Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Gabapentin can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established. If such signs or symptoms are present, the patient should be evaluated immediately. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. This disorder is variable in its expression, and other organ systems not noted here may be involved. 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. Some of these reactions have been fatal or life-threatening. If the Gabapentin 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).ĥ.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivityĭrug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with Gabapentin. Gabapentin capsules should be swallowed whole with water. The use of Gabapentin in patients less than 12 years of age with compromised renal function has not been studied.īecause 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.Īdminister Gabapentin orally with or without food. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault: Hemodialysis 125 † 150 † 200 † 250 † 350 †Ĭreatinine clearance (CLCr) is diffcult to measure in outpatients. Post-Hemodialysis Supplemental Dose (mg)† TID = Three times a day BID = Two times a day QD = Single daily doseįor patients with creatinine clearance 30 to 59 400 to 1400 200 BID 300 BID 400 BID 500 BID 700 BID Gabapentin Dosage Based on Renal Function The maximum time interval between doses should not exceed 12 hours.Ģ.3 Dosage Adjustment in Patients with Renal Impairmentĭosage 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): Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. Gabapentin may be administered as the capsule formulations. The recommended maintenance dose of Gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. The recommended maintenance dose of Gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. 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 maximum time between doses should not exceed 12 hours. Administer Gabapentin three times a day using 300 mg or 400 mg capsules. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. The recommended maintenance dose of Gabapentin is 300 mg to 600 mg three times a day. The starting dose is 300 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 demonstratedĢ.2 Dosage for Epilepsy with Partial Onset Seizures 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 adults with postherpetic neuralgia, Gabapentin 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).
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