Doxazosin mesylate 2 mg Tablet, 90-count — NDC 62135-052-90 (Billing 62135-0052-90)
This is a package of 90 tablets of Doxazosin mesylate 2 mg Tablet from Chartwell RX, LLC, marketed since Oct 2000 and currently FDA-listed; retail pharmacies pay about $0.0636 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 62135-052-90 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 62135 labeler · 052 product · 90 package
- Package marketed since
- Jun 6, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 90 EA per package
- Barcode (UPC)
- 0362135052904, 0362135051907, 0362135053901, 0362135054908
- FDA record last changed
- Jul 24, 2026
Other active recalls for Doxazosin Mesylate (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 015585
- GCN: 33432
- GPI-14 (Medi-Span): 36202005100320
- HICL (First Databank): 006031
- AHFS class code: 24:16.00.00
- RxCUI (RxNorm): 197625
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the alpha-Adrenergic Blocker class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Doxazosin tablets are used for two main things: relieving the urinary symptoms of an enlarged prostate (BPH) — things like a weak stream, frequent urges to urinate, or waking up at...
- Yes, that's actually one of the most common things people notice, especially with the first dose or after a dose increase. Doxazosin can cause your blood pressure to drop when you...
- I felt really dizzy after my first dose — is that normal?
- For regular doxazosin tablets, you can take them either in the morning or the evening — just pick a consistent time and stick with it. If you're taking Cardura XL (the extended-rel...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Doxazosin Mesylate — tap one for details:
Doxazosin Mesylate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.064 | $5.72 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1425 | $12.83 / 90 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62135-0052-90 You're viewing this Main listing | 90 TABLET in 1 BOTTLE | 2023-06-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Doxazosin 2 mg 00093-2069-01 | Teva | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 00832-0357-11 | Upsher-Smith | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 00904-5523-61 | Major | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 16571-0166-01 | Rising | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 23155-0093-01 | Heritage | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin Mesylate 2 mg 29300-0352-01 | Unichem | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 50268-0223-15 | AvPAK | 50 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 59651-0893-01 | Aurobindo | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 59762-2420-07 | Mylan | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 60505-0094-00 | Apotex | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin mesylate 2 mgthis 62135-0052-90 | Chartwell | 90 tablets | $0.064 | — | Availability likely | — |
| Doxazosin 2 mg 68084-0851-01 | American | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 68382-0784-01 | Zydus | 100 tablets | $0.064 | AB | Availability likely | — |
| Doxazosin 2 mg 16729-0414-01 | Accord | 100 tablets | $0.069 | AB | Availability likely | +8% |
| Cardura 2 mg 00049-2512-10 | ROERIG | 100 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 42291-0258-10 | AvKARE | 1000 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 43063-0739-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 50090-5773-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 50090-6401-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 55154-7996-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 68071-3341-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 68071-3811-06 | NuCare | 60 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 68071-4273-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 68788-8422-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 70518-1560-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Doxazosin 2 mg 70518-3667-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Doxazosin 2 mg 70518-3965-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 70771-1113-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 71335-0309-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 71335-2395-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 71335-3081-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 71610-0153-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 71610-0482-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 72189-0117-60 | direct | 60 tablets | — | AB | FDA listed | — |
| Doxazosin 2 mg 84677-0045-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Doxazosin Mesylate 2 mg 53747-0352-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Chartwell RX, LLC labeler code 62135
- Acyclovir 200 mg Capsule NDC 62135-039-50
- Fosinopril Sodium 10 mg Tablet NDC 62135-041-90
- Fosinopril Sodium 20 mg Tablet NDC 62135-042-90
- Fosinopril Sodium 40 mg Tablet NDC 62135-043-90
- HYDROXYZINE HYDROCHLORIDE 50 mg/25mL Syrup NDC 62135-050-24
- Doxazosin mesylate 1 mg Tablet NDC 62135-051-90
- Doxazosin mesylate 4 mg Tablet NDC 62135-053-90
- Doxazosin mesylate 8 mg Tablet NDC 62135-054-90
- Cetirizine Hydrochloride Oral Solution 5 mg/5mL Solution NDC 62135-057-41
- Tolmetin Sodium 200 mg Tablet NDC 62135-062-30
- Ethosuximide 250 mg/5mL Solution NDC 62135-064-47
- Trihexyphenidyl Hydrochloride 2 mg/5mL Solution NDC 62135-065-47
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1 ) Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of Hypertension
⏱️ Dosage and 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 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Doxazosin Tablets, USP: 1 mg, 2 mg, 4 mg, or 8 mg. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg doxazosin (free base). Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of doxazosin mesylate 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 mesylate tablets. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Postural hypotension with or without syncope may occur. ( 5.1 ) Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. ( 5.2 ) Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards. ( 5.3 )
🤒 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 Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 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 mesylate with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.2 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Monitor for hypotension. ( 8.6 , 12.3 )
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data with doxazosin mesylate in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. However, untreated hypertension during pregnancy can result in increased maternal risks [see Clinical Considerations ] . In animal reproduction studies, no adverse developmental effects were observed when doxazosin was orally administered to pregnant rabbits and rats during the period of organogenesis at doses of up to 41 and 20 mg/kg, respectively (exposures in rabbits and rats were 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose).
