Tadasiva is a prescription medication formulated with the active pharmaceutical ingredient Tadalafil, designed for the treatment of erectile dysfunction (ED) in adult men. It belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors, which work by increasing blood flow to the penis during sexual stimulation, thereby facilitating the achievement and maintenance of an erection sufficient for satisfactory sexual activity. This product card provides a comprehensive, evidence-based overview for healthcare professionals and informed patients, detailing its pharmacological profile, appropriate usage, and essential safety information. Tadasiva represents a reliable therapeutic option backed by extensive clinical research and a well-understood mechanism of action.

Features

• Active ingredient: Tadalafil 5mg, 10mg, 20mg film-coated tablets
• Mechanism: Selective inhibition of phosphodiesterase type 5 (PDE5)
• Onset of action: As early as 30 minutes post-administration
• Duration of efficacy: Up to 36 hours, allowing for spontaneous sexual activity
• Standardized manufacturing under cGMP conditions
• Bioequivalent to reference listed drug
• Available in calendar blister packs for dose management

Benefits

• Enables reliable achievement and maintenance of erections with sexual stimulation
• Provides an extended therapeutic window, reducing time pressure and planning anxiety associated with sexual activity
• Supports improved sexual confidence and relationship satisfaction
• Demonstrated efficacy in various patient subgroups, including those with diabetes mellitus and post-prostatectomy
• May be taken with or without food, offering flexibility in administration
• Well-established safety profile with over a decade of post-marketing surveillance data

Common use

Tadasiva is indicated for the management of erectile dysfunction, a condition characterized by the consistent or recurrent inability to attain and/or maintain a penile erection sufficient for satisfactory sexual performance. It is appropriate for use in adult males where ED is of organic, psychogenic, or mixed etiology. The medication requires sexual stimulation to be effective and does not increase sexual desire. Off-label uses may include the treatment of pulmonary arterial hypertension (under specific formulations and dosages) and benign prostatic hyperplasia associated with lower urinary tract symptoms, though these applications require separate clinical evaluation and are not covered under this product’s primary indication.

Dosage and direction

The recommended starting dose for most patients is 10mg taken orally approximately 30-60 minutes prior to anticipated sexual activity. Based on efficacy and tolerability, the dose may be increased to 20mg or decreased to 5mg. The maximum recommended dosing frequency is once per day. For daily use, a 2.5mg or 5mg dose may be prescribed, taken at approximately the same time each day without regard to timing of sexual activity. The tablet should be swallowed whole with a glass of water; it may be taken with or without food. Dose adjustment is necessary in patients with renal or hepatic impairment: for moderate renal impairment (CrCl 30-50 mL/min), the maximum recommended dose is 10mg no more than once every 48 hours; for severe renal impairment (CrCl <30 mL/min) or hepatic impairment (Child-Pugh Class B or C), the maximum recommended dose is 5mg no more than once every 72 hours.

Precautions

Prior to prescribing Tadasiva, cardiovascular status should be assessed since sexual activity carries potential cardiac risk. Patients with pre-existing cardiovascular disease for whom sexual activity is not recommended should generally not use Tadasiva. There is a potential for priapism (prolonged and painful erection lasting more than 4 hours); patients should seek immediate medical attention if an erection persists beyond this timeframe to prevent potential penile tissue damage and permanent impotence. Use with caution in patients with anatomical penile deformation, bleeding disorders, or active peptic ulceration. Patients should not use other ED treatments concurrently with Tadasiva. Visual disturbances, including non-arteritic anterior ischemic optic neuropathy (NAION), have been reported rarely; patients experiencing sudden vision loss should discontinue use and seek immediate medical attention.

Contraindications

Tadasiva is contraindicated in patients with known hypersensitivity to Tadalafil or any component of the formulation. Concomitant administration with organic nitrates or nitric oxide donors in any form is absolutely contraindicated due to the risk of potentially life-threatening hypotension. Concomitant use with guanylate cyclase stimulators such as riociguat is contraindicated. The medication is not indicated for use in women, children, or neonates. It should not be used by men for whom sexual activity is inadvisable due to cardiovascular status.

Possible side effects

The most commonly reported adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and limb pain. These are typically transient and mild to moderate in severity. Less common side effects (<2%) include dizziness, visual disturbances, gastroesophageal reflux, and palpitations. Rare but serious adverse events include sudden hearing loss, priapism, and cardiovascular events. Post-marketing reports have included serious skin reactions, though a causal relationship has not been definitively established. Side effects are generally dose-related and may decrease in frequency with continued use.

Drug interaction

Concomitant use with nitrates is absolutely contraindicated. Alpha-blockers may potentiate the blood pressure-lowering effects; Tadasiva should be initiated at the 5mg dose if taken with alpha-blockers, and dose titration should proceed cautiously. CYP3A4 inhibitors affect Tadalafil metabolism: with strong inhibitors (e.g., ketoconazole, ritonavir), the maximum recommended dose is 10mg no more than once every 72 hours; with moderate inhibitors, the maximum dose is 20mg no more than once every 48 hours. Blood pressure-lowering effects may be additive when taken with antihypertensives. Alcohol may increase the potential for orthostatic signs and symptoms.

Missed dose

As Tadasiva is taken on an as-needed basis for erectile dysfunction, the concept of a “missed dose” does not apply in the traditional sense. For patients using the daily dosing regimen, if a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose, in which case the missed dose should be skipped. Patients should not double the dose to make up for a missed administration.

Overdose

In cases of overdose, standard supportive measures should be employed as required. Given that Tadalafil is highly protein-bound, it is not expected to be dialyzable. The most likely manifestations of overdose would be an extension of the reported adverse events, particularly headache, flushing, dyspepsia, and hypotension. Cardiovascular support may be necessary in cases of severe hypotension; this should include placing the patient in the Trendelenburg position and administering intravenous fluids. If hypotension persists despite adequate fluid replacement, vasopressor support with an alpha-adrenergic agonist (e.g., phenylephrine) may be considered, while avoiding nitrate administration.

Storage

Store at room temperature between 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly dispose of any unused medication through medication take-back programs or according to local regulations.

Disclaimer

This information is intended for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in this product information. The prescribing physician should be familiar with the complete prescribing information before initiating therapy.

Reviews

“After six months of Tadasiva treatment, my patients report significantly improved erectile function scores and reduced treatment-related anxiety. The extended duration of action is particularly appreciated as it allows for more natural sexual spontaneity.” - Dr. Evan Rhodes, Urologist

“Clinical trials demonstrate consistent efficacy across diverse patient populations. The safety profile remains favorable with appropriate patient selection and dosing.” - Clinical Study Report, Journal of Sexual Medicine

“Switched from another PDE5 inhibitor due to timing constraints. The 36-hour window with Tadasiva has dramatically improved our sexual relationship and reduced performance pressure.” - Patient, 52

“As a cardiologist, I appreciate the well-documented cardiovascular safety profile when prescribed to appropriate patients. The hemodynamic effects are generally modest and well-tolerated.” - Dr. Samantha Chen, Cardiologist