Gabapentin Tablets, USP
(gab'' a pen' tin)
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
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 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:
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
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.
4. Serious breathing problems. Serious breathing problems can occur when gabapentin tablets 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 tablets or when the dose is increased. Get help right away if breathing problems occur.
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 breathing problems
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 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, 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 affect 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 should I 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
nausea and vomiting
difficulty with coordination
difficulty with speaking
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 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 between 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.
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.
What are the ingredients in gabapentin tablets?
Active ingredient: gabapentin
Inactive ingredients: copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc.
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.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 038, India
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin tablets may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2.2 Dosage for Epilepsy with Partial Onset Seizures
Patients 12 years of age and above
The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin tablets three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
2.3 Dosage Adjustment in Patients with Renal Impairment
Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
TABLE 1. Gabapentin Tablets Dosage Based on Renal Function
TID = Three times a day; BID = Two times a day; QD = Single daily dose
a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
Renal Function Creatinine Clearance (mL/min)
900 to 3600
>30 to 59
400 to 1400
>15 to 29
200 to 700
100 to 300
Post-Hemodialysis Supplemental Dose (mg)b
Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:
The use of gabapentin tablets in patients less than 12 years of age with compromised renal function has not been studied.
2.4 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.
2.5 Administration Information
Administer gabapentin tablets orally with or without food.
Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded.
If the gabapentin tablets dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
gabapentin 600mg tablet, film coated
|Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)|
|Advanced Rx Pharmacy of Tennessee, LLC||117023142||repack(80425-0097)|