clevidipine

Therapeutic Classification: antihypertensives

Pharmacologic Classification: calcium channel blockers (dihydropyridine)

Indications ⬆ ⬇

REMS

Reduction of BP when oral therapy is not feasible/desirable.

Action ⬆ ⬇

Inhibits calcium transport into vascular smooth muscle, resulting in inhibition of excitation-contraction coupling and subsequent contraction.
Decreases systemic vascular resistance; does not reduce cardiac filling pressure (preload). Has no effect on venous capacitance vessels.

Therapeutic effects:

Decreases BP.

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailibility.

Distribution: Unknown.

Protein Binding: >99.5%.

Metabolism/Excretion: Rapidly metabolized by esterases in plasma and tissue to inactive metabolites; metabolites are excreted in urine (63–74%) and feces (7–22%).

Half-Life: Initial phase: 1 min; terminal phase: 15 min.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	2–4 min	30 min*	end of infusion

*Time to target BP.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Allergy to soybeans or eggs/egg products;
Defective lipid metabolism including pathologic hyperlipidemia, lipoid nephrosis or acute pancreatitis;
Severe aortic stenosis.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.
Geri: Initiate therapy at low end of dose range and titrate dose cautiously in older adults; consider age-related changes in hepatic, renal, or cardiac function, concomitant diseases, or other drug therapy;

Adv. Reactions/Side Effects ⬆ ⬇

CV: HF, hypotension, rebound hypertension, reflex tachycardia

GI: nausea, vomiting

MS: arthralgia

Neuro: headache

Resp: hypoxemia

Interactions ⬆ ⬇

Drug-drug:

↑risk of excess hypotension with other antihypertensives.
Does not protect against effects of abrupt beta blocker withdrawal.

Route/Dosage ⬆ ⬇

IV (Adults ): Initial dose: 1–2 mg/hr; Dose titration: Double dose every 90 sec initially; as BP approaches goal, ↑ dose by less than doubling and lengthen the time between dose adjustments to every 5–10 min. Usual dose required is 4–6 mg/hr. Severe hypertensive patients may require higher doses with a maximum of 16 mg/hr or less. Doses up to 32 mg/hr have been used, but generally should not exceed 21 mg/hr in a 24 hr period due to lipid load.

Availability ⬆ ⬇

Emulsion for injection: 0.5 mg/mL

Assessment ⬆ ⬇

Monitor BP and heart rate during infusion, and until vital signs stabilize. Hypotension and reflex tachycardia may occur with rapid upward titration. Monitor patients receiving prolonged clevidipine infusions and who have not been transitioned to other antihypertensive therapies for the possibility of rebound hypertension for at least 8 hr after infusion is stopped; additional adjustments may be needed.

Implementation ⬆ ⬇

Discontinue clevidipine or titrate downward during initiation of oral therapy; consider time to onset of the oral agent’s effect. Continue BP monitoring until desired effect is achieved.

IV Administration:

Intermittent Infusion: Diluent: Do not dilute. Invert vial gently several times before use to ensure emulsion uniformity prior to administration. Solution is milky white; inspect for particulate matter and discoloration. Commercially available standard plastic cannulae may be used to administer the infusion. Administer via central line or peripheral line. Solution is in single-use vials; discard unused portion 4 hr after stopper puncture. Store in refrigerator; once emulsion reaches room temperature, stable for 2 mo, do not re-refrigerate.
Rate: Initiate intravenous infusion at 1–2 mg/hr. Administer using an infusion device allowing calibrated infusion rates.
Y-Site Incompatibility: Do not administer in the same line as other medications.

Patient/Family Teaching ⬆ ⬇

Inform patient of the rationale for use of clevidipine.
Advise patients to contact a health care professional immediately if signs of a new hypertensive emergency (neurological symptoms, visual changes, evidence of HF) occur.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Encourage patients with underlying hypertension to continue follow-up care and to continue taking their oral antihypertensive medication(s) as directed.

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

18124- Fresenius Kabi Austria GmbH
- 18124-011- Cleviprex
  - 18124-011-00- 10 CARTON in 1 CARTON (18124-011-00) > 1 VIAL, SINGLE-USE in 1 CARTON > 100 mL in 1 VIAL, SINGLE-USE

18124- Fresenius Kabi Austria GmbH
- 18124-011- Cleviprex
  - 18124-011-25- 4 CARTON in 1 CARTON (18124-011-25) > 1 VIAL, SINGLE-USE in 1 CARTON > 250 mL in 1 VIAL, SINGLE-USE

18124- Fresenius Kabi Austria GmbH
- 18124-011- Cleviprex
  - 18124-011-50- 10 CARTON in 1 CARTON (18124-011-50) > 1 VIAL, SINGLE-USE in 1 CARTON > 50 mL in 1 VIAL, SINGLE-USE

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Pronunciation ⬇

Classifications ⬆ ⬇