📋 Clinical Overview

A fixed-dose combination (FDC) tablet containing Tadalafil, a long-acting phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED), and Dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI) for premature ejaculation (PE). This combination is specifically indicated for men with comorbid ED and PE, addressing both conditions simultaneously. It is a prescription-only medicine in India.

💊 Dosage & Administration

Adult: One tablet (Tadalafil 10mg + Dapoxetine 30mg) taken orally with a full glass of water, approximately 1-3 hours before anticipated sexual activity. Should not be taken more than once in 24 hours.

Note: Take on an empty stomach or with a light meal for optimal and predictable effect. A high-fat meal may delay the absorption of tadalafil. Tablet should be swallowed whole, not crushed or chewed. Sexual stimulation is required for tadalafil to be effective.

⚠️ Contraindications

Hypersensitivity to tadalafil, dapoxetine, or any excipient.
Patients with cardiac conditions where sexual activity is inadvisable (e.g., severe heart failure, unstable angina).
Patients with severe hepatic impairment (Child-Pugh Class C).
Concomitant use with nitrates (e.g., nitroglycerin, isosorbide) or nitric oxide donors in any form.
Concomitant use with potent CYP3A4 inhibitors like ritonavir, ketoconazole, itraconazole.
Concomitant use with monoamine oxidase inhibitors (MAOIs), thioridazine, or other SSRIs/SNRIs/tricyclic antidepressants.
Patients with a history of mania or severe depression.
Patients with postural hypotension or history of syncope.

🔬 Mechanism of Action

Tadalafil: Inhibits PDE5 enzyme in the corpus cavernosum of the penis, preventing degradation of cyclic guanosine monophosphate (cGMP). Elevated cGMP leads to smooth muscle relaxation, increased blood flow, and erection in response to sexual stimulation. Dapoxetine: Rapidly inhibits presynaptic serotonin reuptake, increasing serotonin activity in the synaptic cleft within the central nervous system (specifically the hypothalamic nuclei). This is believed to enhance serotonergic tone, increasing intravaginal ejaculatory latency time (IELT) and improving control over ejaculation.

🤕 Side Effects

Headache
Flushing (feeling of warmth/redness in face)
Nasal congestion
Dyspepsia (indigestion)
Nausea
Dizziness
Dry mouth
Insomnia
Fatigue

🤰 Special Populations

Pregnancy: Not indicated for use in women. Category not assigned.

Driving: May cause dizziness, syncope, or blurred vision. Patients should not drive or operate heavy machinery until they know how the drug affects them, especially after the first dose.

🔄 Drug Interactions

Organic Nitrates (Nitroglycerin, Isosorbide)	Profound hypotension, risk of myocardial infarction, stroke, or death.	Contraindicated
Potent CYP3A4 Inhibitors (Ketoconazole, Itraconazole, Ritonavir, Clarithromycin)	Markedly increases plasma levels of tadalafil and dapoxetine, increasing toxicity risk.	Contraindicated
Alpha-blockers (Doxazosin, Tamsulosin, Prazosin)	Additive blood pressure lowering, risk of symptomatic hypotension (dizziness, fainting).	Major - Avoid concomitant use. If necessary, initiate alpha-blocker at lowest dose.
Other PDE5 Inhibitors (Sildenafil, Vardenafil)	Additive effects, increased risk of side effects.	Major - Do not combine.
Other SSRIs/SNRIs/Tricyclics (Fluoxetine, Sertraline, Venlafaxine, Amitriptyline)	Increased risk of serotonin syndrome.	Contraindicated
MAO Inhibitors (Phenelzine, Selegiline)	Risk of serotonin syndrome.	Contraindicated
Thioridazine	Increased thioridazine levels, risk of QT prolongation.	Contraindicated
Moderate CYP3A4 Inhibitors (Erythromycin, Grapefruit Juice)	May increase tadalafil/dapoxetine exposure. Use with caution.	Moderate
CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin)	May decrease plasma levels, reducing efficacy.	Moderate

🔁 Alternatives to Tadalis Dapoxetine

Same composition (Tadalafil (10mg) + Dapoxetine (30mg)), different brands:

M Force Duo Erectafil D Tadlong D Tadarise D