A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Caduet Indications, Dosage, Storage, Stability - Amlodipine besylate/atorvastatin
Caduet Indications, Dosage, Storage, Stability - Amlodipine besylate/atorvastatin
INDICATIONS AND USAGE
CADUET (amlodipine and atorvastatin) is indicated in patients
for whom treatment with both amlodipine and atorvastatin is appropriate.
Amlodipine
1. Hypertension: Amlodipine
is indicated for the treatment of hypertension. It may be used alone or in combination
with other antihypertensive agents;
2. Chronic Stable Angina: Amlodipine
is indicated for the treatment of chronic stable angina, for the treatment of
confirmed or suspected vasospastic angina and for the treatment of hypertension.
Amlodipine may be used alone or in combination with other antianginal or antihypertensive
agents;
3. Vasospastic Angina (Prinzmetal’s
or Variant Angina): Amlodipine is indicated for the treatment of confirmed
or suspected vasospastic angina. Amlodipine may be used as monotherapy or in
combination with other antianginal drugs.
AND
Atorvastatin
1. Heterozygous Familial and Nonfamilial:
Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C,
LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson
Types IIa and IIb);
2. Elevated Serum TG Levels:
Atorvastatin is indicated as an adjunct to diet for the treatment of patients
with elevated serum TG levels (Fredrickson Type IV);
3. Primary Dysbetalipoproteinemia:
Atorvastatin is indicated for the treatment of patients with primary dysbetalipoproteinemia
(Fredrickson Type III) who do not respond adequately to diet;
4. Homozygous Familial Hypercholesterolaemia:
Atorvastatin is indicated to reduce total-C and LDL-C in patients with homozygous
familial hypercholesterolemia as an adjunct to other lipid-lowering treatments
(e.g., LDL apheresis) or if such treatments are unavailable;
5. Pediatric Patients: Atorvastatin
is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels
in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial
hypercholesterolemia if after an adequate trial of diet therapy the following
findings are present:
a. LDL-C remains ³ 190 mg/dL or
b. LDL-C remains ³ 160 mg/dL and:
· there is a positive family history of premature
cardiovascular disease or
· two or more other CVD risk factors are present
in the pediatric patients.
Therapy with lipid-altering agents should be a component of
multiple-risk-factor intervention in individuals at increased risk for atherosclerotic
vascular disease due to hypercholesterolemia. Lipid-altering agents should be
used, in addition to a diet restricted in saturated fat and cholesterol, only
when the response to diet and other nonpharmacological measures has been inadequate
(see National Cholesterol Education Program (NCEP) Guidelines, summarized
in Table 8).
|
Table 8. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints
for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
|
|
Risk Category
|
LDL Goal (mg/dL)
|
LDL Level at Which to Initiate Therapeutic Lifestyle Changes
(mg/dL)
|
LDL Level at Which to Consider Drug Therapy (mg/dL)
|
|
CHD a or CHD risk equivalents (10-year risk
>20%)
|
<100
|
³100
|
³130 (100-129: drug optional)
b
|
|
2+ Risk Factors (10-year risk £20%)
|
<130
|
³130
|
10-year risk 10%-20%: ³130
10-year risk <10%: ³ 160
|
|
0-1 Risk factor c
|
<160
|
³160
|
³190 (160-189: LDL-lowering
drug optional)
|
|
a CHD, coronary heart disease
|
|
b Some authorities recommend use of LDL-lowering
drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved
by therapeutic lifestyle changes. Others prefer use of drugs that primarily
modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical
judgement also may call for deferring drug therapy in this subcategory.
|
|
c Almost all people with 0-1 risk factor have
10-year risk <10%; thus, 10-year risk assessment in people with 0-1
risk factor is not necessary.
|
After the LDL-C goal has been achieved, if the TG is still
> 200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target
of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each
risk category.
