Tadarise-5 Tadalafil Tablets 5mg

5mg Cialis is used for the daily maintenance treatment of men with erectile dysfunction or unsatisfactory erection quality. It is not a typical "male enhancement" drug; its mechanism of action involves dilating the capillaries in the penile region, resulting in minimal side effects. Due to its 36-hour half-life, only one tablet is required daily for maintenance therapy. For patients with erectile dysfunction, continuous use for three months leads to significant symptom improvement. If a user prefers to take it only on an as-needed basis before sexual activity, the single dose can be increased to achieve satisfactory results, up to a maximum of 6 tablets. According to prescribing statistics from the Chinese Medical Association, this product ranks first among medications recommended by andrologists!

【Drug Name】

Generic Name: Tadalafil Tablets

English Name: Tadalafil Tablets

Pinyin: Tadalafil Pian

【Ingredients】 Tadalafil.

【Indications】 Treatment of erectile dysfunction in men.

【Specification】 5mg × 100 tablets/box

【Dosage and Administration】

Long-term treatment: One tablet daily; for patients with erectile dysfunction, continuous use for three months leads to significant symptom improvement.

On-demand oral use:

1. For adult men: The recommended dose is 10mg, taken before sexual activity; intake is not affected by food. If the 10mg dose is ineffective, 20mg may be taken. It can be taken at least 30 minutes before sexual activity. The maximum frequency of administration is once daily. Continuous daily use is generally not recommended, as the safety of long-term daily use has not been established, and the drug's effects often last longer than one day.

2. For elderly men: No dosage adjustment is required for the elderly.

3. For men with renal impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. For patients with severe renal impairment, the maximum recommended dose is 10mg.

4. For men with hepatic impairment: The recommended dose is 10mg, taken before sexual activity; intake is not affected by food. Clinical safety data regarding the use of tadalafil in patients with severe hepatic impairment (Child-Pugh class C) are limited; if prescribed to such patients, a careful benefit-risk assessment must be conducted by the prescribing physician for each individual. There are no data available on the use of doses higher than 10 mg in patients with hepatic impairment.

5. Men with diabetes: No specific data available for diabetic patients.

[Adverse Reactions] The most frequently reported adverse reactions are headache and dyspepsia; eyelid swelling, eye pain, and conjunctival hyperemia are uncommon adverse reactions. Reports indicate that adverse reactions associated with tadalafil are transient and mild to moderate in severity.

[Contraindications]

1. This product must not be used by patients with a known hypersensitivity to tadalafil or any of the excipients in the formulation.

2. Clinical studies have shown that tadalafil potentiates the hypotensive effects of nitrates. This is considered to result from the combined action of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, the use of this product is contraindicated in patients who are taking any form of nitrates. Sexual activity carries a potential cardiac risk for patients with heart disease. Consequently, treatments for erectile dysfunction, including tadalafil, should not be used in patients with heart disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risks associated with sexual activity in patients with pre-existing heart disease.

3. Clinical trials have not included patients with the following cardiovascular conditions; therefore, the use of tadalafil is strictly contraindicated in these populations:

(1) Patients who have experienced a myocardial infarction within the last 90 days.

(2) Patients with unstable angina or angina occurring during sexual intercourse.

(3) Patients with heart failure classified as New York Heart Association (NYHA) class 2 or greater within the past 6 months.

(4) Patients with uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled hypertension.

(5) Patients who have experienced a stroke within the past 6 months. 【Precautions】

1. Before considering pharmacological treatment, a medical history should be obtained and a physical examination performed to diagnose erectile dysfunction and identify potential underlying causes. Since there is a degree of association between cardiovascular risk and sexual activity, physicians should consider the cardiovascular status of patients before initiating treatment for erectile dysfunction, including treatment with tadalafil. Tadalafil has vasodilatory properties that result in mild and transient decreases in blood pressure; this effect may potentiate the blood-pressure-lowering effects of nitrates.

2. Serious cardiovascular events—including myocardial infarction, unstable angina, ventricular arrhythmias, shock, and transient ischemic attacks—have been observed in clinical trials of tadalafil. Additionally, hypertension and hypotension (including orthostatic hypotension) have occasionally been reported in clinical trials. Most patients experiencing these events had pre-existing cardiovascular risk factors; however, it is not currently possible to determine whether these events were directly related to those risk factors.

3. Visual defects and non-arteritic anterior ischemic optic neuropathy (NAION) have been reported in association with the use of tadalafil and other PDE5 inhibitors. Patients should be advised to stop taking tadalafil and consult a physician immediately if they experience sudden vision loss or visual defects.

