希爱力(Tadalafil)的中文说明书

Cialis (Tadalafil) is a phosphodiesterase 5 (PDE5) inhibitor and needs to be taken under the guidance of a professional physician.

Indications of Cialis (Tadalafil)

1. Erectile dysfunction

It is suitable for the treatment of erectile dysfunction (ED).

2. Benign prostatic hyperplasia

Cialis is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

3. Erectile dysfunction and benign prostatic hyperplasia

Cialis is indicated for the treatment of the signs and symptoms of ED and BPH (ED/BPH).

4. Limitations of use

If Cialis is used in combination with finasteride for the initial treatment of BPH, such use is recommended not to exceed 26 weeks, because the incremental benefit of Cialis gradually decreases from 4 weeks to 26 weeks, and the incremental benefit after 26 weeks is unknown.

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Cialis (Tadalafil) usage and dosage

1. Take Cialis as needed to treat erectile dysfunction

For most patients who use Cialis as needed, the recommended starting dose is 10 mg, taken before expected sexual activity.

Based on individual efficacy and tolerability, the dose may be increased to 20 mg or reduced to 5 mg. In most patients, the maximum recommended dosing frequency is once daily.

2. Take Cialis once a day to treat erectile dysfunction

The recommended starting dose for once-daily use is 2.5mg, taken at about the same time every day, without taking into account the time of sexual activity.

Based on individual efficacy and tolerability, the once-daily dose of Cialis may be increased to 5 mg.

3. Take Cialis once a day to treat benign prostatic hyperplasia

The recommended dosage for once-daily use is 5mg, taken at about the same time every day.

When using Cialis in combination with finasteride for the initial treatment of BPH, the recommended dose is 5 mg once daily, taken at approximately the same time each day, for up to 26 weeks.

4. Take Cialis once a day to treat erectile dysfunction and benign prostatic hyperplasia

The recommended dose of Cialis for once-daily use is 5mg, taken at approximately the same time every day, regardless of the time of sexual activity.

5. How to take the medicine

Take it with food. Cialis can be taken without considering the influence of food.

6. Medication for specific groups

(1), renal insufficiency

Take Cialis as needed

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

Creatinine clearance less than 30mL/min or receiving hemodialysis: the maximum dose is 5mg, no more than once every 72 hours.

Once-daily Cialis

Erectile Dysfunction

Creatinine clearance less than 30 mL/min or receiving hemodialysis: Once-daily Cialis is not recommended.

Benign prostatic hyperplasia and erectile dysfunction/benign prostatic hyperplasia

Creatinine clearance 30 to 50 mL/min: The recommended starting dose is 2.5 mg. Depending on individual response, an increase to 5 mg may be considered.

Creatinine clearance less than 30mL/min or receiving hemodialysis: once-daily Cialis is not recommended.

(2) Hepatic insufficiency

Take Cialis as needed

Mild or moderate (ChildPugh Class A or B): The dose should not exceed 10 mg, once a day. Once-daily Cialis has not been extensively evaluated in patients with hepatic impairment and caution is recommended.

Severe (Child Pugh C): Cialis is not recommended.

Once-daily Cialis

Mild or Moderate (ChildPugh Class A or B): Once-daily Cialis has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if these patients are prescribed once-daily Cialis.

Severe (Child Pugh C): Cialis is not recommended.

Cialis (Tadalafil) Contraindications

1. Nitrates

It is prohibited to use Cialis in patients who are taking any form of organic nitrates (regular and/or intermittent). In clinical pharmacology studies, Cialis has been shown to enhance the antihypertensive effects of nitrates.

2. Hypersensitivity reaction

Cialis is contraindicated in patients with known severe hypersensitivity reactions to tadalafil (Cialis or ADCIRCA). Hypersensitivity reactions, including Stevens-Johnson syndrome and exfoliative dermatitis, have been reported [see Adverse Reactions (6.2)].

3. Concomitant use of guanylyl cyclase (GC) stimulators

It is prohibited to use Cialis in patients who are taking GC stimulators (such as riociguat). PDE5 inhibitors (including Cialis) may enhance the antihypertensive effects of GC stimulants.

