IC8

Question 1

Nayzilam is the brand name for ____

Answer 1

Midazolam

Question 2

Dosage form: Nayzilam

Answer 2

Nasal spray

Question 3

Dose for one spray of nayzilam

Answer 3

5mg

Question 4

Nayzilam: Max dose & treatment duration

Answer 4

• No more than 2 doses of NAYZILAM to treat a single episode.
• NAYZILAM be used to treat no more than one episode every three days and no more than 5 episodes per month

Question 5

Nayzilam: When should you not administer a second dose?

Answer 5

• if the patient has trouble breathing or - if there is excessive sedation that is uncharacteristic of the patient during a seizure cluster episode

Question 6

Class of nayzilam

Answer 6

Benzodiazepine

Question 7

Use of Nayzilam and______ may result in profound sedation, respiratory depression, coma, and death.

Answer 7

opioids

Question 8

Is nayzilam a controlled substance?

Answer 8

Yes, under schedule IV

Question 9

Nayzilam: adverse effects

Answer 9

• Cardiorespiratory (resp depression, airway obstruction, oxygen desaturation, apnea, cardiac arrest, death)
• Risk of abuse

Question 10

Imitrex is the brand name for _____

Answer 10

Sumatriptan

Question 11

Imitrex: dosage form & avail doses

Answer 11

Nasal spray in 5mg/ 20mg

Question 12

Imitrex: indication

Answer 12

Acute treatment for migraine

Question 12

Imitrex: When to take an additional 2nd dose?

Answer 12

2 hours after 1st dose if:
- migraine has not resolved by 2 hours after taking IMITREX nasal spray, or
- returns after a transient improvement

Question 13

Imitrex: Max daily dose

Answer 13

40mg

Question 14

Imitrex: storage condition

Answer 14

Store IMITREX between 2°C to 30°C
Protect from light

Question 15

Ideal drug candidate for CNS drug delivery (Lipinski’s rule of 5)

Answer 15

1. </= 5 H bond donor (H bonded to EW atom)
2. </= 10 H bond acceptor (EW atom e.g. Cl, O)
3. MW < 500 Da
   (< 300 Da for access of hydrophilic drugs
   < 1 kDa for access of lipophilic drugs)
4. LogP < 5
5. Unionised

Question 16

How do in-situ gels work

Answer 16

Low viscosity solutions initially but increase viscosity once administered (activated by stimulus e.g. changes in salt conc, pH, temp)

Question 17

Advantages for intranasal route

Answer 17

Non-invasive
Can be self-administered
Bypass hepatic first-pass effect
Short onset of effect

Question 18

Disadvantages for intranasal route

Answer 18

Irritation (esp powder)

Question 19

_____occurred at a similar rate in both midazolam groups, but euphoric mood occurred at a ____ in NAYZILAM compared to the oral midazolam syrup

Answer 19

Somnolence; greater rate

Question 20

Physical dependence is a state of adaptation that is manifested by a ____ that can be produced by abrupt cessation, rapid dose reduction, decreasing blood levels of the drug, and/or administration of an antagonist.

Answer 20

specific withdrawal syndrome

Question 21

NAYZILAM is supplied in boxes of __ nasal spray units, each contained within ______.

Answer 21

2; an individual blister pack

Question 22

NAYZILAM: STORAGE & handling

Answer 22

• Do not open the blister packaging until ready to use.
• Do not test or prime before use.
• Do not use if the nasal spray unit appears damaged.
• Store at controlled room temperature 20°C to 25°C

Question 23

Can you sell or give away NAYZILAM ?

Answer 23

No, it may harm others and is against the law.

Question 24

When to take a second spray of NAYZILAM?

Answer 24

One additional spray into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose.

if NO trouble breathing or excessive sedation that is uncharacteristic of the patient during a seizure cluster episode

Question 25

Max use for tx of headache episodes for Imitrex / month

Answer 25

4 headaches (in 30 days); maybe can use more but safety not proven

Question 26

Imitrex: side effects

Answer 26

Local irritative symptoms such as burning, numbness, paresthesia, discharge, and pain or soreness

symptoms were transient and generally resolved < 2h

Question 27

Imitrex: Is administration of two 5-mg doses, 1 dose in each nostril, equivalent to administration of a single 10-mg dose in 1 nostril?

Answer 27

Yes

Question 28

Counselling for imitrex

Answer 28

• Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
• If your headache comes back after the first nasal spray or you only get some relief from your headache, you can use a second nasal spray 2 hours after the first nasal spray.
• Do not use more than 40 mg of IMITREX nasal spray in a 24-hour period.
• It is not known how using IMITREX nasal spray for a long time affects the nose and throat.
• If you use too much IMITREX, call your healthcare provider or go to the nearest hospital emergency room
  right away.
• You should write down when you have headaches and when you use IMITREX so you can talk with your
  healthcare provider about how IMITREX is working for you.

Question 29

Inactive ingredients in IMITREX

Answer 29

monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and purified water USP.

Question 30

Unique regulations for nasal sprays

Answer 30

1. Pump delivery (Durability of device & Reproducibility of pump spray weight)
2. Spray Content Uniformity (SCU) (Amount of drug delivered per pump)
3. Spray Pattern and Plume Geometry

Question 31

Advantages & disadvantages of breath-powdered delivery system

Answer 31

(+) avoids negative pressure and “traps” powder in nasal cavity -> Less loss of drug

(-) may cause irritation

Question 32

Situations where buffering/ pH adjusting agents is not
needed

Answer 32

• Single use
• No ionisable compound