Trokendi XR Flashcards by Jonathan Bruni

Which of the following are reason for nonadherence with AEDs? Select all that apply.

The patient forgets to take the medicine
The patient is not experiencing symptoms
The patient is experiencing side effects from the medication
The patient missed doses previously and had no negative consequences

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The ability to continue taking medicine regularly for long periods of time is called ______.

Adherence
Endurance
Persistance
Compliance

Persistance

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Which of the following are potential consequences of nonadherence to an AED regimen? Select all that apply.

Hospitalization
Occurrence of seizures
Potential physical injury
Increase in seizure frequency

Occurrence of seizures
Potential physical injury
Increase in seizure frequency

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Topamax is an important drug for the treatment of _____ and _____ seizures. Select all that apply.

Partial onset
Secondarily generalized
Secondarily generalized tonic
Primary generalized tonic-clonic

Partial onset

Primary generalized tonic-clonic

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_____ is a multiparticulate (beads) extended-release technology that controls the delivery of medication.

Solutrol
Emutrol
Mircotrol
EnSoTrol

Mircotrol

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Microtrol is used in products physicians know and trust, such as _____ and _______. Select all that apply.

Trileptal
Carbatrol
Adderall XR
Tegretol XR

Carbatrol

Adderall XR

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Each Trokendi XR dosage strength contains a customized ratio of _____ select beads that enable controlled delivery of medication.

One
Two
Three
Four

Three

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Trokendi XR combines the proven control of _____ with the proven benefits of ______. Select all that apply.

Topamax
Solutrol
Carbatrol
Microtrol

Topamax

Microtrol

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The rate and extent of absorption of a drug into the bloodstream is used to measure _____.

Biosimilarity
Bioavailability
Bioequivalence
Biofunctionality

Bioavailability

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Two similar drugs are said to be ______ if the show comparable bioavailability.

Biosimilar
Biogeneric
Bioequivalent
Biocomparable

Bioequivalent

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_____ studies are designed to evaluate a drug in health volunteers.

Phase I
Phase II
Phase III
Phase IV

Phase I

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The Phase I, single-center, multiple-dose, randomized study had a _____ design.

Dual Arm
Crossover
Single Arm
Double-over

Crossover

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______ studies are the first controlled clinical trials of the drug to assess the safety and efficacy in a small number of patients in the target population.

Phase I
Phase II
Phase III
Phase IV

Phase II

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The key findings of the bioavailability study is that Trokendi XR is _____ Topamax.

Bioequivalent to
Not as effective as
Faster acting than
Dosed more frequently than

Bioequivalent to

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The goal of the conversion study was to assess the effects on the patient when _____ from Topamax to Trokendi XR.

Turning
Toggling
Switching
Displacing

Switching

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The subjects in the Phase I bioavailability study were _____.

Cured patients
Healthy adults
Newly Diagnosed
Patients with epilepsy

Healthy adults

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In the conversion study, at steady state Trokendi XR once daily produced similar blood levels with a ______ rise to C-max Compared with Topamax.

Faster
Slower
Similar
Equivalent

Slower

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In the conversion study, at steady state Trokendi XR once daily produced similar blood levels and _____ peak-to-trough fluctuation compared with Topamax.

More
Wider
Larger
Smaller

Smaller

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In the conversion study, _____ of patients reported that once-daily Trokendi XR had a positive impact on their treatment adherence.

91.9%

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The most widely used system to classify epileptic seizures is from the _____.

Epilepsy Association
International Epilepsy Society
Epilepsy Foundation of America
International League Against Epilepsy

International League Against Epilepsy

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The classification system divides seizures into two main groups of _____ seizures.

Simple and complex
Simple and tonic-clonic
Partial and primary generalized
Partial and secondary generalized

Partial and primary generalized

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The Seizure classification system based the type of seizure on _____.

Symptom cluster
Duration of effect
Level of consciousness
Area of Origin in the brain

Area of Origin in the brain

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Partial seizures account for about ______ if all new-onset cases of epilepsy in adults.

30%
60%
70%
90%

90%

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Partial seizures account for about ____ of all seizure types in adults.

30%
60%
70%
90%

60%

Generalized seizures account for about _____ of all seizures types in adults. 30% 60% 70% 90%

30%

A key feature of partial (focal) seizures is that their point of origin is in ______ of the brain. One hemisphere The parietal lobe Both hemispheres The sensory-motor cortex

One hemisphere

A key feature of generalized seizures is that their point of origin is in ______ of the brain. One hemisphere The parietal lobe Both hemispheres The sensory-motor cortex

Both hemispheres

Partial seizures are classified as ______. Select all that apply Simple Complex Generalized Secondarily generalized

Simple Complex Secondarily generalized

Partial seizures that become secondarily generalized are considered to be ______ primary generalized seizures. Similar to Different from An adaptation of In the same category as

Different from

The key difference between simple partial seizures and complex partial seizures is the patient's level of _____ during the seizure. Consciousness Symptom intensity Physical movement Sensory manifestation

Consciousness

Which type of simple partial seizures is often used in clinical trials? Motor Psychic Sensory Autonomic