4. Clinical safety data regarding the use of this product in patients with severe hepatic impairment (Child-Pugh class C) are limited; if prescribing to such patients, the physician must conduct a careful benefit-risk assessment for each individual.

【Use in Children】 This product must not be used by individuals under 18 years of age.

【Use in Elderly Patients】 Healthy elderly subjects (65 years of age or older) exhibit a lower clearance rate for oral tadalafil, resulting in an AUC that is 25% higher than that of healthy subjects aged 19–45. This age-related difference is not clinically significant, and no dose adjustment is required.

【Use in Pregnant and Lactating Women】 This product is not intended for use by women. Studies of tadalafil in pregnant women have not been conducted. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development.

[Drug Interactions] The interaction studies described below utilized 10 mg and/or 20 mg doses of tadalafil. Since the doses used in these studies were 10 mg, clinically relevant drug interactions cannot be entirely ruled out when higher doses are used in clinical practice. Effects of other drugs on tadalafil: Tadalafil is primarily metabolized by CYP3A4. Compared to tadalafil alone, ketoconazole (200 mg daily), a selective CYP3A4 inhibitor, increased tadalafil (10 mg) exposure (AUC) by 2-fold and Cmax by 15%. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) by 4-fold and Cmax by 22%. Ritonavir (200 mg twice daily), a protease inhibitor and an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) by 2-fold but had no effect on Cmax. Although specific interaction studies have not been conducted, other protease inhibitors (e.g., saquinavir) and other CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, itraconazole, and grapefruit juice) would likely increase plasma concentrations of tadalafil; consequently, the incidence of unpredictable adverse reactions may increase. The role of transporters (e.g., P-glycoprotein) in the distribution of tadalafil is unknown; therefore, drug interactions involving transporter inhibitors are possible.

[Overdose] In healthy subjects, single doses up to 500 mg and multiple daily doses up to a total of 100 mg in patients resulted in adverse events similar to those observed at lower doses. In the event of overdose, standard supportive measures should be adopted. Haemodialysis contributes negligibly to tadalafil elimination. [Pharmacology and Toxicology] This drug is indicated for erectile dysfunction (ATC code G04BE). Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil leads to increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and blood inflow into the penile tissue, producing an erection. Tadalafil has no effect in the absence of sexual stimulation. In vitro studies have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in the smooth muscle of the corpus cavernosum, vascular and visceral smooth muscle, skeletal muscle, platelets, kidneys, lungs, and brain. Tadalafil is more potent against PDE5 than against other phosphodiesterases. Tadalafil is more than 10,000 times more potent against PDE5 than against PDE1, PDE2, and PDE4, which are found in the heart, brain, blood vessels, liver, and other organs. Tadalafil is more than 10,000 times more potent against PDE5 than against PDE3, which is found in the heart and blood vessels. Selectivity for PDE5 over PDE3 is important because PDE3 is involved in cardiac contractility. Furthermore, tadalafil is approximately 700 times more potent against PDE5 than against PDE6, an enzyme found in the retina that is involved in phototransduction. Tadalafil is more than 10,000 times more potent against PDE5 than against PDE7 through PDE10. Three studies involving 1,054 patients in a home-use setting established the time to response for tadalafil. Compared with placebo, the drug demonstrated statistically significant improvements in erectile function, the ability to engage in successful sexual intercourse, and the ability to achieve and maintain an erection sufficient for successful sexual intercourse, with effects observed as early as 16 minutes and lasting up to 36 hours after dosing. Compared with placebo, administration of tadalafil to healthy subjects resulted in no significant differences in supine systolic and diastolic blood pressure (mean maximum reductions of 1.6/0.8 mmHg, respectively) or standing systolic and diastolic blood pressure (mean maximum reductions of 0.2/4.6 mmHg, respectively), nor were there significant changes in heart rate. In studies evaluating the effects of tadalafil on vision, the Farnsworth-Munsell 100-hue color test revealed no impairment in color discrimination (blue/green). This finding is consistent with tadalafil's lower affinity for PDE6 compared to PDE5. Across all clinical trials, reports of changes in color vision were rare (<0.1%). Two studies were conducted in men taking tadalafil (10 mg or 20 mg daily) for six months to investigate its effects on spermatogenesis. The results showed no significant difference between tadalafil and placebo regarding the proportion of men experiencing a 50% or greater reduction in sperm concentration. Furthermore, neither dosage of tadalafil showed significant adverse effects on sperm count, morphology, or motility compared to placebo. However, one study involving daily administration of 10 mg for six months showed a reduction in sperm concentration in the treatment group compared to placebo.

