Gabapentin Teva

/ Teva

Gabapentin is given orally with or without food.
Epilepsy: Gabapentin is recommended for add-on therapy in patients over 12 years of age. Evidence bearing on its safety and effectiveness in children is not available. When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week.
Adults and pediatric patients over 12 years of age: In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by administering 300 mg three times a day (TID) on Day 1, or by titrating the dose as described in the Table Thereafter, the dose can be increased in three equally divided doses up to a maximum dose of 3600 mg/day. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The maximum time between doses in the three times a day (TID) schedule should not exceed 12 hours to prevent breakthrough convulsions.
For dosing chart and initial titration dosage of gabapentin in adults based on renal function:  For full details see prescribing information.
Dosage adjustment in patients undergoing hemodialysis: For patients undergoing hemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg is recommended, then 200 to 300 mg of gabapentin following each 4 hours of hemodialysis.
For full details see prescribing information.

Epilepsy: Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy.
Neuropathic Pain: Treatment of neuropathic pain in diabetic neuropathy or postherpetic neuropathy (neuralgia).

Known hypersensitivity to gabapentin or to any other ingredient of the preparation.

Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus. When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution of alternative anticonvulsant medication, this should be done gradually over a minimum of one week. Gabapentin is not generally considered effective in the treatment of absence seizures and may exacerbate these seizures in some patients. Consequently, gabapentin should be used with caution in patients who have mixed seizure disorders that include absence seizures. Patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations. Patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentinor morphine should be reduced appropriately.
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking antiepileptic drugs including gabapentin. 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.
Suicidal Ideation and Behavior: Suicidal ideation and behavior have been reported in patients treated with anti-epileptic drugs (AED) in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behavior. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for gabapentin.
Increase in Seizure Frequency: As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the onset of new types of seizures with gabapentin.
Withdrawal-precipitated seizure: Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency and the precipitation of status epilepticus. When in the judgment of the clinician there is a need for dose reduction, discontinuation or substitution of alternative anticonvulsant medication, this should be done gradually over a minimum of one week.
Status Epilepticus: In the placebo controlled studies, the incidence of status epilepticus in patients receiving gabapentin was 0.6% vs. 0.5% with placebo.
Sudden and Unexplained Deaths: During the course of premarketing development of gabapentin, 8 sudden and unexplained deaths were recorded among 2203 patients. Some of these could represent seizure-related deaths in which the seizure was not observed (e.g., at night).
Effect on Ability to Drive and Operate Machinery: Gabapentin can produce drowsiness and dizziness, as well as possible blurred or double vision. Therefore patients should be cautioned that the drug may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).

Epilepsy: The most commonly observed adverse events associated with the use of gabapentin in combination with other antiepileptic drugs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus.
Approximately 7% of the 2074 individuals who received gabapentin in premarketing clinical trials discontinued because of an adverse event. The adverse events most commonly associated with withdrawal were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea and/or vomiting (0.6%), and dizziness (0.6%).
Incidence in Controlled Clinical Trials: treatment-emergent signs and symptoms that occurred in at least 1% of gabapentin-treated patients with epilepsy participating in placebo-controlled trials and were numerically more common in the gabapentin group. In these studies, either gabapentin or placebo was added to the patient’s current antiepileptic drug therapy. Adverse events were usually mild to moderate in intensity. The prescriber should be aware that these figures, obtained when gabapentin was added to concurrent antiepileptic drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.
For full details see prescribing information.

Note: Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs. Thus gabapentin may be used in combination with other antiepileptic drugs without concern for alteration of the blood concentrations of gabapentin or of other antiepileptic drugs
Gabapentin/Phenytoin/Carbamazepine/Valproic Acid/Phenobarbital: There is no interaction between gabapentin and phenytoin, valproic acid, carbamazepine or phenobarbital. Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving antiepileptic agents.
Gabapentin/Central Nervous System Depressants/Alcohol: Concomitant administration may lead to increased CNS depression.
Gabapentin/Morphine: In a study involving healthy volunteers, when a 60mg controlled-release morphine capsule was administered 2 hours prior to a 600mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.
Gabapentin//Naproxen: Coadministration)of naproxen sodium capsules (250 mg) with gabapentin (125 mg) appears to increase the amount of gabapentin absorbed by 12%to 15%.Gabapentin had no effect on naproxen pharmacokinetic parameters. These doses are lower than the therapeutic doses for both drugs. The magnitude of interaction within the recommended dose ranges of either drug is not known.
Gabapentin/Hydrocodone: Coadministration of gabapentin (125 to 500 mg) decreases hydrocodone (10 mg) Cmax and AUC values in a dose-dependent manner relative to administration of hydrocodone alone; Cmax and AUC values are 3%to 4% lower, respectively, after administration of 125 mg gabapentin and 21% to 22% lower, respectively, after administration of 500 mg gabapentin. The mechanism for this interaction is unknown. Hydrocodone increases gabapentin AUC values by 14%.The magnitude of interaction at other doses is not known.
Gabapentin/Oral Contraceptives: Co-administration of gabapentin with oral contraceptives including norethisterone and/or ethinyl estradiol does not influence the steady-state pharmacokinetics of either component.
Gabapentin/Antacids: In a clinical study where gabapentin and an aluminium and magnesium containing antacid were given at the same time, gabapentin’s bioavailability was reduced by up to 24%. It is therefore recommended that gabapentin be taken about two hours following any such antacid administration.
Gabapentin/Probenecid: Renal excretion of gabapentin is unaltered by probenecid.
Gabapentin/Cimetidine: The slight decrease in renal excretion of gabapentin observed when co-administered with cimetidine is not expected to be of clinical importance.
Drug/Food Interactions: Food has no effect on gabapentin pharmacokinetics.
For full details see prescribing information.

Pregnancy: There are no adequate data from the use of gabapentin in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Lactation: Gabapentin is secreted into human milk following oral administration. A nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentin.Because the effect on the nursing infant is unknown, gabapentin should be used in women who are nursing only if the benefits clearly outweigh the risks.
For full details see prescribing information.        

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg.
Manifestations: Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.
Acute oral overdose of gabapentin 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.
Treatment: 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.