Motor

The term "generalized" to describe generalized seizures indicates that the involved neural network is ______. Deep in the amygdala Bilaterally distributed Deep in the brain stem Unilaterally distributed

Bilaterally distributed

Which type of generalized seizure does the following describe: "Previously known as "grand mal"; symptoms are stiffening of the limbs followed by rhythmic jerking of limbs. Atonic Tonic Absence Tonic-clonic

Tonic-clonic

Which type of generalized seizure is also called a "drop attack"? Atonic Tonic Absence Tonic-clonic

Atonic

Which of the following are features of Lennox-Gastaut Syndrome? Select all that apply. Abnormal EEG Onset in adulthood Cognitive impairment Multiple seizure types

Abnormal EEG Cognitive impairment Multiple seizure types

A main difference between the current and proposed classification system is that the new classification simplifies the descriptions of ______. Automatisms Focal Seizures Generalized seizures Lennox-Gastaut Syndrome

Focal Seizures

The safety and efficacy data in the Trokendi XR PI is based primarily on that form the ______. Topamax PI Pharmacokinetic studies Trokendi XR clinical studies Clinical experience with topiramate

Topamax PI

Which types of studies did Supernus conduct on Trokendi XR? Select all that apply. Phase I Phase II Phase III Phase IV

Phase I | Phase II

In the research on Trokendi XR, Supernus demonstrated that Trokendi XR is _______ Topamax. Bioequivalent to More effective than Better tolerated than Less bioavailable than

Bioequivalent to

Fo which types of seizures is Trokendi XR indicated? Select all that apply. Partial onset Generalized absence Generalized tonic-clonic Lennox-Gastaut Syndrome

Partial onset Generalized tonic-clonic Lennox-Gastaut Syndrome

For which patient population is Trokendi XR indicated? Select all that apply. Monotherapy for patients 6+ years Monotherapy for patients 10+ years Adjunctive therapy for patients 6+ years Adjunctive therapy for patients 10+ years

Monotherapy for patients 10+ years | Adjunctive therapy for patients 6+ years

Trokendi XR is contraindicated in which of the following types of patients? Select all that apply. Taking concomitant metformin With alcohol use at any time during Trokendi XR use With metabolic acidosis who are taking concomitant metformin With alcohol use within 6 hours prior and 6 hours after Trokendi XR use

With metabolic acidosis who are taking concomitant metformin | With alcohol use within 6 hours prior and 6 hours after Trokendi XR use

Which of the following are Trokendi XR dosage strengths? Select all that apply. 25 mg 50 mg 100 mg 200 mg

25 mg 50 mg 100 mg 200 mg

Switching from Topamax to Trokendi XR is ______. mg to mg 1 mg to 1.5 mg 1 mg to 2 mg 1 mg to 3 mg

mg to mg

Which of the following are warnings and precautions in the Trokendi XR PI? Select all that apply. Dizziness Paresthesia Oligohydrosis Metabolic acidosis

Oligohydrosis | Metabolic acidosis

Which of the following are among the most common adverse reactions in the controlled monotherapy trial in adults taking topiramate? Select all that apply. Anorexia Somnolence Weight increase Metabolic acidosis

Anorexia | Somnolence

Approximately ______ of the 159 adult patients in the 400 mg/day monotherapy group discontinued therapy due to adverse reactions. 12% 15% 21% 26%

21%

Which of the following are among the most common adverse reactions in the controlled adjunctive-therapy clinical trial in pediatric patients taking topiramate? Diarrhea Paresthesia Mood problems Weight increas

Diarrhea Paresthesia Mood problems

Approximately _______ of the 57 pediatric patients in the 400 mg/day adjunctive therapy group discontinued therapy due to adverse reactions. 12% 15% 21% 26%

12%

With which of the following drugs does topiramate interact? Select all that apply. Lithium Alcohol CNS depressants Oral Contraceptives

Lithium Alcohol CNS depressants Oral Contraceptives

In which pregnancy category is topiramate? A B C D

Efficacy and safety of topiramate as initial monotherapy was established in a multicenter, randomized, double-blind trial in approximately ______ patients. 285 470 1,075 1,550

470

How many adjunctive therapy trials were conducted on topiramate? 1 3 5 9

How many topiramate trials were conducted on patients with Lennox-Gastaut Syndrome? 1 2 3 4

Which of the following are main differences between Trokendi XR and Topamax? Select all that apply. Patient age Seizure types Delivery Systems Pharmacokinetics

Patient age Delivery Systems Pharmacokinetics

The minimum age of the patient population for monotherapy with Trokendi XR is ______. 4 years of age 6 years of age 8 years of age 10 years of age

10 years of age

Which warning is in the Trokendi XR but is not in the Topamax PI? Kidney Stones Suicidal ideation Interaction with Alcohol Withdrawal of other AEDs

Interaction with Alcohol

Compared with the immediate-release formulation, Trokendi XR produced smoother and more consistent ______. Metabolism Bioavailability Bioequivalence Plasma concentrations

Plasma concentrations