Vidalista 60 (Tadalafil Tablets I.P. 60 mg) — Clinical Monograph

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Overview

Vidalista 60 is a prescription-only phosphodiesterase type 5 (PDE5) inhibitor containing Tadalafil 60 mg as its active ingredient.
Manufactured by Centurion Remedies Pvt. Ltd., this high-strength formulation is indicated for the management of erectile dysfunction (ED) and other vascular conditions requiring PDE5 inhibition, under strict medical supervision.

Tadalafil facilitates penile erection by enhancing nitric oxide–mediated vasodilation in the corpus cavernosum, thereby improving penile blood flow in response to sexual stimulation.
The medication has a prolonged duration of action (up to 36 hours), attributed to its extended half-life, making it one of the longest-acting PDE5 inhibitors in clinical use.

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Pharmacological Classification

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Mechanism of Action

Tadalafil acts as a selective inhibitor of the cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) enzyme.
This enzyme is predominantly located in the corpus cavernosum, vascular smooth muscle, and pulmonary vasculature.

1. During sexual stimulation, nitric oxide (NO) is released from nerve endings and endothelial cells within the penile tissue.

2. NO activates the enzyme guanylate cyclase, increasing intracellular cGMP levels.

3. cGMP induces smooth muscle relaxation, promoting vasodilation and enhanced blood inflow into erectile tissue.

4. PDE5 breaks down cGMP, terminating the erection.

5. Tadalafil inhibits PDE5, sustaining elevated cGMP concentrations, thereby prolonging the erectile response.

Pharmacodynamic Characteristics

• Selectivity for PDE5 over PDE1–PDE4 contributes to minimal cardiovascular side effects.

• Does not influence penile blood flow in the absence of sexual stimulation.

• Maintains normal diurnal blood pressure in normotensive individuals.

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Therapeutic Indications

Tadalafil 60 mg is indicated for:

1. Erectile Dysfunction (ED):

   • Restoration of erectile function in adult males when inadequate erection prevents satisfactory sexual activity.

   • Indicated particularly for moderate to severe ED where lower doses (10–40 mg) are insufficient.

2. Benign Prostatic Hyperplasia (BPH):

   • Management of lower urinary tract symptoms (LUTS) secondary to BPH (when prescribed in lower doses).

3. Pulmonary Arterial Hypertension (PAH):

   • Improves exercise capacity and delays clinical worsening (under specialist guidance).

Note: The 60 mg strength is not recommended for initial therapy. It is reserved for cases requiring higher PDE5 inhibition under professional supervision.

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Pharmacokinetics

Pharmacokinetic Advantages

• Long terminal half-life allows once-daily or alternate-day dosing strategies.

• Food has minimal effect on absorption rate or extent.

• Stable pharmacokinetic profile even after multiple doses.

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Dosage and Administration

Important: All dosing must be individualized according to patient response and tolerability.

Recommended Dosing for Erectile Dysfunction

• Starting dose: Typically 10–20 mg prior to anticipated sexual activity.

• Titration: Dose may be increased stepwise to 60 mg only in patients who do not respond adequately to lower strengths.

• Maximum frequency: Once per 24 hours.

• Administration: Oral, with water, independent of food intake.

Chronic / Daily Dosing (Maintenance Therapy)

• For men engaging in sexual activity frequently (> twice weekly), a daily regimen of 2.5–5 mg may be used under supervision.

Missed Dose

• Not applicable to as-needed dosing. For daily therapy, take as soon as remembered; skip if near next scheduled dose.

Overdose

• Symptoms: Severe hypotension, headache, priapism, syncope.

• Management: Supportive measures, monitoring of hemodynamics. Hemodialysis is ineffective due to high protein binding.

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Target Population

• Adult men (≥ 18 years) diagnosed with erectile dysfunction.

• Patients with vascular or metabolic causes of ED (e.g., diabetes, atherosclerosis).

• Individuals with psychogenic ED requiring adjunctive pharmacotherapy.

• Not intended for women, pediatric, or adolescent populations.

• Use with caution in elderly men (> 65 years) with comorbidities.

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Clinical Benefits

1. Enhanced erectile response in men unresponsive to standard PDE5 inhibitor doses.

2. Extended therapeutic window allowing spontaneity in sexual activity.

3. Improved satisfaction and performance in validated sexual-function indexes (IIEF-5 scores).

4. High selectivity ensures minimal systemic vasodilation.

5. Convenient oral dosing without significant food interference.

6. Predictable pharmacokinetics and consistent results with repeated use.

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Problem Addressed — Erectile Dysfunction

Erectile dysfunction (ED) is defined as the consistent inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse.
The condition affects both physiological and psychological health, often secondary to endothelial dysfunction, vascular disease, diabetes, hormonal imbalance, or medication effects.

Vidalista 60 (Tadalafil 60 mg) targets the vascular etiology by restoring the NO–cGMP pathway responsible for penile erection.
By inhibiting PDE5, Tadalafil preserves intracellular cGMP, sustaining smooth-muscle relaxation and enhancing penile blood flow during arousal.
This mechanism enables natural erectile function and restores quality of life for affected patients when non-pharmacologic interventions alone are insufficient.

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Contraindications

• Concomitant nitrate therapy (risk of profound hypotension).

• Severe cardiac disease precluding sexual activity.

• Recent myocardial infarction or stroke (within 6 months).

• Severe hepatic or renal impairment.

• Uncontrolled hypotension (< 90/50 mmHg) or uncontrolled hypertension (> 170/100 mmHg).

• Known hypersensitivity to Tadalafil or tablet excipients.

• Degenerative retinal disorders (e.g., retinitis pigmentosa).

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Warnings and Precautions

1. Cardiovascular Considerations

   • Assess cardiac risk before initiating therapy; sexual activity itself poses hemodynamic stress.

2. Priapism

   • Painful, prolonged erection > 4 hours requires immediate medical attention to prevent tissue damage.

3. Visual and Auditory Effects

   • Discontinue immediately if sudden vision or hearing loss occurs.

4. Interaction with Alcohol and CYP3A4 Modulators

   • Alcohol enhances hypotensive risk.

   • CYP3A4 inhibitors (ketoconazole, ritonavir) increase plasma concentrations of Tadalafil.

   • CYP3A4 inducers (rifampicin, phenytoin) may reduce efficacy.

5. Renal and Hepatic Impairment

   • Adjust dose or avoid high-strength (60 mg) formulations.

6. Concomitant Alpha-Blocker Use

   • Combination can cause symptomatic hypotension; initiate with lowest doses and medical monitoring.

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Adverse Reactions

Most side effects are dose-dependent and subside within hours. Persistent or severe events require medical evaluation.

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Drug Interactions

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Special Populations

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Storage and Stability

• Store below 30°C, away from direct light and moisture.

• Keep in original blister packaging until administration.

• Shelf life: typically 24–36 months (refer to carton).

• Keep out of reach of children and pets.

• Dispose of unused medication in accordance with pharmaceutical waste regulations.

Conclusion

Vidalista 60 (Tadalafil 60 mg) is a potent PDE5 inhibitor providing reliable and long-acting pharmacologic support for the treatment of erectile dysfunction in adult men.
Through selective inhibition of PDE5, it restores physiological erectile mechanisms, improves penile hemodynamics, and enhances overall sexual performance when used under appropriate clinical supervision.

Its extended half-life offers a unique therapeutic advantage for patients requiring longer efficacy windows.
However, as with all PDE5 inhibitors, judicious prescribing, thorough cardiovascular evaluation, and comprehensive patient education are essential to maximize benefits and ensure safety.