Trokendi XR Flashcards

1
Q

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

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

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

Adherence
Endurance
Persistance
Compliance

A

Persistance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

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

A

Occurrence of seizures
Potential physical injury
Increase in seizure frequency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

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

A

Partial onset

Primary generalized tonic-clonic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

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

Solutrol
Emutrol
Mircotrol
EnSoTrol

A

Mircotrol

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

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

Trileptal
Carbatrol
Adderall XR
Tegretol XR

A

Carbatrol

Adderall XR

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

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

One
Two
Three
Four

A

Three

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

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

Topamax
Solutrol
Carbatrol
Microtrol

A

Topamax

Microtrol

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

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

Biosimilarity
Bioavailability
Bioequivalence
Biofunctionality

A

Bioavailability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

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

Biosimilar
Biogeneric
Bioequivalent
Biocomparable

A

Bioequivalent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

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

Phase I
Phase II
Phase III
Phase IV

A

Phase I

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

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

Dual Arm
Crossover
Single Arm
Double-over

A

Crossover

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

______ 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

A

Phase II

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

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

A

Bioequivalent to

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

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

Turning
Toggling
Switching
Displacing

A

Switching

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

The subjects in the Phase I bioavailability study were _____.

Cured patients
Healthy adults
Newly Diagnosed
Patients with epilepsy

A

Healthy adults

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

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

A

Slower

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

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

A

Smaller

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

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

  1. 6%
  2. 7%
  3. 8%
  4. 9%
A

91.9%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

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

A

International League Against Epilepsy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

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

A

Partial and primary generalized

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

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

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

A

Area of Origin in the brain

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

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

30%
60%
70%
90%

A

90%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

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

30%
60%
70%
90%

A

60%

25
Q

Generalized seizures account for about _____ of all seizures types in adults.

30%
60%
70%
90%

A

30%

26
Q

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

A

One hemisphere

27
Q

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

A

Both hemispheres

28
Q

Partial seizures are classified as ______. Select all that apply

Simple
Complex
Generalized
Secondarily generalized

A

Simple
Complex
Secondarily generalized

29
Q

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

A

Different from

30
Q

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

A

Consciousness

31
Q

Which type of simple partial seizures is often used in clinical trials?

Motor
Psychic
Sensory
Autonomic

A

Motor

32
Q

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

A

Bilaterally distributed

33
Q

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

A

Tonic-clonic

34
Q

Which type of generalized seizure is also called a “drop attack”?

Atonic
Tonic
Absence
Tonic-clonic

A

Atonic

35
Q

Which of the following are features of Lennox-Gastaut Syndrome? Select all that apply.

Abnormal EEG
Onset in adulthood
Cognitive impairment
Multiple seizure types

A

Abnormal EEG
Cognitive impairment
Multiple seizure types

36
Q

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

A

Focal Seizures

37
Q

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

A

Topamax PI

38
Q

Which types of studies did Supernus conduct on Trokendi XR? Select all that apply.

Phase I
Phase II
Phase III
Phase IV

A

Phase I

Phase II

39
Q

In the research on Trokendi XR, Supernus demonstrated that Trokendi XR is _______ Topamax.

Bioequivalent to
More effective than
Better tolerated than
Less bioavailable than

A

Bioequivalent to

40
Q

Fo which types of seizures is Trokendi XR indicated? Select all that apply.

Partial onset
Generalized absence
Generalized tonic-clonic
Lennox-Gastaut Syndrome

A

Partial onset
Generalized tonic-clonic
Lennox-Gastaut Syndrome

41
Q

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

A

Monotherapy for patients 10+ years

Adjunctive therapy for patients 6+ years

42
Q

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

A

With metabolic acidosis who are taking concomitant metformin

With alcohol use within 6 hours prior and 6 hours after Trokendi XR use

43
Q

Which of the following are Trokendi XR dosage strengths? Select all that apply.

25 mg
50 mg
100 mg
200 mg

A

25 mg
50 mg
100 mg
200 mg

44
Q

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

A

mg to mg

45
Q

Which of the following are warnings and precautions in the Trokendi XR PI? Select all that apply.

Dizziness
Paresthesia
Oligohydrosis
Metabolic acidosis

A

Oligohydrosis

Metabolic acidosis

46
Q

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

A

Anorexia

Somnolence

47
Q

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

12%
15%
21%
26%

A

21%

48
Q

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

A

Diarrhea
Paresthesia
Mood problems

49
Q

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

12%
15%
21%
26%

A

12%

50
Q

With which of the following drugs does topiramate interact? Select all that apply.

Lithium
Alcohol
CNS depressants
Oral Contraceptives

A

Lithium
Alcohol
CNS depressants
Oral Contraceptives

51
Q

In which pregnancy category is topiramate?

A
B
C
D

A

D

52
Q

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

A

470

53
Q

How many adjunctive therapy trials were conducted on topiramate?

1
3
5
9

A

9

54
Q

How many topiramate trials were conducted on patients with Lennox-Gastaut Syndrome?

1
2
3
4

A

1

55
Q

Which of the following are main differences between Trokendi XR and Topamax? Select all that apply.

Patient age
Seizure types
Delivery Systems
Pharmacokinetics

A

Patient age
Delivery Systems
Pharmacokinetics

56
Q

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

A

10 years of age

57
Q

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

A

Interaction with Alcohol

58
Q

Compared with the immediate-release formulation, Trokendi XR produced smoother and more consistent ______.

Metabolism
Bioavailability
Bioequivalence
Plasma concentrations

A

Plasma concentrations