DARIFENACIN HBR ER 7.5MG 30 TAB
Generic: Darifenacin
DARIFENACIN HBR ER 7.5MG 30 TAB
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Identification
Darifenacin
Darifenacin
Macleods Pharmaceuticals Limited
HUMAN PRESCRIPTION DRUG
Administration
TABLET, EXTENDED RELEASE
ORAL
ANDA207302
Active Ingredients
| Ingredient | Strength |
|---|---|
| DARIFENACIN HYDROBROMIDE | 7.5 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS & USAGE Darifenacin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 )
Dosage & Administration
2 DOSAGE & ADMINISTRATION The recommended starting dose of darifenacin is 7.5 mg orally once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy. Darifenacin should be taken orally once daily with water. Darifenacin may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed. For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of darifenacin should not exceed 7.5 mg. Darifenacin is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Warnings & Precautions ( 5.6 ), Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. The recommended starting dose of 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 ( 2 ) The daily dose of darifenacin should not exceed 7.5 mg in the following patients: • Patients with moderate hepatic impairment (Child- Pugh B) ( 2 , 8.6 ) • Patients taking potent CYP3A4 inhibitors ( 2 , 7.1 ) Darifenacin is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) ( 2 , 8.6 ) Darifenacin may be taken with or without food. The tablet should be swallowed whole with water and not chewed, divided or crushed ( 2 )
Adverse Reactions
6 ADVERSE REACTIONS The most frequently reported adverse reactions (greater than 3%) for darifenacin are: constipation, dry mouth, headache, dyspepsia, nausea, urinary tract infection, accidental injury, and flu symptoms ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 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. The safety of darifenacin was evaluated in controlled clinical trials in a total of 8,830 patients, 6,001 of whom were treated with darifenacin. Of this total, 1,069 patients participated in three, 12-week, randomized, placebo-controlled, fixed-dose efficacy and safety studies (Studies 1, 2 and 3). Of this total, 337 and 334 patients received darifenacin 7.5 mg daily and 15 mg daily, respectively. In all long-term trials combined, 1,216 and 672 patients received treatment with darifenacin for at least 24 and 52 weeks, respectively. In Studies 1, 2 and 3 combined, the serious adverse reactions to darifenacin were urinary retention and constipation. In Studies 1, 2 and 3 combined, dry mouth leading to study discontinuation occurred in 0%, 0.9%, and 0% of patients treated with darifenacin 7.5 mg daily, darifenacin 15 mg daily and placebo, respectively. Constipation leading to study discontinuation occurred in 0.6%, 1.2%, and 0.3% of patients treated with darifenacin 7.5 mg daily, darifenacin 15 mg daily and placebo, respectively. Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events in 2% or more of patients treated with 7.5 mg or 15 mg darifenacin, and greater than placebo in Studies 1, 2 and 3. In these studies, the most frequently reported adverse reactions were dry mouth and constipation. The majority of the adverse reactions were mild or moderate in severity and most occurred during the first two weeks of treatment. Table 1: Incidence of Identified Adverse Reactions, Derived from All Adverse Events Reported in greater than or equal to 2% of Patients Treated with Darifenacin Extended-Release Tablets and More Frequent with darifenacin than with Placebo in Studies 1, 2, and 3 Body System Adverse Reaction % of Subjects Darifenacin 7.5 mg N= 337 Darifenacin 15 mg N=334 Placebo N=388 Digestive Dry Mouth 20.2 35.3 8.2 Constipation 14.8 21.3 6.2 Dyspepsia 2.7 8.4 2.6 Abdominal Pain 2.4 3.9 0.5 Nausea 2.7 1.5 1.5 Diarrhea 2.1 0.9 1.8 Urogenital Urinary Tract Infection 4.7 4.5 2.6 Nervous Dizziness 0.9 2.1 1.3 Body as a Whole Asthenia 1.5 2.7 1.3 Eye Dry Eyes 1.5 2.1 0.5 Other adverse reactions reported by 1% to 2% of darifenacin -treated patients include: abnormal vision, accidental injury, back pain, dry skin, flu syndrome, hypertension, vomiting, peripheral edema, weight gain, arthralgia, bronchitis, pharyngitis, rhinitis, sinusitis, rash, pruritus, urinary tract disorder and vaginitis. Study 4 was a randomized, 12-week, placebo-controlled, dose-titration regimen study in which darifenacin was administered in accordance with dosing recommendations [see Dosage and Administration ( 2 )]. All patients initially received placebo or darifenacin 7.5 mg daily, and after two weeks, patients and physicians were allowed to adjust upward to darifenacin 15 mg if needed. In this study, the most commonly reported adverse reactions were also constipation and dry mouth. Table 2 lists the identified adverse reactions, derived from all adverse events reported in greater than 3% of patients treated with darifenacin and greater than placebo. Table 2: Number (%) of Adverse Reactions, Derived from All Adverse Events Reported in greater than 3% of Patients Treated with Darifenacin Extended-Release Tablets, and More Frequent with Darifenacin than Placebo, in Study 4 Adverse Reaction Darifenacin 7.5 mg /15 mg N=268 Placebo N=127 Constipation 56 (20.9 % ) 10 (7.9 % ) Dry Mouth 50 (18.7 % ) 11 (8.7 % ) Headache 18 (6.7 %) 7 (5.5 % ) Dyspepsia 12 (4.5 % ) 2 (1.6 % ) Nausea 11 (4.1 %) 2 (1.6 % ) Urinary Tract Infection 10 (3.7 % ) 4 (3.1 % ) Accidental Injury 8 (3.0 % ) 3 (2.4 % ) Flu Syndrome 8 (3.0 % ) 3 (2.4 % ) 6.2 Post Marketing Experience The following adverse reactions have been reported during post- approval use of darifenacin extended-release tablets (darifenacin). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure. Dermatologic: erythema multiforme, interstitial granuloma annulare General: hypersensitivity reactions, including angioedema with airway obstruction and anaphylactic reaction Central Nervous: confusion, hallucinations and somnolence Cardiovascular: palpitations and syncope
Information for Patients
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). Patients should be informed that anticholinergic agents, such as darifenacin, may produce clinically significant adverse effects related to anticholinergic pharmacological activity including constipation, urinary retention and blurred vision. Heat prostration (due to decreased sweating) can occur when anticholinergics such as darifenacin are used in a hot environment. Because anticholinergics, such as darifenacin, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects have been determined. Patients should read the patient information leaflet before starting therapy with darifenacin. Patients should be informed that darifenacin may produce clinically significant angioedema that may result in airway obstruction. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing. Darifenacin extended-release tablets should be taken once daily with water. They may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed. Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA The brands listed are the trademarks of their respective owners and are not trademarks of Macleods’. Revised: November 2022
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.