Dosage of CADUET must be individualized on the basis of both effectiveness and tolerance
for each individual component in the treatment of hypertension/angina and hyperlipidemia.
Amlodipine (Hypertension or angina)
Adults: The usual initial antihypertensive oral dose of amlodipine
is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly
individuals, or patients with hepatic insufficiency may be started on 2.5 mg once
daily and this dose may be used when adding amlodipine to other antihypertensive
therapy.
Dosage should be adjusted according to each patient's need. In general, titration
should proceed over 7 to 14 days so that the physician can fully assess the patient's
response to each dose level. Titration may proceed more rapidly, however, if clinically
warranted, provided the patient is assessed frequently.
The recommended dose of amlodipine for chronic stable or vasospastic angina is 5-10
mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Most patients will require 10 mg for adequate effect. See ADVERSE REACTIONS
section for information related to dosage and side effects.
The recommended dose range of amlodipine for patients with coronary artery disease
is 5-10 mg once daily. In clinical studies the majority of patients required 10
mg (see CLINICAL PHARMACOLOGY, Clinical studies).
Children: The effective antihypertensive oral dose of amlodipine 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. (see CLINICAL PHARMACOLOGY).
Atorvastatin (Hyperlipidemia)
Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia
(Fredrickson Types IIa and IIb)
The recommended starting dose of atorvastatin is 10 or 20 mg once daily. Patients
who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once
daily. The dosage range of atorvastatin is 10 to 80 mg once daily. Atorvastatin
can be administered as a single dose at any time of the day, with or without food.
The starting dose and maintenance doses of atorvastatin should be individualized
according to patient characteristics such as goal of therapy and response (see
current NCEP
Guidelines). After initiation and/or upon titration
of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage
adjusted accordingly.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years
of age)
The recommended starting dose of atorvastatin is 10 mg/day; the maximum recommended
dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient
population). Doses should be individualized according to the recommended goal of
therapy (see current NCEP Pediatric Panel Guidelines1, CLINICAL
PHARMACOLOGY, and INDICATIONS AND USAGE.) Adjustments should
be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia
The dosage of atorvastatin in patients with homozygous FH is 10 to 80 mg daily.
Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g.,
LDL apheresis) in these patients or if such treatments are unavailable. Note: a
2.5/80 mg CADUET tablet is not available. Management of patients needing a 2.5/80 mg
combination requires individual assessments of dyslipidemia and therapy with the
individual components as a 2.5/80 mg CADUET tablet is not available.
Concomitant Lipid Lowering Therapy
Atorvastatin may be used with bile acid resins. The combination of statins and fibrates should generally
be used with caution (see WARNINGS, Skeletal Muscle, and PRECAUTIONS, Drug Interactions).
Dosage in Patients With Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin;
thus, dosage adjustment in patients with renal dysfunction is not necessary (see
WARNINGS, Skeletal Muscle, and CLINICAL PHARMACOLOGY,
Specific Populations).
Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or a Combination of Ritonavir
plus Saquinavir or Lopinavir plus Ritonavir
In patients taking cyclosporine, therapy should be limited to LIPITOR 10 mg once
daily. In patients taking clarithromycin, itraconazole or in patients with HIV taking a combination
of ritonavir plus saquinavir or lopinavir plus ritonavir, for doses of atorvastatin
exceeding 20 mg, appropriate clinical assessment is recommended to ensure that the
lowest dose necessary of atorvastatin is employed (see WARNINGS, Skeletal Muscle,
and PRECAUTIONS, Drug Interactions).
CADUET
CADUET may be substituted for its individually titrated components. Patients may
be given the equivalent dose of CADUET or a dose of CADUET with increased amounts
of amlodipine, atorvastatin or both for additional antianginal effects, blood pressure
lowering, or lipid lowering effect.
CADUET 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 CADUET should be selected based on
the continuation of the component being used and the recommended starting dose for
the added monotherapy.
CADUET may be used to initiate treatment in patients with hyperlipidemia and either
hypertension or angina. The recommended starting dose of CADUET should be based
on the appropriate combination of recommendations for the monotherapies. The maximum
dose of the amlodipine component of CADUET is 10 mg once daily. The maximum dose
of the atorvastatin component of CADUET is 80 mg once daily.
See above for detailed information related to the dosing and administration of amlodipine
and atorvastatin.
- National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert
Panel on Blood Cholesterol Levels in Children Adolescents. Pediatrics. 89(3):495-501.
1992.