, low substituted

hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized maize starch and Opadry YS-

1-7003 (hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80).

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

* All trademark names are the property of their respective owners.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Industries Ltd.

Halol-Baroda Highway,

Halol-389 350, Gujarat, India.

ISS. 11/2017

PJPI0121H

Revised: 12/2017

Document Id: 350f325c-8704-4d7a-b709-bdaccc9442f2

34391-3

Set id: 7bdf4a6f-ab1d-4ea7-b4fc-701730c0723b

Version: 4

Effective Time: 20171226

A-S Medication Solutions