[Pharmacokinetics] Absorption: Tadalafil is rapidly absorbed following oral administration, with the mean maximum observed plasma concentration (Cmax) reached at a median time of 2 hours post-dose. The absolute bioavailability of orally administered tadalafil has not been determined. The rate and extent of tadalafil absorption are unaffected by food; therefore, the drug may be taken with or without food. The time of administration (morning or evening) has no clinically significant effect on the rate or extent of absorption. Distribution: The mean volume of distribution is approximately 63 L, indicating distribution into tissues. At therapeutic concentrations, 94% of tadalafil in plasma is protein-bound. Protein binding is not affected by renal impairment. In healthy subjects, less than 0.0005% of the administered dose was detected in semen. Biotransformation: Tadalafil is primarily metabolized by the cytochrome P450 (CYP) 3A4 isoform. The major circulating metabolite is methylcatechol glucuronide. This metabolite is at least 13,000 times less potent than tadalafil against PDE5; therefore, the observed metabolite concentrations are not clinically active. Clearance: In healthy subjects, the mean oral clearance of tadalafil is 2.5 L/h, and the mean half-life is 17.5 hours. Tadalafil is excreted primarily as inactive metabolites, mainly in the feces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose). Linearity/Non-linearity: In healthy subjects, tadalafil pharmacokinetics are linear with respect to time and dose. Within the 2.5–20 mg dose range, AUC increases proportionally with the dose. Steady-state plasma concentrations are achieved within 5 days of once-daily dosing. Pharmacokinetic characteristics measured in patients with erectile dysfunction are similar to those in subjects without erectile dysfunction. Special Populations: Elderly—Healthy elderly subjects (65 years of age or older) exhibit lower oral clearance of tadalafil, resulting in an AUC 25% higher than that in healthy subjects aged 19–45. This age-related difference is not clinically significant, and no dose adjustment is required. Patients with renal impairment—In clinical pharmacology studies using single doses of tadalafil (5–20 mg), tadalafil exposure (AUC) approximately doubled in patients with mild (creatinine clearance 51–80 mL/min) or moderate (creatinine clearance 31–50 mL/min) renal impairment and in patients with end-stage renal disease undergoing dialysis. In patients undergoing hemodialysis, Cmax was observed to be 41% higher than in healthy subjects. Hemodialysis contributes negligibly to tadalafil clearance. Patients with hepatic impairment—In subjects with mild to moderate hepatic impairment (Child-Pugh Class A and B), tadalafil AUC is similar to that in healthy subjects; therefore, no dose adjustment is required. There is limited clinical safety information regarding the use of this product in patients with severe hepatic impairment (Child-Pugh class C); if prescribed to such patients, a careful benefit-risk assessment must be conducted by the prescribing physician. There are currently no data regarding the administration of tadalafil at doses exceeding 10 mg daily in patients with hepatic impairment. In patients with diabetes, the AUC of tadalafil is approximately 19% lower than in healthy subjects; however, despite this difference...

[Storage] Store at room temperature.

[Packaging] Aluminum-plastic blister pack; 100 tablets per box.

Product Name: Cialis / Tadarise-5 (Tadalafil Tablets 5mg)

Common Name: Cialis

Ingredients: Each tablet contains 5mg of tadalafil

Dosage Form: Tablet

Quantity: 100 tablets

Manufacturer: Sunrise Remedies

Indication: Treatment of erectile dysfunction in men.

Dosage and Administration:

1. Adult men: The recommended dose is 10mg, taken prior to sexual activity; it may be taken with or without food. If the 10mg dose is not sufficiently effective, the dose may be increased to 20mg. It should be taken at least 30 minutes before sexual activity. The maximum frequency of administration is once daily. Continuous daily use is not recommended, as the safety of long-term use has not been established; furthermore, the effects of tadalafil often persist for more than 24 hours.

2. Elderly men: No dosage adjustment is required.

3. Men with renal impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. For patients with severe renal impairment, the maximum recommended dose is 10mg.

4. Men with hepatic impairment: The recommended dose is 10mg, taken prior to sexual activity; it may be taken with or without food. Clinical safety data regarding the use of tadalafil in patients with severe hepatic impairment (Child-Pugh class C) are limited; if prescribed to such patients, a careful benefit-risk assessment must be conducted by the prescribing physician. There are no data available on doses exceeding 10mg in patients with hepatic impairment.

5. Men with diabetes: No dosage adjustment is required for diabetic patients.