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GABARONE is a brand name for Gabapentin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE GABARONE is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy GABARONE is indicated for: Postherpetic neuralgia…
Verbatim from this product's FDA label. Tap a section to expand.
2) Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily Patients 3 to 11 years of age: starting dose range is 10 to 15mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses.
1 Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, GABARONE may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day).
The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
2 Dosage for Epilepsy with Partial Onset Seizures Patients 12 Years of Age and Above The starting dose is 300 mg three times a day. The recommended maintenance dose of GABARONE is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well administered in long-term clinical studies.
Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration. Administer GABARONE three times a day using 300 mg or 400 mg, 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 Years The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of GABARONE in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses.
The recommended maintenance dose of GABARONE in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. GABARONE may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations.
Dosages up to 50 mg/kg/day have been administered in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours. 3 Dosage Adjustment in Patients with Renal Impairment 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): TABLE 1.
gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted 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.
Postherpetic Neuralgia The most common adverse reactions associated with the use of GABARONE in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received GABARONE and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction.
The adverse reactions that most frequently led to withdrawal in GABARONE -treated patients were dizziness, somnolence, and nausea. Table 3 lists adverse reactions that occurred in at least 1% of GABARONE -treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the GABARONE group than in the placebo group.
TABLE 3. Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia a Reported as blurred vision GABARONE N=336 % Placebo N=227 % Body as a Whole Asthenia 6 5 Infection 5 4 Accidental injury 3 1 Digestive System Diarrhea 6 3 Dry mouth 5 1 Constipation 4 2 Nausea 4 3 Vomiting 3 2 Metabolic and Nutritional Disorders Peripheral edema 8 2 Weight gain 2 0 Hyperglycemia 1 0 Nervous System Dizziness 28 8 Somnolence 21 5 Ataxia 3 0 Abnormal thinking 3 0 Abnormal gait 2 0 Incoordination 2 0 Respiratory System Pharyngitis 1 0 Special Senses Amblyopia a 3 1 Conjunctivitis 1 0 Diplopia 1 0 Otitis media 1 0 Other reactions in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome.
6) Respiratory Depression: May occur with GABARONE when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. 1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with GABARONE.
Some of these reactions have been fatal or life- threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.
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 signs or symptoms are present, the patient should be evaluated immediately. GABARONE should be discontinued if an alternative etiology for the signs or symptoms cannot be established. 2 Anaphylaxis and Angioedema GABARONE can cause anaphylaxis and angioedema after the first dose or at any time during treatment.
Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue GABARONE and seek immediate medical care should they experience signs or symptoms of anaphylaxis or angioedema.
3 Effects on Driving and Operating Heavy Machinery Patients taking GABARONE should not drive until they have gained sufficient experience to assess whether GABARONE impairs their ability to drive. Driving performance studies conducted with a prodrug of gabapentin (gabapentin enacarbil tablet, extended-release) indicate that gabapentin may cause significant driving impairment.
4 CONTRAINDICATIONS GABARONE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to gabapentin or its ingredients (4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) ≥60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID >30 to 59 400 to 1400 200 BID 300 BID 400 BID 500 BID 700 BID >15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD 15 a 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg) b Hemodialysis 125 b 150 b 200 b 250 b 350 b Creatinine clearance (CLCr) is difficult to measure in outpatients.
85 for female patients) 72 x serum creatinine (mg/dL) The use of GABARONE in patients less than 12 years of age with compromised renal function has not been studied. 4 Dosage in Elderly 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.
5 Administration Information Administer GABARONE orally with or without food. Inform patients that, should they divide the scored 600 mg or 800 mg GABARONE 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 GABARONE 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).
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.
Epilepsy with Partial Onset Seizures (Adjunctive Therapy) The most common adverse reactions with GABARONE in combination with other antiepileptic drugs in patients > 12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus.
8)] . Approximately 7% of the 2074 patients > 12 years of age and approximately 7% of the 449 pediatric patients 3 to 12 years of age who received GABARONE in premarketing clinical trials discontinued treatment because of an adverse reaction.
6%). 1%). Table 4 lists adverse reactions that occurred in at least 1% of GABARONE -treated patients > 12 years of age with epilepsy participating in placebo-controlled trials and were numerically more common in the GABARONE group. In these studies, either GABARONE or placebo was added to the patient's current antiepileptic drug therapy.
TABLE 4. Adverse Reactions in Pooled Placebo-Controlled Add-On Trials in Epilepsy Patients >12 Years of Age a Plus background antiepileptic drug therapy b Amblyopia was often described as blurred vision. GABARONE a N=543 % Placebo a N=378 % Body as a Whole Fatigue 11 5 Increased weight 3 2 Back pain 2 1 Peripheral edema 2 1 Cardiovascular Vasodilatation 1 0 Digestive System Dyspepsia 2 1 Dry mouth or throat 2 1 Constipation 2 1 Dental abnormalities 2 0 Nervous System Somnolence 19 9 Dizziness 17 7 Ataxia 13 6 Nystagmus 8 4 Tremor 7 3 Dysarthria 2 1 Amnesia 2 0 Depression 2 1 Abnormal thinking 2 1 Abnormal coordination 1 0 Respiratory System Pharyngitis 3 2 Coughing 2 1 Skin and Appendages Abrasion 1 0 Urogenital System Impotence 2 1 Special Senses Diplopia 6 2 Amblyopia b 4 1 Among the adverse reactions occurring at an incidence of at least 10% in GABARONE -treated patients, somnolence and ataxia appeared to exhibit a positive dose-response relationship.
