Doxazosin Mesylate (Page 4 of 5)

14 CLINICAL STUDIES

14.1 Benign Prostatic Hyperplasia (BPH)

The efficacy of doxazosin mesylate was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. Doxazosin mesylate treatment was superior to placebo in improving patient symptoms and urinary flow rate. Significant relief with doxazosin mesylate was seen as early as one week into the treatment regimen, with doxazosin mesylate-treated patients (N=173) showing a significant (p<0.01) increase in maximum flow rate of 0.8 mL/sec compared to a decrease of 0.5 mL/sec in the placebo group (N=41). In long-term studies, improvement was maintained for up to 2 years of treatment. In 66–71% of patients, improvements above baseline were seen in both symptoms and maximum urinary flow rate.

In three placebo-controlled studies of 14–16 weeks’ duration, obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning) of BPH were evaluated at each visit by patient-assessed symptom questionnaires. The bothersomeness of symptoms was measured with a modified Boyarsky questionnaire. Symptom severity/frequency was assessed using a modified Boyarsky questionnaire or an AUA-based questionnaire. Uroflowmetric evaluations were performed at times of peak (2–6 hours post-dose) and/or trough (24 hours post-dose) plasma concentrations of doxazosin mesylate.

The results from the three placebo-controlled studies (N=609) showing significant efficacy with 4 mg and 8 mg doxazosin are summarized in Table 3. In all three studies, doxazosin mesylate resulted in statistically significant relief of obstructive and irritative symptoms compared to placebo. Statistically significant improvements of 2.3–3.3 mL/sec in maximum flow rate were seen with doxazosin mesylate in Studies 1 and 2, compared to 0.1–0.7 mL/sec with placebo.

Table 3 SUMMARY OF EFFECTIVENESS DATA IN PLACEBO-CONTROLLED TRIALS
(click image for full-size original)

In one fixed-dose study (Study 2), doxazosin mesylate therapy (4 to 8 mg, once daily) resulted in a significant and sustained improvement in maximum urinary flow rate of 2.3–3.3 mL/sec (Table 3) compared to placebo (0.1 mL/sec). In this study, the only study in which weekly evaluations were made, significant improvement with doxazosin mesylate vs. placebo was seen after one week. The proportion of patients who responded with a maximum flow rate improvement of ≥3 mL/sec was significantly larger with doxazosin mesylate (34–42%) than placebo (13–17%). A significantly greater improvement was also seen in average flow rate with doxazosin mesylate (1.6 mL/sec) than with placebo (0.2 mL/sec). The onset and time course of symptom relief and increased urinary flow from Study 1 are illustrated in Figure 1.

Image of Figure 1-Study 1
(click image for full-size original)
Image of Figure 1-Study 1
(click image for full-size original)

14.2 Hypertension

In a pooled analysis of placebo-controlled hypertension studies with about 300 hypertensive patients per treatment group, doxazosin, at doses of 1 to 16 mg given once daily, lowered blood pressure at 24 hours by about 10/8 mmHg compared to placebo in the standing position and about 9/5 mmHg in the supine position. Peak blood pressure effects (1–6 hours) were larger by about 50–75% (i.e., trough values were about 55–70% of peak effect), with the larger peak-trough differences seen in systolic pressures. There was no apparent difference in the blood pressure response of Caucasians and Blacks or of patients above and below age 65. In the same patient population, patients receiving doxazosin mesylate gained a mean of 0.6 kg compared to a mean loss of 0.1 kg for placebo patients.

TABLE 4 Mean Changes in Blood Pressure from Baseline to the Mean of the Final Efficacy Phase in Normotensives (Diastolic BP <90 mmHg) in Two Double-blind, Placebo-controlled U.S. Studies with Doxazosin Mesylate 1 to 8 mg once daily.

PLACEBO(N=85)

DOXAZOSIN MESYLATE (N=183)
Sitting BP (mmHg) Baseline Change Baseline Change
Systolic 128.4 –1.4 128.8 –4.9*
Diastolic 79.2 –1.2 79.6 –2.4*
Standing BP (mmHg) Baseline Change Baseline Change
Systolic 128.5 –0.6 128.5 –5.3*
Diastolic 80.5 –0.7 80.4 –2.6*
*p ≤0.05 compared to placebo

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1591

NDC: 50090-1591-0 30 TABLET in a BOTTLE

NDC: 50090-1591-1 100 TABLET in a BOTTLE

Product: 50090-1968

NDC: 50090-1968-0 30 TABLET in a BOTTLE

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.