Cialis (Tadalafil) Precautions

1. Cardiovascular

Doctors should consider the patient's cardiovascular status, because sexual activity is associated with a certain degree of cardiac risk. Therefore, erectile dysfunction treatments, including Cialis, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular condition. Patients who develop symptoms when initiating sexual activity should be advised to avoid further sexual activity and seek immediate medical attention.

2. Potential drug interactions with once-daily doses of Cialis

Once-daily doses of Cialis provide sustained plasma tadalafil levels and should be considered when evaluating potential interactions with medications such as nitrates, alpha-blockers, antihypertensives, and strong CYP3A4 inhibitors, as well as heavy alcohol consumption.

3. Prolonged erections

Cialis should be used with caution in patients who may be susceptible to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or patients with abnormal penile anatomy (such as curvature, cavernous fibrosis, or Peyronie's disease).

4. Effects on eyes

Patients known to suffer from hereditary retinal degenerative diseases (including retinitis pigmentosa) are not included in clinical trials and are not recommended for use in these patients.

5. Sudden loss of hearing

Patients should stop taking PDE5 inhibitors (including Cialis) and seek medical attention immediately if they experience sudden hearing loss or loss.

6. Alpha-blockers and antihypertensive drugs

Physicians should discuss with patients the potential risk that Cialis may enhance the antihypertensive effects of alpha-blockers and antihypertensive drugs.

Adverse reactions of Cialis (Tadalafil)

1. Systemic: weakness, facial edema, fatigue, pain, peripheral edema

2. Cardiovascular: angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitations, syncope, tachycardia

3 , Digestive system: Abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, elevated GGTP, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoid bleeding, rectal bleeding

4. Musculoskeletal: joint pain, neck pain

5. Nervous system: dizziness, hypoesthesia, insomnia, Abnormal sensation, drowsiness, dizziness

6. Kidney and urinary system: renal function impairment

7. Respiratory system: dyspnea, epistaxis, pharyngitis

8. Skin and appendages: itching, rash, sweating

9. Ophthalmology: blurred vision, color vision changes, conjunctivitis (including conjunctiva) congestion), eye pain, increased tears, eyelid swelling

10. Otology: sudden hearing loss or loss, tinnitus

11. Genitourinary system: increased erection, spontaneous penile erection

Cialis (Tadalafil) drug interactions

1. Nitrates

Cialis is contraindicated in patients taking any form of organic nitrates.

2. Alpha-blockers

Caution should be used when PDE5 inhibitors are combined with alpha-blockers. PDE5 inhibitors (including Cialis) and alpha-adrenergic blockers are vasodilators with antihypertensive effects. When vasodilators are used concomitantly, additive hypotensive effects are expected.

3. Antihypertensive drugs

PDE5 inhibitors (including tadalafil) are mild systemic vasodilators. Clinical pharmacology studies were conducted to evaluate the potentiation of the antihypertensive effect of tadalafil on selected antihypertensive drugs (amlodipine, angiotensin II receptor blockers, benfluthiazide, enalapril, and metoprolol). A small decrease in blood pressure occurred when tadalafil was coadministered with these drugs compared to placebo.

4. Antacids

Concurrent administration of antacids (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent absorption rate of tadalafil but did not change the exposure (AUC) of tadalafil.

Cialis (Tadalafil) medication for specific groups of people

1. Pregnancy

Cialis (Tadalafil) is not suitable for use by women.

2. Lactation period

Cialis is not suitable for use by women.

3. Pediatric use

Cialis is not suitable for pediatric patients, and its safety and effectiveness for patients under 18 years of age have not yet been determined.

4. Medication in the Elderly

No overall differences in efficacy or safety were observed between older (>65 years and ≥75 years) and younger (≤65 years) subjects, but it should be considered that some older people are more sensitive to drugs.

Storage of Cialis (Tadalafil)

Cialis (Tadalafil) is stored at 25°C (77°F), with an allowed excursion between 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature], please keep out of the reach of children.