clevidipine

(redirected from Cleviprex)

clevidipine

(kle-vi-di-peen) ,

Cleviprex

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: calcium channel blockers

Indications

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 (pre-load). 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 and 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

ROUTEONSETPEAKDURATION
IV2–4 min30 min*end of infusion
*Time to target BP.

Contraindications/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: Geriatric: Titrate dose cautiously, initiate therapy at low end of dose range; consider age-related changes in hepatic, renal, or cardiac function, concomitant diseases, or other drug therapy; Obstetric: Use only if maternal benefit outweighs potential risk to fetus; Lactation: Consider possible infant exposure; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Cardiovascular

  • HF
  • hypotension
  • rebound hypertension
  • reflex tachycardia

Respiratory

  • hypoxemia

Gastrointestinal

  • nausea
  • vomiting

Musculoskeletal

  • arthralgia

Interactions

Drug-Drug interaction

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

Route/Dosage

Intravenous (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

Nursing implications

Nursing 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.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)

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.
  • Intravenous Administration
  • pH: 6.0–8.0.
  • 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 Compatibility: Water for Injection, USP, 0.9% NaCl, D5W, D5/0.9% NaCl, D5/LR, LR, 10% amino acid
  • 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 female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
  • Encourage patients with underlying hypertension to continue follow-up care and to continue taking their oral antihypertensive medication(s) as directed.

Evaluation/Desired Outcomes

  • Decrease in BP.
References in periodicals archive ?
Meanwhile, Cleviprex (clevidipine) is the only other FDA-approved drug at The Medicines Company.
The company recalled the affected lots of Cleviprex after detecting tiny particles of stainless steel during a routine inspection.
Parsippany NJ) won approval to market its drug Cleviprex for patients with difficult-to-treat high blood pressure.
As far as Cleviprex is concerned, the Medicines Company is yet to resume normal supply of the product.
New Analyses Demonstrates Use of Cleviprex for Controlling
We are also looking forward to the Cleviprex ramp and an interim analysis on phase III candidate, Cangrelor in 2009.
ECLIPSE, the largest safety program to date comparing intravenous antihypertensive therapies, found that Cleviprex is safe and effective for managing blood pressure in patients undergoing cardiac surgery and provides more precise blood pressure control than three commonly used IV antihypertensives.
Cleviprex is a novel, investigational drug rationally designed to meet the needs of the acute care practitioner for an intravenous hypertensive agent.
If approved, Cleviprex may provide a potentially important new treatment option for acute hypertension, a condition which affects nearly 3 million people in the U.
The ECLIPSE data show that Cleviprex offers reliable and effective perioperative blood pressure control.
Besides this, the company received approval for Cleviprex (calcium channel blocker) in August, and late-stage candidate Cangrelor (anticoagulant) is progressing in phase III trials.