VIRECTA PLUS® contains two pharmacologically active ingredients: sildenafil 100 mg and dapoxetine 60 mg. The combination is designed to address two distinct male sexual-health problems: erectile dysfunction (ED) and premature ejaculation (PE). Sildenafil is a phosphodiesterase type-5 (PDE5) inhibitor used for ED, while dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) used in appropriate adult men with premature ejaculation.

1. Active Ingredients

Sildenafil

Sildenafil selectively inhibits phosphodiesterase type-5 (PDE5). During sexual stimulation, nitric oxide signaling increases cyclic guanosine monophosphate (cGMP) in penile tissue. PDE5 normally breaks down cGMP; inhibition of PDE5 helps maintain cGMP levels, promoting relaxation of cavernosal smooth muscle and increasing penile blood flow. Sexual stimulation is still required for an erection to occur.

Dapoxetine

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) with a relatively short duration of action. By increasing serotonergic activity in the central nervous system, it can increase the time to ejaculation and improve control over ejaculation in men with premature ejaculation. The EMA describes dapoxetine as a medicine for premature ejaculation in appropriately selected men aged 18–64 years.

2. Therapeutic Role

Erectile Dysfunction

Sildenafil is an established oral treatment for erectile dysfunction, a condition characterized by the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual activity.

PDE5 inhibitors such as sildenafil are commonly used as first-line pharmacological therapy for ED. Clinical evidence demonstrates improvement in erectile function, erection rigidity, orgasmic function and overall sexual satisfaction in appropriately selected men.

Premature Ejaculation

Dapoxetine is specifically used for premature ejaculation in appropriately diagnosed adult men. It acts centrally through serotonin reuptake inhibition and may improve ejaculatory control and increase the time before ejaculation.

Therefore, VIRECTA PLUS is intended to provide pharmacological support for:

Erectile function + Ejaculatory control

3. How VIRECTA PLUS Works

Sildenafil 100 mg

PDE5 inhibition → increased cGMP activity → relaxation of penile smooth muscle → increased penile blood flow → improved erectile response during sexual stimulation.

Dapoxetine 60 mg

Serotonin reuptake inhibition → increased serotonergic neurotransmission → improved ejaculatory control and delayed ejaculation in appropriate patients.

The two ingredients therefore act through different physiological pathways, addressing two different components of male sexual dysfunction.

4. Administration

Because VIRECTA PLUS contains sildenafil 100 mg + dapoxetine 60 mg, the individual doses should not be increased or repeated without medical advice.

For sildenafil alone, the usual recommended starting dose is 50 mg taken approximately 1 hour before sexual activity, with a maximum recommended frequency of once daily; the dose may be adjusted to 25–100 mg according to effectiveness and tolerability.

For dapoxetine-containing treatment, the EMA product information states that the usual dose is 30 mg, with the dose potentially increased to 60 mg, taken 1–3 hours before anticipated sexual activity, and not more than once in 24 hours.

Because the VIRECTA PLUS tablet already contains the higher 100 mg sildenafil dose and 60 mg dapoxetine dose, it is particularly important that its use be determined by a physician rather than self-adjusted.

5. Important Contraindication — NITRATES

DO NOT TAKE VIRECTA PLUS WITH NITRATES

This is one of the most important safety considerations.

Sildenafil can markedly potentiate the blood-pressure-lowering effect of organic nitrates because both drugs influence the nitric oxide/cGMP pathway. Concomitant use can result in severe, potentially life-threatening hypotension.

Examples include:

• Nitroglycerin / glyceryl trinitrate
• Isosorbide mononitrate
• Isosorbide dinitrate
• Other organic nitrate preparations
• Organic nitrites such as amyl nitrite

Patients using nitrates for angina must not use sildenafil-containing products.

If chest pain develops after taking sildenafil, the patient should not self-administer nitroglycerin and should seek emergency medical attention, informing healthcare personnel that sildenafil was taken.

