Amlodipine Besylate and Atorvastatin Calcium (Page 11 of 13)

14.10 Atorvastatin for Homozygous Familial Hypercholesterolemia

In a study without a concurrent control group, 29 patients ages 6 years to 37 years with HoFH received maximum daily doses of 20 to 80 mg of atorvastatin. The mean LDL-C reduction in this study was 18%. Twenty-five patients with a reduction in LDL-C had a mean response of 20% (range of 7% to 53%, median of 24%); the remaining 4 patients had 7% to 24% increases in LDL-C. Five of the 29 patients had absent LDL-receptor function. Of these, 2 patients also had a portacaval shunt and had no significant reduction in LDL-C. The remaining 3 receptor-negative patients had a mean LDL-C reduction of 22%.

14.11 Atorvastatin for Heterozygous Familial Hypercholesterolemia in Pediatric Patients

In a double-blind, placebo-controlled study followed by an open-label phase, 187 boys and post-menarchal girls 10 years to 17 years of age (mean age 14.1 years) with HeFH or severe hypercholesterolemia, were randomized to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks. Inclusion in the study required 1) a baseline LDL-C level ≥ 190 mg/dL or 2) a baseline LDL-C level ≥ 160 mg/dL and positive family history of FH or documented premature cardiovascular disease in a first or second-degree relative. The mean baseline LDL-C value was 218.6 mg/dL (range: 138.5 to 385 mg/dL) in the atorvastatin group compared to 230 mg/dL (range: 160 to 324.5 mg/dL) in the placebo group. The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and uptitrated to 20 mg if the LDL-C level was > 130 mg/dL. The number of atorvastatin-treated patients who required uptitration to 20 mg after Week 4 during the double-blind phase was 78 (55.7%).

Atorvastatin significantly decreased plasma levels of total-C, LDL-C, TG, and apolipoprotein B during the 26-week double-blind phase (see Table 14).

Table 14. Lipid-Altering Effects of Atorvastatin in Adolescent Boys and Girls with Heterozygous Familial Hypercholesterolemia or Severe Hypercholesterolemia (Mean Percentage Change from Baseline at Endpoint in Intention-to-Treat Population)

DOSAGE N Total-C LDL-C HDL-C TG Apo B
Placebo 47 -1.5 -0.4 -1.9 1 0.7
Atorvastatin 140 -31.4 -39.6 2.8 -12 -34

The mean achieved LDL-C value was 130.7 mg/dL (range: 70 to 242 mg/dL) in the atorvastatin group compared to 228.5 mg/dL (range: 152 to 385 mg/dL) in the placebo group during the 26-week double-blind phase.

Atorvastatin was also studied in a three year open-label, uncontrolled trial that included 163 patients with HeFH who were 10 years to 15 years old (82 boys and 81 girls). All patients had a clinical diagnosis of HeFH confirmed by genetic analysis (if not already confirmed by family history). Approximately 98% were Caucasian, and less than 1% were Black or Asian. Mean LDL-C at baseline was 232 mg/dL. The starting atorvastatin dosage was 10 mg once daily and doses were adjusted to achieve a target of <130 mg/dL LDL-C. The reductions in LDL-C from baseline were generally consistent across age groups within the trial as well as with previous clinical studies in both adult and pediatric placebo-controlled trials.

14.12 Amlodipine besylate and atorvastatin calcium for Hypertension and Dyslipidemia

In a double-blind, placebo-controlled study, a total of 1660 patients with co-morbid hypertension and dyslipidemia received once daily treatment with eight dose combinations of amlodipine and atorvastatin (5/10, 10/10, 5/20, 10/20, 5/40, 10/40, 5/80, or 10/80 mg), amlodipine alone (5 mg or 10 mg), atorvastatin alone (10 mg, 20 mg, 40 mg, or 80 mg), or placebo. In addition to concomitant hypertension and dyslipidemia, 15% of the patients had diabetes mellitus, 22% were smokers, and 14% had a positive family history of cardiovascular disease. At eight weeks, all eight combination-treatment groups of amlodipine and atorvastatin demonstrated statistically significant dose-related reductions in systolic blood pressure (SBP), diastolic blood pressure (DBP), and LDL-C compared to placebo, with no overall modification of effect of either component on SBP, DBP, and LDL-C (Table 15).

