Your family or other caregivers should also be alert to changes in your mood or symptoms. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking Neurontin for seizures without your doctor's advice, and tell your doctor right away if you become pregnant. Gabapentin can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.
How should I take Neurontin? Take Neurontin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Neurontin can be taken with or without food. If you break a Neurontin tablet and take only half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days. If your doctor changes your brand, strength, or type of gabapentin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of gabapentin you receive at the pharmacy.
Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose. Wear a medical alert tag or carry an ID card stating that you have seizures. Any medical care provider who treats you should know that you take seizure medication. Lactation Risk Summary Gabapentin is secreted in human milk following oral administration. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neurontin and any potential adverse effects on the breastfed infant from Neurontin or from the underlying maternal condition.
Pediatric Use Safety and effectiveness of Neurontin in the management of postherpetic neuralgia in pediatric patients have not been established. 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 14. 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 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. 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 decreased 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.
Renal Impairment 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. Drug Abuse and Dependence Gabapentin is not a scheduled drug. Abuse Gabapentin does not exhibit affinity for benzodiazepine, opiate mu, delta or kappa , or 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. Dependence 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. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of Neurontin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed.
All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with Neurontin. 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. If overexposure occurs, call your poison control center at 1-800-222-1222. Neurontin can be taken before or after meal.
If you split the tablet and take half of it, make sure that the other half is taken in your next dose. Do not use broken tablet as soon as possible or within few days. Do not take Gabapentin for seizures without informing your doctor even if you are feeling good. There is tendency of having increased seizures when you stop using the drug all of a sudden. You might need to use it little by little prior stopping the medication completely. If your seizures are getting worse, and you experience them frequently despite the Neurontin taken, then you need to consult your doctor.
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The dependence and abuse potential of gabapentin has not been evaluated in human studies. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of Neurontin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with Neurontin.
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. If overexposure occurs, call your poison control center at 1-800-222-1222. Neurontin Description The active ingredient in Neurontin capsules, tablets, and oral solution is gabapentin, which has the chemical name 1- aminomethyl cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.
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 capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Each Neurontin tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: Neurontin - Clinical Pharmacology Mechanism of Action The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown. Pharmacokinetics All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans.
Oral Bioavailability Gabapentin bioavailability is not dose proportional; i. Elimination Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin is not appreciably metabolized in humans. Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing. Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance. In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin can be removed from plasma by hemodialysis.
Specific Populations Age The effect of age was studied in subjects 20—80 years of age. Renal clearance CLr and CLr adjusted for body surface area also declined with age; however, the decline in the renal clearance of gabapentin with age can largely be explained by the decline in renal function. Gender Although no formal study has been conducted to compare the pharmacokinetics of gabapentin in men and women, it appears that the pharmacokinetic parameters for males and females are similar and there are no significant gender differences.
Race Pharmacokinetic differences due to race have not been studied. Because gabapentin is primarily renally excreted and there are no important racial differences in creatinine clearance, pharmacokinetic differences due to race are not expected. Peak plasma concentrations were similar across the entire age group and occurred 2 to 3 hours postdose. Accordingly, oral clearance normalized per body weight was higher in the younger children. Apparent oral clearance of gabapentin was directly proportional to creatinine clearance. Gabapentin elimination half-life averaged 4.
Some people have thoughts about suicide while taking this medicine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking Neurontin for seizures without your doctor's advice, and tell your doctor right away if you become pregnant. Gabapentin can pass into breast milk, but effects on the nursing baby are not known.
Tell your doctor if you are breast-feeding. How should I take Neurontin? Take Neurontin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Neurontin can be taken with or without food. If you break a Neurontin tablet and take only half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days. If your doctor changes your brand, strength, or type of gabapentin, your dosage needs may change.
Ask your pharmacist if you have any questions about the new kind of gabapentin you receive at the pharmacy. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose. You might need to use it little by little prior stopping the medication completely. If your seizures are getting worse, and you experience them frequently despite the Neurontin taken, then you need to consult your doctor. If you want to get a good result, make sure you use Gabapentin on regular basis. Refill your prescription prior the time it completely run out of stock.
Dosage The typical dosage of Neurontin Generic Gabapentin normally begins with 300mg, meanwhile your doctor may increase it to about 1800mg daily. A distinctive adult dose for epilepsy could range from 900mg-1800mg daily. For regular-release pills, capsules, and liquid, the dosage is taken 3-4 times per day.