All brand names listed are registered trademarks of their respective owners and are not trademarks of DAVA Pharmaceuticals.

Manufactured for:
Dava Pharmaceuticals, Inc.
Fort Lee, NJ 07024, USA

Manufactured by:
Patheon Puerto Rico, Inc.
Manati, Puerto Rico 00674,

Revised 6/2016APX1018/2

PATIENT INFORMATION Doxazosin Mesylate (dox az’ oh sin mes’ i late) Tablets

What are Doxazosin Mesylate Tablets? Doxazosin mesylate tablets are a prescription medicine that contains doxazosin mesylate and is called an “alpha-blocker”. Doxazosin mesylate tablets are used to treat:

  • the symptoms of benign prostatic hyperplasia (BPH)
  • high blood pressure (hypertension)
It is not known if doxazosin mesylate tablets are safe and effective in children.

Who should not take Doxazosin Mesylate Tablets? Do not take Doxazosin Mesylate Tablets if you:

  • are allergic to doxazosin, other quinazolines, or any of the ingredients in doxazosin mesylate tablets. See the end of this Patient Information leaflet for a complete list of ingredients in doxazosin mesylate tablets.

What should I tell my healthcare provider before taking Doxazosin Mesylate Tablets? Before taking Doxazosin Mesylate 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 mesylate tablets.
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if doxazosin mesylate tablets will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if doxazosin mesylate passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take doxazosin mesylate tablets.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Doxazosin mesylate tablets may affect the way other medicines work, and other medicines may affect the way doxazosin mesylate tablets works causing side effects.

Especially tell your healthcare provider if you take:

  • other medicine for high blood pressuremedicine to treat erectile dysfunction (ED) called a phosphodiesterase type 5 (PDE-5) inhibitor. The use of doxazosin mesylate 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 Mesylate Tablets?

  • Take doxazosin mesylate tablets exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much doxazosin mesylate tablets to take and when to take it.
  • Your healthcare provider may need to change your dose of doxazosin mesylate tablets until it is the right dose for you.

What should I avoid while taking Doxazosin Mesylate Tablets? Do not drive or perform any hazardous task until at least 24 hours after you have taken doxazosin mesylate tablets if you are taking:

  • your first dose of doxazosin mesylate tablets
  • doxazosin mesylate tablets for the first time after your healthcare provider has increased your dose of doxazosin mesylate tablets
  • doxazosin mesylate tablets for the first time after any breaks (interruptions) in your treatment with doxazosin mesylate tablets

What are the possible side effects of Doxazosin Mesylate Tablets? Doxazosin Mesylate 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 mesylate 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 mesylate 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 mesylate tablets. See “What should I avoid while taking doxazosin mesylate 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 mesylate tablets. If you need to have cataract surgery, be sure to tell your healthcare provider if you take or have taken doxazosin mesylate tablets.
  • A painful erection that will not go away. Doxazosin mesylate tablets can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.

The most common side effects of doxazosin mesylate tablets are:

  • weakness or lack of energy (asthenia)
  • dizziness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of doxazosin mesylate tablets. For more information, ask your healthcare provider or pharmacist.

General information about the safe and effective use of Doxazosin Mesylate Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use doxazosin mesylate tablets for a condition for which it was not prescribed. Do not give doxazosin mesylate tablets to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about doxazosin mesylate tablets. For more information, ask your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.

What are the ingredients in Doxazosin Mesylate Tablets? Active ingredient: doxazosin mesylate Inactive ingredients: microcrystalline cellulose, NF; lactose, NF; sodium starch glycolate, NF; magnesium stearate, NF and sodium lauryl sulfate, NF. The 2 mg tablet contains D&C yellow #10 Aluminum Lake and FD&C yellow #6 Aluminum Lake; the 4 mg tablet contains FD&C yellow #6 Aluminum Lake; the 8 mg tablet contains FD&C blue #2 Aluminum Lake and D&C yellow #10 Aluminum Lake.

Manufactured for: Dava Pharmaceuticals, Inc. Fort Lee, NJ 07024, USA

Manufactured by:Patheon Puerto Rico, Inc.Manati, Puerto Rico 00674, USA

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 06/2016

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