india Tadalafil Tablets Vidalista 40mg

[Drug Name]

Generic Name: Tadalafil Tablets

English Name: Tadalafil Tablets

Pinyin: Tadalafei Pian

Specification: 40 mg/tablet; 40 tablets/box

Manufacturer: Centurion Laboratories Pvt Ltd

[Composition]

Active Ingredient: Tadalafil

Chemical Name: (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

Molecular Formula: C₂₂H₁₉N₃O₄

Molecular Weight: 389.41

[Description]

This product is a yellow film-coated tablet; the core appears white or off-white after the coating is removed.

[Indications]

1. Erectile dysfunction (ED) in men.

2. Erectile dysfunction combined with benign prostatic hyperplasia (BPH).

3. Pulmonary arterial hypertension (PAH, WHO Group 1) in adults: to improve exercise capacity; indicated for idiopathic/heritable PAH and PAH associated with connective tissue disease (indication specific to the 40 mg dosage).

[Dosage and Administration]

(I) Pulmonary Arterial Hypertension (40 mg standard regimen)

Recommended dosage: 40 mg orally once daily; may be taken with or without food; swallow the tablet whole—do not break or split it.

Initial dosage recommendations: 40 mg directly for patients with normal renal function; for mild to moderate renal impairment (creatinine clearance 31–80 mL/min), start at 20 mg once daily and increase to 40 mg if tolerated.

Severe renal impairment (<30 mL/min) or dialysis: Use is not recommended.

Hepatic function: Mild to moderate impairment (Child-Pugh Class A/B): 20 mg once daily, not to exceed 40 mg; severe impairment (Class C): Contraindicated.

Elderly (>65 years): No dosage adjustment required. (II) Erectile Dysfunction (ED, standard dosage)

On-demand use: Starting dose of 10 mg, taken 30 minutes before sexual activity; may be increased to 20 mg or reduced to 5 mg; maximum frequency of once daily; effect lasts up to 36 hours.

Once-daily use: 2.5 mg once daily (qd) at a fixed time; may be increased to 5 mg once daily.

【Contraindications】

1. Nitrates: Concomitant use is strictly prohibited in any form (short-acting/long-acting; oral/sublingual/spray), as it may cause severe hypotension, syncope, or even death.

2. Guanylate cyclase (GC) stimulators (e.g., riociguat): Concomitant use enhances the blood pressure-lowering effect; contraindicated.

3. Hypersensitivity: Contraindicated in patients allergic to tadalafil or any excipients.

4. Severe cardiovascular disease: Contraindicated in patients with myocardial infarction within the past 90 days, unstable angina, heart failure (≥Class II) within the past 6 months, refractory arrhythmia, hypotension (<90/50 mmHg), or stroke within the past 6 months.

【Adverse Reactions】

(I) Common (≥10%)

Headache, facial flushing, dyspepsia, nasal congestion, back pain, myalgia.

(II) Uncommon (1%–10%)

Dizziness, visual abnormalities (blurred vision, blue-green color distortion, photosensitivity), conjunctival hyperemia, nausea, diarrhea, rash, palpitations, tachycardia, hypotension.

(III) Rare (<1%, including post-marketing reports)

Cardiovascular: Myocardial infarction, sudden cardiac death, stroke, chest pain.

Ocular: Non-arteritic anterior ischemic optic neuropathy (NAION), visual field defects, retinal vascular occlusion.

Auditory: Sudden hearing loss/decrease (accompanied by tinnitus or dizziness).

Genitourinary: Prolonged erection (>4 hours), priapism (>6 hours; may lead to penile necrosis). Systemic: Hypersensitivity reactions (urticaria, Stevens-Johnson syndrome, exfoliative dermatitis), migraine, seizures, transient amnesia.

【Precautions】

1. Risk of hypotension: Concomitant use with alpha-blockers (e.g., terazosin), antihypertensives, or alcohol can significantly lower blood pressure, potentially causing dizziness or syncope; the 40 mg dose carries a higher risk of hypotension and is contraindicated with alpha-blockers.

2. Priapism: Seek immediate medical attention for erections lasting >4 hours; erections lasting >6 hours constitute a medical emergency and may cause permanent damage to erectile tissue. Use with caution in patients with sickle cell anemia, myeloma, leukemia, or anatomical penile abnormalities (curvature, induration).

3. Vision/Hearing: Discontinue use and seek emergency care immediately if sudden vision loss (unilateral or bilateral) or hearing loss occurs.

