Doxazosin mesylate 4 mg/1
Doxazosin mesylate · TABLET · Chartwell RX, LLC
Doxazosin mesylate is a tablet containing doxazosin mesylate at 4 mg/1, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Doxazosin mesylate
- Generic Name
- Doxazosin mesylate
- NDC Code (Product)
62135-053- Manufacturer
- Chartwell RX, LLC
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075646
- Marketing Start
- 10/18/2000
Recall History
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.
Pfizer Inc.
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
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 is an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) ( 1.1 ) • Treatment of Hypertension ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablet is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablet is 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 Prevention, Detection,…
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 of 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, monitor blood pressure for at least 6 hours following administration. If Doxazosin tablet 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 tablet 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 tablet is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desired redu…
Contraindications
4 CONTRAINDICATIONS The use of Doxazosin tablet 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. ( 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 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 is used concomitantly with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ]. 7.2 Phosphodiesterase-5 (PDE-5) Inhibitors Concomitant administration of Doxazosin 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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 tablet 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 vs. placebo are summarized in Table 1. Table 1. Adverse Reactions Occurring More than 1% More Frequently in BPH Patients Treated with Doxazosin …
Frequently Asked Questions
What is Doxazosin mesylate used for?
Doxazosin mesylate contains Doxazosin mesylate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Doxazosin mesylate a controlled substance?
Doxazosin mesylate is not classified as a controlled substance by the DEA.
What is the generic name for Doxazosin mesylate?
The generic name for Doxazosin mesylate is Doxazosin mesylate. There are 11 other brand versions of Doxazosin mesylate.
What is the NDC code for Doxazosin mesylate 4 mg/1?
The NDC (National Drug Code) for Doxazosin mesylate 4 mg/1 is 62135-053, listed by Chartwell RX, LLC.