Prescription Drug Information: Darifenacin 7.5 Mg

DARIFENACIN 7.5 MG- darifenacin hydrobromide tablet, extended release
DARIFENACIN 15 MG- darifenacin hydrobromide tablet, extended release
Proficient Rx LP

1 INDICATIONS AND USAGE

Darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

2 DOSAGE AND ADMINISTRATION

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.

Darifenacin extended-release tablets should be taken once daily with water. Darifenacin extended-release tablets 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 extended-release tablets should not exceed 7.5 mg. Darifenacin extended-release tablets are 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)]

3 DOSAGE FORMS AND STRENGTHS

Darifenacin extended-release tablets 7.5 mg are white, film coated round tablets, one side debossed with “AL”, and the other side “110”.

Darifenacin extended-release tablets 15 mg are pink, film coated round tablets, one side debossed with “AL”, and the other side “111”.

4 CONTRAINDICATIONS

Darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions:

urinary retention
gastric retention, or
uncontrolled narrow-angle glaucoma.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Urinary Retention

Darifenacin extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

5.2 Decreased Gastrointestinal Motility

Darifenacin extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Darifenacin, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, and myasthenia gravis.

5.3 Controlled Narrow-Angle Glaucoma

Darifenacin extended-release tablets should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks.

5.4 Angioedema

Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, darifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.5 Central Nervous System Effects

Darifenacin extended-release tablets is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2)]. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how darifenacin affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6 Patients with Hepatic Impairment

The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg for patients with moderate hepatic impairment (Child-Pugh B). Darifenacin extended-release tablets has not been studied in patients with severe hepatic impairment (Child-Pugh C) and therefore is not recommended for use in this patient population [see Dosage and Administration (2) Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

6 ADVERSE REACTIONS

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 extended-release tablets was evaluated in controlled clinical trials in a total of 8,830 patients, 6,001 of whom were treated with darifenacin extended-release tablets. 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 extended-release tablets 7.5 mg daily and 15 mg daily, respectively. In all long-term trials combined, 1,216 and 672 patients received treatment with darifenacin extended-release tablets for at least 24 and 52 weeks, respectively.

In Studies 1, 2 and 3 combined, the serious adverse reactions to darifenacin extended-release tablets were urinary retention and constipation.

In Studies 1, 2 and 3 combined, dry mouth leading to study discontinuation occurred in 0 percent, 0.9 percent, and 0 percent of patients treated with darifenacin extended-release tablets 7.5 mg daily, darifenacin extended-release tablets 15 mg daily and placebo, respectively.

Constipation leading to study discontinuation occurred in 0.6 percent, 1.2 percent, and 0.3 percent of patients treated with darifenacin extended-release tablets 7.5 mg daily, darifenacin extended-release tablets15 mg daily and placebo, respectively.

Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events in 2 percent or more of patients treated with 7.5 mg or 15 mg darifenacin extended-release tablets, 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 Extended -Release Tablets Than With Placebo In Studies 1, 2, and 3

Body System

Adverse Reaction

% of Subjects

Darifenacin Extended-Release Tablets 7.5 mg N = 337

Darifenacin Extended-Release Tablets 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 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 extended-release tablets-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 darifenacinn extended-release tablets was administered in accordance with dosing recommendations [see Dosage and Administration (2)]. All patients initially received placebo or darifenacin extended-release tablets 7.5 mg daily, and after two weeks, patients and physicians were allowed to adjust upward to darifenacin extended-release tablets 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 n extended-release tablets 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 Extended-Release Tablets Than Placebo, In Study 4

Adverse Reaction

Darifenacin Extended-Release Tablets 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%)

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.