Amlodipine use in specific populations: Difference between revisions
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{{CMG}}; {{AE}} {{AK}} | {{CMG}}; {{AE}} {{AK}} | ||
== | == USE IN SPECIFIC POPULATIONS== | ||
=== | === Pregnancy=== | ||
'''Pregnancy Category C''' | '''Pregnancy Category C''' | ||
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<sup>9</sup>Based on patient weight of 50 kg. | <sup>9</sup>Based on patient weight of 50 kg. | ||
=== | === Nursing Mothers=== | ||
It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while NORVASC is administered. | It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while NORVASC is administered. | ||
=== | === Pediatric Use=== | ||
Effect of NORVASC on blood pressure in patients less than 6 years of age is not known. | Effect of NORVASC on blood pressure in patients less than 6 years of age is not known. | ||
=== | === Geriatric Use=== | ||
Clinical studies of NORVASC 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 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 [see [[Amlodipine dosage and administration|Dosage and Administration (2.1)]]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44e5ad27-e062-461a-bdf4-192d852fbc49#nlm42230-3 | publisher = | date = | accessdate = 6 March 2014 }}</ref> | Clinical studies of NORVASC 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 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 [see [[Amlodipine dosage and administration|Dosage and Administration (2.1)]]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44e5ad27-e062-461a-bdf4-192d852fbc49#nlm42230-3 | publisher = | date = | accessdate = 6 March 2014 }}</ref> | ||
Revision as of 01:18, 13 March 2014
| Amlodipine |
|---|
| NORVASC®, AMLODIPINE®, AMLODIPINE BESYLATE® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Dosage Forms and Strengths |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Overdosage |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| Clinical Studies |
| How Supplied/Storage and Handling |
| Patient Counseling Information |
| Labels and Packages |
| Clinical Trials on Amlodipine |
| ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (respectively, 8 times8 and 23 times9 the maximum recommended human dose of 10 mg on a mg/m2 basis) during their respective periods of major organogenesis. However, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose.
8Based on patient weight of 50 kg.
9Based on patient weight of 50 kg.
Nursing Mothers
It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while NORVASC is administered.
Pediatric Use
Effect of NORVASC on blood pressure in patients less than 6 years of age is not known.
Geriatric Use
Clinical studies of NORVASC 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 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 [see Dosage and Administration (2.1)].[1]
References
- ↑ "NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH]". Retrieved 6 March 2014.