Doxazosin use in specific populations

Doxazosin
Doxazosin®, Cardura® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Doxazosin
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 POPULATION

Pregnancy

Teratogenic Effects, Pregnancy Category C.

Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations 10 and 4 times human Cmax and AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of harm to the fetus. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, doxazosin should be used during pregnancy only if clearly needed.

Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats.

Nonteratogenic Effects

In peri-postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes.

Nursing Mothers

Studies in lactating rats given a single oral dose of 1 mg/kg of [2-14C]-doxazosin indicate that doxazosin accumulates in rat breast milk with a maximum concentration about 20 times greater than the maternal plasma concentration. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when doxazosin is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of doxazosin as an antihypertensive agent have not been established in children.

Geriatric Use

The safety and effectiveness profile of doxazosin in BPH was similar in the elderly (age > 65 years) and younger (age < 65 years) patients.

For hypertension

Clinical studies of Doxazosin Tablets 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.