Efficacy profile - hypertension

Demonstrated to effectively treat hypertension^1*

Mean reduction in sitting systolic blood pressure (SBP)/diastolic blood pressure (DBP)

• 80% of isolated systolic hypertension (ISH) patients achieved SBP study targets with NORVASC vs. 54% with hydrochlorothiazide (HCTZ) (p=0.0003)¹

Demonstrated to provide SBP control over 24 hours even after a missed dose^2†‡

Ambulatory systolic blood pressure (mmHg)

‡ NORVASC should always be prescribed as once-daily therapy.

* Single-blind, randomized, parallel-group, multicentre, 8-week comparative study. Patients with isolated systolic hypertension were randomized to either NORVASC 5 mg/day (n=97) or HCTZ 50 mg/day (n=100) and titrated to either 10 mg/day or 100 mg/day, respectively, if target SBP £150 mmHg was not achieved. Changes in standing SBP were not significant between groups. Definition of therapeutic success was achievement of sitting SBP £150 mmHg by study end. Mean standing SBP at baseline in the NORVASC group was 178.7 mmHg.

† Double-blind, randomized, parallel-group, 12-week study. After a single-blind, 4-week, run-in placebo period, patients were randomized to enalapril 20 mg (n=15) or NORVASC 5 mg (n=15). Dosage was doubled in patients not attaining sitting DBP below 90 mmHg. At the end of week 12, patients underwent ambulatory BP monitoring for 48 hours. On the first day of this period, patients received active treatment, and on the second day, placebo to simulate a missed dose.

References:

1. Calvo C, et al. A comparative evaluation of amlodipine and hydrochlorothiazide as monotherapy in the treatment of isolated systolic hypertension in the elderly. Clin Drug Invest. 2000;19(5):317-326.
2. Hernández-Hernández R, et al. The effects of missing a dose of enalapril versus amlodipine on ambulatory blood pressure. Blood Press Monit. 1996;1(2):121-126.

Safety profile – hypertension¹

• In the 805 hypertensive patients treated with NORVASC in controlled clinical trials, adverse effects were reported in 29.9% of patients and required discontinuation of therapy due to side effects in 1.9% of patients
• The most common adverse reactions in controlled clinical trials were edema (8.9%) and headache (8.3%)

Reference:

1. Upjohn Canada ULC. NORVASC Product Monograph. Available from:https://www.pfizer.ca/sites/default/files/202006/NORVASC_PM_E_236351_2020.05.27.pdf

Recommended dosing

Hypertension¹  

• Recommended starting dose: 5 mg once daily
• If necessary, the dose can be increased to 10 mg/day after 1-2 weeks
• The recommended initial dose in patients >65 years of age or patients with impaired renal function is 5 mg once daily. If required, increasing in the dose should be done gradually and with caution.
• Dosage requirements have not been established in patients with impaired hepatic function. When NORVASC is used in these patients, the dosage should be carefully and gradually adjusted depending on patients tolerance and response. A lower starting dose of 2.5 mg once daily should be considered.
• 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; dose should be determined based upon the medical need of the patients. 

Available doses

Please refer to the Product Monograph for complete dosing instructions.

Reference:

1. Upjohn Canada ULC. NORVASC Product Monograph. Available from: https://www.pfizer.ca/sites/default/files/202006/NORVASC_PM_E_236351_2020.05.27.pdf