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Arctic > Cream > Flashcards

Cream Flashcards

1
Q

0.3% cream Indication

A

Zoryve 0.3% cream is indicated for the topical treatment of plaque psoriasis, including the intertriginous areas, in patients 6 years and older

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2
Q

0.15% cream Indication

A

is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older

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3
Q

administration

A

apply to affected areas once daily and rub in completely. wash hands after application, unless cream is for treatment of hands

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4
Q

dosage

A

0.3% per gram

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5
Q

packaging

A

60 g tubes

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6
Q

CI

A

moderate-to-severe liver impairment (Child-Pugh B or C)

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7
Q

Most common AE that led to discontinuation in DERMIS 1, 2

A

urticaria (0.3%)

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8
Q

Most common AEs (7)

A
  1. Diarrhea (3.1%)
  2. Headache (2.4%)
  3. Insomnia (1.4%)
  4. Nausea (1.2%)
  5. Application site pain (1%)
  6. URI (1%)
  7. UTI (1%)
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9
Q

Drug interactions:

A

co-administration with CYP3A4 INHIBITORS or dual inhibitors that simultaneously affect 3A4 and 1A2

(keto/itra/fluconazole, erythro/clarithromycin, grapefruit juice)

(fluvoxamine, enoxacin are dual)

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10
Q

drugs that are dual inhibitors of CYP3A4 and CYP1A2

A
  1. Erythromycin
  2. Ketoconazole
  3. Fluvoxamine
  4. Enoxacin
  5. Cimetidine
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11
Q

Pharmacokinetics: Zoryve + 3A4/1A2 inhibitor

A

increase systemic exposure of roflumilast and results in increased AEs

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12
Q

Use in pregnancy?

A

insufficient data. in animal studies with rats and rabbits, no fetal structural abnormalities at 36- and 31-times the maximium dose

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13
Q

Safe with labor/delivery?

A

avoid using during labor and delivery; no studies, however animal studies show that disrupted the l/d process in mice

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14
Q

use in lactation?

A

no data, but roflumilast is detected in milk of lactating rats and is likely to be in human milk.

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15
Q

Pediatric: the safety and effectiveness of Zoryve cream has been established in patients of ___ years of age

A

6

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16
Q

Geriatric: Use in geriatric?

A

13% of patients in clinical trials with Zoryve were geriatric and no overall differences in safety or effectiveness were detected

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17
Q

Use in hepatic impairment?

A

CI in moderate-to-severe liver impairment (Child-Pugh B or C); no dosage adjustment is needed in patients with mild (Child-Pugh A) hepatic impairment

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18
Q

Each gram of the cream contains __ of API?

A

3 mg

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19
Q

what has been added to adjust pH?

A

hydrochloric acid

20
Q

MoA

A

inhibit PDE4, leading to accumulation of intracellular cAMP. The specific mechanisms by which it exerts therapeutic action is not well defined

21
Q

active metabolite of Zoryve

A

Roflumilast N-oxide

22
Q

Pharmacodynamics

A

unknown

23
Q

Absorption

A

In this study, on average, patients applied 3 to 6.5 g of ZORYVE cream once daily for 15 days. Plasma concentrations of roflumilast and roflumilast N-oxide were quantifiable in all be 2 patients at Day 15. Following application of ZORYVE cream, the plasma versus time profile was relatively flat, generally with a peak-to-trough ratio <2. In adults, the mean ± SD systemic exposure (AUC0-24) was 72.7 ± 53.1 and 628 ± 648 hng/mL for roflumilast and the N-oxide metabolite, respectively. In adolescents, the mean ± SD AUC0-24 was 25.1 ± 24.0 and 140 ± 179 hng/mL for roflumilast and the N-oxide metabolite, respectively

24
Q

distribution

A

Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively

25
Q

elimination

A

The plasma clearance after short-term IV infusion of roflumilast is on average about 9.6 L/h. Following topical administration, the half-lives of roflumilast and the N-oxide metabolite were 4.0 and 4.6 days, respectively

26
Q

Metabolism

A

Roflumilast is extensively metabolized via Phase I (CYP4500) and Phase II (conjugation) reactions. The N-oxide metabolite is the only major metabolite observed in the plasma of humans. Following oral administration, roflumilast and roflumilast N-oxide account for the majority (87.5%) of the total dose administered in plasma. Roflumilast was not detectable in urine, while roflumilast N-oxide was only a trace metabolite (<1%). Other conjugated metabolites, such as roflumilast N-oxide glucuronide and 4-amino-3,5-dichloropyridine N-oxide were detected in urine

27
Q

PK: Hepatic Impairment AUC

A

The AUC of roflumilast and roflumilast N-oxide were increased by 51% and 24%, respectively, in Child-Pugh A patients and 92% and 41%, respectively in Child-Pugh B patient, as compared to age-, weight-, and gender-matched healthy participants

28
Q

PK: Hepatic impairment Cmax

A

The Cmax of roflumilast and roflumilast N-oxide were increased by 3% and 26%, respectively, in Child-Pugh A patients and by 26% and 40%, respectively, in Child-Pugh B patients, as compared to healthy participants

29
Q

renal impariment?

A

no studies; following oral administration in 12 patients with severe renal impairment, no clinically significant differences in the PK of roflumilast were observed

30
Q

Roflumilast + erythromycin: Cmax

A

increased 40%, decreased 34% active metabolite

31
Q

Roflumilast + erythromycin: AUC

A

increased 70%, 4% active metabolite

32
Q

Roflumilast + ketoconazole: Cmax

A

increased 23%, decreased 38% active metabolite

33
Q

Roflumilast + ketoconazole: AUC

A

increased 99%, 3% active metabolite

34
Q

Roflumilast + fluvoxamine: Cmax

A

increased 12%, decreased 210% active metabolite

35
Q

Roflumilast + fluvoxamine: AUC

A

increased 156%, 52% active metabolite

36
Q

Roflumilast + enoxacin: Cmax

A

increased 20%, decreased 14% active metabolite

37
Q

Roflumilast + enoxacin: AUC

A

increased 56%, 23% active metabolite

38
Q

Roflumilast + cimetidine: Cmax

A

increased 46%, decreased 4% active metabolite

39
Q

Roflumilast + cimetidine: AUC

A

Increased 85%, 27% active metabolite

40
Q

carcinoma?

A

stastically significant increases in the incidence of undifferentiated carcinomas of the nasal epithelium in hamsters at doses 12-times the MRHD; no evidence at lower doses

41
Q

effect on sperm?

A

no effect on human semen parameters or reproductive hormones during the 3-month treatment period and the following 3 month off-treatment period

42
Q

storage?

A

20-25 C (68 F to 77F); excursions permitted between 59 F and 86 F

43
Q

Patient counseling: lactation

A

advise to use on the smallest area of skin for the shortest duration of timewhile breastfeeding; do not apply directly to nipple/areola to avoid direct exposure

44
Q

Patient counseling: administration

A

apply to affected areas 1 time a day. rub the cream in completely until you no longer see it on your skin. wash your hands (unless treating hands)

45
Q
A

Arctic (12 decks)

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