A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival [see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats.
Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of adverse developmental effects. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. In peri- and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of doxazosin mesylate have not been established in children.
🧓 Geriatric Use ▾
8.5Geriatric Use Benign Prostatic Hyperplasia (BPH) The safety and effectiveness profile of doxazosin mesylate was similar in the elderly (age ≥ 65 years) and younger (age < 65 years) patients. Hypertension Clinical studies of doxazosin mesylate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Experience with doxazosin mesylate overdosage is limited. Two adolescents, who each intentionally ingested 40 mg doxazosin mesylate with diclofenac or acetaminophen, were treated with gastric lavage with activated charcoal and made full recoveries. A two-year-old child who accidently ingested 4 mg doxazosin mesylate was treated with gastric lavage and remained normotensive during the five-hour emergency room observation period.
A six-month-old child accidentally received a crushed 1 mg tablet of doxazosin mesylate and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg doxazosin mesylate (blood level = 0.9 mcg/mL; normal values in hypertensives = 0.02 mcg/mL); death was attributed to a grand mal seizure resulting from hypotension. A 39-year-old female who ingested 70 mg doxazosin mesylate, alcohol, and Dalmane ® (flurazepam) developed hypotension which responded to fluid therapy.
The oral LD 50 of doxazosin is greater than 1000 mg/kg in mice and rats. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of fluid. As doxazosin is highly protein bound, dialysis would not be indicated.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
🧬 Mechanism of Action ▾
12.1Mechanism of Action Benign Prostatic Hyperplasia (BPH) The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream, hesitancy, and incomplete emptying are related to two components, anatomical (static) and functional (dynamic). The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate.
The dynamic component of BPH is associated with an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha 1 adrenoceptor, which is present in high density in the prostatic stroma, prostatic capsule and bladder neck. Blockade of the alpha 1 receptor decreases urethral resistance and may relieve the obstruction and BPH symptoms and improve urine flow.
Hypertension The mechanism of action of doxazosin mesylate is selective blockade of the alpha 1 (postjunctional) subtype of adrenergic receptors. Studies in normal human subjects have shown that doxazosin competitively antagonized the pressor effects of phenylephrine (an alpha 1 agonist) and the systolic pressor effect of norepinephrine. Doxazosin and prazosin have similar abilities to antagonize phenylephrine.
The antihypertensive effect of doxazosin mesylate results from a decrease in systemic vascular resistance. The parent compound doxazosin is primarily responsible for the antihypertensive activity. The low plasma concentrations of known active and inactive metabolites of doxazosin (2-piperazinyl, 6'- and 7'-hydroxy and 6- and 7-O-desmethyl compounds) compared to parent drug indicate that the contribution of even the most potent compound (6'-hydroxy) to the antihypertensive effect of doxazosin in man is probably small.
The 6'- and 7'-hydroxy metabolites have demonstrated antioxidant properties at concentrations of 5 µM, in vitro .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Doxazosin Tablets, USP are available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, or 8 mg of doxazosin as the free base. NDC and Pack Size Strength Description NDC 62135-051-90 (Bottle of 90) 1 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "105" on the other side.
NDC 62135-052-90 (Bottle of 90) 2 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "106" on the other side. NDC 62135-053-90 (Bottle of 90) 4 mg White to off-white, round scored tablets, debossed with "C" over bisect" E" on one side and "107" on the other side. NDC 62135-054-90 (Bottle of 90) 8 mg White to off-white, round scored tablets, debossed with "C" over bisect "E" on one side and "108" on the other side.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed.
Avoid excessive heat. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Keep this and all medication out of the reach of children.
📋 Description ▾
11 DESCRIPTION Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23 H 25 N 5 O 5 · CH 4 O 3 S and the molecular weight is 547.6.
It has the following structure: Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate. "Image Description"
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Postural Hypotension Advise patients of the possibility of syncopal and orthostatic symptoms, especially at the initiation of therapy, and urged to avoid driving or hazardous tasks for 24 hours after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. Advise patients to report symptoms to their healthcare provider.
