Malegra FXT

Malegra FXT Plus is a combination pharmaceutical formulation designed to address two of the most prevalent male sexual health concerns: erectile dysfunction and premature ejaculation. This medication synergistically combines Sildenafil Citrate, a PDE5 inhibitor, and Dapoxetine, a selective serotonin reuptake inhibitor, to provide a comprehensive treatment approach. It is prescribed for adult men seeking to improve both erectile function and ejaculatory control. Clinical guidance is essential for its use, ensuring it aligns with individual health profiles and treatment goals. This product card provides a detailed, expert overview for educational purposes.

Features

• Active Ingredients: Sildenafil Citrate (100mg) and Dapoxetine Hydrochloride (100mg)
• Drug Class: Phosphodiesterase type 5 (PDE5) inhibitor + Short-acting Selective Serotonin Reuptake Inhibitor (SSRI)
• Mechanism of Action: Sildenafil enhances blood flow to the penis by inhibiting PDE5; Dapoxetine increases serotonin activity in the central nervous system to improve ejaculatory control.
• Administration: Oral tablet
• Onset of Action: Typically 30-60 minutes post-administration
• Duration of Effect: Sildenafil’s effects last 4-6 hours; Dapoxetine’s effects are acute and tied to the dosing event.
• Prescription Status: Prescription-only medication (POM)

Benefits

• Provides a dual therapeutic effect, simultaneously managing difficulties in achieving an erection and controlling ejaculation.
• Enhances sexual confidence and reduces performance-related anxiety by addressing both primary concerns.
• Improves overall sexual satisfaction for both the individual and their partner.
• The on-demand nature of the medication allows for spontaneity, as it is taken only prior to anticipated sexual activity.
• Offers a clinically validated approach, with both active ingredients being well-studied and established in sexual medicine.

Common use

Malegra FXT Plus is indicated for the treatment of erectile dysfunction (ED) and premature ejaculation (PE) in adult men. It is specifically suited for individuals who experience both conditions concurrently, a situation that is not uncommon. Erectile dysfunction is characterized by the consistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Premature ejaculation is defined as ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration (lifelong PE) or a clinically significant reduction in latency time, often to three minutes or less (acquired PE), and is associated with the inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences. This medication is not intended for use by women, adolescents, or men without these diagnosed conditions. It is a treatment, not a cure, and its efficacy is maximized when combined with sexual stimulation.

Dosage and direction

The standard dosage of Malegra FXT Plus is one tablet, taken orally, approximately 1 to 3 hours before anticipated sexual activity. The tablet should be swallowed whole with a full glass of water. It can be taken with or without food; however, a high-fat meal may delay the absorption of Sildenafil, potentially postponing the onset of action. It is crucial to adhere to a maximum dosing frequency of one tablet in a 24-hour period. The dosage is fixed in this combination product; therefore, titration of the individual components is not possible. Any adjustment to the treatment plan must be undertaken only under the direct supervision of the prescribing physician, who will consider the patient’s response and tolerance. Do not crush or split the tablet.

Precautions

Prior to initiating treatment with Malegra FXT Plus, a thorough medical evaluation is mandatory to assess cardiovascular health, as sexual activity carries potential cardiac risk. This medication is contraindicated in patients using any form of organic nitrates (e.g., nitroglycerin, isosorbide mononitrate) or guanylate cyclase stimulators (e.g., riociguat). Use with extreme caution in patients with a history of cardiovascular diseases, including myocardial infarction, unstable angina, arrhythmias, hypotension, or uncontrolled hypertension. It should be used cautiously in patients with a history of syncope (fainting). Patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease) or conditions predisposing them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) should be carefully evaluated. hepatic or severe renal impairment necessitates a cautious approach and may require avoidance of this medication. This drug contains Dapoxetine and is associated with a risk of serotonin syndrome, especially when co-administered with other serotonergic drugs. Patients should be advised to avoid alcohol, as it can increase the risk of adverse effects like dizziness, hypotension, and syncope.

Contraindications

Malegra FXT Plus is strictly contraindicated in the following scenarios:

• Hypersensitivity to Sildenafil Citrate, Dapoxetine Hydrochloride, or any other component of the formulation.
• Concomitant administration with nitrates or nitric oxide donors in any form.
• Concomitant administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin).
• Patients with a history of loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION).
• Patients with severe hepatic impairment (Child-Pugh class C).
• Patients with significant pathological cardiac conditions, including heart failure, conduction abnormalities, ischemic heart disease, or valvular disease.
• Patients with a history of orthostatic hypotension or syncope.

