Doxazosin 8 mg/1
Doxazosin · TABLET · Zydus Lifesciences Limited
Doxazosin is an oral tablet used to treat high blood pressure and urinary symptoms caused by an enlarged prostate. It works by relaxing blood vessels and muscles in the prostate and bladder to improve blood flow and urine flow.
Key Facts
- Brand Name
- Doxazosin
- Generic Name
- Doxazosin
- NDC Code (Product)
70771-1115- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 8 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208719
- Marketing Start
- 08/31/2017
Recall History
Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Unichem Pharmaceuticals USA Inc.
Tablets/Capsules Imprinted with Wrong ID
Aidapak Services, LLC
Labeling: Label Mixup: DOXAZOSIN MESYLATE, Tablet, 1 mg may have potentially been mislabeled as the following drug: PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: W003872, EXP: 6/27/2014.
Mylan Pharmaceuticals Inc.
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Viatris Inc
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Northwind Pharmaceuticals LLC
CGMP Deviations
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Doxazosin tablets are an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) • Treatment of HypertensionTreatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose may be titrated at 1 to 2 week intervals, up to 8 mg once daily.( 2.2 ) • For the treatment hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ( 2.3 ) 2.1 Dosing Information Following the initial dose and with each dose increase of doxazosin tablets, monitor blood pressure for at least 6 hours following administration. If doxazosin tablets administration is discontinued for several days, therapy should be restarted using the initial dosing regimen. 2.2 Benign Prostatic Hyperplasia The recommended initial dosage of doxazosin tablets is 1 mg given once daily either in the morning or evening. Depending on the individual patient’s urodynamics and BPH symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg, and thereafter to 4 mg and 8 mg once daily. The maximum recommended dose for BPH is 8 mg once daily. Routinely monitor blood pressure in these patients. 2.3 Hypertension The initial dosage of doxazosin tablets is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desir…
Contraindications
4 CONTRAINDICATIONS The use of doxazosin tablets is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. • Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in doxazosin tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. ( 7.1 ) • Concomitant administration of doxazosin tablets with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.2 ) 7.1 CYP 3A Inhibitors In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin. Monitor blood pressure and for symptoms of hypotension when doxazosin tablets are used concomitantly with strong CYP3A inhibitors [ see Clinical Pharmacology ( 12.3 ) ]. 7.2 Phosphodiesterase-5 (PDE-5) Inhibitors Concomitant administration of doxazosin tablets with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. Monitor blood pressure and for symptoms of hypotension [ see Warnings and Precautions ( 5.1 ) ].
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions from clinical trials are Fatigue, malaise, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Benign Prostatic Hyperplasia (BPH) The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of doxazosin tablets in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with doxazosin tablets vs placebo are summarized in Table 1. Table 1. Adverse Reactions Occurring more than 1% More Frequently in BPH Patients Treated with Doxazosin Tablet…
Frequently Asked Questions
What is Doxazosin used for?
Doxazosin is an oral tablet used to treat high blood pressure and urinary symptoms caused by an enlarged prostate. It works by relaxing blood vessels and muscles in the prostate and bladder to improve blood flow and urine flow.
Is Doxazosin a controlled substance?
Doxazosin is not classified as a controlled substance by the DEA.
What is the generic name for Doxazosin?
The generic name for Doxazosin is Doxazosin. There are 3 other brand versions of Doxazosin.
What is the NDC code for Doxazosin 8 mg/1?
The NDC (National Drug Code) for Doxazosin 8 mg/1 is 70771-1115, listed by Zydus Lifesciences Limited.