If you are a consumer or patient please visit this version. The starting dose is mg three times a day. The maximum time between doses should not exceed 12 hours. The maximum time interval between doses should not exceed 12 hours. Dosage adjustment in patients 12 years gabapentin ad alcolismo age and older with renal impairment gabapentin ad alcolismo undergoing hemodialysis is recommended, as follows see dosing recommendations above for effective doses in each indication :.
Creatinine clearance CLCr is difficult to gabapentin ad alcolismo in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should gabapentin ad alcolismo adjusted based on creatinine clearance values in these patients.
Inform patients that, should they divide the scored mg or mg NEURONTIN tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded. If the NEURONTIN dose is reduced, discontinued, or substituted with an alternative medication, this gabapentin ad alcolismo be done gradually over a minimum of 1 week a longer period may be needed at the discretion of the prescriber.
Some of these reactions have been fatal or life-threatening. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved.
It is important to note that early manifestations of gabapentin ad alcolismo, 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. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Driving performance studies conducted with a prodrug of gabapentin gabapentin enacarbil tablet, extended-release indicate that gabapentin may cause significant driving impairment.
Prescribers and patients should be aware that patients' ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by NEURONTIN, can be imperfect. Whether the impairment is related to somnolence [see Warnings and Precautions 5. During the controlled trials in patients gabapentin ad alcolismo post-herpetic neuralgia, somnolence, and dizziness were reported at a greater rate compared to placebo in patients receiving NEURONTIN, gabapentin ad alcolismo dosages up to mg per day: i.
In addition, patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations and may require dose adjustment [see Drug Interactions 7. 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.
Pooled analyses of 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.
In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27, AED-treated patients was 0. There were four suicides in drug-treated patients in the trials gabapentin ad alcolismo 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 Gabapentin ad alcolismo 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 gabapentin ad alcolismo suicidal thoughts or behavior was generally consistent among drugs gabapentin ad alcolismo 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— years in the clinical trials analyzed.
Table 2 shows absolute and relative risk by indication for all evaluated AEDs. 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. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal gabapentin ad alcolismo 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 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. Gabapentin use in pediatric patients with epilepsy 3 to 12 years of age is associated with the occurrence of CNS related adverse reactions. The most significant of these can be classified into the following categories: 1 emotional lability primarily behavioral problems2 hostility, including aggressive behaviors, 3 thought disorder, gabapentin ad alcolismo concentration problems and change in school performance, and 4 hyperkinesia primarily restlessness and hyperactivity.
Among the gabapentin-treated patients, most of the reactions were mild to moderate in intensity. One of these reactions, a report of hostility, was considered serious. Discontinuation of gabapentin treatment occurred in 1. One placebo-treated patient 0. In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in rats [see Nonclinical Toxicology The clinical significance of this finding is unknown.
Clinical experience during gabapentin ad alcolismo 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 NEURONTIN, it is impossible to know whether the incidence seen in this cohort is or is not gabapentin ad alcolismo by treatment. Some of these could represent seizure-related deaths in which the seizure was not observed, e.
This represents an incidence of 0. Gabapentin ad alcolismo 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 NEURONTIN ranging from gabapentin ad alcolismo. Consequently, whether these figures are reassuring or raise further concern depends on gabapentin ad alcolismo of the populations reported upon to the NEURONTIN cohort and the accuracy of the estimates provided.
The following serious adverse reactions are discussed in greater detail in other sections:. Because clinical trials are gabapentin ad alcolismo 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. The most common adverse reactions associated with the use of NEURONTIN in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema.
There were no clinically gabapentin ad alcolismo differences between men and women in the types and incidence of adverse reactions. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse reactions by race. The adverse reactions most commonly associated with withdrawal in pediatric patients were emotional lability 1. Gabapentin ad alcolismo these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Reproductive system and breast disorders: breast enlargement, changes in libido, ejaculation disorders and anorgasmia. Skin and subcutaneous tissue disorders: angioedema [see Warnings and Precautions 5. Gabapentin ad alcolismo reactions following the abrupt discontinuation of gabapentin have also been reported. The most frequently reported reactions were anxiety, insomnia, nausea, pain, and sweating.
Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of gabapentin ad alcolismo coadministered antiepileptic drugs [see Clinical Pharmacology 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 It is recommended that gabapentin be taken gabapentin ad alcolismo least 2 hours following Maalox administration [see Clinical Pharmacology In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality when administered to pregnant animals at doses similar to or lower than those used clinically [see Data gabapentin ad alcolismo.
In the U. The background risk of major birth defects and miscarriage for the indicated population is unknown. Gabapentin caused a marked decrease in neuronal synapse formation in gabapentin ad alcolismo of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair.
The clinical significance of these findings is unknown. Gabapentin is secreted in human milk following oral administration. The effects on gabapentin ad alcolismo breastfed infant and on milk production are unknown. Safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 gabapentin ad alcolismo has not been established [see Clinical Studies There was a larger treatment effect in gabapentin ad alcolismo 75 years of age gabapentin ad alcolismo older compared to 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 gabapentin ad alcolismo 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.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have gabapentin ad alcolismo renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients [see Dosage and Administration 2.
Dosage adjustment in adult patients with compromised renal function is necessary [see Dosage and Administration 2. Pediatric patients with renal insufficiency have not been studied. Dosage adjustment in patients undergoing hemodialysis is necessary [see Dosage and Administration 2. Gabapentin does not exhibit affinity for benzodiazepine, opiate mu, delta or kappaor cannabinoid 1 receptor sites. A small number of postmarketing cases report gabapentin misuse and abuse.
These individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. When prescribing gabapentin carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse e.
There are rare postmarketing gabapentin ad alcolismo of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. Such symptoms gabapentin ad alcolismo agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin.
Most of these gabapentin ad alcolismo had a history gabapentin ad alcolismo poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. The dependence and abuse potential of gabapentin has gabapentin ad alcolismo been evaluated in human studies. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed.
All patients recovered with supportive care. 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.