| Hypertensive disease

Cleviprex vs Norvasc

Side-by-side clinical, coverage, and cost comparison for hypertensive disease.

Deep comparison between: Cleviprex vs Norvasc with Prescriber.AI

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Safety signalsNorvasc has a higher rate of injection site reactions vs Cleviprex based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Norvasc but not Cleviprex, including UnitedHealthcare

Category

Cleviprex

Norvasc

At A Glance

RouteIV infusion

FrequencyContinuous infusion

ClassDihydropyridine CCB

RouteOral

FrequencyOnce daily

ClassCalcium channel blocker

Indications

Hypertensive disease

Hypertensive disease
Stable angina
Angina Pectoris, Variant
Coronary Artery Disease

Dosing

Hypertensive disease Initiate IV infusion at 1-2 mg/hour; double dose at 90-second intervals initially, then increase by less than doubling every 5-10 minutes as goal blood pressure is approached; maintenance 4-6 mg/hour; maximum 16 mg/hour (up to 32 mg/hour for severe hypertension); lipid load limit 1000 mL or an average of 21 mg/hour per 24 hours.

Hypertensive disease - Adults The usual initial antihypertensive oral dose of NORVASC is 5 mg once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding NORVASC to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Hypertensive disease - Pediatric patients The effective antihypertensive oral dose in pediatric patients ages 6-17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.

Stable angina The recommended dose for chronic stable angina is 5-10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

Angina Pectoris, Variant The recommended dose for vasospastic angina is 5-10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

Coronary Artery Disease The recommended dose range for patients with coronary artery disease is 5-10 mg once daily. In clinical studies, the majority of patients required 10 mg.

Contraindications

Allergy to soybeans, soy products, eggs, or egg products
Defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis accompanied by hyperlipidemia
Severe aortic stenosis

Known sensitivity to amlodipine

Drug Interactions

1074View drug interactions

1162View drug interactions

Adverse Reactions

Most common Headache, nausea, vomiting, acute renal failure, atrial fibrillation

Serious Myocardial infarction, cardiac arrest, syncope, dyspnea

Postmarketing Increased blood triglycerides, ileus, hypersensitivity, hypotension, nausea, decreased oxygen saturation, reflex tachycardia

Most common adverse reactions (incidence >1%) The most common adverse reaction to amlodipine is edema which occurred in a dose related manner (up to 10.8% at 10 mg dose vs 0.6% placebo). Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue (4.5%), nausea (2.9%), abdominal pain (1.6%), and somnolence (1.4%).

Dose-related adverse reactions Edema: 1.8% (2.5 mg), 3.0% (5 mg), 10.8% (10 mg) vs 0.6% (placebo). Dizziness: 1.1% (2.5 mg), 3.4% (5 mg), 3.4% (10 mg) vs 1.5% (placebo). Flushing: 0.7% (2.5 mg), 1.4% (5 mg), 2.6% (10 mg) vs 0.0% (placebo). Palpitation: 0.7% (2.5 mg), 1.4% (5 mg), 4.5% (10 mg) vs 0.6% (placebo).

Gender differences For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men: Edema (14.6% female vs 5.6% male), Flushing (4.5% female vs 1.5% male), Palpitations (3.3% female vs 1.4% male).

Less common adverse reactions (<1% but >0.1%) Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis. Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General: allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Musculoskeletal: arthralgia, arthrosis, muscle cramps, myalgia. Psychiatric: sexual dysfunction, insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory: dyspnea, epistaxis. Skin: angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular. Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus. Urinary: micturition frequency, micturition disorder, nocturia. Autonomic: dry mouth, sweating increased. Metabolic: hyperglycemia, thirst. Hemopoietic: leukopenia, purpura, thrombocytopenia.

Postmarketing experience Gynecomastia has been reported infrequently. Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. A possible association between extrapyramidal disorder and amlodipine has been reported.

Pharmacology

Clevidipine is a dihydropyridine L-type calcium channel blocker that lowers blood pressure by inhibiting calcium influx in arterial smooth muscle, reducing systemic vascular resistance without affecting venous preload or cardiac filling pressure.

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. In patients with exertional angina, NORVASC reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise. In vasospastic angina, NORVASC blocks constriction and restores blood flow in coronary arteries and arterioles, inhibiting coronary spasm. Following administration of therapeutic doses to hypertensive patients, NORVASC produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients.

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Cleviprex