Use in children aged 6 years and above: The treatment is started with a low initial dose, which is gradually increased over a period of approximately 3 days.
It is usually given in 3 divided doses, by taking the tablets each day, usually once in the morning, once in the afternoon and once in the evening. Gabapentin is not recommended for use in children below 6 years of age. Because adequate historical data are not available, it is impossible to say whether or not treatment with gabapentin is associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar population not treated with gabapentin.
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. Carcinogenesis, Mutagenesis, Impairment of Fertility. The clinical significance of this finding is unknown.
Clinical experience during gabapentin's premarketing development provides no direct means to assess its potential for inducing tumors in humans.
Without knowledge of the background incidence and recurrence in a similar population not treated with gabapentin, it is impossible to know whether the incidence seen in this cohort is or is not affected by treatment. Some of these could represent seizure-related deaths in which the seizure was not observed, e. This represents an incidence of 0. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving gabapentin ranging from 0.
Consequently, whether these figures are reassuring or raise further concern depends on comparability of the populations reported upon to the gabapentin cohort and the accuracy of the estimates provided. Some of these events have been fatal or life-threatening. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved.
Your condition will not improve any faster and the risk of serious side effects may increase. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Gabapentin did not demonstrate mutagenic or genotoxic potential in three in vitro and four in vivo assays.
It was negative in the Ames test and the in vitro HGPRT forward mutation assay in Chinese hamster lung cells; it did not produce significant increases in chromosomal aberrations in the in vitro Chinese hamster lung cell assay; it was negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus test in Chinese hamster bone marrow; it was negative in the in vivo mouse micronucleus assay; and it did not induce unscheduled DNA synthesis in hepatocytes from rats given gabapentin.
In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically.
Gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. The clinical significance of these findings is unknown.
This can be done by calling the toll free number 1- , and must be done by patients themselves. Information on the registry can also be found at the website http: Nursing Mothers Gabapentin is secreted into human milk following oral administration. Effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see Clinical Studies ].
There was a larger treatment effect in patients 75 years of age and older compared with younger patients who received the same dosage. However, other factors cannot be excluded. The types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age.
Clinical studies of NEURONTIN in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Discontinuation of gabapentin treatment occurred in 1. One placebo-treated patient 0. Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency.
Of these, 14 patients had no prior history of status epilepticus either before treatment or while on other medications. Because adequate historical data are not available, it is impossible to say whether or not treatment with gabapentin is associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar population not treated with gabapentin.
In standard preclinical in vivo lifetime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar adenocarcinomas was identified in male, but not female, rats. Carcinogenesis, Mutagenesis, Impairment of Fertility. The clinical significance of this finding is unknown. Without knowledge of the background incidence and recurrence in a similar population not treated with gabapentin, it is impossible to know whether the incidence seen in this cohort is or is not affected by treatment.
During the course of premarketing development of gabapentin 8 sudden and unexplained deaths were recorded among a cohort of patients treated patient-years of exposure. Some of these could represent seizure-related deaths in which the seizure was not observed, e. This represents an incidence of 0. There was no consistent pattern indicating that age had any effect on the response to gabapentin. There were insufficient numbers of patients of races other than Caucasian to permit a comparison of efficacy among racial groups.
For all partial seizures in the intent-to-treat population, the response ratio was statistically significantly better for the gabapentin group Patients had up to 48 hours of baseline and up to 72 hours of double-blind video EEG monitoring to record and count the occurrence of seizures. There were no statistically significant differences between treatments in either the response ratio or responder rate. NDC Bottles of NDC mg capsules: NDC mg tablets: Administration Information Inform patients that gabapentin is taken orally with or without food.
Inform patients that, should they divide the scored mg or mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Advise patients to discard half-tablets not used within 28 days of dividing the scored tablet. 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.
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. Inform patients that it is not known how long this effect lasts [see Warnings and Precautions 5. 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.
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 breast feeding or intend to breast feed during therapy [see Use in Specific Populations 8.
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