Tadapox: Uses, dosage, side effects, warnings & patient reviews

What is Tadapox?

Tadapox is a prescription medication that combines two active pharmaceutical ingredients in a single tablet: tadalafil (20 mg) and dapoxetine (60 mg). It is manufactured as a generic drug and is not authorized for sale or distribution in the United States by the FDA.

The tadalafil component is a phosphodiesterase type 5 (PDE5) inhibitor. It is the same active ingredient found in the FDA-approved medication Cialis, indicated for the treatment of erectile dysfunction. Tadalafil works by relaxing blood vessels in the penis to facilitate blood flow upon sexual stimulation.

The dapoxetine component is a short-acting selective serotonin reuptake inhibitor (SSRI). It is specifically indicated for the treatment of premature ejaculation and is marketed in some countries under the brand name Priligy. Dapoxetine increases the time to ejaculation by modulating serotonin levels in the central nervous system.

How to Take Tadapox

Administration of Tadapox must follow a healthcare provider’s specific instructions. Self-prescribing or deviation from prescribed dosing is not recommended.

Standard Administration

The typical Tadapox dosage is one tablet (containing tadalafil 20 mg and dapoxetine 60 mg) taken orally, with a full glass of water. It is intended for use on an as-needed basis, approximately 1 to 3 hours before anticipated sexual activity.

The tablet should be swallowed whole and can be taken with or without food. However, consuming Tadapox with a high-fat meal may delay the absorption of tadalafil and reduce its peak effectiveness.

Dosing Frequency and Limitations

• Do not take more than one tablet within a 24-hour period.
• The clinical efficacy and safety of taking this medication daily have not been established for this fixed-dose combination.
• Sexual stimulation is required for the tadalafil component to be effective.

Side Effects of Tadapox

The side effect profile of Tadapox is a combination of those associated with its individual components, tadalafil and dapoxetine. For context on common side effects associated with ED medications, see a urologist’s guide to what is normal.

What is Tadapox Used For?

Tadapox has a dual indication for adult men experiencing both specified sexual health conditions simultaneously.

Primary Medical Indications

Tadapox is prescribed for the treatment of:

1. Erectile Dysfunction (ED): The tadalafil component is indicated for men with ED, a condition characterized by the consistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
2. Premature Ejaculation (PE): The dapoxetine component is indicated for men with PE, defined as ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration, and which causes distress.

It is intended for patients in whom both conditions are formally diagnosed. The medication is not indicated for use by women, adolescents, or men without these diagnoses.

Important Considerations

• Tadapox is a treatment for symptoms and does not cure the underlying physiological or psychological causes of ED or PE.
• Dapoxetine is not approved for any medical use by the U.S. FDA.
• The use of this fixed-dose combination for other conditions is considered off-label and must be determined by a physician based on individual clinical evaluation.

Important Safety Concerns and Considerations

U.S. Regulatory Status and Drug Quality

Tadapox is not approved by the U.S. Food and Drug Administration (FDA). Dapoxetine, one of its active ingredients, is not an approved pharmaceutical agent in the United States for any indication. Medications obtained from international or unregulated online sources may be counterfeit, containing incorrect doses, wrong active ingredients, or harmful contaminants. For general warnings about such products, see a urologist’s perspective on unregulated ED medications.

Cardiovascular and Cerebrovascular Risk

Both tadalafil and dapoxetine can affect blood pressure. Tadalafil causes mild, transient vasodilation. Dapoxetine is associated with orthostatic hypotension and syncope. Therefore, Tadapox is contraindicated in men for whom sexual activity is inadvisable due to underlying cardiovascular conditions, such as unstable angina, recent myocardial infarction, or stroke. Patients with significant heart disease require careful evaluation before use.

Risk of Serotonin Syndrome

Due to the dapoxetine component, Tadapox poses a risk of serotonin syndrome, a potentially life-threatening condition resulting from excessive serotonergic activity in the central nervous system. This risk is markedly increased with concurrent use of other serotonergic drugs (e.g., other SSRIs, SNRIs, tricyclic antidepressants, triptans, tramadol, St. John’s Wort) or monoamine oxidase inhibitors (MAOIs).

Neurological Effects: Syncope and Prodromal Symptoms

Dapoxetine has a notable risk of causing syncope (fainting), often preceded by prodromal symptoms such as nausea, dizziness, lightheadedness, sweating, and anxiety. Activities requiring mental alertness, such as driving, should be avoided, especially during initial use or dose adjustment.

