Generic: GABAPENTIN
1 INDICATIONS AND USAGE Gabapentin tablets are indicated for the management of postherpetic neuralgia. Gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablets are indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation: Gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affe...
1 INDICATIONS AND USAGE Gabapentin tablets are indicated for the management of postherpetic neuralgia. Gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablets are indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation: Gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (See Warnings and Precautions )
5 WARNINGS AND PRECAUTIONS Gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. The safety and effectiveness of gabapentin in patients with epilepsy has not been studied. Gabapentin tablets are not substitutable with other gabapentin products Antiepileptic drugs, including gabapentin, the active ingredient in gabapentin, increase the risk of suicidal thoughts or behavior ( 5.1 ) Abrupt o...
5 WARNINGS AND PRECAUTIONS Gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. The safety and effectiveness of gabapentin in patients with epilepsy has not been studied. Gabapentin tablets are not substitutable with other gabapentin products Antiepileptic drugs, including gabapentin, the active ingredient in gabapentin, increase the risk of suicidal thoughts or behavior ( 5.1 ) Abrupt or rapid discontinuation may increase the risk for seizures. Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation. Taper gabapentin gradually over a minimum of 1 week. ( 5.2 ) Respiratory depression may occur with gabapentin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. ( 5.3 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs(AEDs), including gabapentin, the active ingredient in gabapentin tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.Suicidal behavior and ideation have also been reported in patients after discontinuation of gabapentin [see Warnings and Precautions ( 5.3 )]. Patients treated with any AED for anyindication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood orbehavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs. Table 3: Risk by Indication for Antiepileptic Drugs (including gabapentin, the active ingredient in gabapentin tablets) in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing gabapentin must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which products containing active components that are AEDs (such as gabapentin, the active component in gabapentin tablets) are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that gabapentin tablets contain gabapentin which is also used to treat epilepsy and that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. 5.2 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation After discontinuationof short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed in some patients [see Adverse Reactions ( 6.2 ) and Drug Abuse and Dependence ( 9.3 )] .Suicidal behavior and ideation have also been reported in patients after discontinuation of gabapentin [see Warnings and Precautions ( 5.1 )] . If gabapentin is discontinued,this should be done gradually over a minimum of 1 week or longer (at the discretion of theprescriber). 5.3 Respiratory Depression There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when co- administrated with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe gabapentin with another CNS depressant, particularly an opioid, or to prescribe gabapentin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating gabapentin at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including gabapentin). 5.4 Tumorigenic Potential In standard preclinical in vivo lifetime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar adenocarcinomas was identified in male, but not female, rats. The clinical significance of this finding is unknown. In clinical trials of gabapentin therapy in epilepsy comprising 2,085 patient-years of exposure in patients over 12 years of age, new tumors were reported in 10 patients, and pre-existing tumors worsened in 11 patients, during or within 2 years after discontinuing the drug. However, no similar patient population untreated with gabapentin was available to provide background tumor incidence and recurrence information for comparison. Therefore, the effect of gabapentin therapy on the incidence of new tumors in humans or on the worsening or recurrence of previously diagnosed tumors is unknown. 5.5 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan Hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established. 5.6 Laboratory Tests Clinical trial data do not indicate that routine monitoring of clinical laboratory procedures is necessary for the safe use of gabapentin. The value of monitoring gabapentin blood concentrations has not been established.
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions ( 5.2 )] • Respiratory Depression [see Warnings and Precautions ( 5.3 )] • Tumorigenic Potential [see Warnings and Precautions ( 5.4 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [s...
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions ( 5.2 )] • Respiratory Depression [see Warnings and Precautions ( 5.3 )] • Tumorigenic Potential [see Warnings and Precautions ( 5.4 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.5 )] • Laboratory Tests [see Warnings and Precautions ( 5.6 )] The most common adverse reaction (greater than or equal to 5% and twice placebo) is dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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. A total of 359 patients with neuropathic pain associated with postherpetic neuralgia have received gabapentin at doses up to 1,800 mg daily during placebo-controlled clinical studies. In clinical trials in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with gabapentin and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the gabapentin treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of gabapentin -treated patients who experienced adverse reactions in clinical studies, the majority of those adverse reactions were either "mild" or "moderate”. Table 4 lists all adverse reactions, regardless of causality, occurring in at least 1% of patients with neuropathic pain associated with postherpetic neuralgia in the gabapentin group for which the incidence was greater than in the placebo group. Table 4: Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia (Events in at Least 1% of all Gabapentin -Treated Patients and More Frequent Than in the Placebo Group) Body System – Preferred Term Gabapentin N = 359 % Placebo N = 364 % Ear and Labyrinth Disorders Vertigo 1.4 0.5 Gastrointestinal Disorders Diarrhea Dry mouth Constipation Dyspepsia 3.3 2.8 1.4 1.4 2.7 1.4 0.3 0.8 General Disorders Peripheral edema Pain 3.9 1.1 0.3 0.5 Infections and Infestations Nasopharyngitis Urinary tract infection 2.5 1.7 2.2 0.5 Investigations Weight increased 1.9 0.5 Musculoskeletal and Connective Tissue Disorders Pain in extremity Back pain 1.9 1.7 0.5 1.1 Nervous System Disorders Dizziness Somnolence Headache Lethargy 10.9 4.5 4.2 1.1 2.2 2.7 4.1 0.3 In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain relationship to gabapentin were reported during the clinical development for the treatment of postherpetic neuralgia. Events in more than 1% of patients but equally or more frequently in the gabapentin-treated patients than in the placebo group included blood pressure increase, confusional state, gastroenteritis viral, herpes zoster, hypertension, joint swelling, memory impairment, nausea, pneumonia, pyrexia, rash, seasonal allergy, and upper respiratory infection. 6.2 Postmarketing and Other Experience with other Formulations of Gabapentin In addition to the adverse experiences reported during clinical testing of gabapentin, the following adverse experiences have been reported in patients receiving other formulations of marketed gabapentin. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuation, breast enlargement, bullous pemphigoid, elevated creatine kinase, elevated liver function tests, erythema multiforme, fever, hyponatremia, jaundice, movement disorder, Stevens-Johnson syndrome. There are postmarketing reports of withdrawal symptoms after discontinuation of gabapentin. Reported adverse reactions include, but are not limited to, seizures, depression, suicidal ideation and behavior, agitation, confusion, disorientation, psychotic symptoms, anxiety, insomnia, nausea, pain, sweating, tremor, headache, dizziness, and malaise [see Warnings and Precautions ( 5.2 )]. There are postmarketing reports of life-threatening or fatal respiratory depression in patients taking gabapentin with opioids or other central nervous system (CNS) depressants, or in the setting of underlying respiratory impairment.
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.