Norvasc Protect Dosage/Direction for Use

General Considerations: Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) is a combination product targeting concomitant cardiovascular conditions, hypertension/angina and dyslipidemia.
The dosage range for Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) is 5 mg/10 mg to a maximum dose of 10 mg/20 mg once daily. The starting dose and maintenance dose should be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and dyslipidemia. Current treatment guidelines should be consulted to establish treatment goals for patients based on their baseline characteristics. Doses may be taken at any time of day with or without food.
As a component of multiple risk factor intervention, amlodipine/atorvastatin should be used in addition to non-pharmacological measures, including an appropriate diet, exercise and weight reduction in obese patients, smoking cessation, and to treat underlying medical problems, when the response to these measures have been inadequate.
Following initiation and/or titration of amlodipine/atorvastatin, lipid levels should be analyzed and BP measured within 2 to 4 weeks, and dosage of amlodipine and atorvastatin components should be adjusted accordingly. Titration for BP response may proceed more rapidly if clinically warranted.
Initial Therapy: Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. The recommended starting dose of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) should be based on the appropriate combination of recommendations for the amlodipine and atorvastatin components considered separately. The maximum dose of the amlodipine component of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) is 10 mg once daily. The maximum dose of the atorvastatin component of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) is 20 mg once daily.
Substitution Therapy: Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) may be substituted for its individually titrated components. Patients may be given the equivalent dose of Amlodipine besilate and Atorvastatin calcium or a dose of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) with increased amounts of amlodipine, atorvastatin or both for additional antianginal effects, BP lowering, or lipid lowering effect.
Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) may be used to provide additional therapy for patients already on one of its components. As initial therapy for one indication and continuation of treatment of the other, the recommended starting dose of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) should be selected based on continuation of the component being used previously and on the recommended starting dose for the component being added.
Concomitant Medication (see also Interactions): The amlodipine component of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) has been safely co-administered with thiazide diuretics, alpha blockers, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, long-acting nitrates, and with sublingual nitroglycerine. Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) has also been safely administered with the aforementioned medicines.
The atorvastatin component of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) may be used in combination with a bile acid-binding resin for additive effect on lipid lowering. The combination of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors and fibrates should generally be avoided (see Precautions and Interactions).
Special Populations and Special Considerations for Dosing: Coronary Artery Disease (Amlodipine Studies): For patients with CAD, the recommended dosage range is 5 mg to 10 mg of amlodipine once daily. In clinical studies, the majority of patients required 10 mg once daily (see Pharmacology: Pharmacodynamics: Amlodipine/Atorvastatin Pharmacodynamics: Use in Patients with Coronary Artery Disease under Actions).
Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia (Atorvastatin Studies): The majority of patients are controlled with 10 mg of atorvastatin once daily. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia (Atorvastatin Studies): In a compassionate-use study of patients with homozygous FH, most patients responded to 80 mg of atorvastatin with a greater than 15% reduction in LDL-C (18%-45%).
Use in Patients with Impaired Hepatic Function: Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) should not be used in patients with hepatic impairment (see Contraindications and Precautions).
Use in Patients with Impaired Renal Function: No adjustment of the dose is required in patients with impaired renal function (see Precautions).
Use in the Elderly: No adjustment of the dose is required in elderly patients.
Use in Children: There have been no studies conducted to determine the safety or effectiveness of Amlodipine besilate/Atorvastatin calcium (Norvasc Protect) (combination product) in pediatric populations. However, there have been studies in pediatric populations with amlodipine alone and atorvastatin alone (see as follows).
Studies with amlodipine: The recommended antihypertensive oral dose in pediatric patients aged 6 to 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 (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
The effect of amlodipine on BP in patients less than 6 years of age is not known.
Studies with atorvastatin: Use in Pediatric Patients with Severe Dyslipidemias: For patients aged 10 years and above, the recommended starting dose is 10 mg of atorvastatin per day. The dose may be increased to 80 mg daily according to the response and tolerability. Doses should be individualized according to the recommended goal of therapy (see Indications/Uses and Pharmacology: Pharmacodynamics under Actions). Adjustments should be made at intervals of 4 weeks or more.
Experience in pediatric patients younger than 10 years of age is derived from open-label studies (see Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics: Special Populations under Actions).
Use in Combination with Other Medicinal Compounds: Studies with atorvastatin: In cases where co-administration of atorvastatin with cyclosporine, telaprevir, the combination tipranavir/ritonavir, or glecaprevir/pibrentasvir is necessary, the dose of atorvastatin should not exceed 10 mg.
Use of atorvastatin is not recommended in patients taking letermovir co-administered with cyclosporine.
Pharmacokinetic drug interactions that result in increased systemic concentration of atorvastatin have also been noted with other human immunodeficiency virus (HIV) protease inhibitors (lopinavir/ritonavir, saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir, fosamprenavir/ritonavir and nelfinavir), hepatitis C (HCV) protease inhibitors (boceprevir, elbasvir/grazoprevir, simeprevir), clarithromycin, itraconazole, and letermovir. Caution should be used when co-prescribing atorvastatin and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed (see Skeletal Muscle Effects under Precautions and Interactions).