Table 15. Effects of Amlodipine and Atorvastatin on Blood Pressure and LDL-C

BP (mmHg) Atorvastatin
Amlodipine 0 mg 10 mg 20 mg 40 mg 80 mg
0 mg — -9.8/-4.3 -1.5/-0.8 -3.2/-0.6 -3.2/-1.8 -3.4/-0.8
5 mg -10.7/-4.9 -12.3/-6.1 -9.7/-4 -9.2/-5.1
10 mg -13.2/-7.1 -12.9/-5.8 -13.1/-7.3 -13.3/-6.5 -14.6/-7.8
LDL-C (% change) Atorvastatin
Amlodipine 0 mg 10 mg 20 mg 40 mg 80 mg
0 mg — 1 -32.3 -38.4 -42 -46.1
5 mg -37.6 -41.2 -43.8 -47.3
10 mg -1.4 -35.5 -37.5 -42.1 -48

16 HOW SUPPLIED/STORAGE AND HANDLING

Amlodipine besylate and atorvastatin calcium tablets contain amlodipine besylate USP and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below.

Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/10 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘407’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-323-30

Bottles of 60 NDC 43598-323-60

Bottles of 90 NDC 43598-323-90

Bottles of 500 NDC 43598-323-05

Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/20 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘408’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-320-30

Bottles of 60 NDC 43598-320-60

Bottles of 90 NDC 43598-320-90

Bottles of 500 NDC 43598-320-05

Amlodipine besylate and atorvastatin calcium tablets 2.5 mg/40 mg are white to off-white, round, film coated tablets debossed ‘R’ on one side and ‘409’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-317-30

Bottles of 60 NDC 43598-317-60

Bottles of 90 NDC 43598-317-90

Bottles of 500 NDC 43598-317-05

Amlodipine besylate and atorvastatin calcium tablets 5 mg/10 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘410’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-322-30

Bottles of 60 NDC 43598-322-60

Bottles of 90 NDC 43598-322-90

Bottles of 500 NDC 43598-322-05

Amlodipine besylate and atorvastatin calcium tablets 5 mg/20 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘411’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-319-30

Bottles of 60 NDC 43598-319-60

Bottles of 90 NDC 43598-319-90

Bottles of 500 NDC 43598-319-05

Amlodipine besylate and atorvastatin calcium tablets 5 mg/40 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘412’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-316-30

Bottles of 60 NDC 43598-316-60

Bottles of 90 NDC 43598-316-90

Bottles of 500 NDC 43598-316-05

Amlodipine besylate and atorvastatin calcium tablets 5 mg/80 mg are white to off-white, oval shaped, film coated tablets debossed ‘R’ on one side and ‘413’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-314-30

Bottles of 60 NDC 43598-314-60

Bottles of 90 NDC 43598-314-90

Bottles of 500 NDC 43598-314-05

Amlodipine besylate and atorvastatin calcium tablets 10 mg/10 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘414’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-321-30

Bottles of 60 NDC 43598-321-60

Bottles of 90 NDC 43598-321-90

Bottles of 500 NDC 43598-321-05

Amlodipine besylate and atorvastatin calcium tablets 10 mg/20 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘415’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-318-30

Bottles of 60 NDC 43598-318-60

Bottles of 90 NDC 43598-318-90

Bottles of 500 NDC 43598-318-05

Amlodipine besylate and atorvastatin calcium tablets 10 mg/40 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘416’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-315-30

Bottles of 60 NDC 43598-315-60

Bottles of 90 NDC 43598-315-90

Bottles of 500 NDC 43598-315-05

Amlodipine besylate and atorvastatin calcium tablets 10 mg/80 mg are blue, oval shaped, film coated tablets debossed ‘R’ on one side and ‘417’ on other side and are supplied in bottles of 30’s, 60’s, 90’s and 500’s.

Bottles of 30 NDC 43598-313-30

Bottles of 60 NDC 43598-313-60

Bottles of 90 NDC 43598-313-90

Bottles of 500 NDC 43598-313-05

Store Amlodipine besylate and atorvastatin calcium tablets at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

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