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tadalafil (Rx)Brand and Other Names:Adcirca, Cialis

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet (Adcirca)

  • 20mg

tablet (Cialis)

  • 2.5mg
  • 5mg
  • 10mg
  • 20mg
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Erectile Dysfunction

Cialis

PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily

Once-daily use: 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability

Dosing considerations

  • PRN use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 10 mg/72 hr
  • Once-daily use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 2.5 mg/day

Benign Prostatic Hyperplasia

Treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction

Cialis

BPH: 5 mg PO once daily

BPH with erectile dysfunction: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity

With finasteride for BPH: tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks

Pulmonary Arterial Hypertension

Adcirca

40 mg PO once daily; dividing dose for more frequent dosing is not recommended

Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability

Dosing considerations

  • If possible, avoid coadministration with CYP3A4 inhibitors; if coadministration is essential, long-term therapy is indicated, or strong CYP3A4 inhibitors are required, modify or hold dose
  • Patients already taking strong CYP3A4 inhibitor who require tadalafil: 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability
  • Patients already taking tadalafil who require strong CYP3A4 inhibitor: Avoid using tadalafil while starting strong CYP3A4 inhibitor; stop tadalafil ≥24 hours before starting strong CYP3A4 inhibitor; after 1 week, resume tadalafil at 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability

Geriatric Dosing

Erectile Dysfunction

  • Cialis
  • No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered

Pulmonary Arterial Hypertension

  • Adcirca
  • Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance

Dosing Modifications

Renal impairment (erectile dysfunction)

  • Cialis (PRN use)
  • Mild (CrCl ≥51 mL/min): No dosage adjustment needed
  • Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr
  • Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr
  • Cialis (once-daily use)
  • CrCl ≥30 mL/min: No dosage adjustment needed
  • CrCl <30 mL/min: Not recommended

Renal impairment (pulmonary arterial hypertension)

  • Adcirca
  • Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability
  • Severe (CrCl <30 mL/min and on hemodialysis): Avoid use

Hepatic impairment (erectile dysfunction)

  • Cialis (PRN use)
  • Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily
  • Severe (Child-Pugh class C): Not recommended
  • Cialis (once-daily use)
  • Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised
  • Severe (Child-Pugh class C): Not recommended

Hepatic impairment (pulmonary arterial hypertension)

  • Adcirca
  • Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily
  • Severe (Child-Pugh class C): Avoid use

Muscular Dystrophy (Orphan)

Orphan designation for Duchenne muscular dystrophy (DMD)

Sponsor

  • Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285

Use not indicated

Safety and efficacy in pediatric patients not established

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Interactions

Interaction Checker

tadalafil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (11-42%)

            Myalgia (1-14%)

            Respiratory tract infection (3-13%)

            Nasopharyngitis (2-13%)

            Dyspepsia (1-13%)

            Flushing (1-13%)

            Back pain (2-12%)

            Nausea (10-11%)

            1-10%

            Nasal congestion (≤9%)

            Gastroesophageal reflux disease (1-3%)

            Hypertension (1-3%)

            Bronchitis (≤2%)

            Genitourinary tract infection (≤2%)

            <1%

            Amnesia

            Angina pectoris

            Arthralgia

            Change in color vision

            Conjunctival hyperemia

            Dyspnea

            Epistaxis

            Postmarketing reports

            Hypotension

            Visual Loss

            Hearing loss

            Priapism

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            Warnings

            Contraindications

            Hypersensitivity, including Stevens-Johnson syndrome and exfoliative dermatitis

            Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

            Coadministration with nitrates

            • Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
            • Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
            • A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined

            Cautions

            Use caution in patients with anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, myocardial infarction in preceding 90 days, unstable angina, angina occurring during sexual intercourse, NYHA class 2 or greater heart failure in preceding 6 months, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, cerebrovascular accident in preceding 6 months, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors

            May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa

            Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy

            May increase risk of sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician

            Risk of sudden hearing loss

            CYP3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, indinavir, ritonavir) may significantly increase tadalafil serum levels

            CYP3A4 inducers (eg, rifampin, St John’s wort) may decrease tadalafil serum levels

            Potentiates hypotensive effect of nitrates (see Contraindications)

            Concomitant use with alpha blockers (other than tamsulosin 0.4 mg/day) should be stabilized before initiation of phosphodiesterase (PDE)-5 inhibitors; patients with instability on alpha-blocker therapy alone are at increased risk for symptomatic hypotension with concurrent PDE-5 inhibitor therapy

            Not to be taken with other PDE-5 inhibitors (eg, sildenafil, vardenafil)

            Not recommended in patients with pulmonary veno-occlusive disease

            Advise patients to seek emergency treatment if an erection lasts >4 hr

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Use not recommended in nursing women

            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

            Erectile dysfunction: Inhibits PDE-5, increasing cyclic guanosine monophosphate (cGMP) to allow smooth-muscle relaxation and inflow of blood into corpus cavernosum

            Pulmonary arterial hypertension (PAH): Inhibits PDE-5, increasing cGMP to allow relaxation of pulmonary vascular smooth-muscle cells and vasodilation of pulmonary vasculature

            Absorption

            Duration: ≤36 hr

            Peak plasma time: Erectile dysfunction, 0.5-6 hr; PAH, 2-8 hr

            Distribution

            Protein bound: 94%

            Vd: Erectile dysfunction, 63 L; PAH, 77 L

            Metabolism

            Metabolized in liver by CYP3A4

            Elimination

            Half-life: Erectile dysfunction, 15-17.5 hr; PAH (not on bosentan), 35 hr

            Total body clearance: Erectile dysfunction, 2.5 L/hr; PAH (not on bosentan), 1.6 L/hr

            Excretion: Feces (61%), urine (36%)

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            Administration

            Instructions

            Erectile dysfunction (PRN use): Take before anticipated sexual activity

            Erectile dysfunction (once-daily use): Take at approximately same time each day without regard to timing of sexual activity

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            Images

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            Formulary

            FormularyPatient Discounts

            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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            Select a class to view formulary status for similar drugs

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