Gabapentin is indicated for: 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.
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Capsules: 100 mg: White to off-white powder filled in size "3" hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink. 300 mg: White to off-white powder filled in size "1" hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink. 400 mg: White to off-white powder filled in size "0" hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink. Tablets: 600 mg: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with "SG" on one side and "177" on other side with bisect line on both sides. 800 mg: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with "SG" on one side and "178" on other side with bisect line on both sides.
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 and tablets, USP are supplied as follows:
NDC 71610-437 - Gabapentin, USP 800 mg Tablets - Rx Only
| 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71610-437-92 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3723-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71610-437-92 | Gabapentin | 270 in 1 BOTTLE | TABLET | 270 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-437-92 | EA - Each | 71610-437 | 174e85d7-cc90-45d9-befc-994ca85621e4 | 1 | 2020-08-06 |
| 69367-135-04 | EA - Each | 69367-135 | 335b10f0-e6be-4300-993f-f5a36b9d5177 | 1 | 2018-06-11 |
| 69367-135-06 | EA - Each | 69367-135 | f32d02d9-253c-41c2-bdcf-74726c7c166f | 1 | 2016-07-19 |
Gabapentin is indicated for: 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 to off-white powder filled in size "3" hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink. 300 mg: White to off-white powder filled in size "1" hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink. 400 mg: White to off-white powder filled in size "0" hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink. Tablets: 600 mg: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with "SG" on one side and "177" on other side with bisect line on both sides. 800 mg: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with "SG" on one side and "178" on other side with bisect line on both sides.
Gabapentin is 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 and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.
Gabapentin capsules and tablets, USP are supplied as follows:
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 USA Manufactured for: Westminster Pharmaceuticals, LLC Olive Branch, MS 38654 USA Rx Only Rev: 05/17
Gabapentin Capsules, USP Gabapentin Tablets, USP (gab'' a pen' tin) Read the Medication Guide before you start taking gabapentin 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? 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: 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. 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-thecounter 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 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 and tablets between 68°F to 77°F (20°C to 25°C). 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 healthc...
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 800 mg 270 71610-437-92 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20200706JH
NDC 71610-437 - Gabapentin, USP 800 mg Tablets - Rx Only