Priapism Advise patients of the possibility of priapism and to seek immediate medical attention if symptoms occur. This product's label may have been updated. For full prescribing information, please visit www.chartwellpharma.com.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Chartwell RX, LLC. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71479 Revised 05/2023 Print Patient Information at: www.chartwellpharma.com/our-products/
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption After oral administration of therapeutic doses, peak plasma levels of doxazosin mesylate occur at about 2–3 hours. Bioavailability is approximately 65%, reflecting first-pass metabolism of doxazosin by the liver. The effect of food on the pharmacokinetics of doxazosin mesylate was examined in a crossover study with twelve hypertensive subjects.
Reductions of 18% in mean maximum plasma concentration (C max ) and 12% in the area under the concentration-time curve (AUC) occurred when doxazosin mesylate was administered with food. Neither of these differences is clinically significant. In a crossover study in 24 normotensive subjects, the pharmacokinetics and safety of doxazosin were shown to be similar with morning and evening dosing regimens.
The AUC after morning dosing was, however, 11% less than that after evening dosing and the time to peak concentration after evening dosing occurred significantly later than that after morning dosing (5.6 vs. 3.5 hours). Distribution At the plasma concentrations achieved by therapeutic doses, approximately 98% of the circulating drug is bound to plasma proteins.
Metabolism Doxazosin mesylate is extensively metabolized in the liver, mainly by O-demethylation of the quinazoline nucleus or hydroxylation of the benzodioxan moiety. In vitro studies suggest that the primary pathway for elimination is via CYP 3A4; however, CYP 2D6 and CYP 2C9 metabolic pathways are also involved to a lesser extent. Although several active metabolites of doxazosin have been identified, the pharmacokinetics of these metabolites have not been characterized.
Excretion Plasma elimination of doxazosin is biphasic, with a terminal elimination half-life of about 22 hours. Steady-state studies in hypertensive patients given doxazosin doses of 2 to 16 mg once daily showed linear kinetics and dose proportionality. In two studies, following the administration of 2 mg orally once daily, the mean accumulation ratios (steady-state AUC vs. first-dose AUC) were 1.2 and 1.7.
Enterohepatic recycling is suggested by secondary peaking of plasma doxazosin concentrations. In a study of two subjects administered radiolabelled doxazosin 2 mg orally and 1 mg intravenously on two separate occasions, approximately 63% of the dose was eliminated in the feces and 9% of the dose was found in the urine. On average only 4.8% of the dose was excreted as unchanged drug in the feces and only a trace of the total radioactivity in the urine was attributed to unchanged drug.
Specific Populations Geriatric The pharmacokinetics of doxazosin mesylate in young (< 65 years) and elderly (≥65 years) subjects were similar for plasma half-life values and oral clearance. Renal Impairment Pharmacokinetic studies in elderly patients and patients with renal impairment have shown no significant alterations compared to younger patients with normal renal function. Hepatic Impairment Administration of a single 2 mg dose to patients with cirrhosis (Child-Pugh Class A) showed a 40% increase in exposure to doxazosin.
The impact of moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment on the pharmacokinetics of doxazosin is not known [ see Use in Specific Populations (8.6) ]. Drug Interactions There are only limited data on the effects of drugs known to influence the hepatic metabolism of doxazosin (e.g., cimetidine). Cimetidine: In healthy volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and a slight but not significant increase in mean C max and mean half-life of doxazosin.
In vitro data in human plasma indicate that doxazosin mesylate has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Benign Prostatic Hyperplasia (BPH) Administration of doxazosin mesylate to patients with symptomatic BPH resulted in a statistically significant improvement in maximum urinary flow rate [ see Clinical Studies (14.1) ]. Effect on Normotensive Patients with Benign Prostatic Hyperplasia (BPH) Although blockade of alpha 1 adrenoceptors also lowers blood pressure in hypertensive patients with increased peripheral vascular resistance, doxazosin mesylate treatment of normotensive men with BPH did not result in a clinically significant blood pressure lowering effect (Table 4).
The proportion of normotensive patients with a sitting systolic blood pressure less than 90 mmHg and/or diastolic blood pressure less than 60 mmHg at any time during treatment with doxazosin mesylate 1–8 mg once daily was 6.7% with doxazosin and not significantly different (statistically) from that with placebo (5%). Hypertension Administration of doxazosin mesylate results in a reduction in systemic vascular resistance. In patients with hypertension, there is little change in cardiac output.