6. Other Important Drug Interactions

Alpha-blockers

Sildenafil can enhance the blood-pressure-lowering effects of alpha-blockers and may cause symptomatic hypotension or dizziness. Patients should be medically stable on alpha-blocker therapy, and sildenafil is generally initiated at a lower dose when used in this setting.

Examples include:

• Tamsulosin
• Doxazosin
• Terazosin
• Alfuzosin

CYP3A4 inhibitors

Sildenafil is metabolized substantially through CYP3A4. Strong CYP3A4 inhibitors can significantly increase sildenafil exposure.

Examples include:

• Ritonavir
• Ketoconazole
• Itraconazole
• Some macrolide antibiotics
• Certain HIV protease inhibitors

For example, ritonavir can increase sildenafil exposure substantially; current prescribing information recommends strict dose limitation when sildenafil is used with ritonavir.

Dapoxetine is also metabolized through pathways including CYP3A4 and CYP2D6, and potent CYP3A4 inhibitors can increase dapoxetine concentrations; concomitant treatment with potent CYP3A4 inhibitors is contraindicated in the European product information.

7. Medicines That Require Particular Attention With Dapoxetine

Because dapoxetine is an SSRI, it should not be combined indiscriminately with other serotonergic medicines.

Particular caution is required with:

• Other SSRIs
• SNRIs
• Tricyclic antidepressants
• MAO inhibitors
• Other serotonergic medicines
• Certain medicines affecting CYP2D6/CYP3A4

Combining serotonergic medicines may increase the risk of excessive serotonergic activity, including serotonin syndrome.

Patients should therefore inform their physician about all antidepressants, psychiatric medicines and other prescription or non-prescription medicines they are taking before using VIRECTA PLUS.

8. Alcohol

Alcohol should be avoided or minimized with dapoxetine-containing treatment.

Dapoxetine may cause dizziness, drowsiness or fainting, and alcohol can increase these effects and increase the risk of injury. The EMA specifically warns that alcohol may increase the effects of dapoxetine and the risk of fainting and other adverse effects.

9. Common Adverse Effects

Because VIRECTA PLUS contains two active medicines, adverse effects associated with either ingredient may occur.

Sildenafil-associated effects may include:

• Headache
• Facial flushing
• Dyspepsia/indigestion
• Nasal congestion
• Dizziness
• Visual disturbances, including altered color perception
• Back or muscle discomfort in some patients

PDE5 inhibitor clinical literature identifies headache, flushing, dyspepsia and nasal congestion among commonly reported effects.

Dapoxetine-associated effects may include:

• Nausea
• Dizziness
• Headache
• Somnolence
• Diarrhea
• Dry mouth
• Fatigue
• Difficulty concentrating
• Orthostatic symptoms or fainting

Dizziness and fainting are particularly important because dapoxetine can produce orthostatic hypotension/syncope in susceptible individuals.

10. Serious Adverse Effects Requiring Immediate Medical Attention

Prolonged erection

An erection lasting more than 4 hours constitutes a medical emergency because prolonged penile ischemia can result in permanent erectile dysfunction.

Seek emergency medical attention immediately.

Sudden vision loss

Sudden visual loss or significant visual disturbance requires immediate medical evaluation. Rare ocular events, including non-arteritic anterior ischemic optic neuropathy (NAION), have been reported in association with PDE5 inhibitors.

Sudden hearing loss

Sudden hearing loss, particularly when accompanied by dizziness or tinnitus, should receive immediate medical evaluation.

Severe allergic reaction

Stop the medicine and seek urgent medical attention in case of:

• Facial or throat swelling
• Difficulty breathing
• Severe rash
• Fainting

11. Cardiovascular Considerations

Sexual activity itself produces cardiovascular stress. Erectile dysfunction can also coexist with cardiovascular disease and may sometimes be an early marker of vascular disease.

Patients with:

• Unstable angina
• Severe cardiovascular disease
• Recent serious cardiovascular events
• Uncontrolled hypertension
• Significant hypotension
• Serious arrhythmias

should undergo appropriate medical evaluation before receiving ED therapy.

