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CLEVIPREX is a brand name for Clevidipine, supplied as a emulsion. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CLEVIPREX (clevidipine) is indicated for: The management of acute elevation of blood pressure in perioperative settings. 1.1 Pediatrics (<18 years of age): The safety and effectiveness of CLEVIPREX in children under 18 years of age have not been established. 1.2 Geriatrics (≥65 years of age): Of the 1406 subjects…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Blood pressure and heart rate should be monitored continuously during infusion and afterwards until vital signs are stable. Patients who are on prolonged infusions should be monitored for the possibility of rebound hypertension for at least 8 hours after stopping the infusion.
2 Recommended Dose and Dosage Adjustment CLEVIPREX is intended for intravenous use only. Titrate the drug to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.
Initial dose:
Initiate the intravenous infusion of CLEVIPREX at a rate of 1 to 2 mg/h.
Dose titration:
The dose may be doubled at short (90 second) intervals until the desired blood pressure level is about to be reached. Continue titration until the desired target range is achieved by increasing the dose in smaller increments and at longer intervals (5 to 10 minutes).
A 1 to 2 mg/h increase will generally produce an additional 2 to 4 mmHg decrease in systolic pressure.
Maintenance dose:
The desired therapeutic response for most patients occurs at doses of 4 to 6 mg/h. Patients may require doses up to 32 mg/h, but there is limited experience at this dose rate.
Maximum dose:
The maximum dose is 32 mg/h, although most patients were treated with doses of 16 mg/h or less. No more than 1000 mL of CLEVIPREX infusion is recommended in the initial 24-hour CLEVIPREX (clevidipine) Page 5 of 25 period due to the associated potential lipid load.
There is little experience with infusion durations beyond 72 hours at any dose.
Transition to an oral anti-hypertensive agent:
Discontinue CLEVIPREX or titrate downward while appropriate oral therapy is established. When an oral anti-hypertensive agent is being instituted, consider the lag time of onset of the oral agent’s effect. Continue blood pressure monitoring until desired effect is achieved.
Hepatic or Renal Impairment:
1 Adverse Reaction Overview CLEVIPREX (clevidipine) was administered to 1099 hypertensive patients in peri-operative settings. No association between gender, age, race, or ethnicity and the incidence of adverse events was observed. Although infusions of lipid containing products may be associated with increases in triglycerides, no consistent changes in triglyceride levels were observed with CLEVIPREX.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. There were many adverse events associated with the operative procedure, but relatively few that could plausibly be related to the anti-hypertensive drugs.
Thus, the ability to differentiate the adverse event profile between treatments was limited. 2% for all active comparators. The most common adverse reactions leading to study drug discontinuation in all groups were hypertension and, when combined with a beta-blocker, hypotension.
The incidence of serious adverse events and associated discontinuation rates within 1 hour of the drug infusion were similar among patients receiving CLEVIPREX and all active comparators. Placebo-controlled peri-operative studies The placebo-controlled experience with CLEVIPREX in the peri-operative setting was both small and brief (about 30 minutes).
CLEVIPREX (clevidipine) Page 10 of 25 Table 3 lists the treatment-emergent adverse events and the category “any common adverse event” in the ESCAPE-1 and ESCAPE-2 studies (see 14 CLINICAL TRIALS). CLEVIPREX (clevidipine) Page 11 of 25 Table 3 Common Adverse Events in Placebo-controlled Peri-operative Studies Adverse Event ESCAPE-1 ESCAPE-2 CLEVIPREX N=53 n (%) Placebo N=51 n (%) CLEVIPREX N=61 n (%) Placebo N=49 n (%) Any common1 adverse event 27 (51%) 21 (41%) 32 (53%) 24 (49%) Cardiac disorders Atrial fibrillation 7 (13%) 6 (12%) 13 (21%) 6 (12%) Gastrointestinal disorders Nausea 3 (6%) 5 (10%) 13 (21%) 6 (12%) General disorders and administration site conditions Pyrexia 11 (19%) 7 (14%) 3 (5%) 3 (6%) Psychiatric disorders Insomnia NR2 NR2 7 (12%) 3 (6%) Renal and urinary disorders Acute renal failure 5 (9%) 1 (2%) 4 (7%) 4 (8%) Respiratory, thoracic and mediastinal disorders Atelectasis 3 (6%) 0 (0%) NR2 NR2 1 Where the rate with CLEVIPREX exceeded the rate with placebo by at least 5% in one of the two trials.
