Terazosin (Page 4 of 7)

Pregnancy

Teratogenic Effects :

Pregnancy Category C

Terazosin capsules were not teratogenic in either rats or rabbits when administered at oral doses up to 280 and 60 times, respectively, the maximum recommended human dose. Fetal resorptions occurred in rats dosed with 480 mg/kg/day, approximately 280 times the maximum recommended human dose. Increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed in offspring of rabbits dosed with 60 times the maximum recommended human dose. These findings (in both species) were most likely secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women and the safety of terazosin in pregnancy has not been established. Terazosin capsules are not recommended during pregnancy unless the potential benefit justifies the potential risk to the mother and fetus.

Nonteratogenic Effects :

In a peri- and post-natal development study in rats, significantly more pups died in the group dosed with 120 mg/kg/day (> 75 times the maximum recommended human dose) than in the control group during the three-week postpartum period.

Nursing Mothers :

It is not known whether terazosin is excreted in breast milk. Because many drugs are excreted in breast milk, caution should be exercised when terazosin capsules are administered to a nursing woman.

Pediatric Use :

Safety and effectiveness in pediatric patients have not been determined.

ADVERSE REACTIONS

Benign Prostatic Hyperplasia

The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1%, and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p ≤ 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS) adjusted for the length of drug treatment has shown that the risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals.

TABLE 1. Adverse Reactions During Placebo-Controlled Trials Benign Prostatic Hyperplasia
*
Includes weakness, tiredness, lassitude, and fatigue.
p ≤ 0.05 comparison between groups.
Body System

Terazosin

(N = 636)

Placebo

(N = 360)

BODY AS A WHOLE

*Asthenia

Flu Syndrome

7.4%

2.4%

3.3%

1.7%

CARDIOVASCULAR SYSTEM

Hypotension

Palpitations

Postural Hypotension

0.6%

0.9%

3.9%

0.6%

1.1%

0.8%

DIGESTIVE SYSTEM

1.7% 1.1%

METABOLIC AND NUTRITIONAL DISORDERS

Peripheral Edema

0.9%

0.3%

NERVOUS SYSTEM

Dizziness

Somnolence

9.1%

3.6%

4.2%

1.9%

RESPIRATORY SYSTEM

Dyspnea

1.7%

0.8%

SPECIAL SENSES

1.3% 0.6%

UROGENITAL SYSTEM

Impotence

1.6%

0.6%

Additional adverse events have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to terazosin. The safety profile of patients treated in the long-term open-label study was similar to that observed in the controlled studies.

The adverse events were usually transient and mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In the placebo-controlled clinical trials, the rates of premature termination due to adverse events were not statistically different between the placebo and terazosin groups. The adverse events that were bothersome, as judged by their being reported as reasons for discontinuation of therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group, are shown in Table 2.

TABLE 2. Discontinuation During Placebo-Controlled Trials Benign Prostatic Hyperplasia
Body System

Terazosin

(N = 636)

Placebo

(N = 360)

BODY AS A WHOLE

Fever

0.5%

0.0%

CARDIOVASCULAR SYSTEM

Postural Hypotension

0.5%

0.0%

DIGESTIVE SYSTEM

0.5% 0.3%

NERVOUS SYSTEM

Dizziness

2.0%

1.1%

RESPIRATORY SYSTEM

0.5% 0.3%

SPECIAL SENSES

0.6% 0.0%

UROGENITAL SYSTEM

0.5% 0.3%

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