EXAM QUESTIONS AND ANSWERS VERIFIED
100% CORRECT
What does phase 1 of a nonclinical study entail and what is the goal? - ANSWER -
Initial introduction of the new drug to humans, usually in healthy volunteers.
- Goal of obtaining pharmacokinetic and pharmacologic effects of the drug in order
to design a valid phase 2 study.
What does phase 2 of a nonclinical study entail and what is the goal? - ANSWER
-Initial controlled efficacy studies in patients with the disease or condition.
- Determine optimal doses of the drug, common short term side effects and risks
What does phase 3 of a nonclinical study entail and what is the goal? - ANSWER
-Evaluate the overall risk-to-benefit relationship of the drug and to provide an
adequate basis for product labeling.
- Generally has broader inclusion and exclusion criteria than phase 2 for a more
accurately representative population of people taking the medication
What does phase 4 of a nonclinical study entail and what is the goal? - ANSWER
-- Drug has been approved, post marketing activities
- Elucidate specific issues about a drug, which are considered important for
optimal use but not essential to know before drug approval
- Studies for approval of additional indications
- Surveillance for adverse events
Amisulpiride, fluphenazine, haloperidol, perphenazine, pimozide , and sulpiride
are all classified by this mechanism of action. - ANSWER -Dopamine receptor
antagonists.
"Dopamine blockers"
- Antipsychotics
- Reduce positive episodes of psychotic episodes
Chlorpromazine, loxapine, thioridazine are all classified by this mechanism of
action. - ANSWER -Dopamine and serotonin receptor antagonists.
Akathisia is a side effect of which medication class? - ANSWER -Dopamine D2
blockers
,- Amisulpiride, fluphenazine, haloperidol, perphenazine, pimozide , and sulpiride
- Dopamine and serotonin blockers: Chlorpromazine, loxapine, thioridazine
What is the most common acute manifestation of EPS? - ANSWER -Akathisia
- inability to sit still, restlessness
- Onset after 5 days
- Treat with anticholinergics or can use propranolol
What is the most effective treatment of EPS? - ANSWER -Anticholinergic agents
- Can also use amantadine but is not a first line agent
- Should try to reduce side effects by lowering dose of antipsychotic FIRST
What are the main clinical features of Neuroleptic Malignant Syndrome?
(NMS results from dopamine blockers) - ANSWER -- Hyperthermia
- Severe muscular rigidity (PRESENTS AS THIS)
- Autonomic instability (hyperthermia, tachycardia, high BP, tachypnea,
diaphoresis)
- Changing levels of consciousness
*Often associated with elevations in creatinine phosphokinase (CPK) and aldolase
What medication is effective in treating neuroleptic malignant syndrome and what
is the dosing? - ANSWER -Dantrolene (Dantrium)
IV 0.8-2.5 mg/kg every 6 hours
- Max dailt dose 10mg/kg
- Convert to oral when symptoms subside
- Treatment normally lasts 5-10 days unless a long acting injectable medication
was the cause
What is the supportive treatment for neuroleptic malignant syndrome?
(Aside from Dantrolene) - ANSWER -- Discontinue antipsychotics
- Correct fluid and electrolyte imbalances
- Treat fever, hyper and hypotension
- Bromocriptine or Amantadine can be added
Can antipsychotics be resumed after neuroleptic malignant syndrome resolves? -
ANSWER -Yes
- Preference for low potency medications
, What is tardive dyskinesia? - ANSWER -A movement disorder that can follow
chronic treatment with antipsychotic medications.
- Characterized by mouth and tongue movements, facial grimacing, irregular limb
movements, slow writhing trunk movements
What is the likely underlying cause of Tardive Dyskinesia? - ANSWER -
Increased sensitivity of dopamine receptors in the basal ganglia.
Should dopamine blockers be increased to reduce tardive dyskinesia sympptoms?
- ANSWER -Only if the movements are severe and incapacitating.
- The disorder is most often not progressive and can improve in most patients.
- Can be switched to dopamine-serotonin antagonists such as clozapine
What are withdrawal emergent dyskinesias? - ANSWER -If patients have their
dosages of antipsychotic medication either decreased or discontinued, abnormal
movements may worsen temporarily or appear for the first time and then diminish.
Which patient populations are at highest risk for tardive dyskinesia? - ANSWER -
- Older women
- Patients with affective disorders
- 10-20% incidence in treatment >1 year
How often should patients receiving dopamine blockers be evaluated for tardive
dyskinesia? - ANSWER -Every 6 months
- Can evaluate severity using the Abnormal Involuntary Movements Scale (AIMS)
Why does clozapine (Clozaril, DSA antipsychotic) have a lower risk of tardive
dyskinesia? - ANSWER -It does not result in the increased sensitivity of striatal
D2 receptors, which is associated with typical neuroleptics and has been theorized
to result in TD.
What is the mechanism of action of the two medications approved for treatment of
Tardive Dyskinesia? - ANSWER -VMAT2 inhibitors
- Can be given in conjunction with antipsychotics
What medication is contraindicaated in the treatment of antipsychotic induced
hypotension? - ANSWER -Epinephrine
- due to beta stimulation it worsens hypotension