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.
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.
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.
| 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:
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| Who should not take Doxazosin Mesylate Tablets? Do not take Doxazosin Mesylate Tablets if you:
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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:
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:
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| How should I take Doxazosin Mesylate Tablets?
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| 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:
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What are the possible side effects of Doxazosin Mesylate Tablets? Doxazosin Mesylate Tablets may cause serious side effects, including:
The most common side effects of doxazosin mesylate tablets are:
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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