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CADUET (AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM) TABLETS: USE IN SPECIFIC POPULATIONS

Labor and Delivery

No studies have been conducted in pregnant women on the effect of Caduet, amlodipine or atorvastatin on the mother or the fetus during labor or delivery, or on the duration of labor or delivery. Amlodipine has been shown to prolong the duration of labor in rats.

Nursing Mothers

Amlodipine

It is not known whether the amlodipine component of Caduet is excreted in human milk.

Atorvastatin

It is not known whether the atorvastatin component of Caduet is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Nursing rat pups taking atorvastatin had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother's milk. Animal breast milk drug levels may not accurately reflect human breast milk levels. Because another drug in this class passes into human milk and because statins have a potential to cause serious adverse reactions in nursing infants, women taking Caduet, which includes atorvastatin, should be advised not to nurse their infants.

Pediatric Use

There have been no studies conducted to determine the safety or effectiveness of Caduet in pediatric populations.

Amlodipine

The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

Atorvastatin

Safety and effectiveness in patients 10-17 years of age with heterozygous familial hypercholesterolemia have been evaluated in controlled clinical trials of 6 months duration in adolescent boys and postmenarchal girls. Patients treated with atorvastatin had an adverse experience profile generally similar to that of patients treated with placebo, the most common adverse experiences observed in both groups, regardless of causality assessment, were infections. Doses greater than 20 mg have not been studied in this patient population. In this limited controlled study, there was no significant effect on growth or sexual maturation in boys or on menstrual cycle length in girls. Adolescent females should be counseled on appropriate contraceptive methods while on atorvastatin therapy. Atorvastatin has not been studied in controlled clinical trials involving pre-pubertal patients or patients younger than 10 years of age.

Clinical efficacy with doses of atorvastatin up to 80 mg/day for 1 year have been evaluated in an uncontrolled study of patients with homozygous FH including 8 pediatric patients.

Geriatric Use

There have been no studies conducted to determine the safety or effectiveness of Caduet in geriatric populations.

Amlodipine

Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection of the amlodipine component of Caduet for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40-60%, and a lower initial dose may be required.

Atorvastatin

Of the 39,828 patients who received Lipitor in clinical studies, 15,813 (40%) were >= 65 years old and 2,800 (7%) were >= 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older adults cannot be ruled out. Advanced age ( >= 65 years) is a predisposing factor for myopathy.

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