Malegra FXT (100 mg sildenafil and 40 mg fluoxetine) is a generic treatments used for erectile dysfunction. Erectile dysfunction (ED) is a prevalent but a sensitive condition that society and the patient population is not willing to discuss for fear of social stigma and the embarrassment the topic entails. This condition does not only affect the individual suffering from the dysfunction, as it also affects the partners of the patients suffering from ED as noted by the study “Partner responses to sildenafil citrate (Viagra) treatment of erectile dysfunction” by Montorsi et.al . The same study  also determined that by treating ED suffered by the patient, not only does the patient gets improved sexual response, the relationship also with the partner improves. That means to say that ED treatment is also holistic in nature, as not only the physiological aspect is improved, as it also affects the patients psychosocially.
Sildenafil Citrate (SC) treatment is “the” treatment for ED as it was the first of the treatments available for ED. Its effectiveness is without question in treating ED of various etiologies, so it is widely used for many of ED conditions, even for ED cases with underlying causes. The only problem, for some, is the current treatment’s very expensive pricing and some problems regarding insurance related with the ED treatment as mentioned by the 2000 study, “The cost-effectiveness of sildenafil. Annals of internal medicine” by Smith et.al .
Since that is the case, more and more patients seek for more affordable alternatives for SC treatment. Fortunately for the patients, pharmaceutical companies like Sunrise Remedies Pvt. Ltd.  and others manufacture generic SC for patient use. These generic SC meds contain the same active ingredients as the brand-name treatment and as mentioned by the patients these generic meds like the Malegra product line is also as effective as the originally prescribed treatment for ED. The product in question, Malegra FXT, however, is not purely SC; aside from its 100 mg sildenafil content, it also has 40 mg fluoxetine in each tablet. The product is indicated for Erectile Dysfunction and Premature Ejaculation (or PE) and is used by patients to treat their ED which coincides with PE.
Sunrise Remedies Pvt. Ltd. Profile
The company manufacturing Malegra FXT, Sunrise Remedies Pvt. Ltd. has its roots traced back to 1995 in Gujarat (India) . Aside from its specialization in manufacturing ED meds including the Malegra line, it is also famous for making Ayurvedic remedies for its clients . The company has well-known products under its name, like JESIBI Cream and VOLIN sleeping pills, which are both natural remedies . Although there are a number of other products sold by the company, it seemingly leans towards the manufacturing of sexual enhancement products, as aside from ED, it also has herbal remedies made for the buyers.
Regarding accreditations, Sunrise Remedies has Schedule M (2008), Certification of Schedule T, and GMP for Ayurvedic manufacturing of products . For pharmaceutical-grade products, however, the company did not disclose whether it already has WHO-GMP or US FDA approvals for its manufacturing processes or its products, so there’s a bit of a question in that area. Sunrise Remedies has GMP approval but only for its Ayurvedic products only .
Sildenafil and Fluoxetine Studies
Aside from Erectile Dysfunction, Premature Ejaculation is one of the common male sexual disorders seen in the patient population since a lot of patients are now opening up regarding the condition, treatment for PE has already evolved and has been innovated to include more treatment modalities. One of the found treatments for PE is the use of SSRIs (selective serotonin reuptake inhibitors) which directly influences serotonin and therefore controls the premature ejaculatory response. One of these SSRIs is fluoxetine, which was primarily used as an antidepressant drug. In the study “Selective serotonin-reuptake inhibitors in the treatment of premature ejaculation” by Moreland et.al., it was discussed that fluoxetine and other SSRIs (fluvoxamine, paroxetine, sertraline, citalopram, and escitalopram) are able to delay the ejaculation reaction . According to the research, the use of these SSRIs are convenient and with just minimal adverse effects and that SSRI use for PE is a good alternative to the previous treatment modalities for PE, although there are still some concerns about SSRI use .