). 1 Dosing Considerations Blood pressure and heart rate should be monitored continuously during infusion and afterwards until vital signs are stable. Patients who are on prolonged infusions should be monitored for the possibility of rebound hypertension for at least 8 hours after stopping the infusion.
2 Recommended Dose and Dosage Adjustment CLEVIPREX is intended for intravenous use only. Titrate the drug to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.
Initial dose:
Initiate the intravenous infusion of CLEVIPREX at a rate of 1 to 2 mg/h.
Dose titration:
The dose may be doubled at short (90 second) intervals until the desired blood pressure level is about to be reached. Continue titration until the desired target range is achieved by increasing the dose in smaller increments and at longer intervals (5 to 10 minutes).
A 1 to 2 mg/h increase will generally produce an additional 2 to 4 mmHg decrease in systolic pressure.
Maintenance dose:
The desired therapeutic response for most patients occurs at doses of 4 to 6 mg/h. Patients may require doses up to 32 mg/h, but there is limited experience at this dose rate.
Maximum dose:
The maximum dose is 32 mg/h, although most patients were treated with doses of 16 mg/h or less. No more than 1000 mL of CLEVIPREX infusion is recommended in the initial 24-hour CLEVIPREX (clevidipine) Page 5 of 25 period due to the associated potential lipid load.
There is little experience with infusion durations beyond 72 hours at any dose.
CLEVIPREX is contraindicated in patients with: Allergy to clevidipine, soybeans, soybean oil, soy products, eggs or egg products, or peanut. Defective lipid metabolism such as pathologic hyperlipidemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.
Severe aortic stenosis (see 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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During clinical trials, there was limited experience in patients with hepatic or renal impairment. From all clinical trials, there were 78 patients with abnormal liver function and 121 patients with moderate to severe renal impairment.
No dose adjustment was required for these patients. Health Canada has not authorized an indication for pediatric use. Table 1 provides a guideline for dosing conversion from mg/h to mL/h. 4 Administration Maintain strict aseptic technique while handling CLEVIPREX.
005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental contamination. However, CLEVIPREX can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards.
Do not use if contamination is suspected. Once the stopper is punctured use within 12 hours and discard any unused portion (see 7 WARNINGS AND PRECAUTIONS). CLEVIPREX is supplied in sterile, single-use, 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. Discard products that are discoloured or contain particulate matter.
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 either a central line or peripheral line.
2 micron pore size may be used when administering CLEVIPREX. CLEVIPREX should not be infused in the same line as other medications. 9% Sodium Chloride 10% amino acid
2 Not reported. Peri-operative clinical studies using active controls Three studies called ECLIPSE compared CLEVIPREX to three active controls: nitroglycerin, sodium nitroprusside, and nicardipine (see 14 CLINICAL TRIALS). Drug exposure in these studies was longer, the pooled mean maximum dose being 10 mg/h, and the mean duration of treatment was 8 hours.
The adverse events observed within 1 hour of the end of the infusion were similar in all patients who received CLEVIPREX and those who received the comparator drugs. Rebound hypertension was assessed as the maximum increase in systolic blood pressure (SBP) from the last measurement on study drug to 1 hour after termination of the study drug.
