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Enablex
Overview
What is Enablex?
ENABLEX (darifenacin) is an extended-release tablet which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.
Chemically, darifenacin hydrobromide is -2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is CHNO.HBr.
The structural formula is
Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5.
ENABLEX is a once a day extended release tablet and contains the following inactive ingredients: dibasic calcium phosphate, hypromellose (hydroxypropyl methylcellulose), magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15-mg tablet also contains iron oxide red and iron oxide yellow.
What does Enablex look like?
What are the available doses of Enablex?
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What should I talk to my health care provider before I take Enablex?
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How should I use Enablex?
ENABLEX
(darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
The recommended starting dose of ENABLEX
(darifenacin) extended-release tablets is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy.
ENABLEX extended-release tablets should be taken once daily with liquid. They may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.
For patients with moderate hepatic impairment or when coadministered with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of ENABLEX should not exceed 7.5 mg. ENABLEX is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
What interacts with Enablex?
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What are the warnings of Enablex?
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What are the precautions of Enablex?
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What are the side effects of Enablex?
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What should I look out for while using Enablex?
ENABLEX
(darifenacin)extended-release tabletsare contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.
What might happen if I take too much Enablex?
Overdosage with antimuscarinic agents, including ENABLEX (darifenacin) extended-release tablets, can result in severe antimuscarinic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended. ENABLEX has been administered in clinical trials at doses up to 75 mg (five times the maximum therapeutic dose) and signs of overdose were limited to abnormal vision.
How should I store and handle Enablex?
StorageStore Pantoprazole sodium delayed-release tablets 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.]StorageStore Pantoprazole sodium delayed-release tablets 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.]ENABLEX 7.5 mg extended-release tablets are round, shallow, convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.Bottle of 30 NDC 54868-5704-0ENABLEX 15 mg extended-release tablets are round, shallow, convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.Bottle of 30 NDC 54868-5363-0ENABLEX 7.5 mg extended-release tablets are round, shallow, convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.Bottle of 30 NDC 54868-5704-0ENABLEX 15 mg extended-release tablets are round, shallow, convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.Bottle of 30 NDC 54868-5363-0ENABLEX 7.5 mg extended-release tablets are round, shallow, convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.Bottle of 30 NDC 54868-5704-0ENABLEX 15 mg extended-release tablets are round, shallow, convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.Bottle of 30 NDC 54868-5363-0ENABLEX 7.5 mg extended-release tablets are round, shallow, convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.Bottle of 30 NDC 54868-5704-0ENABLEX 15 mg extended-release tablets are round, shallow, convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.Bottle of 30 NDC 54868-5363-0
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
ENABLEX (darifenacin)extended-release tabletsare contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.The daily dose of ENABLEX should not exceed 7.5 mg when coadministered with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone)(see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Caution should be taken when ENABLEX is used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants (see CLINICAL PHARMACOLOGY).
The concomitant use of ENABLEX with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to effects on gastrointestinal motility.
During the clinical development of ENABLEX (darifenacin) extended-release tablets, a total of 7,363 patients and volunteers were treated with doses of darifenacin from 3.75 mg to 75 mg once daily.
The safety of ENABLEX was evaluated in Phase II and III controlled clinical trials in a total of 8,830 patients, 6,001 of whom were treated with ENABLEX. Of this total, 1,069 patients participated in three, 12-week, Phase III, fixed-dose efficacy and safety studies. Of this total, 337 and 334 patients received ENABLEX 7.5 mg daily and 15 mg daily, respectively. In all long-term trials combined, 1,216 and 672 patients received treatment with ENABLEX for at least 24 and 52 weeks, respectively.
In all placebo-controlled trials combined, the incidence of serious adverse events for 7.5 mg, 15 mg and placebo was similar.
In all fixed-dose Phase III studies combined, 3.3% of patients treated with ENABLEX discontinued due to all adverse events versus 2.6% in placebo. Dry mouth leading to study discontinuation occurred in 0%, 0.9%, and 0% of patients treated with ENABLEX 7.5 mg daily, ENABLEX 15 mg daily and placebo, respectively. Constipation leading to study discontinuation occurred in 0.6%, 1.2%, and 0.3% of patients treated with ENABLEX 7.5 mg daily, ENABLEX 15 mg daily and placebo, respectively.
Table 4 lists the adverse events reported (regardless of causality) in 2% or more of patients treated with 7.5-mg or 15-mg ENABLEX extended-release tablets and greater than placebo in the three, fixed-dose, placebo-controlled Phase III studies (Studies 1, 2 and 3). Adverse events were reported by 54% and 66% of patients receiving 7.5 mg and 15 mg once-daily ENABLEX extended-release tablets, respectively, and by 49% of patients receiving placebo. In these studies, the most frequently reported adverse events were dry mouth and constipation. The majority of adverse events in ENABLEX-treated subjects were mild or moderate in severity and most occurred during the first two weeks of treatment.
Other adverse events reported, regardless of causality, by ≥1% of ENABLEX patients in either the 7.5 mg or 15 mg once-daily darifenacin-dose groups in these fixed-dose, placebo-controlled Phase III studies include: abnormal vision, accidental injury, back pain, dry skin, flu syndrome, pain, hypertension, vomiting, peripheral edema, weight gain, arthralgia, bronchitis, pharyngitis, rhinitis, sinusitis, rash, pruritus, urinary tract disorder and vaginitis.
Study 4 was a 12-week, placebo-controlled, dose-titration regimen study in which ENABLEX was administered in accordance with dosing recommendations (see DOSAGE AND ADMINISTRATION). All patients initially received placebo or ENABLEX 7.5 mg daily, and after two weeks, patients and physicians were allowed to adjust upward to ENABLEX 15 mg if needed. In this study, the most commonly reported adverse events were also constipation and dry mouth. The incidence of discontinuation due to all adverse events was 3.1% and 6.7% for placebo and for ENABLEX, respectively. Table 5 lists the adverse events (regardless of causality) reported in >3% of patients treated with ENABLEX extended-release tablets and greater than placebo.
Acute urinary retention (AUR) requiring treatment was reported in a total of 16 patients in the ENABLEX Phase I-III clinical trials. Of these 16 cases, seven were reported as serious adverse events, including one patient with detrusor hyperreflexia secondary to a stroke, one patient with benign prostatic hypertrophy (BPH), one patient with irritable bowel syndrome (IBS) and four overactive bladder (OAB) patients taking darifenacin 30 mg daily. Of the remaining nine cases, none were reported as serious adverse events. Three occurred in OAB patients taking the recommended doses, and two of these required bladder catheterization for 1-2 days.
Constipation was reported as a serious adverse event in six patients in the ENABLEX Phase I-III clinical trials, including one patient with benign prostatic hypertrophy (BPH), one OAB patient taking darifenacin 30 mg daily, and only one OAB patient taking the recommended doses. The latter patient was hospitalized for investigation with colonoscopy after reporting nine months of chronic constipation that was reported as being moderate in severity.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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