PDE5 inhibitors have vasodilatory effects and can lower blood pressure, making cardiovascular assessment important in selected patients.

12. Patients Who Should Not Self-Use VIRECTA PLUS

Medical assessment is particularly important for men with:

• Known cardiovascular disease
• Low blood pressure
• Uncontrolled hypertension
• Previous stroke or myocardial infarction
• Significant liver disease
• Severe kidney disease
• Retinal/optic nerve disorders
• A history of fainting
• Significant psychiatric disorders
• Bipolar disorder or previous manic episodes
• Current antidepressant therapy
• Concomitant alpha-blocker therapy
• Concomitant nitrate therapy
• Treatment with potent CYP3A4 inhibitors

13. Not an Aphrodisiac

VIRECTA PLUS does not directly increase sexual desire (libido).

Sildenafil facilitates the physiological erectile response when sexual stimulation occurs; it does not create an erection in the absence of sexual stimulation.

Dapoxetine is intended to improve ejaculatory control, rather than to act as a general sexual stimulant.

14. Food Considerations

Sildenafil can be taken with or without food. However, a high-fat meal may delay the onset of sildenafil's effect, so patients seeking a predictable onset should follow the product's prescribing information regarding food.

Alcohol should be avoided or minimized because of the additional dizziness, hypotension and fainting risks associated particularly with dapoxetine.

15. Storage

• Store according to the manufacturer's labeled storage conditions, generally in a dry place at controlled room temperature and protected from excessive heat and moisture.
• Keep out of reach of children.

16. Key Counseling Points

Before taking VIRECTA PLUS, the patient should know:

1. Do not use with nitrates.
2. Do not take more than the prescribed dose.
3. Do not combine it with other sildenafil/PDE5 inhibitors.
4. Do not combine it with other dapoxetine/SSRIs without medical advice.
5. Avoid excessive alcohol.
6. Inform the physician about cardiovascular disease and all medications.
7. Seek emergency help for an erection lasting more than 4 hours.
8. Seek urgent medical attention for sudden vision or hearing loss.
9. Dizziness or fainting can occur; avoid driving or hazardous activities if affected.
10. Sexual activity may carry cardiovascular risk in men with significant heart disease.

Patient Disclaimer

VIRECTA PLUS® contains pharmacologically active medicines and should not be considered a dietary supplement or a general sexual-enhancement product. It should be used only in accordance with the approved local prescribing information and after appropriate medical assessment. Sildenafil is contraindicated with nitrate medicines because of the risk of severe hypotension. Dapoxetine can cause dizziness, orthostatic hypotension and fainting and has important interactions with serotonergic medicines and potent CYP3A4 inhibitors. Patients with cardiovascular disease, low blood pressure, significant liver or kidney disease, or those taking antidepressants, nitrates, alpha-blockers or other interacting medicines should consult a physician before use. Do not self-medicate, do not exceed the prescribed dose, and seek emergency medical care for chest pain, fainting, sudden vision/hearing loss, severe allergic reactions, or an erection lasting longer than 4 hours.

References

1. U.S. National Library of Medicine / NCBI — Medical and Surgical Therapy of Erectile Dysfunction (Endotext) — sildenafil/PDE5 inhibitors, mechanism, cardiovascular considerations and nitrate contraindication.
2. U.S. FDA / DailyMed — Sildenafil prescribing information — indication, dosing, contraindications and drug interactions.
3. U.S. FDA / DailyMed — Sildenafil prescribing information, current labeling — dosing, nitrates, alpha-blockers and CYP3A4 interactions.
4. European Medicines Agency (EMA) — Priligy (dapoxetine) — indication, mechanism and patient-use information.
5. European Medicines Agency — Priligy product information — dosing, alcohol, dizziness, fainting and driving precautions.
6. European Medicines Agency — Dapoxetine drug-interaction assessment — CYP3A4 metabolism and contraindication with potent CYP3A4 inhibitors.
7. NCBI/PubMed — PDE5 inhibitors in erectile dysfunction — efficacy, contraindications and drug interactions.