Names and pronunciation
(vye-ga′ba-trin) Sabril, Vigadrone
PDF page 1366
Loading InternPractice…
Drug reference
(vye-ga′ba-trin) Sabril, Vigadrone
PDF page 1366
Func. class.: Anticonvulsant
PDF page 1366
Chem. class.: GABA transaminase inhibitor
PDF page 1366
ACTION: May inhibit reuptake and metabolism of GABA; may increase seizure threshold; structurally similar to GABA
PDF page 1366
USES: Adjunct treatment of partial seizures in adults and children ≥12 yr, infantile spasm
PDF page 1366
CONTRAINDICATIONS: Hyper sensitivity to this product Precautions: Pregnancy, breastfeeding, children <2 yr, geriatric patients, renal/ hepatic disease, suicidal thoughts/behav iors, abrupt discontinuation
PDF page 1366
Black Box Warning: Visual disturbance; requires an experienced clinician Black Box Warning: Visual impairment: Prescribers must be registered with the SHARE program due to risk of permanent vision loss; if no clinical response in 2-4 wk of pediatric patients or 3 mo in adults discontinue, provide vision assessment before and after ≤4 wk at least q3mo, and 3-6 mo after last dose • Acute encephalopathy: sedation, ataxia, confusion, disorientation, progressing to stupor; risk factors include high dose, rapid upward titration, renal impairment • Suicidal ideation: changes in mood, increased depression, notify prescriber • Renal studies: urinalysis, BUN, urine cre atinine q3mo in those with renal disease • Hepatic studies: ALT, AST, bilirubin • Description of seizures: location, dura tion, presence of aura • Mental status: mood, sensorium, affect, behavioral changes; if mental status changes, notify prescriber • Assistance with ambulation during early part of treatment; dizziness occurs • Seizure precautions: padded side rails; move objects that may harm patient • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; pregnant pa- tients should enroll in the North American Antiepileptic Drug Pregnancy Registry, 1-888-233-2334; do not breastfeed, ex- creted in breast milk Black Box Warning: That drug may cause vision impairment; that regular ex ams will be needed; to notify prescriber at once if loss of vision occurs • To notify prescriber if pregnancy is planned or suspected; not to breastfeed
PDF pages 1366, 1367
SIDE EFFECTS CNS: Headache, memory impairment, dizziness, irritability, lethargy, malignant hyperthermia, insomnia, suicidal ideation CV: Edema EENT: Visual impairment GI: Nausea, vomiting, diarrhea, increased appetite, abdominal pain, GI bleeding, hemorrhoids, weight gain, constipation GU: Impotence, dysmenorrhea HEMA: Anemia INTEG: Pruritus, rash RESP: Coughing, respiratory depression, pulmonary embolism
PDF pages 1366, 1367
INTERACTIONS Increase: CNS depression—CNS depressants Increase: Serious ophthalmic effects (glau- coma, retinopathy): azaTHIOprine, chloro- quine, corticosteroids, deferoxamine, etham- butol, hydroxychloroquine, interferons, loxapine, mecasermin, rh-IGF-1, pentostatin, phenothiazine, phosphodiesterase inhibitors, tamoxifen, thiothixene; avoid concurrent use Drug/Lab Test Decrease: ALT/AST
PDF page 1367
DOSAGE AND ROUTES Partial seizures • Adult/child ≥17 yr/>60 kg: PO 500 mg bid, titrate in 500-mg increments at weekly intervals up to 1.5 g bid • Child 2 to 16 years, greater than 60 kg: PO initial, 500 mg twice daily orally; may increase by 500mg once weekly to MAX, 1500 mg twice daily. • Child 2-16 yr, 25-60 kg: PO 500 mg/ day divided bid, increase weekly; max 2000/day divided bid • Child 2 to 16 years, greater than 20 kg to 25 kg: PO Initial, 500 mg/day orally given in 2 divided doses; may increase once weekly to MAX, 1500 mg/day given in 2 divided doses. • Child 2-16 yr, ≥15-20 kg: PO 450 mg/ day divided bid, increase weekly to max 1300 mg/day divided bid • Child 2-16 yr, 10-15 kg: PO 350 mg/ day divided bid, increase weekly to max 1050 mg/day divided bid Renal dose • Adult: PO CCr 50-80 mL/min, reduce dose by 25%; CCr 30-49 mL/min, reduce dose by 50%; CCr 10-29 mL/min, reduce dose by 75% Infantile spasm • Infant >1 mo/child ≤2 yr: PO 50 mg/ kg/day in 2 divided doses, titrate in incre ments of 25 to 50 mg/kg/day q3days, max 150 mg/kg/day
PDF page 1366
Available forms: Tabs 500 mg; powder for oral solution 500 mg
PDF page 1366
Administer: • Give without regard to meals PO route (tab) • Use safe handling procedures PO route (oral sol) • Reconstitute immediately before using • Empty contents of appropriate number of packets into clean cup • For each packet, dissolve 10 mL water, concentration 50 mg/mL; do not use other liquids • Stir until dissolved, sol should be clear • Use calibrated oral syringe to measure correct dosage • Discard any unused sol • Store at room temperature
PDF page 1366
Assess:
PDF page 1367
Evaluate: • Therapeutic response: decreased sei zure activity • Beers: avoid in older adults unless safer alternatives are unavailable; may cause ataxia, impaired psychomotor function
PDF page 1367
CLINICAL CONSIDERATIONS
PDF page 1367
Patient and caregiver information: • To carry emergency ID stating patient’s name, products taken, condition, pre scriber’s name and phone number • To avoid driving, other activities that require alertness • Not to discontinue medication quickly after long-term use • To notify prescriber if pregnancy is planned or suspected • To report suicidal thoughts/behaviors immediately • To avoid alcohol; drowsiness, dizziness may occur
PDF page 1367
PHARMACOKINETICS Absorption >95%, no protein binding, widely distributed, not metabolized, excretion in urine 80% parent drug, excretion slowed in renal disease, peak 2 hr, half-life 7.5 hr
PDF page 1367
• Adult/child ≥17 yr/>60 kg: PO 500 mg bid, titrate in 500-mg increments at weekly intervals up to 1.5 g bid
PDF page 1366
• Child 2 to 16 years, greater than 60 kg: PO initial, 500 mg twice daily orally; may increase by 500mg once weekly to MAX, 1500 mg twice daily.
PDF page 1366
• Child 2-16 yr, 25-60 kg: PO 500 mg/ day divided bid, increase weekly; max 2000/day divided bid
PDF page 1366
• Child 2 to 16 years, greater than 20 kg to 25 kg: PO Initial, 500 mg/day orally given in 2 divided doses; may increase once weekly to MAX, 1500 mg/day given in 2 divided doses.
PDF page 1366
• Child 2-16 yr, ≥15-20 kg: PO 450 mg/ day divided bid, increase weekly to max 1300 mg/day divided bid
PDF page 1366
• Child 2-16 yr, 10-15 kg: PO 350 mg/ day divided bid, increase weekly to max 1050 mg/day divided bid Renal dose
PDF page 1366
• Adult: PO CCr 50-80 mL/min, reduce dose by 25%; CCr 30-49 mL/min, reduce dose by 50%; CCr 10-29 mL/min, reduce dose by 75% Infantile spasm
PDF page 1366
• Infant >1 mo/child ≤2 yr: PO 50 mg/ kg/day in 2 divided doses, titrate in incre ments of 25 to 50 mg/kg/day q3days, max 150 mg/kg/day
PDF page 1366