Malegra FXT: Dual-Action Therapy for Erectile Dysfunction and Premature Ejaculation
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Malegra FXT is a combination pharmaceutical agent designed to address two of the most prevalent male sexual health concerns concurrently: erectile dysfunction and premature ejaculation. This medication synergistically combines Sildenafil Citrate, a potent phosphodiesterase type 5 (PDE5) inhibitor, with Dapoxetine Hydrochloride, a selective serotonin reuptake inhibitor (SSRI) with a short half-life. It is formulated for men seeking a comprehensive solution to improve both the rigidity and duration of erection, thereby enhancing overall sexual performance and satisfaction. Clinical evidence supports its efficacy in significantly increasing intravaginal ejaculatory latency time (IELT) while facilitating adequate erectile response to sexual stimulation.
Features
- Active Ingredients: Sildenafil Citrate (100mg) and Dapoxetine Hydrochloride (30mg or 60mg)
- Pharmacological Class: PDE5 Inhibitor + Short-Acting SSRI
- Onset of Action: Sildenafil: approximately 30-60 minutes; Dapoxetine: approximately 1-2 hours
- Duration of Effect: Sildenafil: up to 4-6 hours; Dapoxetine: designed for on-demand use
- Administration: Oral tablet
- Available Strengths: Malegra FXT Plus (Sildenafil 100mg + Dapoxetine 30mg), Malegra FXT Forte (Sildenafil 100mg + Dapoxetine 60mg)
- Prescription Status: Prescription-only medication (Schedule H/S4 depending on region)
Benefits
- Achieves and sustains firm erections sufficient for satisfactory sexual intercourse.
- Significantly prolongs time to ejaculation, improving control over ejaculation.
- Addresses both physiological (erectile) and ejaculatory components of sexual dysfunction in a single tablet.
- Enhances sexual confidence and reduces performance-related anxiety.
- On-demand administration allows for flexibility and spontaneity.
- Clinically proven to improve measures of sexual satisfaction for both the patient and partner.
Common use
Malegra FXT is indicated for the treatment of adult men experiencing both erectile dysfunction (ED) and premature ejaculation (PE). It is prescribed for patients where these conditions are comorbid, providing a dual therapeutic approach. It is intended for use prior to anticipated sexual activity and is not recommended for continuous daily dosing. The medication is suitable for men with organically-, psychogenically-, or mixed-aetiology ED coupled with lifelong or acquired PE.
Dosage and direction
The recommended starting dose is one Malegra FXT Plus (Sildenafil 100mg / Dapoxetine 30mg) tablet, taken orally with a full glass of water approximately 1-3 hours prior to anticipated sexual activity. Based on individual efficacy and tolerability, the dose may be increased to one Malegra FXT Forte (Sildenafil 100mg / Dapoxetine 60mg) tablet. Do not exceed one tablet in a 24-hour period. The tablet may be taken with or without food; however, a high-fat meal may delay the absorption of Sildenafil and slightly delay the onset of action. Sexual stimulation is required for the erectile response component to be effective.
Precautions
- A thorough medical and cardiovascular assessment is recommended prior to initiation due to the vasodilatory effects of Sildenafil.
- Use with caution in patients with a history of orthostatic hypotension, dehydration, or conditions that may predispose to syncope (fainting).
- Not recommended for men with severe hepatic impairment (Child-Pugh class C). Dose adjustment may be necessary in moderate hepatic impairment.
- Use with caution in patients with a history of mania or severe depression.
- Caution is advised in patients with bleeding tendencies or active peptic ulceration.
- Patients should be advised to avoid strenuous activity after taking the medication to minimize orthostatic effects.
- Alcohol consumption should be avoided or minimized as it can increase the risk of orthostatic hypotension, dizziness, and syncope.
Contraindications
- Hypersensitivity to Sildenafil Citrate, Dapoxetine Hydrochloride, or any excipients in the formulation.
- Concomitant administration with any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate/dinitrate) or nitric oxide donors.
- Concomitant administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir).
- Concomitant administration with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI.
- Patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION).
- Patients with severe cardiovascular disorders (e.g., unstable angina, severe heart failure, recent myocardial infarction, life-threatening arrhythmias) where sexual activity is inadvisable.
- Patients with significant inherited retinal diseases (e.g., retinitis pigmentosa).
Possible side effect
The following adverse reactions have been reported, primarily associated with the individual components. Most are mild to moderate and transient.
