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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
Q

First order processes are dependent on…?

A

concentration. First order elimination is directly proportional to the drug concentration (i.e. constant fraction eliminated per unit time.)

26
Q

What are some examples of drugs that do not obey the normal pharmocokinetic laws w/ respect to drug half-life?

A

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
Q

T/F: Plasma drug concentration (Cp) decreases exponentially with time.

A

TRUE.

28
Q

T/F: Zero order elimination is dependent on plasma concentration.

A

FALSE. Zero order elimination is constant, regardless of plasma concentration (Cp).

29
Q

What is phase I metabolism?

A

Phase I Metabolism - introduces polar functional group & makes drug more reactive; most frequently involves activity of cytochrome P450 system.

30
Q

What are the most likely dental drugs that are capable of producing CYP450 enzyme inhibition are…?

A

antibiotics

31
Q

How are macrolide antibiotics involved w/ CYP450 enzyme inhibition?

A

Macrolide antibiotics, like erythromycin & clarithromycin, inhibit CYP3A4.

32
Q

How is the “azole” antifungal agent, itraconazole, involved w/ CYP450 enzyme inhibition?

A

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
Q

What happens when you combine ciprofloxacin and theophylline?

A

cardiac dysrhythmias & convulsions

34
Q

What happens when you combine metronidazole with alcohol?

A

“disulfarum-like” reaction: palpitations, headache, N/V

35
Q

What happens when you combine metronidazole with warfarin?

A

increase potential for hemorrhage

36
Q

What happens when you combine metronidazole with phenytoin?

A

drowsiness, confusion, ataxia

37
Q

What is phase 2 metabolism?

A

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
Q

Steady state drug level is reached only after how many half lives?

A

4-5 half lives

39
Q

For toxic drugs, the first blood sample should be taken after how many half-lives?

A

2 half lives (assuming no loading dose has been given)

40
Q

T/F: Safer drugs have lower TI (therapeutic index) values.

A

FALSE. Safer drugs have higher TI values. Drugs w/ low TI values include digoxin, lithium, theophylline, & warfarin.

41
Q

What effect does a competitive antagonist have on the curve?

A

Shifts curve to the right (no change in efficacy); can be overcome by increasing concentration of the agonist.

42
Q

What effect does a non-competitive antagonist have on the curve?

A

Shifts the curve down (decreases efficacy)

43
Q

What effect does a partial agonist (alone) have on the curve?

A

Acts at the same site as a full agonist but with lower maximal effect (decrease in efficacy)

44
Q

What does scientific evidence say about GREEN TEA?

A

Improves mental alertness (caffeine content)

  • Vit K may antagonize anticoagulants
  • induces hepatotoxicity w/ potential to cause interactions w/ concurrent drugs
45
Q

What does scientific evidence say about GARLIC?

A

reduce BP (by inhibiting platelet aggregation) & hypercholesterolemia

  • potentiation of effects of anti-platelet drugs, like NSAIDs & warfarin
46
Q

What does scientific evidence say about ECHINACEA?

A

upper respiratory tract infections

  • can cause poor wound healing & opportunistic infections
47
Q

What does scientific evidence say about GINGER?

A

relief of nausea & vomiting

  • inhibits platelet aggregations, so may have potentiation of effects of anti-platelet drugs, like NSAIDs & warfarin
48
Q

What does scientific evidence say about GINGKO BILOBA?

A

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
Q

What does scientific evidence say about GINSENG?

A

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
Q

What does scientific evidence say about FLAXSEED OIL?

A

laxative, may reduce cholesterol

  • may reduce bioavailability of concurrent meds
51
Q

What does scientific evidence say about ST JOHN’S WORT?

A

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
Q

What does scientific evidence say about SAW PALMETTO?

A

does not reduce size of enlarged prostrate, but this is why ppl take it

53
Q

What does scientific evidence say about KAVA?

A

may be effective for insomnia, but is linked to severe hepatotoxicity

  • potentiation of CNS-acting drugs like anesthetics that produce sedation
54
Q

What does scientific evidence say about RED YEAST RICE?

A

no demonstrable effect, but ppl take it to reduce cholesterol

  • additive effect w/ other drugs producing muscle dmg
55
Q

VIT C can cause what complications?

A

in high doses, Vit C can cause hemolytic anemia&raquo_space; acute renal failure

56
Q

VIT E can cause what complications?

A

in excessive doses, can cause bleeding in pts w/ vit K deficiency, immunological and sexual dysfunction

57
Q

VIT B6 can cause what complications?

A

in high doese, periopheral neuropathy, perioral numbness, & “stocking glove” sensory loss

D4 Pharm (1 decks)

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