RELGAABI 400 mg/1
Gabapentin · CAPSULE · Method Pharmaceuticals, LLC
RELGAABI is a capsule containing gabapentin at 400 mg/1, taken oral. Manufactured by Method Pharmaceuticals, LLC.
Key Facts
- Brand Name
- RELGAABI
- Generic Name
- Gabapentin
- NDC Code (Product)
58657-234- Manufacturer
- Method Pharmaceuticals, LLC
- Strength
- 400 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204989
- Marketing Start
- 04/15/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RELGAABI 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 RELGAABI is indicated for: Postherpetic neuralgia in adults ( 1 ) 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 ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Postherpetic Neuralgia ( 2.1 ) o Dose can be titrated up as needed to a dose of 1800 mg/day o Day 1: Single 300 mg dose o Day 2: 600 mg/day (i.e., 300 mg two times a day) o Day 3: 900 mg/day (i.e., 300 mg three times a day) Epilepsy with Partial Onset Seizures ( 2.2 ) Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is reached by upward titration over a period of approximately 3 days Dose should be adjusted in patients with reduced renal function ( 2.3 , 2.4 ) 2.1 Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, RELGAABI 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 r…
Contraindications
4 CONTRAINDICATIONS RELGAABI is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to RELGAABI or its ingredients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Concentrations increased by morphine; may need dose adjustment ( 5.4 , 7.1 ) 7.1 Opioids Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine) [see Warnings and Precautions (5.8) ]. Hydrocodone Coadministration of RELGAABI with hydrocodone decreases hydrocodone exposure [see Clinical Pharmacology (12.3) ] . The potential for alteration in hydrocodone exposure and effect should be considered when RELGAABI is started or discontinued in a patient taking hydrocodone. Morphine When gabapentin is administered with morphine, patients should be observed for signs of CNS depression, such as somnolence, sedation and respiratory depression [see Clinical Pharmacology (12.3) ]. 7.2 Other Antiepileptic Drugs Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs [see Clinical Pharmacology (12.3) ]. 7.3 Maalox ® (aluminum hydroxide, magnesium hydroxide) The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid (Maalox ® ) …
Adverse Reactions
6 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) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Increased Risk of Seizures and Other Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.6) ] Status Epilepticus [see Warnings and Precautions (5.7) ] Respiratory Depression [see Warnings and Precautions (5.8) ] Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were: Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema ( 6.1 ) Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus ( 6.1 ) Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility ( 6.1 ) To…
Frequently Asked Questions
What is RELGAABI used for?
RELGAABI contains Gabapentin. It is a capsule taken oral. Consult your doctor for specific uses.
Is RELGAABI a controlled substance?
RELGAABI is not classified as a controlled substance by the DEA.
What is the generic name for RELGAABI?
The generic name for RELGAABI is Gabapentin. There are 12 other brand versions of Gabapentin.
What is the NDC code for RELGAABI 400 mg/1?
The NDC (National Drug Code) for RELGAABI 400 mg/1 is 58657-234, listed by Method Pharmaceuticals, LLC.