Prior to initiating therapy with atorvastatin, secondary causes
for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism,
nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy,
and alcoholism) should be excluded, and a lipid profile performed to measure
total-C, LDL-C, HDL-C, and TG. For patients with TG <400 mg/dL (<4.5 mmol/L),
LDL-C can be estimated using the following equation: LDL-C = total-C - (0.20
x [TG] + HDL-C). For TG levels >400 mg/dL (>4.5 mmol/L), this equation
is less accurate and LDL-C concentrations should be determined by ultracentrifugation.
The antidyslipidemic component of CADUET has not been studied
in conditions where the major lipoprotein abnormality is elevation of chylomicrons
(Fredrickson Types I and V).
The NCEP classification of cholesterol levels in pediatric
patients with a familial history of hypercholesterolemia or premature cardiovascular
disease is summarized below:
|
Table 9: NCEP Classification of Cholesterol Levels in
Pediatric Patients
|
|
Category
|
Total-C (mg/dL)
|
LDL-C (mg/dL)
|
|
Acceptable
|
<170
|
<110
|
|
Borderline
|
170-199
|
110-129
|
|
High
|
³200
|
³130
|
DOSAGE AND ADMINISTRATION
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. Management of patients needing 2.5 mg amlodipine
requires individual assessments of hypertension and therapy with the individual
amlodipine component, since an amlodipine 2.5 mg CADUET tablet is not available.
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.
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)
The patient should be placed on a standard cholesterol-lowering
diet before receiving atorvastatin and should continue on this diet during treatment
with atorvastatin.
Hypercholesterolemia (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 NCEP Guidelines, summarized in Table
7). After initiation and/or upon titration of atorvastatin, lipid levels should
be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
Since the goal of treatment is to lower LDL-C, the NCEP recommends
that LDL-C levels be used to initiate and assess treatment response. Only if
LDL-C levels are not available, should total-C be used to monitor therapy.
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 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 Therapy
Atorvastatin may be used in combination with a bile acid binding
resin for additive effect. The combination of HMG-CoA reductase inhibitors and
fibrates should generally be avoided (see WARNINGS,
Skeletal Muscle, and PRECAUTIONS, DRUG
INTERACTIONS for other drug-DRUG INTERACTIONS).
Dosage in Patients With Renal Insufficiency
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 CLINICAL PHARMACOLOGY,
Pharmacokinetics).
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,
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.
HOW SUPPLIED
CADUET tablets contain amlodipine besylate and atorvastatin
calcium equivalent to amlodipine and atorvastatin in the dose strengths described
below.
CADUET tablets are differentiated by Tablet color/size and
are engraved with "Pfizer" on one side and a unique number on the
other side. CADUET Tablets are supplied for oral administration in the following
strengths and package configurations:
|
Table 11: CADUET Packaging Configurations
|
|
CADUET
|
|
Package Configuration
|
Tablet Strength (amlodipine besylate/atorvastatin calcium)
mg
|
NDC #
|
Engraving
|
Tablet Color
|
|
Bottle of 30
|
5/40
|
0069-2190-30
|
CDT 054
|
White
|
|
Bottle of 30
|
5/80
|
0069-2260-30
|
CDT 058
|
White
|
|
Bottle of 30
|
10/40
|
0069-2250-30
|
CDT 104
|
Blue
|
|
Bottle of 30
|
10/80
|
0069-2270-30
|
CDT 108
|
Blue
|
|
Bottle of 30
|
5/10
|
0069-2150-30
|
CDT 051
|
White
|
|
Bottle of 30
|
5/20
|
0069-2170-30
|
CDT 052
|
White
|
|
Bottle of 30
|
10/10
|
0069-2160-30
|
CDT 101
|
Blue
|
|
Bottle of 30
|
10/20
|
0069-2180-30
|
CDT 102
|
Blue
|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature].
Manufactured by: Pfizer Ireland Pharmaceuticals
Dublin, Ireland
DISTRIBUTED BY: Pfizer Labs, Division
of Pfizer Inc, NY, NY 10017, 69-6113-00-0 30 January 2004, © 2004 PFIZER
INC
top
