Question

The FDA has recently (2019) approved TWO new drugs for depression management, the first one is showing a beneficial effect in POSTPARTUM DEPRESSION (PPD) and the second one toward TREATMENT-RESISTANT DEPRESSION (TRD). ANSWERING THE FOLLOWING QUESTION  1. Dose strength 2 Mechanism of actions 3. Specific clinical indication and why 4. Any contraindications 5. Possible side effects 6. Discontinuation side effects  Explain it in detail in your own language without citing the sites

Answer 1

new drugs for depression management, - POSTPARTUM DEPRESSION (PPD)

Zulesso (brexanolone), is delivered via intravenous infusion.

DRUG DOSAGE: 5mg/mL (100mg/20mL single-dose vial)

ROUTE: IV

Mechanism o action : Zulesso "acts on the main inhibitory neurotransmitter system in the brain, the GABA system," explained Deligiannidis, who helps direct women's behavioral health at Zucker Hillside Hospital, in Glen Oaks, N.Y.

The drug's active ingredient is synthetic allopregnanolone, a steroid that the body also makes naturally.

"Allopregnanolone is known to modulate the stress response system in humans, which has been shown to be abnormally functioning in women with postpartum depression," Deligiannidis explained.

Clinical indications:

indicated for the treatment of postpartum depression (PPD)

Administer as a continuous infusion of a total of 60 i 3 (2.5 days), pull the security need to intervene, and the setting is a continuous pulse oximetry

dosage
0-4 hours: start at 30 mg / kg / hr
Increase 4-24 hours to 60 mg / kg / hr
24-52 hours Increase to 90 mg / kg / h (not understood to reduce to 60 mg / kg / h)
52 to 56 hours, then 60 mg / kg / hr
60 to 56 hours, so it is 30 mg / kg / hr
shape modifications
Excessive sedation
If you plan to do it, that the infusion to avoid excessive sedation occurs at all times: I will teach you
To enter below the mainstream hydrogen or rare infusion
hypoxia
Stop infusion immediately, even if oximetry reveals hypoxia
After hypoxia, so as not to receive the influx of
renal insufficiency
Mild to severe (EGFR ≥15 ml / min / 1.73m²): no dose adjustment necessary
End-stage renal disease (EGFR <15 ml / min / 1.73m²) lives; potential build-up of used brexanolone solubilizing agent (i.e. sodium or betadex sulfobutyl)
liver impairment
No hydrogen adjustment necessary

CONTRAINDICATIONS: None

POSSIBLE SIDE EFFECTS:

Sedation, somnolence (13-21%)

Dizziness, presyncope, vertigo (12-13%)

Dry mouth (3-11%)

Loss of consciousness (3-5%)

Flushing, hot flush (2-5%)

Tachycardia (3%)

Diarrhea (2-3%)

Oropharyngeal pain (2-3%)

Dyspepsia (2%)

SPECIAL CONSIDERATIONS:

precautions
Sudden and quiet fainting
It is required to become less important as a kind of suspension occurs, either by suspending clinical trials consectetuer in patients receiving infusion, sedation and sleep,
No lion or hydrogen society, for example, has lost or altered
It is not a thing in view of all the loss suffered by patients who are conscious and told, sedation, or from an expert or for any other day and night,
Caution: it is potentially dangerous to perform activities that require mental alertness (for example, driving) after the infusion to disperse the sedative effect
Oxygenation in continuous monitor pulse oximetry
Suicidal thoughts and behaviors: in your
Combined placebo-controlled developments of trials with long-term administration of antidepressant drugs (SSRIs, antidepressants and others) that ~ 77,000 4,500 pediatric and adult patients, the incidence in elderly patients treated with suicidal thoughts and behaviors in an antidepressant year would be greater ≤ 24 patients than those treated with placebo
Brexanolone does not directly affect the monoaminergic systems; brexanolone once snatched from birth, the risk of developing, and therefore the number of unknown relationship with the great suicidal thoughts,
Summary of the drug trade
Co-administration may be fibrous (eg, opioids, benzodiazepines) may increase the likelihood or severity of adverse reactions to sedation.
In the placebo-controlled studies of brexanolone, a higher percentage of treated patients prompting the use of antidepressants reported events related to sedation.