RiteMED Gabapentin

Adjunctive therapy in treatment of partial seizures w/ & w/o secondary generalization in adults & childn ≥6 yr. Monotherapy in treatment of partial seizures w/ & w/o secondary generalization in adults & adolescents ≥12 yr. Treatment of peripheral neuropathic pain eg, painful diabetic neuropathy & post-herpetic neuralgia in adults.

Epilepsy Adult & adolescent Effective dosing range: 900-3,600 mg/day. Initial titration: 300 mg once daily on day 1, followed by 300 mg bid on day 2, then 300 mg tid on day 3; or by administering 300 mg tid on day 1. Thereafter, based on individual patient response & tolerability, dose can be further increased in 300 mg/day increments every 2-3 days up to max dose of 3,600 mg/day. Total daily dose should be divided in 3 single doses. Max time interval between doses should not exceed 12 hr to prevent breakthrough convulsions. Childn ≥6 yr Initially 10-15 mg/kg/day; effective dose is reached by upward titration over a period of approx 3 days. Effective dose: 25-35 mg/kg/day. Total daily dose should be divided in 3 single doses. Max time interval between doses should not exceed 12 hr. Peripheral neuropathic pain Adult Initial titration: 300 mg once daily on day 1, followed by 300 mg bid on day 2, then 300 mg tid on day 3. Alternatively, initially 900 mg/day as 3 equally divided doses. Thereafter, based on individual patient response & tolerability, dose can be further increased in 300 mg/day increments every 2-3 days up to max dose of 3,600 mg/day. Slower dose titration may be appropriate for individual patients. All indications Patient w/ renal impairment CrCl >80 mL/min 900-3,600 mg/day, 50-79 mL/min 600-1,800 mg/day, 30-49 mL/min 300-900 mg/day, 15-29 mL/min 150-600 mg/day administered, <15 mL/min 150-300 mg/day. Total daily dose should be administered as 3 divided doses. 150-mg dose to be administered as 300 mg every other day. Anuric patient undergoing hemodialysis who have never received gabapentin Loading dose: 300-400 mg, then 200-300 mg following each 4 hr of hemodialysis. Renally impaired patient undergoing hemodialysis Maintenance dose following dose for patient w/ renal impairment. 200-300 mg additional dose (in addition to maintenance dose) following each 4-hr hemodialysis treatment.

May be taken with or without food: Swallow whole w/ sufficient fluid.

Hypersensitivity.

Consider discontinuation if patient develops acute pancreatitis. Not considered effective against primary generalized seizures eg, absences & may aggravate these seizures in some patients. Abrupt w/drawal in epileptic patients may precipitate status epilepticus. Some patients may experience an increase in seizure frequency or the onset of new types of seizures. Monitor patients for signs of suicidal ideation & behaviors & appropriate treatment should be considered. Immediately evaluate patient for early manifestations of hypersensitivity eg, fever or lymphadenopathy, even w/o rash & discontinue treatment if an alternative etiology for signs or symptoms cannot be established. Severe, life-threatening, systemic hypersensitivity reactions eg, DRESS have been reported. Carefully observe for signs of CNS depression eg, somnolence, sedation & resp depression in patients who require concomitant treatment w/ opioids. Carefully evaluate patients for history of drug abuse & observe for possible signs of drug abuse eg, drug-seeking behavior, dose escalation, development of tolerance. Caution in patients w/ mixed seizures including absences. Associated w/ dizziness & somnolence, which could increase occurrence of accidental injury (fall). Reports of confusion, loss of consciousness & mental impairment. False +ve readings in semi-quantitative determination of total urine protein by dipstick tests. Somnolence, peripheral edema & asthenia may be more frequent in elderly patients >65 yr. Effects of long-term (>36 wk) therapy on learning, intelligence, & development in childn & adolescents have not been adequately studied.

Viral infection; somnolence, dizziness, ataxia; fatigue, fever. Pneumonia, resp infection, UTI, infection, otitis media; leucopenia; anorexia, increased appetite; hostility, confusion & emotional lability, depression, anxiety, nervousness, abnormal thinking; convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations eg, paresthesia, hypesthesia, abnormal coordination, nystagmus, increased/decreased/absent reflexes; visual disturbances eg, amblyopia, diplopia; vertigo; HTN, vasodilatation; dyspnea, bronchitis, pharyngitis, cough, rhinitis; vomiting, nausea, dental abnormalities, gingivitis, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence; facial edema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne; arthralgia, myalgia, back pain, twitching; incontinence; impotence; peripheral or generalized edema, abnormal gait, asthenia, pain, malaise, flu syndrome; decreased WBC count, wt gain; accidental injury, fracture, abrasion.

Reports of resp depression &/or sedation w/ opioid. Increased mean AUC w/ morphine. Reduced bioavailability w/ antacids containing Al & Mg.

Anticonvulsants

N02BF01 - gabapentin ; Belongs to the class of gabapentinoids. Used to relieve pain and other conditions.

Rx