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Cleviprex (clevidipine butyrate) injectable emulsion(五)
2013-09-22 11:22:07 来源: 作者: 【 】 浏览:8378次 评论:0
erum triglyceride levels was zero at 6 hours after cessation of therapy
- No relationship between change in triglyceride levels and total dose of Cleviprex received (Pearson抯 correlation coefficient = -0.0269) Cleviprex Provides a Reliable Transition to Oral Antihypertensive Therapy
  • 98% (115 of 118) of eligible patients successfully transitioned to oral therapy to a predefined target BP within 6 hours of discontinuing Cleviprex
  • Patients were maintained on a steady infusion of Cleviprex without evidence of tachyphylaxis, drug accumulation, or rebound hypertension on discontinuation

DOSING AND ADMINISTRATION

Predictable BP Control With Convenient Dosing

Cleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. Invert vial gently several times before use to ensure uniformity of the emulsion prior to administration. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Administer Cleviprex using an infusion device allowing calibrated infusion rates. Commercially available standard plastic cannulae may be used to administer the infusion. Administer Cleviprex by a central line or a peripheral line.

Cleviprex should not be administered in the same line as other medications.

Cleviprex should not be diluted, but it can be administered with

  • Water for Injection, USP
  • Sodium Chloride (0.9%) Injection, USP
  • Dextrose (5%) Injection, USP
  • Dextrose (5%) in Sodium Chloride (0.9%) Injection, USP
  • Dextrose (5%) in Ringers Lactate Injection, USP
  • Lactated Ringers Injection, USP
  • 10% amino acid
Non朩eight-Based Dosing Regimen

Cleviprex is intended for intravenous (IV) use and should be titrated to achieve the desired blood pressure (BP) reduction. Dosage must be individualized, depending on the BP to be obtained, and the response of the patient. No dosage adjustment is required for patients with underlying hepatic or renal impairment.

Maintenance Dose
  • Most patients will achieve desired therapeutic response at 4-6 mg/h
Maximum Dose
  • Most patients have received maximum doses of 16 mg/h or less
  • Because of lipid load restrictions, no more than 1000 mL, or an average of 21 mg/h, is recommended per 24-hour period
  • There is little experience with infusions beyond 72 hours at any dose
Transitioning From Cleviprex to Oral Antihypertensive Therapy
  • Discontinue Cleviprex or titrate downward while appropriate oral therapy is established
  • When an oral antihypertensive agent is being instituted, consider the lag time of onset of the oral agent抯 effect
  • Continue monitoring BP until desired effect is achieved
Storing Cleviprex
  • Leave Cleviprex vials in cartons until administration to protect from light
    - Protection from light during administration is not required
  • Vials should be stored refrigerated at 2-8癈 (36-46癋). Do not freeze
  • Vials in cartons may be transferred to 25癈 (77癋, USP controlled room temperature) for a period not to exceed 2 months, indicated by the "Discard By" Date marked by the dispensing pharmacist, and should not be returned to refrigerated storage after beginning room temperature storage

PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information ne

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