TEZRULY 1 mg/mL
Terazosin · SOLUTION · ANI Pharmaceuticals, Inc.
TEZRULY is a solution containing terazosin at 1 mg/mL, taken oral. Manufactured by ANI Pharmaceuticals, Inc..
Key Facts
- Brand Name
- TEZRULY
- Generic Name
- Terazosin
- NDC Code (Product)
70954-592- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 1 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA218139
- Marketing Start
- 04/18/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE TEZRULY TM (terazosin) is an alpha-1 adrenoceptor antagonist indicated for: The treatment of signs and symptoms of benign prostatic hyperplasia (BPH) (1.1) The treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. (1.2) 1.1 Benign Prostatic Hyperplasia TEZRULY is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult males [see Clinical Studies (14.1)] . 1.2 Hypertension TEZRULY is indicated for the treatment of hypertension, to lower blood pressure in adults [see Clinical Studies (14.2)] . Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exerci…
Dosage & Administration
2 DOSAGE & ADMINISTRATION For the treatment of BPH: Initiate therapy at 1 mg orally once daily at bedtime. Titrate the dose upwards step-wise from 2 mg to 10 mg once daily. Doses of 10 mg once daily are generally required for a clinical response. Data is insufficient to support doses greater than 20 mg once daily. (2.1) For the treatment hypertension: Initiate therapy at 1 mg orally once daily at bedtime. Usual recommended dose range is 1 mg to 5 mg once daily. If response is substantially diminished at 24 hours, increase the dose or use twice daily. Dose may be titrated as needed up to 20 mg once daily. (2.2) If terazosin is discontinued for more than a few days, restart using the initial dosing regimen. (2.1) 2.1 Recommended Dosage for Benign Prostatic Hyperplasia Initial Dose: 1 mg orally once daily at bedtime. This dose should not be exceeded as an initial dose. Closely follow patients during initial administration in order to minimize the risk of severe hypotensive response, including syncope. For administration instructions, see Dosage and Administration (2.3). Subsequent Doses: The dose should be increased in a stepwise fashion from 2 mg to 10 mg orally once daily to achieve…
Contraindications
4 CONTRAINDICATIONS TEZRULY is contraindicated in patients known to be hypersensitive to terazosin or any component of TEZRULY. Hypersensitivity to terazosin hydrochloride or any other ingredient in TEZRULY. (4)
Drug Interactions
7 DRUG INTERACTIONS Co-administration of verapamil with terazosin increases the systemic exposure of terazosin [see Clinical Pharmacology (12.3)] , which may increase the risk of hypotenstion. To reduce the risk of hypotension, dosage reduction and re-titration of either agent may be necessary [see Warnings and Precautions (5.3)] . Co-administration of verapamil with terazosin increases the systemic exposure of terazosin and may lead to hypotension. Dosage reduction and re-titration of either agent may be necessary. (7)
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Syncope and ‘‘First-dose’’ Effect [see Warnings and Precautions (5.1)] Orthostatic Hypotension [see Warnings and Precautions (5.2)] Priapism [see Warnings and Precautions (5.3)] Intraoperative Floppy Iris Syndrome [see Warnings and Precautions (5.5)] In treatment of BPH, the most common adverse reactions (≥1% of patients and at a higher incidence than placebo) were asthenia, flu syndrome, postural hypotension, nausea, somnolence, vertigo, dyspnea, nasal congestion/rhinitis, blurred vision/amblyopia and erectile dysfunction. (6.1) In treatment of hypertension, the most common adverse reactions where the incidence on terazosin was ≥ 5%, where the incidence on terazosin was at least 2% and greater than placebo or where the reaction was of particular interest were asthenia, back pain, pain in the extremities, headache, palpitations, postural hypotension, tachycardia, nausea, edema, peripheral edema, weight gain, depression, dizziness, libido, decreased, nervousness, paresthesia, somnolence, dyspnea, nasal congestion, sinusitis, blurred vision, and erectile dysfunction. (6…
Frequently Asked Questions
What is TEZRULY used for?
TEZRULY contains Terazosin. It is a solution taken oral. Consult your doctor for specific uses.
Is TEZRULY a controlled substance?
TEZRULY is not classified as a controlled substance by the DEA.
What is the generic name for TEZRULY?
The generic name for TEZRULY is Terazosin. There are 11 other brand versions of Terazosin.
What is the NDC code for TEZRULY 1 mg/mL?
The NDC (National Drug Code) for TEZRULY 1 mg/mL is 70954-592, listed by ANI Pharmaceuticals, Inc..