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D4 Pharm > L1 - General Principles > Flashcards

L1 - General Principles Flashcards

1
Q

What type of participants are involved in phase 1 clinical trials?

A

healthy paid “volunteers”

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2
Q

What type of participants are involved in phases 2 & 3 clinical trials?

A

patients w/ a clinical condition that could benefit from drug tx

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3
Q

What is phase 4 of the clinical trials?

A

post-marketing surveillance, drug safety, patterns of use and new indications

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4
Q

When does the original patent for a drug expire?

A

20 years after being granted

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5
Q

What are schedule I drugs?

A

Schedule I

  • illegal/restricted to research; high abuse potential
  • hallucinogens, heroin, marijuana
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6
Q

What are schedule II drugs?

A

Schedule II

  • requires Rx; high abuse potential; no refills or verbal orders
  • amphetamines, barbituates, opiates (single, combo)
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7
Q

What are schedule III drugs?

A

Schedule III

  • requires Rx; moderate abuse potential; max 5 refills/6mos; verbal orders allowed
  • anabolic steroids, dronabinol, ketamine, opiates (some combos)
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8
Q

What are schedule IV drugs?

A

Schedule IV

  • requires Rx; low/moderate abuse potential; max 5 refills/6mos; verbal orders allowed
  • appetite suppressants, benzodiazepines, sedative/hyponotics
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9
Q

What are schedule V drugs?

A

Schedule V

  • requires Rx or OTC; limited abuse potential; max refills/6mo; verbal orders allowed
  • opiate or opiate-derivative antidiarrheals and antitussives
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10
Q

When an opioid is prescribed for injury pain, and the prescription is presented to a pharmacist __ weeks after issuance, the drug may no longer be indicated.

A

When an opioid is prescribed for injury pain, and the prescription is presented to a pharmacist 2 weeks after issuance, the drug may no longer be indicated.

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11
Q

The CSA prohibits filling or refilling orders for substances in schedules III & IV > ___months after their date of issuance.

A

The CSA prohibits filling or refilling orders for substances in schedules III & IV > _6_months after their date of issuance.

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12
Q

T/F: Schedule II drugs may be refilled.

A

FALSE. No prescription order for a schedule II drug may be refilled under any circumstances.

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13
Q

The time it takes an oral drug to produce a biological effect is dependent upon…?

A

the rate of drug resorption

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14
Q

Drugs pass across biological membranes by active or passive processes. ONLY _______ molecules can pass readily.

A

Drugs pass across biological membranes by active or passive processes. ONLY UNCHARGED molecules can pass readily.

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15
Q

The lower the pH relative to pKa, the _____ will be the fraction of drug in protonated form.

A

The lower the pH relative to pKa, the __greater__ will be the fraction of drug in protonated form.

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16
Q

T/F: Weak acids are mostly uncharged in an acidic environment. Weak bases are mostly uncharged in a basic environment.

A

BOTH TRUE

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17
Q

What is drug bioavailability?

A

Percentage of a drug dose that is distributed to the systemic circulation following an oral drug dose

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18
Q

What is volume of distribution?

A

Volume of distribution defines the drug dose required to achieve a given plasma drug concentration. Distribution volumes give a rough indication of where the drug goes in the body.

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19
Q

T/F: If a drug has high Vd, it will rapidly dispersed away from the plasma to plentiful tissue sites.

A

TRUE

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20
Q

T/F: If a drug has a broad therapeutic index, a small increase in free plasma drug concentration may be sufficient to product toxicity.

A

FALSE. If a drug has a NARROW therapeutic index, a small increase in free plasma drug concentration may be sufficient to product toxicity.

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21
Q

What is pharmocokinetics?

A

temporal effects of the body on a drug

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22
Q

What is pharmodynamics?

A

describes the effects (consequences) of the drug upon the functioning of a receptor

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23
Q

What is clearance?

A

Clearance (mL/min) = volume of drug-containing blood that is cleansed of drug per unit time.

24
Q

For most dental drugs, what type of elimination predominates? What about for inhalational anesthetics?

