INDICATIONS AND USAGE（适应症）

Erectile Dysfunction

Tadalafil tablets USP are indicated for the treatment of erectile dysfunction (ED).

Benign Prostatic Hyperplasia

Tadalafil tablets USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Erectile Dysfunction and Benign Prostatic Hyperplasia

Tadalafil tablets USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

Limitation of Use

If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets USP decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets USP beyond 26 weeks is unknown.

DOSAGE（服用剂量）

Tadalafil Tablets for Use as Needed for Erectile Dysfunction

The recommended starting dose of tadalafil  tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.

The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.

Tadalafil tablets for use as needed were shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of tadalafil tablets, this should be taken into consideration.

Tadalafil Tablet for Once Daily Use for Erectile Dysfunction

The recommended starting dose of tadalafil  tablet for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

The tadalafil tablet dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Tadalafil Tablet for Once Daily Use for Benign Prostatic Hyperplasia

The recommended dose of tadalafil tablet for once daily use is 5 mg, taken at approximately the same time every day.

When therapy for BPH is initiated with tadalafil tablet and finasteride, the recommended dose of tadalafil tablet for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

Tadalafil Tablet for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose of tadalafil tablet for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Use with Food

Tadalafil tablets may be taken without regard to food.

Use in Specific Populations

Renal Impairment

Tadalafil Tablets  for Use as Needed

Creatinine clearance 30 mL/min to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.

Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours.

Tadalafil Tablet for Once Daily Use

Erectile Dysfunction  

Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablet for once daily use is not recommended.

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

Creatinine clearance 30 mL/min to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.

Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablet for once daily use is not recommended.

Hepatic Impairment  

Tadalafil Tablets for Use as Needed

Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of tadalafil tablet once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.

Severe (Child Pugh Class C): The use of tadalafil tablets are not recommended.

Tadalafil Tablet for Once Daily Use

Mild or moderate (Child Pugh Class A or B): Tadalafil tablet for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if tadalafil tablet for once daily use is prescribed to these patients.

Severe (Child Pugh Class C): The use of tadalafil tablet is not recommended.

ADVERSE REACTIONS（不良反应）

Body as a Whole - asthenia, face edema, fatigue, pain, peripheral edema

Cardiovascular - angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive - abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal - arthralgia, neck pain

Nervous - dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo

Renal and Urinary - renal impairment

Respiratory - dyspnea, epistaxis, pharyngitis

Skin and Appendages - pruritus, rash, sweating

Ophthalmologic - blurred vision, changes in color vision, conjunctivitis (including   conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids

Otologic - sudden decrease or loss of hearing, tinnitus

Urogenital - erection increased, spontaneous penile erection

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/741102c1-8809-44d4-9098-3dc8c0604764/spl-doc?hl=Tadalafil

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