darifenacin (Rx)

Brand and Other Names:Enablex
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Dosing & Uses

AdultPediatric

Dosing Forms & Strength

tablet, extended release

  • 7.5mg
  • 15mg

Overactive Bladder

Indicated for overactive bladder with symptoms of urge incontinence, urgency, and frequency

Initial: 7.5 mg PO qDay

May be increased to 15 mg based on patient response as early as 2 weeks later

Do not increase dose if taking concomitant CYP3A4 inhibitors

Hepatic Impairment

Moderate: Do not exceed initial dose of 7.5 mg/day

Severe: Not recommended

Administration

Swallow with water, do not crush, chew or cut

Safety and efficacy not established

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Interactions

Interaction Checker

and darifenacin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dry mouth (19-35%)

            Constipation (15-21%)

            1-10%

            Abdominal pain (2-4%)

            Dizziness (2%)

            Dry eyes (2%)

            Dyspepsia (3-8%)

            Nausea (2-4%)

            UTI (4-5%)

            Vaginitis (>1%)

            Back pain (>1%)

            Rhinitis (>1%)

            Abnormal vision (>2%)

            Vomiting (>1%)

            Weight gain (>1%)

            Flu-like syndrome (1-3%)

            Peripheral edema (>1%)

            Postmarketing Reports

            Dermatologic: Erythema multiforme, interstitial granuloma annulare

            General: Hypersensitivity reactions, including angioedema with airway obstruction and anaphylactic reaction; hallucinations

            Cardiovascular: Palpitations

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            Warnings

            Contraindications

            Urinary retention

            Uncontrolled narrow-angle glaucoma

            Severe hepatic impairment

            Paralytic ileus

            GI or Gu obstruction

            Hypersensitivity

            Cautions

            Bladder outflow obstruction, controlled narrow-angle glaucoma, decreased GI motility, renal/hepatic impairment

            Angioedema of the face, lips, tongue, and/or larynx have been reported, in some cases angioedema occurred after the first dose

            CNS anticholinergic effects reported including headache, confusion, hallucinations, and somnolence

            Heat prostration may occur in the presence of increased environmental temperature

            Use caution in patients with decreased GI motility, hiatal hernia, reflux esophagitis, and ulcerative colitis

            Use caution in patients with controlled narrow-angle glaucoma and patients with hepatic impairment, or myesthenia gravis

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Excretion in milk unknown; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive muscarinic receptor antagonist of the M3 muscarinic receptor; receptor blocking limits bladder contractions, and reduce symptoms of bladder irritability/overactivity

            Absorption

            Protein Bound: 98%

            Vd: 163 L

            Peak plasma time: 7 hr

            Metabolism

            Liver, by CYP3A4 and CYP2D6

            Elimination

            Half-Life: 13-19 hr

            Excretion: 60% urine; 40% feces

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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