topiramate

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topiramate

 [to-pi´rah-māt]
a substituted monosaccharide used as an anticonvulsant in treatment of partial seizures; administered orally.

topiramate

Apo-Topiramate, Co-Topiramate, Dom-Topiramate, Gen-Topiramate, Novo-Topiramate, PHL-Topiramate, PMS-Topiramate, Ratio-Topiramate, Sandoz-Topiramate , Topamax

Pharmacologic class: Sulfamate-substituted monosaccharide derivative

Therapeutic class: Anticonvulsant

Pregnancy risk category C

Action

Blocks sodium channels, enhancing the action of gamma-amino butyrate (a neurotransmitter); also inhibits amino acid excitatory receptors

Availability

Sprinkle capsules: 15 mg, 25 mg

Tablets: 25 mg, 50 mg, 100 mg, 200 mg

Indications and dosages

Adjunct in partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome

Adults and children older than age 17: Initially, 25 to 50 mg P.O. daily. To achieve adequate response, may increase by 25 to 50 mg weekly, up to 200 mg b.i.d.

Children ages 2 to 16: Initially, up to 25 mg P.O. daily; increase at 1- or 2-week intervals in increments of 1 to 3 mg/kg/day given in two divided doses to achieve adequate response.

Migraine prophylaxis

Adults: Dosage titrated to 100 mg P.O. daily as follows: 25 mg/day during week 1, 25 mg b.i.d. during week 2, 25 mg in morning and 50 mg in evening during week 3, and 50 mg b.i.d. during week 4

Monotherapy for epilepsy

Adults and children ages 10 and older: Initially, 50 mg P.O. daily in two divided dosages. Increase dosage weekly by increments of 50 mg for first 4 weeks, then 100 mg for weeks 5 and 6. Maximum dosage is 400 mg/day in two divided doses.

Children ages 2 to younger than 10: Initially, 25 mg/day P.O. nightly for first week. Titrate dosage over 5 to 7 weeks, with total maximum daily dosage based on weight.

Dosage adjustment

• Renal impairment

Off-label uses

• Cluster headaches

• Infantile spasms

• Mood stabilization

Contraindications

None

Precautions

Use cautiously in:

• renal or hepatic impairment, dehydration, urolithiasis, glaucoma, myopia, patients at increased risk for hyperammonemia (such as those with inborn errors of metabolism or reduced mitochondrial activity)

• concurrent use of other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or patients on ketogenic diet (avoid use)

• concurrent use of other drugs that predispose patients to heat-related disorders (such as carbonic anhydrase inhibitors, drugs with anticholinergic activity)

• pregnant or breastfeeding patients.

• children younger than age 2 (safety and efficacy not established).

Administration

• Give without regard to meals.

• Don't break tablets, because of bitter taste.

• Administer capsules either whole or by opening capsule carefully and sprinkling entire contents into small amount of soft food. Instruct patient to swallow mixture immediately without chewing sprinkles.

Don't stop therapy suddenly. Dosage must be tapered.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, malaise, poor memory and concentration, nervousness, psychomotor slowing, speech and language problems, aggressive reaction, agitation, anxiety, confusion, depression, irritability, ataxia, paresthesia, hyperesthesia, tremor, suicide attempt, increased seizures

EENT: abnormal vision, diplopia, nystagmus, acute myopia, secondary angle-closure glaucoma, decreased hearing, rhinitis, sinusitis, epistaxis, pharyngitis

GI: nausea, constipation, abdominal pain, dry mouth, gastroenteritis, increased salivation (in children), anorexia

GU: renal calculi, urinary incontinence, leukorrhea

Hematologic: purpura, leukopenia, thrombocytopenia

Metabolic: hypocalcemia, hyperchloremia, hypernatremia, hyponatremia, hypophosphatemia, hyperammonemia, metabolic acidosis, hypoglycemia

Musculoskeletal: myalgia, back pain, leg pain

Respiratory: pneumonia

Skin: rash, skin disorder, alopecia, dermatitis, hypertrichosis, eczema, seborrhea, skin discoloration

Other: altered taste, weight loss, thirst, fever, flulike symptoms, hot flashes, infection, edema, hypothermia (when used in conjunction with valproic acid), hyperthermia, decreased sweating, allergic reaction

Interactions

Drug-drug. Carbamazepine: decreased topiramate blood level and effects

Carbonic anhydrase inhibitors (such as acetazolamide): increased risk of renal calculi

CNS depressants: increased risk of CNS depression and other adverse cognitive or neuropsychiatric reactions

Hormonal contraceptives: decreased contraceptive efficacy

Phenytoin: increased phenytoin blood level and effects, decreased topiramate blood level and effects

Valproic acid: decreased effects of both drugs

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, ammonia, aspartate aminotransferase, creatinine: increased levels

Calcium, cholesterol, glucose, phosphate: decreased levels

Sodium: increased or decreased level

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

Monitor seizure type and pattern. Report new seizure types or worsening seizure pattern.

