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Neurontin gabapentin is an anti-epileptic medication used to treat seizures. Neurontin is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Neurontin is also used to treat nerve pain caused by shingles herpes zoster.
The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is The structural formula of gabapentin is:. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3. It is freely soluble in water and both basic and acidic aqueous solutions. Each Neurontin tablet contains mg or mg of gabapentin and the following inactive ingredients: poloxamercopovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax.
Neurontin oral solution contains mg of gabapentin per 5 mL 50 mg per mL and the following inactive ingredients: glycerinxylitolpurified water, and artificial cool strawberry anise flavor. 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 of age and older with renal impairment or undergoing hemodialysis is recommended, as follows see dosing recommendations above for effective doses in each indication :.
Creatinine clearance CLCr is difficult to measure 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 be 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 should be done gradually over a minimum of 1 week a longer period may be needed at the discretion of the prescriber. White elliptical film-coated scored tablets debossed with "NT" and "16" on one side; available in:.
White elliptical film-coated scored tablets debossed with "NT" and "26" on one side; available in:. Clear colorless to slightly yellow solution; each 5 mL of oral solution contains mg of gabapentin; available in:. Revised: Aug Because clinical trials are conducted under widely What is the drug neurontin used to treat 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. TABLE 3. There were no clinically important 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. TABLE 4. TABLE 5. Because 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.
Hepatobiliary disorders: jaundice. Investigations: elevated creatine kinase, elevated liver function tests. Metabolism and nutrition disorders: hyponatremia. Musculoskeletal and connective tissue disorder: rhabdomyolysis. Reproductive system and breast disorders: breast enlargement, changes in libidoejaculation disorders and anorgasmia. Adverse reactions following the abrupt discontinuation of gabapentin have also been reported. The most frequently reported reactions were anxiety, insomnia, nausea, pain, and sweating. Gabapentin does not exhibit affinity for benzodiazepine, opiate mu, delta or kappaor cannabinoid 1 receptor sites.
A small 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 s and symptoms of gabapentin misuse or abuse e.
There are rare postmarketing reports 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 included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. Most of these individuals had a history of poly- substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances.
The dependence and abuse potential of gabapentin has not been evaluated in human studies. 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 hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such s or symptoms are present, the patient should be evaluated immediately.
s 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 ificant 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.
During the controlled trials in patients with post-herpetic neuralgia, somnolence, and dizziness were reported at a greater rate compared to placebo in patients receiving NEURONTIN, in dosages up to mg per day: i. 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 and none in placebotreated patients, but the is too What is the drug neurontin used to treat 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— 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 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 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 s 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 ificant of these can be classified into the following : 1 emotional lability primarily behavioral problems2 hostility, including aggressive behaviors, 3 thought disorder, including 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 placebotreated patient 0. In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in rats [see Nonclinical Toxicology ]. The clinical ificance 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 NEURONTIN, 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 NEURONTIN ranging from 0. Consequently, whether these figures are reassuring or raise further concern depends on comparability of the populations reported upon to the NEURONTIN cohort and the accuracy of the estimates provided.
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. Other drugs with sedative properties may increase these symptoms. 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 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 ].
This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free [see Use In Specific Populations ]. Gabapentin was administered orally to mice and rats in 2-year carcinogenicity studies. Studies deed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity.
It is not known whether gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans. Gabapentin did not demonstrate mutagenic or genotoxic potential in in vitro Ames testHGPRT forward mutation assay in Chinese hamster lung cells and in vivo chromosomal aberration and micronucleus test in Chinese hamster bone marrowmouse micronucleus, unscheduled DNA synthesis in rat hepatocytes assays.
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 ].
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 brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. The clinical ificance of these findings is unknown.
Gabapentin is secreted in human milk following oral administration. The effects on the 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 years has not been established [see Clinical Studies ]. There was a larger treatment effect in patients 75 years of age and 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 s of subjects aged 65 and over to determine whether they responded differently from younger subjects. What is the drug neurontin used to treat 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. Pediatric patients with renal insufficiency have not been studied.What is the drug neurontin used to treat
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