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Ohtuvayre
ensifentrine inhaled
Adult Dosing .
Dosage forms: NEB: 3 mg per 2.5 mL
COPD, maintenance tx
- [3 mg NEB bid]
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- bronchospasm, acute
- caution: hepatic impairment
- caution: depression
- caution: depression hx
- caution: suicidal ideation
Drug Interactions .
Overview
ensifentrine inhaled
PDE3/PDE4 inhibitor inhaled
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- suicidality
- bronchospasm, paradoxical
Common Reactions
- back pain
- HTN
- depression
Safety/Monitoring .
Monitoring Parameters
s/sx depression, behavior changes, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at up to 9x and 79x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2C9 (primary), 2D6 substrate
Excretion: feces primarily, urine <0.3%; Half-life: 10.6-12.6h
Subclass: Phosphodiesterase 3/4 (PDE3/4) Inhibitors, Pulmonary
Mechanism of Action
exact mechanism of action unknown; inhibits phosphodiesterase type 3 and 4 (PDE3/4), leading to increased intracellular cAMP and cGMP levels
Formulary .
No Formulary Selected
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