INNOVAR

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INNOVAR (INNOVAR).

How it works

Innovar is a combination of fentanyl (mu-opioid receptor agonist) and droperidol (butyrophenone antipsychotic that blocks dopamine D2 receptors in the CNS, producing sedation and antiemetic effects).

What the body does with it

Metabolism	Fentanyl: CYP3A4 to norfentanyl; Droperidol: CYP3A4 and CYP1A2 to multiple metabolites.
Excretion	Droperidol: ~75% renal as metabolites, ~22% biliary/fecal. Fentanyl: primarily renal as metabolites (85%), ~9% fecal.
Half-life	Droperidol: terminal t1/2 2.2–2.5 h (infants 4.5 h). Fentanyl: terminal t1/2 3–7 h (mean ~4 h) in adults; prolonged in elderly (up to 16 h) and hepatic impairment.
Protein binding	Fentanyl: ~80–85% bound to albumin and α1-acid glycoprotein. Droperidol: ~85–90% bound to albumin and α1-acid glycoprotein.
Volume of Distribution	Fentanyl: Vd 3–5 L/kg (large distribution to tissues, slow elimination). Droperidol: Vd 1.5–2 L/kg (moderate distribution).
Bioavailability	Fentanyl: IV 100%; transdermal 92% (after depot formation); transmucosal ~50% (buccal) to 70% (nasal); oral <30% due to first-pass. Droperidol: IV 100%; IM ~85% (well absorbed).
Onset of Action	IV: Droperidol 3–10 min, Fentanyl 1–2 min (peak analgesia 5–15 min). IM: Droperidol 10–30 min, Fentanyl 7–15 min.
Duration of Action	IV sedation/analgesia: 1–4 h depending on dose. Residual respiratory depression may persist longer (fentanyl redistribution). Droperidol's antiemetic effect lasts up to 12 h with single dose.

Classification & Brands

Dosing & administration

2-5 mL (droperidol 2.5-5 mg and fentanyl 0.05-0.1 mg) IM/IV every 1-2 hours as needed for neuroleptanalgesia; surgical anesthesia: initial 1 mL/10 kg IM or slow IV, then 0.5 mL increments.

Dosage form	INJECTABLE
Renal impairment	eGFR >60 mL/min: no adjustment; eGFR 30-60: reduce dose by 25-50% due to fentanyl accumulation; eGFR <30: avoid or use with extreme caution, reduce dose by ≥50%, monitor for respiratory depression.
Liver impairment	Child-Pugh A: reduce dose by 25%; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated due to impaired fentanyl metabolism and increased sedation risk.
Pediatric use	Not FDA-approved for pediatric use; limited data: 0.1 mL/kg (droperidol 0.125 mg/kg + fentanyl 0.0025 mg/kg) IM/IV as single dose; max 1.5 mL. Contraindicated in neonates.
Geriatric use	Reduce initial dose by 50-75% (e.g., 0.5-1 mL IM/IV); titrate cautiously; increased risk of hypotension, respiratory depression, and prolonged sedation; monitor renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for INNOVAR (INNOVAR).

Breastfeeding	Fentanyl and droperidol are excreted in breast milk. Fentanyl M/P ratio approximately 0.2–0.4. Potential for sedation and respiratory depression in the infant. Avoid breast-feeding for 24 hours after administration. Discard milk during this period.
Teratogenic Risk	First trimester: Risk of congenital malformations, including cardiac and neural tube defects, associated with droperidol exposure. Second and third trimesters: Risk of extrapyramidal symptoms, neuroleptic malignant syndrome, and neonatal withdrawal. Fentanyl component may cause fetal respiratory depression and intrauterine growth restriction. Use only if maternal benefit outweighs fetal risk.

Warnings & precautions

■ FDA Black Box Warning

Risk of respiratory depression, especially in elderly, debilitated, or opioid-naive patients; risk of QT prolongation and torsade de pointes with droperidol, including at recommended doses.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to fentanyl, droperidol, or components; known QT prolongation; concurrent MAOIs; severe respiratory depression; myasthenia gravis.

Clinical Precautions

Precautions

Monitor respiratory function; avoid in patients with bradycardia, electrolyte abnormalities, or QT prolongation; risk of hypotension, neuroleptic malignant syndrome, and extrapyramidal symptoms.

Clinical Tips & Counseling

Drug interactions

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INNOVAR

Clinical safety rating: caution

Comprehensive clinical and safety monograph for INNOVAR (INNOVAR).

