Qudexy XR (Topiramate Extended-Release Capsules)于2014年3月11日获FDA批准上市
Qudexy® XR 也被批准作为最初的单药治疗两岁以上的患者和年龄在两岁以上的患者的部分起病或原发性广泛性补剂-挛癫痫和辅助疗法, 年龄和年龄的部分发病或原发性广义挛癫痫发作, 或与蓝诺克斯 Gastaut 综合征有关的癫痫发作。
QUDEXY XR CAP 25MG 30 $398.21 TOPIRAMATE UPSHER SMITH LABORATORIES 00245-1071-30
QUDEXY XR CAP 50MG 30 $588.46 TOPIRAMATE UPSHER SMITH LABORATORIES 00245-1072-30
QUDEXY XR CAP 150MG 30 $1146.69 TOPIRAMATE UPSHER SMITH LABORATORIES 00245-1075-30
QUDEXY XR CAP 200MG 30 $1,952.83 TOPIRAMATE UPSHER SMITH LABORATORIES 00245-1073-30
QUDEXY XR CAP 100MG 30 $1069.65 TOPIRAMATE UPSHER SMITH LABORATORIES 00245-1074-30
Qudexy XR (Topiramate Extended-Release Capsules)
QUDEXY XR Rx
Generic Name and Formulations:
Topiramate 25mg, 50mg, 100mg, 150mg, 200mg; ext-rel caps.
Company:
Upsher-Smith Laboratories, Inc.
Select therapeutic use: Migraine and headache
Seizure disorders
Indications for QUDEXY XR:
Prophylaxis of migraine headache.
Adult:
Swallow whole or may open caps and sprinkle contents on a teaspoonful of soft food. Initially 25mg once daily, increase at 1-week intervals by increments of 25mg/week to target dose of 100mg once daily. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose. Concomitant phenytoin and/or carbamazepine: see full labeling.
Children:
<12yrs: not established.
Contraindications:
Concomitant metformin during metabolic acidosis.
Warnings/Precautions:
Discontinue if acute myopia and secondary angle-closure glaucoma occur. Consider discontinuing if other visual problems occur. Obtain baseline and periodic serum bicarbonate during therapy; consider reducing dose or discontinuing if acidosis occurs. Obtain CrCl prior to dosing in patients at high risk for renal insufficiency (eg, older age, diabetes mellitus, hypertension, autoimmune disease). Monitor closely for oligohydrosis and hyperthermia (esp. children). Suicidal tendencies (monitor). Inborn errors of metabolism, reduced hepatic mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Maintain adequate hydration; avoid ketogenic diets. Avoid abrupt cessation. Labor & delivery. Pregnancy: risk of fetal toxicity; consider alternatives. Nursing mothers.
Interactions:
See Contraindications. Increased severity of metabolic acidosis and risk of kidney stone formation with concomitant other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Phenytoin, carbamazepine reduce topiramate levels. May increase phenytoin levels. May antagonize oral contraceptives, valproic acid, glyburide, diltiazem. CNS depression potentiated with alcohol, other CNS depressants; avoid. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). Monitor lithium levels with high-dose topiramate. May be antagonized by valproic acid, lamotrigine. May be potentiated by HCTZ; may need to adjust dose. Caution with concomitant pioglitazone; monitor for adequate glycemic control.
Pharmacological Class:
Sulfamate.
Adverse Reactions:
Paresthesia, anorexia, weight decrease, speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, fever, difficulty with memory, taste perversion, upper RTI, abdominal pain, diarrhea, hypoesthesia, nausea; metabolic acidosis, cognitive/neuropsychiatric reactions, kidney stones, hyperammonemia, hypothermia, increased bleeding risk.
How Supplied:
XR caps—30, 90, 500
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46f54677-3a22-4c38-9b92-923020164e15 |