7 to 12% of patients exhibited greater than 30% increase in SBP. 1 Clinical Trial Adverse Reactions – Pediatrics The safety and effectiveness of CLEVIPREX in children under 18 years of age have not been established. 3 Less Common Clinical Trial Adverse Reactions Adverse reactions occurring in patients treated with CLEVIPREX at a higher frequency than placebo in the ESCAPE-1 or ESCAPE-2 trials included: CLEVIPREX (clevidipine) Page 12 of 25 Blood and lymphatic system disorders: anemia, coagulopathy, leukocytosis Cardiac disorders: right bundle branch block, pericarditis, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, tachycardia, ventricular bigeminy, ventricular extrasystoles, ventricular tachycardia Gastrointestinal disorders: bowel sounds abnormal, constipation, diarrhea General disorders and administration site conditions: anasarca, application site reaction, asthenia, chest discomfort, chest pain, peripheral edema, induration, nodule, secretion discharge Infections and infestations: bacteremia, bacterial infection, bronchitis, cellulitis, oral candidiasis, pneumonia, urinary tract infection, wound infection Injury, poisoning and procedural complications: postoperative anemia, incision site complication, medical device complication, postoperative ileus, post procedural hemorrhage Investigations: abnormal blood gases, decreased cardiac output, abnormal QRS complex electrocardiogram, Gram stain positive, increased international normalised ratio, abnormal liver function test, increased troponin Metabolism and nutrition disorders: acidosis, diabetes mellitus, hyperglycemia, hyponatremia, malnutrition, metabolic acidosis Musculoskeletal and connective tissue disorders: back pain, muscle spasms Nervous system disorders: cerebrovascular accident, dizziness, headache Psychiatric disorders: abnormal behaviour, agitation, anxiety, confusional state, delirium, depression, disorientation, restlessness Renal and urinary disorders: incontinence, oliguria, nephrolithiasis, renal insufficiency Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome, cough, diaphragmatic paralysis, dyspnea, hypoxia, mediastinal hemorrhage, nasal congestion, pleural effusion, pulmonary edema, respiratory distress, respiratory failure, throat tightness, wheezing Skin and subcutaneous tissue disorders: decubitus ulcer, hyperhidrosis, subcutaneous emphysema Surgical and […]
Transition to an oral anti-hypertensive agent:
Discontinue CLEVIPREX or titrate downward while appropriate oral therapy is established. When an oral anti-hypertensive agent is being instituted, consider the lag time of onset of the oral agent’s effect. Continue blood pressure monitoring until desired effect is achieved.
Hepatic or Renal Impairment:
During clinical trials, there was limited experience in patients with hepatic or renal impairment. From all clinical trials, there were 78 patients with abnormal liver function and 121 patients with moderate to severe renal impairment.
No dose adjustment was required for these patients. Health Canada has not authorized an indication for pediatric use. Table 1 provides a guideline for dosing conversion from mg/h to mL/h. 4 Administration Maintain strict aseptic technique while handling CLEVIPREX.
005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental contamination. However, CLEVIPREX can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards.
Do not use if contamination is suspected. Once the stopper is punctured use within 12 hours and discard any unused portion (see 7 WARNINGS AND PRECAUTIONS). CLEVIPREX is supplied in sterile, single-use, 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. Discard products that are discoloured or contain particulate matter.
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 either a central line or peripheral line.
2 micron pore size may be used when administering CLEVIPREX. CLEVIPREX should not be infused in the same line as other medications. 9% Sodium Chloride 10% amino acid 5 OVERDOSAGE There has been no experience of overdosage in human clinical trials.
In clinical trials 1 healthy subject was titrated to a dose above the normal recommended limit (up to 106 mg/h) and experienced mild flushing and a slight transient increase in serum creatinine. The expected major effects of overdose would be hypotension and reflex tachycardia.
2 Pharmacodynamics). In a case of suspected overdosage, CLEVIPREX should be discontinued immediately and the patient’s blood pressure should be supported and monitored. For management of a suspected drug overdose, contact your regional poison control centre.
5 mg/mL is supplied as a sterile, milky-white oil-in-water emulsion for intravenous injection. 5 mg/mL clevidipine. o Each vial is individually packaged in its own carton. o Available in boxes of 10 vials. 5 mg/mL clevidipine. o Each vial is individually packaged in its own carton.
o Available in boxes of 10 vials. Vials are sealed with 32 mm grey bromobutyl rubber stoppers and capped […]