The overall incidence of adverse reactions and the types of adverse reactions seen were similar among men and women treated with GABARONE. The incidence of adverse reactions increased slightly with increasing age in patients treated with either GABARONE or placebo.
Because only 3% of patients (28/921) in placebo-controlled studies were identified as nonwhite (black or other), there are insufficient data to support a statement regarding the distribution of adverse reactions by race. Table 5 lists adverse reactions that occurred in at least 2% of GABARONE -treated patients, age 3 to 12 years of age with epilepsy participating in placebo-controlled trials, and which were numerically more common in the GABARONE group.
TABLE 5. Adverse Reactions in a Placebo-Controlled Add-On Trial in Pediatric Epilepsy Patients Age 3 to 12 Years a Plus background antiepileptic drug therapy GABARONE a N=119 % Placebo a N=128 % Body as a Whole Viral infection 11 3 Fever 10 3 Increased weight 3 1 Fatigue 3 2 Digestive System Nausea and/or vomiting 8 7 Nervous System Somnolence 8 5 Hostility 8 2 Emotional lability 4 2 Dizziness 3 2 Hyperkinesia 3 1 Respiratory System Bronchitis 3 1 Respiratory infection 3 1 Other reactions in more than 2% of pediatric patients 3 to 12 years of age but equally or more frequent in the placebo group included: pharyngitis, upper respiratory infection, headache, rhinitis, convulsions, diarrhea, anorexia, coughing, and otitis media.
2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of GABARONE. 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.
2)] , bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome. 7)]. Adverse reactions following the abrupt discontinuation of gabapentin have also been reported. The most frequently reported reactions were anxiety, insomnia, nausea, pain, and sweating.
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 GABARONE, can be imperfect. The duration of driving impairment after starting therapy with GABARONE is unknown.
4)] or other effects of GABARONE is unknown. 4)] , patients should be advised not to operate complex machinery until they have gained sufficient experience on GABARONE to assess whether GABARONE impairs their ability to perform such tasks.
, 19% in drug versus 9% in placebo for somnolence, 17% in drug versus 7% in placebo for dizziness, and 13% in drug versus 6% in placebo for ataxia. 6% discontinuing for these events, respectively. , 21% in GABARONE-treated patients versus 5% in placebo-treated patients for somnolence and 28% in GABARONE-treated patients versus 8% in placebo-treated patients for dizziness.
Dizziness and somnolence were among the most common adverse reactions leading to discontinuation of GABARONE. Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence and sedation, when GABARONE is used with other drugs with sedative properties because of potential synergy.
1)]. 5 Withdrawal Precipitated Seizure, Status Epilepticus Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. 5% in patients receiving placebo (2 of 378). 5%) had status epilepticus.
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 GABARONE is associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar population not treated with GABARONE.
6 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including GABARONE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
7) of suicidal thinking or behavior compared to patients randomized to placebo. 24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.
There were four suicides in drug-treated patients in the trials and 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 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 (5-100 years) in the clinical trials analyzed.
Table 2 shows absolute and relative risk by indication for all evaluated AEDs. TABLE 2. 9 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.
Anyone considering prescribing GABARONE or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. 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 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. 7 Respiratory Depression There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when co-administered with CNS depressants, including opioids, or in the setting of underlying respiratory impairment.
When the decision is made to co-prescribe GABARONE with another CNS depressant, particularly an opioid, or to prescribe GABARONE to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating GABARONE at a low dose.
The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including GABARONE). 8 Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) 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 problems), 2) 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. 7% versus 0%. One of these reactions, a report of hostility, was considered serious. 9% of gabapentin-treated patients reporting hostility and thought disorder.
4%) withdrew due to emotional lability. 1)] . 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.
In clinical studies in adjunctive therapy in epilepsy comprising 2,085 patient-years of exposure in patients > 12 years of age, new tumors were reported in 10 patients (2 breast, 3 brain, 2 lung, 1 adrenal, 1 non-Hodgkin's lymphoma, 1 endometrial carcinoma in situ ), and preexisting tumors worsened in 11 patients (9 brain, 1 breast, 1 prostate) during or up to 2 years following discontinuation of GABARONE.
Without knowledge of the background incidence and recurrence in a similar population not treated with GABARONE, it is impossible to know whether the incidence seen in this cohort is or is not affected by treatment. 10 Sudden and Unexplained Death in Patients with Epilepsy During the course of premarketing development of GABARONE, 8 sudden and unexplained deaths were recorded among a cohort of 2203 epilepsy patients treated (2103 patient-years of exposure) with GABARONE.
, at night. 0038 deaths per patient-year. 005 for patients with refractory epilepsy). Consequently, whether these figures are reassuring or raise further concern depends on comparability of the populations reported upon to the GABARONE cohort and the accuracy of the estimates provided.