How it works

Innovar is a combination of fentanyl (mu-opioid receptor agonist) and droperidol (butyrophenone antipsychotic that blocks dopamine D2 receptors in the CNS, producing sedation and antiemetic effects).

What the body does with it

Metabolism	Fentanyl: CYP3A4 to norfentanyl; Droperidol: CYP3A4 and CYP1A2 to multiple metabolites.
Excretion	Droperidol: ~75% renal as metabolites, ~22% biliary/fecal. Fentanyl: primarily renal as metabolites (85%), ~9% fecal.
Half-life	Droperidol: terminal t1/2 2.2–2.5 h (infants 4.5 h). Fentanyl: terminal t1/2 3–7 h (mean ~4 h) in adults; prolonged in elderly (up to 16 h) and hepatic impairment.
Protein binding	Fentanyl: ~80–85% bound to albumin and α1-acid glycoprotein. Droperidol: ~85–90% bound to albumin and α1-acid glycoprotein.
Volume of Distribution	Fentanyl: Vd 3–5 L/kg (large distribution to tissues, slow elimination). Droperidol: Vd 1.5–2 L/kg (moderate distribution).
Bioavailability	Fentanyl: IV 100%; transdermal 92% (after depot formation); transmucosal ~50% (buccal) to 70% (nasal); oral <30% due to first-pass. Droperidol: IV 100%; IM ~85% (well absorbed).
Onset of Action	IV: Droperidol 3–10 min, Fentanyl 1–2 min (peak analgesia 5–15 min). IM: Droperidol 10–30 min, Fentanyl 7–15 min.
Duration of Action	IV sedation/analgesia: 1–4 h depending on dose. Residual respiratory depression may persist longer (fentanyl redistribution). Droperidol's antiemetic effect lasts up to 12 h with single dose.

Classification & Brands

Dosing & administration

2-5 mL (droperidol 2.5-5 mg and fentanyl 0.05-0.1 mg) IM/IV every 1-2 hours as needed for neuroleptanalgesia; surgical anesthesia: initial 1 mL/10 kg IM or slow IV, then 0.5 mL increments.

Dosage form	INJECTABLE
Renal impairment	eGFR >60 mL/min: no adjustment; eGFR 30-60: reduce dose by 25-50% due to fentanyl accumulation; eGFR <30: avoid or use with extreme caution, reduce dose by ≥50%, monitor for respiratory depression.
Liver impairment	Child-Pugh A: reduce dose by 25%; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated due to impaired fentanyl metabolism and increased sedation risk.
Pediatric use	Not FDA-approved for pediatric use; limited data: 0.1 mL/kg (droperidol 0.125 mg/kg + fentanyl 0.0025 mg/kg) IM/IV as single dose; max 1.5 mL. Contraindicated in neonates.
Geriatric use	Reduce initial dose by 50-75% (e.g., 0.5-1 mL IM/IV); titrate cautiously; increased risk of hypotension, respiratory depression, and prolonged sedation; monitor renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for INNOVAR (INNOVAR).

Breastfeeding	Fentanyl and droperidol are excreted in breast milk. Fentanyl M/P ratio approximately 0.2–0.4. Potential for sedation and respiratory depression in the infant. Avoid breast-feeding for 24 hours after administration. Discard milk during this period.
Teratogenic Risk	First trimester: Risk of congenital malformations, including cardiac and neural tube defects, associated with droperidol exposure. Second and third trimesters: Risk of extrapyramidal symptoms, neuroleptic malignant syndrome, and neonatal withdrawal. Fentanyl component may cause fetal respiratory depression and intrauterine growth restriction. Use only if maternal benefit outweighs fetal risk.

Warnings & precautions

■ FDA Black Box Warning

Risk of respiratory depression, especially in elderly, debilitated, or opioid-naive patients; risk of QT prolongation and torsade de pointes with droperidol, including at recommended doses.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to fentanyl, droperidol, or components; known QT prolongation; concurrent MAOIs; severe respiratory depression; myasthenia gravis.

Clinical Precautions

Precautions

Monitor respiratory function; avoid in patients with bradycardia, electrolyte abnormalities, or QT prolongation; risk of hypotension, neuroleptic malignant syndrome, and extrapyramidal symptoms.

Clinical Tips & Counseling

Drug interactions

Loading safety data…