FDA Label for Gabapentin
View Indications, Usage & Precautions
Gabapentin Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Medication Guide Section
MEDICATION GUIDE
Gabapentin Capsules 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.
4. Serious breathing problems. Serious breathing problems can occur when gabapentin is 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 or when the dose is increased. Get help right away if breathing problems occur.
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
· have breathing problems
· 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 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. 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.
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.
o Do not change your dose of gabapentin without talking to your healthcare provider.
o Take gabapentin capsules with water.
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 gabapentin?”
· 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 between 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature].
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.
What are the ingredients in gabapentin?
Active ingredient: Gabapentin USP
Inactive ingredients in the capsules: anhydrous lactose, cornstarch, and talc. The 100-mg capsule shell also contains: gelatin, sodium lauryl sulfate, and titanium dioxide.
The 300-mg capsule shell also contains: gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
The 400-mg capsule shell also contains: gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Alkem Laboratories Limited
ALKEM HOUSE, Lower Parel,
Mumbai – 400 013, INDIA
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised : July, 2020
Overdosage Section
OVERDOSAGE
Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.
Acute oral overdoses of gabapentin have been reported. Symptoms have included double vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy, and diarrhea. Fatal respiratory depression has been reported with gabapentin overdose, alone and in combination with other CNS depressants.
Gabapentin can be removed by hemodialysis.
If overexposure occurs, call your poison control center at 1-800-222-1222.
Adverse Reactions Section
ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections:
· Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS (5.1)]
· Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS (5.2)]
· Somnolence/Sedation and Dizziness [see WARNINGS AND PRECAUTIONS (5.4)]
· Withdrawal Precipitated Seizure, Status Epilepticus [see WARNINGS AND PRECAUTIONS (5.5)]
· Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS (5.6)]
· Respiratory Depression [see Warnings and Precautions (5.7)]
· Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.8)]
· Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.10)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Postherpetic Neuralgia
The most common adverse reactions associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema.
In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received gabapentin and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction. The adverse reactions that most frequently led to withdrawal in gabapentin -treated patients were dizziness, somnolence, and nausea.
Table 3 lists adverse reactions that occurred in at least 1% of gabapentin -treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the gabapentin group than in the placebo group.
TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia
NEURONTIN N=336
Placebo
N=227
%
%
Body As A Whole
Asthenia
6
5
Infection
5
4
Accidental injury
3
1
Digestive System
Diarrhea
6
3
Dry mouth
5
1
Constipation
4
2
Nausea
4
3
Vomiting
3
2
Metabolic and Nutritional Disorder
Peripheral edema
8
2
Weight gain
2
0
Hyperglycemia
1
0
Nervous System
Dizziness
28
8
Somnolence
21
5
Ataxia
3
0
Abnormal thinking
3
0
Abnormal gait
2
0
Incoordination
2
0
Respiratory System
Pharyngitis
1
0
Special Senses
Amblyopiaa
3
1
Conjunctivitis
1
0
Diplopia
1
0
Otitis media
1
0
a Reported as blurred vision
Other reactions in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome.
There were no clinically important differences between men and women in the types and incidence of adverse reactions. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse reactions by race.
Epilepsy with Partial Onset Seizures (Adjunctive Therapy)
The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in patients >12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus.
The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients, were viral infection, fever, nausea and/or vomiting, somnolence, and hostility [see Warnings and Precautions (5.8)].
Approximately 7% of the 2074 patients >12 years of age and approximately 7% of the 449 pediatric patients 3 to 12 years of age who received gabapentin in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with withdrawal in patients >12 years of age were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea and/or vomiting (0.6%), and dizziness (0.6%). The adverse reactions most commonly associated with withdrawal in pediatric patients were emotional lability (1.6%), hostility (1.3%), and hyperkinesia (1.1%).
Table 4 lists adverse reactions that occurred in at least 1% of gabapentin-treated patients >12 years of age with epilepsy participating in placebo-controlled trials and were numerically more common in the gabapentin group. In these studies, either gabapentin or placebo was added to the patient’s current antiepileptic drug therapy.
TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials In Epilepsy Patients >12 years of age
Gabapentina N=543 %
Placeboa
N=378 %
Body as a Whole
Fatigue
11
5
Increased Weight
3
2
Back Pain
2
1
Peripheral Edema
2
1
Cardiovascular
Vasodilatation
1
0
Digestive System
Dyspepsia
2
1
Dry Mouth or Throat
2
1
Constipation
2
1
Dental Abnormalities
2
0
Nervous System
Somnolence
19
9
Dizziness
17
7
Ataxia
13
6
Nystagmus
8
4
Tremor
7
3
Dysarthria
2
1
Amnesia
2
0
Depression
2
1
Abnormal thinking
2
1
Abnormal coordination
1
0
Respiratory System
Pharyngitis
3
2
Coughing
2
1
Skin and Appendages
Abrasion
1
0
Urogenital System
Impotence
2
1
Special Senses
Diplopia
6
2
Amblyopiab
4
1
a Plus background antiepileptic drug therapy
b Amblyopia was often described as blurred vision.
Among the adverse reactions occurring at an incidence of at least 10% in gabapentin-treated patients, somnolence and ataxia appeared to exhibit a positive dose-response relationship.
The overall incidence of adverse reactions and the types of adverse reactions seen were similar among men and women treated with gabapentin. The incidence of adverse reactions increased slightly with increasing age in patients treated with either gabapentin or placebo. Because only 3% of patients (28/921) in placebo-controlled studies were identified as nonwhite (black or other), there are insufficient data to support a statement regarding the distribution of adverse reactions by race.
Table 5 lists adverse reactions that occurred in at least 2% of gabapentin-treated patients, age 3 to 12 years of age with epilepsy participating in placebo-controlled trials, and which were numerically more common in the gabapentin group.
TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years
Gabapentina N=119 %
Placeboa
N=128 %
Body as a Whole
Viral Infection
11
3
Fever
10
3
Increased Weight
3
1
Fatigue
3
2
Digestive System
Nausea and/or Vomiting
8
7
Nervous System
Somnolence
8
5
Hostility
8
2
Emotional Lability
4
2
Dizziness
3
2
Hyperkinesia
3
1
Respiratory System
Bronchitis
3
1
Respiratory Infection
3
1
a Plus background antiepileptic drug therapy
Other reactions in more than 2% of pediatric patients 3 to 12 years of age but equally or more frequent in the placebo group included: pharyngitis, upper respiratory infection, headache, rhinitis, convulsions, diarrhea, anorexia, coughing, and otitis media.
6.2 Postmarketing Experience
The following adverse reactions have been identified during postmarketing use of gabapentin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatobiliary disorders: jaundice
Investigations: elevated creatine kinase, elevated liver function tests
Metabolism and nutrition disorders: hyponatremia
Musculoskeletal and connective tissue disorder: rhabdomyolysis
Nervous system disorders: movement disorder
Psychiatric disorders: agitation
Reproductive system and breast disorders: breast enlargement, changes in libido, ejaculation disorders and anorgasmia
Skin and subcutaneous tissue disorders: angioedema [see Warnings and Precautions (5.2)], bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome.
There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking gabapentin with opioids or other CNS depressants, or in the setting of underlying respiratory impairment [see Warnings and Precautions (5.7)].
Adverse reactions following the abrupt discontinuation of gabapentin have also been reported. The most frequently reported reactions were anxiety, insomnia, nausea, pain, and sweating.
Dosage And Administration Section
DOSAGE & ADMINISTRATION
2.1 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin 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 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 three times a day using 300 mg or 400 mg capsules. 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 in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the oral capsule. 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 Dosage Based on Renal Function
Renal Function
Creatinine Clearance
(mL/min)
Total Daily
Dose Range
(mg/day)
Dose Regimen (mg)
≥ 60
900 to 3600
300 TID 400 TID 600 TID
800 TID 1200 TID
> 30 to 59
400 to 1400
200 BID 300 BID 400 BID
500 BID 700 BID
> 15 to 29
200 to 700
200 QD 300 QD 400 QD
500 QD 700 QD
15a
100 to 300
100 QD 125 QD 150 QD
200 QD 300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis
125b 150b 200b 250b 350b
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.
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:
[gabapentin-equation]
The use of gabapentin 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 orally with or without food.
Gabapentin capsules should be swallowed whole with water.
If the gabapentin 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).
Indications And Usage Section
INDICATIONS & USAGE
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
* Please review the disclaimer below.