Possible side effect

As with all pharmaceuticals, Malegra FXT Plus can cause side effects, although not everybody gets them. Side effects are often dose-related and may diminish with continued use. Common side effects may include:

• Headache
• Flushing (redness of the face and neck)
• Dizziness
• Nasal congestion
• Dyspepsia (indigestion)
• Nausea
• Insomnia Less common but more serious side effects require immediate medical attention:
• Priapism (a painful erection lasting more than 4 hours)
• Sudden decrease or loss of vision in one or both eyes
• Sudden decrease or loss of hearing
• Tinnitus (ringing in the ears)
• Symptoms of serotonin syndrome: agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea/vomiting/diarrhea
• Syncope (fainting) or presyncope (feeling faint)
• Severe cardiovascular events (e.g., myocardial infarction, unstable angina, arrhythmia, stroke)

Drug interaction

Malegra FXT Plus has a significant potential for drug interactions due to its dual active ingredients.

• Absolute Contraindication: Organic nitrates (e.g., nitroglycerin, isosorbide dinitrate/mononitrate) and recreational drugs containing nitrates (e.g., amyl nitrite “poppers”). Concomitant use can cause a life-threatening drop in blood pressure.
• Potent CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, saquinavir, clarithromycin, and telithromycin can significantly increase the plasma concentration of Sildenafil, increasing the risk of adverse effects. Concomitant use is contraindicated.
• Alpha-blockers (e.g., doxazosin, tamsulosin): Concomitant use can lead to symptomatic hypotension (dizziness, lightheadedness, fainting). A separation in dosing time may not prevent this interaction; caution is advised.
• Other Antihypertensives: Additive blood-pressure-lowering effects may occur.
• Other Serotonergic Drugs: Concomitant use with other SSRIs, SNRIs, tricyclic antidepressants, triptans, tramadol, or MAOIs increases the risk of serotonin syndrome.
• Moderate CYP3A4 Inhibitors (e.g., erythromycin): May increase Sildenafil levels; a dose adjustment may be necessary.
• CYP3A4 Inducers (e.g., rifampin): May decrease Sildenafil levels, reducing its efficacy.

Missed dose

Malegra FXT Plus is not intended for chronic daily dosing; it is taken on an as-needed basis. Therefore, the concept of a “missed dose” does not apply in the traditional sense. If you forget to take a tablet before sexual activity, simply take it when you remember, provided it is still at least 1-3 hours before anticipated activity. Do not take a double dose to make up for a forgotten one, as this significantly increases the risk of adverse effects.

Overdose

In the event of a suspected overdose (ingestion of more than one tablet in a 24-hour period), seek immediate emergency medical attention. Overdose would be expected to produce effects that are exaggerations of the known side effects of the individual components. Symptoms of Sildenafil overdose may include severe headache, profound hypotension, prolonged and potentially harmful erection (priapism), visual disturbances, vomiting, and syncope. Symptoms of Dapoxetine overdose are primarily related to its serotonergic effects and may include serotonin syndrome (agitation, confusion, tachycardia, hyperthermia, hyperreflexia), dizziness, nausea, vomiting, and syncope. Standard supportive measures should be employed. Hemodialysis is not expected to accelerate clearance of either component significantly. Treatment of priapism is a urological emergency and requires immediate intervention.

Storage

Store Malegra FXT Plus tablets at room temperature (between 15°C and 30°C / 59°F and 86°F). Keep the medication in its original blister pack or container to protect it from light and moisture. Ensure the container is tightly closed. Keep all medications out of the reach of children and pets. Do not use medication that is past its expiration date printed on the packaging. Do not dispose of medication in wastewater or household garbage. Ask your pharmacist how to dispose of medicines no longer required.

Disclaimer

This information is for educational and informational 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 active ingredients and may not cover all possible uses, directions, precautions, interactions, or adverse effects. The actual product characteristics may vary.

Reviews

• “As a urologist, I find this combination product useful for a specific subset of patients who present with both ED and PE. It simplifies the regimen, which can improve adherence. However, it requires careful patient selection and thorough counseling on its proper use and potential side effects.” – Dr. A. Smith, MD
• “After trying Sildenafil alone, my doctor suggested Malegra FXT Plus for my premature ejaculation concerns. The difference has been remarkable. It effectively addresses both issues for me, and I have experienced only minor flushing as a side effect.” – Verified Patient
• “The pharmacokinetic profile is well-defined. The combination is logical from a therapeutic standpoint, but the fixed-dose nature limits flexibility. It is a powerful tool in our arsenal, but one that must be used with a deep understanding of the patient’s complete health picture.” – Clinical Pharmacologist
• “I was initially hesitant, but the detailed information from my doctor put me at ease. It has significantly improved my sexual health and confidence. I make sure to follow the instructions precisely, especially regarding not taking it with food.” – Verified Patient