Terazosin
Product Images NDC 60760-816

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Terazosin (NDC 60760-816). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by St Mary's Medical Park Pharmacy, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

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Chemical structure of terazosin hydrochloride dihydrate showing its molecular formula C19H25N5O4 with hydrochloride and two water molecules, along with the molecular weight of 459.93.*

FDA Label Image

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A data table comparing symptom scores and peak flow rates in three studies of terazosin versus placebo. It shows mean baseline values and mean percentage changes for symptom scores and peak flow rates at various dosages over several weeks, highlighting statistically significant improvements with terazosin compared to placebo.*

FDA Label Image

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This figure presents two line graphs from Study 1 comparing terazosin and placebo groups. The left graph shows the mean change in total symptom score from baseline over three months, with terazosin showing a greater decrease. The right graph depicts the mean increase in peak flow rate (mL/sec) from baseline, where terazosin shows a higher increase than placebo over three months. Sample sizes are noted for each group.*

FDA Label Image

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A line graph titled 'Mean Change in Total Symptom Score from Baseline' from a long-term, open-label, non-placebo controlled study with 494 participants. The x-axis represents months (0 to 30), and the y-axis shows mean changes from baseline, ranging from 0 to -7. Data points indicate a downward trend in symptom score, with a steep drop in the first 3 months followed by a gradual decline. Statistically significant changes (p ≤ 0.05) compared to baseline are marked with asterisks throughout the study period.*

FDA Label Image

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A line graph titled 'Mean Change in Peak Flow Rate from Baseline' showing data from a long-term, open-label, non-placebo controlled study with 494 participants. The vertical axis represents the mean change from baseline in mL/sec, ranging from 0.0 to 4.5, and the horizontal axis represents time in months from 0 to 30. Two data series are plotted with points connected by lines, showing changes over time with statistical significance indicated by asterisks at various months. Mean baseline is noted as 9.9 mL/sec.*

FDA Label Image

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A data table titled 'Mean Changes in Blood Pressure from Baseline to Final Visit in all Double-Blind Placebo-Controlled Studies' showing the number of patients (N) and mean changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for normotensive (DBP ≤ 90 mmHg) and hypertensive patients (DBP > 90 mmHg) treated with placebo or terazosin. Statistically significant reductions are indicated for terazosin compared to placebo.*

FDA Label Image

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A data table titled 'Adverse Reactions During Placebo-Controlled Trials Benign Prostatic Hyperplasia' comparing adverse reactions between terazosin (N=636) and placebo (N=360). It lists body systems and specific adverse effects with percentages for each group, including body as a whole, cardiovascular system, digestive system, metabolic and nutritional disorders, nervous system, respiratory system, special senses, and urogenital system.*

FDA Label Image

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A data table titled 'Discontinuation During Placebo-Controlled Trials Benign Prostatic Hyperplasia' comparing adverse events leading to discontinuation between Terazosin (N=636) and placebo (N=360). The table categorizes events by body system, including body as a whole, cardiovascular, digestive, nervous, respiratory, special senses, and urogenital, listing percentages for symptoms such as fever, headache, postural hypotension, nausea, dizziness, blurred vision, and urinary tract infection.*

FDA Label Image

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A table titled 'Adverse Reactions During Placebo-Controlled Trials Hypertension,' comparing adverse reaction percentages between terazosin (N=859) and placebo (N=506) by body system. It lists reactions such as asthenia, headache, palpitations, nausea, edema, dizziness, nasal congestion, blurred vision, and others, including notes on statistical significance.*

FDA Label Image

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Data table titled 'Discontinuation During Placebo-Controlled Trials Hypertension' comparing adverse events leading to discontinuation between terazosin (N=859) and placebo (N=506). It lists events by body system, including body as a whole, cardiovascular, digestive, metabolic and nutritional disorders, nervous, respiratory systems, and special senses, with percentages for each event under terazosin and placebo groups.*

FDA Label Image

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FDA Label Image

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FDA Label Image

Tera (Terazosin 60760 0816 90)

Label for Terazosin Capsules, USP 5 mg, quantity 90, with an NDC of 60760-816-90. Manufactured by Avet Pharmaceuticals Inc., East Brunswick, NJ, and packaged by St. Mary's Medical Park Pharmacy, Oro Valley, AZ. The label includes storage instructions to keep at controlled room temperature 15°-30°C (59°-86°F) and states 'Use as directed' with prescription only (Rx only).*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.