A

renal & hepatic; inhalational anesthetics eliminated via simple exhalation

25
First order processes are dependent on...?
concentration. First order elimination is directly proportional to the drug concentration (i.e. constant fraction eliminated per unit time.)
26
What are some examples of drugs that do not obey the normal pharmocokinetic laws w/ respect to drug half-life?
Alcohol, aspirin (high dose), & phenytoin (anticonvulsant). The enzymes tasked w/ their elimination from the body are fully saturated at normal therapeutic concentrations. These drugs have a constant (maximal) amount of drug removed in unit time.
27
T/F: Plasma drug concentration (Cp) decreases exponentially with time.
TRUE.
28
T/F: Zero order elimination is dependent on plasma concentration.
FALSE. Zero order elimination is constant, regardless of plasma concentration (Cp).
29
What is phase I metabolism?
Phase I Metabolism - introduces polar functional group & makes drug more reactive; most frequently involves activity of cytochrome P450 system.
30
What are the most likely dental drugs that are capable of producing CYP450 enzyme inhibition are...?
antibiotics
31
How are macrolide antibiotics involved w/ CYP450 enzyme inhibition?
Macrolide antibiotics, like erythromycin & clarithromycin, inhibit CYP3A4.
32
How is the "azole" antifungal agent, itraconazole, involved w/ CYP450 enzyme inhibition?
It inhibits CYP3A4! If it is used to tx oral candidiasis, the dentist should be aware of the potential for drug-drug interaction w/ any 3A4 substrate.
33
What happens when you combine ciprofloxacin and theophylline?
cardiac dysrhythmias & convulsions
34
What happens when you combine metronidazole with alcohol?
"disulfarum-like" reaction: palpitations, headache, N/V
35
What happens when you combine metronidazole with warfarin?
increase potential for hemorrhage
36
What happens when you combine metronidazole with phenytoin?
drowsiness, confusion, ataxia
37
What is phase 2 metabolism?
Phase 2 metabolism - aka conjugation; glucaronic acid, sulfuric acid, acetic acid, or amino acid is added to polar group --> more polar & water soluble product to be eliminated by kidneys
38
Steady state drug level is reached only after how many half lives?
4-5 half lives
39
For toxic drugs, the first blood sample should be taken after how many half-lives?
2 half lives (assuming no loading dose has been given)
40
T/F: Safer drugs have lower TI (therapeutic index) values.
FALSE. Safer drugs have higher TI values. Drugs w/ low TI values include digoxin, lithium, theophylline, & warfarin.
41
What effect does a competitive antagonist have on the curve?
Shifts curve to the right (no change in efficacy); can be overcome by increasing concentration of the agonist.
42
What effect does a non-competitive antagonist have on the curve?
Shifts the curve down (decreases efficacy)
43
What effect does a partial agonist (alone) have on the curve?
Acts at the same site as a full agonist but with lower maximal effect (decrease in efficacy)
44
What does scientific evidence say about GREEN TEA?
Improves mental alertness (caffeine content) - Vit K may antagonize anticoagulants - induces hepatotoxicity w/ potential to cause interactions w/ concurrent drugs
45
What does scientific evidence say about GARLIC?
reduce BP (by inhibiting platelet aggregation) & hypercholesterolemia - potentiation of effects of anti-platelet drugs, like NSAIDs & warfarin
46
What does scientific evidence say about ECHINACEA?
upper respiratory tract infections - can cause poor wound healing & opportunistic infections
47
What does scientific evidence say about GINGER?
relief of nausea & vomiting - inhibits platelet aggregations, so may have potentiation of effects of anti-platelet drugs, like NSAIDs & warfarin
48
What does scientific evidence say about GINGKO BILOBA?
improve memory and claudication (pain and/or cramping in the lower leg due to inadequate blood flow to the muscles.) - inhibits platelet aggregations, so may have potentiation of effects of anti-platelet drugs, like NSAIDs & warfarin
49
What does scientific evidence say about GINSENG?
lower blood glucose & improve immune function - hypoglycemia is possible - inhibits platelet aggregations, so may have potentiation of effects of anti-platelet drugs, like NSAIDs & warfarin
50
What does scientific evidence say about FLAXSEED OIL?
laxative, may reduce cholesterol - may reduce bioavailability of concurrent meds
51
What does scientific evidence say about ST JOHN'S WORT?
no compelling evidence of activity against depression, but this is why ppl take it - induction of P450 enzymes, so may have reduced activity of drugs, like BZDs, warfarin, steroids, HIB protease inhibitors, & heart drugs (Ca chnl blockers & digoxin)
52
What does scientific evidence say about SAW PALMETTO?
does not reduce size of enlarged prostrate, but this is why ppl take it
53
What does scientific evidence say about KAVA?
may be effective for insomnia, but is linked to severe hepatotoxicity - potentiation of CNS-acting drugs like anesthetics that produce sedation
54
What does scientific evidence say about RED YEAST RICE?
no demonstrable effect, but ppl take it to reduce cholesterol - additive effect w/ other drugs producing muscle dmg
55
VIT C can cause what complications?
in high doses, Vit C can cause hemolytic anemia >> acute renal failure
56
VIT E can cause what complications?
in excessive doses, can cause bleeding in pts w/ vit K deficiency, immunological and sexual dysfunction
57
VIT B6 can cause what complications?
in high doese, periopheral neuropathy, perioral numbness, & "stocking glove" sensory loss

D4 Pharm (1 decks)

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