GABAPENTIN 800 mg/1
GABAPENTIN · TABLET, FILM COATED · DIRECT RX
Gabapentin is a prescription medication taken by mouth that is used to treat nerve pain (neuropathic pain) and seizures. It works by affecting how the body processes pain signals and electrical activity in the brain.
Key Facts
- Brand Name
- GABAPENTIN
- Generic Name
- GABAPENTIN
- NDC Code (Product)
72189-092- Manufacturer
- DIRECT RX
- Strength
- 800 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA200651
- Drug Class
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Marketing Start
- 05/15/2020
Recall History
Actavis Elizabeth LLC
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Sciegen Pharmaceuticals Inc
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Lack of Assurance of Sterility
Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
The Harvard Drug Group LLC
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
SUN PHARMACEUTICAL INDUSTRIES INC
Cross Contamination
Glenmark Generics Inc., USA
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
Actavis Elizabeth LLC
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Gabapentin Capsules, USP 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, USP are 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 ADMlNlSTRATION Postherpetic Neuralgia (2.1) Dose can be titrated up as needed to a dose of 1800 mg/day Day 1: Single 300 mg dose Day 2: 600 mg/day (i.e., 300 mg two times a day) 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, 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…
Contraindications
4 CONTRAINDICATIONS Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to gabapentin 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 (5.7) ]. Hydrocodone Coadministration of gabapentin with hydrocodone decreases hydrocodone exposure [ see Clinical Pharmacology (12.3) ]. The potential for alteration in hydrocodone exposure and effect should be considered when gabapentin 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 see Warnings and Precautions (5.4) ] Withdrawal Precipitated Seizure, Status Epilepticus [see see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see 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) ] 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…
Frequently Asked Questions
What is GABAPENTIN used for?
Gabapentin is a prescription medication taken by mouth that is used to treat nerve pain (neuropathic pain) and seizures. It works by affecting how the body processes pain signals and electrical activity in the brain.
Is GABAPENTIN a controlled substance?
GABAPENTIN is not classified as a controlled substance by the DEA.
What is the generic name for GABAPENTIN?
The generic name for GABAPENTIN is GABAPENTIN. There are 12 other brand versions of GABAPENTIN.
What is the NDC code for GABAPENTIN 800 mg/1?
The NDC (National Drug Code) for GABAPENTIN 800 mg/1 is 72189-092, listed by DIRECT RX.