4. Cardiovascular safety: Sexual activity carries cardiac risks; use is not recommended for patients advised against sexual activity due to heart disease. Stop sexual activity and seek medical attention if chest pain, dizziness, or shortness of breath occurs after taking the drug.

5. Hepatic/Renal function: The 40 mg dose is contraindicated in patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (creatinine clearance <30 mL/min).

6. Bleeding risk: PDE5 inhibitors may inhibit platelet aggregation; use with caution in patients with a bleeding tendency or active peptic ulcer.

7. Sexually transmitted diseases: Does not protect against HIV, syphilis, etc.; appropriate protective measures should be taken.

8. Special populations:

Women and children under 18: Contraindicated. 

Elderly: No dosage adjustment required, but increased sensitivity to hypotension.

【Drug Interactions】

1. Potent CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir): Increase plasma concentrations of tadalafil; the 40 mg dose should be reduced to 20 mg once daily.

2. CYP3A4 inducers (rifampicin, carbamazepine, phenytoin): Reduce drug efficacy; concomitant use is not recommended.

3. Nitrates/GC stimulators: Absolute contraindication (see [Contraindications]). 4. Alcohol: Potentiates the blood pressure-lowering effect; alcohol consumption with the 40 mg dose increases the risk of syncope; heavy alcohol consumption is contraindicated.

【Pharmacology and Toxicology】

Mechanism of Action: Tadalafil is a selective, reversible inhibitor of PDE5. Sexual stimulation triggers the release of nitric oxide (NO), activating guanylate cyclase and increasing cGMP levels; this relaxes the smooth muscle of the corpus cavernosum, increasing blood flow and resulting in an erection. In patients with PAH, it inhibits PDE5 in the pulmonary vasculature, dilating pulmonary arteries, reducing pulmonary pressure, and improving exercise tolerance.

Duration of Action: 36 hours for the ED dosage; steady state reached in 24 hours for the 40 mg PAH dosage.

Toxicology: No significant hepatic or renal toxicity observed with long-term high-dose administration. Reproductive toxicity: 20 mg/day for 9 months may slightly reduce sperm concentration but does not affect testosterone levels.

【Pharmacokinetics】

Absorption: Rapidly absorbed after oral administration; peak concentration reached in 2 hours under fasting conditions. High-fat meals delay absorption by 1 hour but do not affect bioavailability.

Distribution: Protein binding rate is 94%; primarily distributed in the lungs, liver, and kidneys.

Metabolism: Metabolized by hepatic CYP3A4; active metabolites are less potent than the parent drug.

Excretion: Feces (61%) and urine (36%); half-life is 17.5 hours; steady state reached after 5 days of 40 mg once-daily dosing.

Special Populations:

Renal Impairment: Creatinine clearance <50 mL/min results in a twofold increase in AUC; dosage reduction is required. 

Hepatic Impairment: Mild to moderate impairment results in a 30% increase in AUC; do not exceed 20 mg once daily.

【Storage】

Store in a sealed container at room temperature (10–30°C); protect from light and moisture. Specifications

Product Name: Tadalafil Tablets (Vidalista) 40mg

Common Name: Tadalafil Tablets

Active Ingredient: Tadalafil

Dosage Form: Tablet

Specification: 40mg/tablet; 40 tablets/box

Manufacturer: Centurion Laboratories Pvt Ltd

Indications:

1. Male erectile dysfunction (ED)

2. Erectile dysfunction co-existing with benign prostatic hyperplasia (BPH)

3. Adult pulmonary arterial hypertension (PAH, WHO Group 1): To improve exercise capacity; indicated for idiopathic/heritable PAH and PAH associated with connective tissue disease (40mg specific indication).

Dosage and Administration:

(I) Pulmonary Arterial Hypertension (40mg standard regimen)

Recommended dose: 40mg orally once daily; may be taken with or without food; swallow the tablet whole—do not break or crush.

Initial dosing recommendations: 40mg for patients with normal renal function; for mild-to-moderate renal impairment (creatinine clearance 31–80 mL/min), start at 20mg once daily and increase to 40mg if tolerated.

Severe renal impairment (<30 mL/min) or dialysis: Use not recommended.

Hepatic function: Mild-to-moderate (Child-Pugh A/B): 20mg once daily, not to exceed 40mg; Severe (Class C): Contraindicated.

Elderly (>65 years): No dosage adjustment required.