• Assess neurologic status closely. Report significant adverse reactions.

Watch for and immediately report signs and symptoms of depression or suicidal ideation.

• Monitor fluid intake and output. Report indications of urinary tract infection, urinary incontinence, or renal calculi.

Monitor vision. If patient becomes acutely nearsighted with symptoms of angle-closure glaucoma (cloudy vision, eye pain), stop drug and contact prescriber right away.

Monitor patient for hyperammonemia and encephalopathy with or without concomitant valproic acid use; measure ammonia level if encephalopathic symptoms occur.

Monitor patient for metabolic acidosis; obtain baseline and periodic measurements of serum bicarbonate. Consider dosage reduction or drug discontinuation if clinically appropriate.

Patient teaching

• Tell patient he may take with or without food.

• Caution patient not to crush or break tablets.

• If patient takes capsules, tell him he may open them, sprinkle contents onto small amount of soft food, and consume immediately. Tell him not to store this mixture.

Caution patient not to stop drug suddenly. Dosage must be tapered.

• Instruct patient to drink plenty of fluids to reduce risk of kidney stones.

Tell patient drug may cause new seizure types or worsen seizure pattern. Instruct him to report these developments immediately.

Instruct patient (and significant other as appropriate) to immediately report signs or symptoms of depression or suicidal thoughts.

Instruct patient how to recognize and immediately report signs and symptoms of hyperammonemia and metabolic acidosis.

Advise patient to immediately report vision changes, especially nearsightedness, cloudy vision, or eye pain.

• Caution patient not to drive or perform other hazardous activities.

• Tell patient not to drink alcohol during drug therapy.

• Advise female patient to notify prescriber of suspected pregnancy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

topiramate

(tō-pîr′ə-māt′)
n.
An anticonvulsant drug used in the treatment of epilepsy and the prevention of migraine headaches.

topiramate

A drug that reduced the sensitivity to firing of nerve cells and is used to prevent epileptic seizures. A brand name is Topamax.
References in periodicals archive ?
Neither firm disclosed the financial terms of the settlement, however the pact detailed that Supernus would grant a licence that allowed the marketing of Zydus' generic version of Trokendi XR (topiramate) extended-release capsules.
'Prescription growth for Trokendi XR improved by 4.8% in the second quarter of 2019 as compared to the first quarter of 2019, but not to the degree we had expected,' said Jack Khattar, President and CEO of Supernus.
Pharmaceutical company Supernus Pharmaceuticals Inc (NasdaqGM:SUPN) reported on Wednesday the receipt of an eighth patent from the US Patent and Trademark Office (USPTO) covering its novel once-daily extended-release topiramate product Trokendi XR.
Pharmaceutical company Supernus Pharmaceuticals Inc (NasdaqCM:SUPN) reported on Monday the receipt of the seventh patent from the United States Patent and Trademark Office (USPTO) covering its novel once-daily extended-release antiepileptic topiramate product, Trokendi XR.
United States-based Supernus Pharmaceuticals has received tentative approval from the US Food and Drug Administration for its Supplemental New Drug Application requesting a label expansion for Trokendi XR, novel once-daily extended release formulation of topiramate for the treatment of epilepsy, to include prophylaxis of migraine headache in adults, it was reported yesterday.
M2 EQUITYBITES-January 31, 2017-Supernus expands protection coverage for Trokendi XR via seventh US patent
M2 PHARMA-August 22, 2016-Supernus passes US FDA tentative approval for expanded label of Trokendi XR to include migraine prophylaxis in adults
M2 EQUITYBITES-August 23, 2016-Supernus Pharmaceuticals receives tentative US FDA approval for Trokendi XR Supplemental New Drug Application
M2 PHARMA-October 23, 2015-Supernus's NDA for Trokendi XR Label accepted for US FDA's review
M2 EQUITYBITES-August 22, 2016-Supernus passes US FDA tentative approval for expanded label of Trokendi XR to include migraine prophylaxis in adults
Pharmaceutical company Supernus Pharmaceuticals (NasdaqGM:SUPN) revealed on Thursday the receipt of the sixth patent from the US Patent and Trademark Office (USPTO) covering its novel once-daily extended-release topiramate product, Trokendi XR, for the treatment of epilepsy.
It has two marketed products for epilepsy, Oxtellar XR (extended-release oxcarbazepine) and Trokendi XR (extended-release topiramate).