Very Common (≥1/10):
- Headache
- Dizziness
- Nausea
Common (≥1/100 to <1/10):
- Flushing (feeling of warmth)
- Nasal congestion
- Insomnia
- Diarrhea
- Dry mouth
- Fatigue
- Visual disturbances (e.g., blurred vision, cyanopsia - seeing a blue tinge)
- Dyspepsia (indigestion)
- Increased sweating
- Anxiety
- Tremor
Uncommon (≥1/1,000 to <1/100):
- Palpitations
- Tachycardia (increased heart rate)
- Orthostatic hypotension (dizziness upon standing)
- Syncope (fainting)
- Erectile duration >4 hours (priapism is rare but requires immediate medical attention)
- Tinnitus
- Vertigo
- Vomiting
- Constipation
- Abdominal pain
- Back pain
- Muscle aches
Rare/Other: Hypersensitivity reactions, seizures (in patients with predisposing factors), angle-closure glaucoma.
Drug interaction
Malegra FXT has a significant potential for drug interactions due to its dual components.
- Nitrates: Absolutely contraindicated. Concomitant use can cause a profound and potentially fatal drop in blood pressure.
- Alpha-blockers (e.g., doxazosin, tamsulosin): Concomitant use can potentiate the blood-pressure-lowering effects, leading to symptomatic hypotension. Not recommended.
- Potent CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): Increase plasma concentrations of Sildenafil and Dapoxetine. Contraindicated or requires significant dose reduction and close monitoring.
- Other PDE5 Inhibitors (e.g., vardenafil, tadalafil): Do not use concomitantly.
- MAOIs (e.g., phenelzine, selegiline): Contraindicated due to risk of serotonin syndrome.
- Other SSRIs, SNRIs, or tricyclic antidepressants: May increase the risk of serotonin syndrome. Use with extreme caution and monitor closely.
- Antiplatelet agents, anticoagulants (e.g., warfarin): Dapoxetine may increase the risk of bleeding. Use with caution.
- Moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, amlodipine, grapefruit juice): May increase Sildenafil levels. A dose adjustment may be necessary.
- Potent CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): May increase Dapoxetine levels. Use with caution.
- Alcohol: Potentiates orthostatic hypotension and dizziness. Avoid or limit consumption.
Missed dose
Malegra FXT is taken on an as-needed basis prior to sexual activity. It is not intended for chronic daily dosing; therefore, a “missed dose” protocol is not applicable. Do not take a double dose to make up for a missed one. Simply take one tablet at the next occasion of anticipated sexual activity, adhering to the minimum 24-hour interval between doses.
Overdose
In case of suspected overdose, seek immediate medical attention or contact a Poison Control Center. Overdose would be expected to produce effects associated with the individual components.
- Sildenafil Overdose: Could lead to severe and prolonged hypotension, syncope, and potentially myocardial ischemia. Supportive measures should be taken, including keeping the patient in the supine position with legs elevated to manage hypotension. Hemodialysis is not expected to accelerate clearance.
- Dapoxetine Overdose: Symptoms may include serotonin syndrome (agitation, confusion, tachycardia, hyperthermia, muscle rigidity), dizziness, nausea, vomiting, and syncope. Treatment is supportive and symptomatic. There is no specific antidote. Gastric lavage and administration of activated charcoal may be considered if presented early. ECG monitoring is advised.
Storage
Store at room temperature (20°C to 25°C or 68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F). Keep the tablets in their original blister pack 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.
Disclaimer
This information is for educational purposes only and is not a substitute for 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 or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the typical properties of the drug and may not cover all possible uses, directions, precautions, or adverse effects.
Reviews
Clinical studies and patient-reported outcomes consistently demonstrate the efficacy of the Sildenafil/Dapoxetine combination. In pivotal Phase III trials, the combination therapy showed statistically significant improvements in both the International Index of Erectile Function (IIEF) score and intravaginal ejaculatory latency time (IELT) compared to placebo. Patient satisfaction scores regarding control over ejaculation and overall sexual experience were markedly higher in the active treatment groups. A meta-analysis of real-world evidence suggests that a majority of patients report a meaningful improvement in their sexual relationship and a reduction in anxiety related to performance. The most frequently cited benefits in post-marketing surveillance are the convenience of a single tablet and the effective management of both conditions simultaneously. Adverse events are generally reported as mild and self-limiting, leading to a low discontinuation rate.