Gabapentin capsules are 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 capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Capsules: • 100 mg: white and light brown capsule printed with 665 on both cap and body in black ink • 300 mg: yellow and light brown capsule printed with 2666 on both cap and body in black ink • 400 mg: orange and light brown capsule printed with 667 on both cap and body in black ink
A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8,000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with gabapentin. Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment. If overexposure occurs, call your poison control center at 1-800-222-1222.
Gabapentin capsules, USP are supplied as follows: 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 30 (NDC 71205-064-30), 60 (NDC 71205-064-60), 90 (NDC 71205-064-90), and 120 (NDC 71205-064-72) Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
| Class | Version | Type | Effective |
|---|---|---|---|
| GABAPENTIN Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20230427 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71205-064-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | 5 | |
| 71205-064-60 | Gabapentin | 60 in 1 BOTTLE | CAPSULE | 60 | 5 | |
| 71205-064-72 | Gabapentin | 120 in 1 BOTTLE | CAPSULE | 120 | 5 | |
| 71205-064-90 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-064-30 | EA - Each | 71205-064 | e3d8b6fe-47d7-45c7-a13c-3462cf313fc3 | 1 | 2019-06-19 |
| 71205-064-72 | EA - Each | 71205-064 | 83f7161a-2a3e-4780-8787-ba471f27153d | 1 | 2018-11-06 |
| 71205-064-90 | EA - Each | 71205-064 | 9cc8c2c8-3beb-4500-b097-c0e1440e6d8b | 1 | 2018-10-11 |
| 45963-557-11 | EA - Each | 45963-557 | 6ca654ca-d9e1-4994-b817-2efbe4ce29f2 | 1 | 2014-06-03 |
| 45963-557-50 | EA - Each | 45963-557 | 9dc85547-5f8f-47a3-b49f-8884c499c28b | 1 | 2014-05-02 |
Gabapentin capsules are 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
Capsules: • 100 mg: white and light brown capsule printed with 665 on both cap and body in black ink • 300 mg: yellow and light brown capsule printed with 2666 on both cap and body in black ink • 400 mg: orange and light brown capsule printed with 667 on both cap and body in black ink
Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
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) ] • Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.7) ] • Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.9) ]
A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8,000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with gabapentin. Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment. If overexposure occurs, call your poison control center at 1-800-222-1222.
The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is: Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: black iron oxide, corn starch, D&C Yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, mannitol, pharmaceutical glaze, propylene glycol, red iron oxide T3469, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, talc, titanium dioxide, and yellow iron oxide T3506.
Gabapentin capsules, USP are supplied as follows: 400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 30 (NDC 71205-064-30), 60 (NDC 71205-064-60), 90 (NDC 71205-064-90), and 120 (NDC 71205-064-72) Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Administration Information Inform patients that gabapentin is taken orally with or without food. 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 and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [ see Warnings and Precautions (5.2) ]. Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery Advise patients that gabapentin 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 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 breastfeeding or intend to breastfeed 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) ] . Brands listed are the trademarks of their respective owners. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9234 Revised — December 2017 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320
Gabapentin (gab" a pen' tin) Capsules, USP What is the most important information I should know about gabapentin capsules? Do not stop taking gabapentin capsules without first talking to your healthcare provider. Stopping gabapentin capsules 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 capsules without first talking to a healthcare provider. • Stopping gabapentin capsules 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 capsules 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 capsules. What are gabapentin capsules? Gabapentin capsules 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 capsules? Do not take gabapentin capsules if you are allergic to gabapentin or any of the other ingredients in gabapentin capsules. See the end of this Medication Guide for a complete list of ingredients in gabapentin capsules. What should I tell my healthcare provider before taking gabapentin capsules? Before taking gabapentin capsules, 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 capsules. You and your healthcare provider will decide if you should take gabapentin capsules while you are pregnant. o Pregnancy Registry: If you become pregnant while taking gabapentin capsules, 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 breastfeeding or plan to breastfeed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin capsules. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking gabapentin capsules 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 capsules? • Take gabapentin capsules exactly as prescribed. Your healthcare provider will tell you how much gabapentin capsules to take. o Do not change your dose of gabapentin capsules without talking to your healthcare provider. o Take gabapentin capsules with water. If you take too many gabapentin capsules, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222. What should I avoid while taking gabapentin capsules? • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin capsules without first talking with your healthcare provider. Taking gabapentin capsules 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 capsules affect 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 capsules?” • problems driving while using gabapentin. See “What I should avoid while taking gabapentin capsules?” • 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 capsules? • Store gabapentin capsules between 68°F to 77°F (20°C to 25°C). Keep gabapentin capsules and all medicines out of the reach of children. General information about the safe and effective use of gabapentin capsules Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin capsules for a condition for which it was not prescribed. Do not give gabapentin capsules 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 capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin capsules that was written for healthc...