Maximum reductions in blood pressure usually occur 2–6 hours after dosing and are associated with a small increase in standing heart rate. Like other alpha 1 -adrenergic blocking agents, doxazosin has a greater effect on blood pressure and heart rate in the standing position.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis: Chronic dietary administration (up to 24 months) of doxazosin mesylate at maximally tolerated doses of 40 mg/kg/day in rats and 120 mg/kg/day in mice revealed no evidence of carcinogenic potential. The highest doses evaluated in the rat and mouse studies are associated with AUCs (a measure of systemic exposure) that are 8 times and 4 times, respectively, the human AUC at a dose of 16 mg/day. Mutagenicity studies revealed no drug- or metabolite-related effects at either chromosomal or subchromosomal levels.
Fertility in Males : Studies in rats showed reduced fertility in males treated with doxazosin at oral doses of 20 (but not 5 or 10) mg/kg/day, about 4 times the AUC exposures obtained with a 12 mg/day human dose. This effect was reversible within two weeks of drug withdrawal. There have been no reports of any effects of doxazosin on male fertility in humans.
📄 Patient Package Insert ▾
PATIENT INFORMATION Doxazosin Tablets, USP (dox-AY-zoe-sin) What are Doxazosin Tablets? Doxazosin tablets are a prescription medicine that contain doxazosin mesylate and is called an "alpha-blocker". Doxazosin tablets are used to treat: the symptoms of benign prostatic hyperplasia (BPH) high blood pressure (hypertension) It is not known if doxazosin tablets is safe and effective in children.
Who should not take doxazosin tablets? Do not take doxazosin mesylate if you : are allergic to doxazosin, other quinazolines, or any of the ingredients in doxazosin tablets. See the end of this Patient Information leaflet for a complete list of ingredients in doxazosin tablets.
What should I tell my healthcare provider before taking doxazosin tablets? Before taking doxazosin tablets, tell your healthcare provider about all of your medical conditions, including if you : have had low blood pressure, especially after taking other medicine. Signs of low blood pressure include fainting, dizziness, and lightheadedness. have any planned eye surgery have prostate cancer or a history of prostate cancer.
Your healthcare provider may have you checked for prostate cancer before you start taking and while you take doxazosin tablets. have liver problems are pregnant or plan to become pregnant. It is not known if doxazosin tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if doxazosin tablets passes into your breastmilk.
Talk to your healthcare provider about the best way to feed your baby if you take doxazosin tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Doxazosin tablets may affect the way other medicines work, and other medicines may affect the way doxazosin tablets works causing side effects.
Especially tell your healthcare provider if you take: other medicine for high blood pressure or medicine to treat erectile dysfunction (ED) called a phosphodiesterase type 5 (PDE-5) inhibitor. The use of doxazosin tablets with PDE-5 inhibitors can lead to a drop in blood pressure or to fainting. Know the medicines you take.
Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take doxazosin tablets? Take doxazosin tablets exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how much doxazosin tablets to take and when to take it. Your healthcare provider may need to change your dose of doxazosin tablets until it is the right dose for you. What should I avoid while taking doxazosin tablets?
Do not drive or perform any hazardous task until at least 24 hours after you have taken doxazosin tablets if you are taking: your first dose of doxazosin tablets doxazosin tablets for the first time after your healthcare provider has increased your dose of doxazosin tablets doxazosin tablets for the first time after any breaks (interruptions) in your treatment with doxazosin tablets What are the possible side effects of doxazosin tablets? Doxazosin tablets may cause serious side effects, including : A sudden drop in blood pressure , especially when you first start treatment or when there is an increase in your dose of doxazosin tablets, is common but can also be serious.
This may cause you to faint, or to feel dizzy or lightheaded. Your risk of having this problem may be increased if you take doxazosin tablets with certain other medicines that lower blood pressure including PDE-5 inhibitors. Your healthcare provider may monitor your blood pressure while you take doxazosin tablets.
See " What should I avoid while taking doxazosin tablets? " Eye problems during cataract surgery . A condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen during cataract surgery if you take or have taken alpha-blockers such as doxazosin tablets. If you need to have cataract surgery, be sure to tell your healthcare provider if y… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Doxazosin Tablets, USP 1 mg - NDC 62135-051-90 - 90's Bottle Label Doxazosin Tablets, USP 2 mg - NDC 62135-052-90 - 90's Bottle Label Doxazosin Tablets, USP 4 mg - NDC 62135-053-90 - 90's Bottle Label Doxazosin Tablets, USP 8 mg - NDC 62135-054-90 - 90's Bottle Label Doxazosin Tablets, USP 1 mg - NDC 62135-051-90 - 90's Bottle Label Doxazosin Tablets, USP 2 mg - NDC 62135-052-90 - 90's Bottle Label Doxazosin Tablets, USP 4 mg - NDC 62135-053-90 - 90's Bottle Label Doxazosin Tablets, USP 8 mg - NDC 62135-054-90 - 90's Bottle Label