Critical Warnings for Tadapox Use

Nitrate Contraindication

Tadapox is absolutely contraindicated in patients taking any form of organic nitrate or nitric oxide donor. This includes prescription nitrates (e.g., nitroglycerin, isosorbide dinitrate/mononitrate) used for angina pectoris and recreational amyl nitrite (“poppers”). Concomitant use can cause a severe, life-threatening decrease in blood pressure.

Contraindication with MAOIs and Other Serotonergic Drugs

Tadapox must not be used concurrently with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Concomitant use with other serotonergic agents is also contraindicated or requires extreme caution due to the risk of serotonin syndrome.

Cardiovascular Status

Physicians should consider the cardiovascular status of patients before initiating any treatment for sexual dysfunction, including Tadapox. Sexual activity is associated with a degree of cardiac risk. Tadapox is not recommended for men with severe cardiovascular disorders where sexual activity is not advised.

Underlying Causes of ED and PE

Erectile dysfunction and premature ejaculation can be symptoms of underlying medical conditions (e.g., hormonal imbalances, neurological issues, psychological factors). Treatment with Tadapox should follow a proper medical evaluation to identify and manage any primary causes.

Priapism

Prolonged erection (>4 hours) and priapism (a painful erection lasting >6 hours) have been reported with PDE5 inhibitor use, including tadalafil. This condition requires immediate medical intervention to prevent permanent tissue damage and subsequent erectile dysfunction.

Tadapox Dosage Information

Dosage must be individualized under the supervision of a qualified healthcare professional. The following information describes standard available strengths and general principles.

Dosage Administration Guidelines

• Initial Dose: The recommended starting dose is one Tadapox tablet (tadalafil 20 mg/dapoxetine 60 mg) taken as needed, 1-3 hours before sexual activity.
• Dosing Frequency: Do not exceed one dose in a 24-hour period.
• Dose Adjustment: Based on efficacy and tolerability, a physician may consider adjusting the dose of the individual components. This typically involves switching to separate prescriptions for tadalafil and dapoxetine to allow for finer titration.
• Renal or Hepatic Impairment: Dose adjustment is recommended for patients with significant renal impairment or mild to moderate hepatic impairment. Tadapox is not recommended for patients with severe hepatic impairment.

Drug Interactions with Tadapox

Tadapox has a significant potential for clinically important drug interactions. A comprehensive review of all concomitant medications, including over-the-counter drugs and herbal supplements, is essential.

Additional Information

Storage and Handling

Store Tadapox tablets at room temperature (between 15°C and 30°C or 59°F and 86°F), in a tightly closed container, away from light, excess heat, and moisture. Keep all medications out of the reach of children and pets.

Mechanism of Action

Tadapox employs a dual pharmacological action:

1. Tadalafil: Inhibits the enzyme phosphodiesterase type 5 (PDE5) in the smooth muscle of the corpus cavernosum of the penis. This inhibition increases levels of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation and inflow of blood during sexual stimulation.
2. Dapoxetine: Acts as a selective serotonin reuptake inhibitor (SSRI) in the central nervous system. By increasing serotonin activity in the synaptic cleft, it modulates the neurochemical ejaculatory reflex, thereby increasing intravaginal ejaculatory latency time (IELT).

Reporting Side Effects

Patients are encouraged to report negative side effects or adverse events to their prescribing physician. In regions with active pharmacovigilance systems, patients may also report directly to national health authorities.

References and Medical Sources

1. European Medicines Agency (EMA). Priligy (dapoxetine) Summary of Product Characteristics. [Updated 2023]. https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-priligy_en.pdf
2. International Society for Sexual Medicine (ISSM). Guidelines for the Diagnosis and Treatment of Premature Ejaculation. [2014]. https://www.issm.info/sexual-health-headlines/dapoxetine-for-premature-ejaculation-has-high-discontinuation-rate
3. MedlinePlus. Dapoxetine. U.S. National Library of Medicine; [Updated 2022]. https://medlineplus.gov/druginfo/meds/a616035.html
4. Drugs.com. Dapoxetine Professional Monograph. Drugs.com; [Updated 2024]. https://www.drugs.com/international/dapoxetine.html

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.