It was also discovered that fluoxetine is more effective when used in conjunction with other drugs, for instance, tadalafil. Mattos et.al. in their study, “Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study” noted that fluoxetine with tadalafil was more effective for the treatment of PE in men without ED than fluoxetine and tadalafil alone .
However, there were other concerns relating to SSRI use in the treatment of PE. Studies determined that the intake of SSRIs for PE have negative effects on the patients’ semen. The study “Semen abnormalities with SSRI antidepressants” identified that participants showed semen alterations when exposed to the SSRIs for as little as 3 months . The results showed that in 3 months’ time, sperm concentration has been reduced, the sperm motility was also reduced, a higher percentage of abnormal spermatozoa became present, and there had been increased levels of sperm DNA fragmentation . Aside from that, exposure to SSRIs was associated with growth retardation in children exposed to them, and SSRIs were also discovered to have endocrine disrupting properties . However, there was no clear implication of SSRI use in terms of fertility, although SSRI use for PE is deemed risky due to its semen-altering properties .
Sildenafil, on the other hand, proves to have more benefits as an ED treatment and is also explored for other uses. For instance, “Sildenafil increases serum testosterone levels by a direct action on the testes” by Spizer et.al. in 2014, presented that sildenafil use in patients was associated with increased testosterone levels as it has a direct effect on adrenal steroidogenesis . The effect is actually a good discovery, as it may become the basis for the development of sildenafil as a potential adrenal steroidogenesis agent for patients.
Description and Mechanism of Action of SC plus Fluoxetine
Sildenafil is one of the known Phosphodiesterase-5-inhibitors (PDE5i) which has a direct action of inhibiting PDE5, which leads to the increase of intracavernosal cyclic guanosine monophosphate levels . The resulting effect is the corporal smooth muscle relaxation and the improvement of the erection in patients struggling with ED .
Fluoxetine, on the other hand, belongs to the family of SSRIs or selective serotonin reuptake inhibitors which (based on the name) inhibits the serotonin uptake which potentiates the ejaculation response. Since the reuptake of serotonin is inhibited, the ejaculation response is delayed .
Malegra FXT Effects for Premature Ejaculation and Erectile Dysfunction
Since Malegra FXT contains 100 mg sildenafil and 40 mg fluoxetine in every pill, patients may experience improvement of the erection and the delay of ejaculation response after taking the medication, although the drug’s effect may only be seen in the presence of sexual stimulation. Results are promising according to research related to both APIs use, so patients can expect a better sexual response after taking the medication. ED and PE may be temporarily treated with drug use, as products like Malegra FXT offer only temporary alleviation for both sexual dysfunctions.
Recommended Doses and Duration of Therapy
For sildenafil, the usual recommended dose is between 25 mg to 100 mg, which depends on what dose the physician deems acceptable for the patient. For fluoxetine, the dosing starts from 20 mg and is effective in improving the intravaginal latency time (IELT) in one study. The 20 mg seemed efficient enough in eliciting improved scores on IELT.
As for Malegra FXT, the required dose is only one pill within a span of 24 hours. There is no recommendation yet for long-term use using any ED/PE medication, so the pill is only to be taken as needed.
Expected Side Effects and Warnings
It was discussed earlier that fluoxetine, when taken for at least 3 months, may cause degeneration of semen quality, although it did not have a direct effect on male fertility . Other side effects that may be expected of fluoxetine include drowsiness, nausea, headache and insomnia, which also are common side effects of sildenafil. Side effects recorded for both drugs vary from one case to another, and some reactions depend on the initial patient condition or the patients’ underlying diseases/medical conditions that could affect the physiological response to the drug.
Sildenafil is known to interact with nitrates so any nitrate-containing medication in all forms are contraindicated for the drug (“Sildenafil citrate and blood-pressure–lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist” by Webb et.al.) , even for Malegra FXT. The result would be catastrophic on the patient’s blood pressure, so generally, any nitrate-containing medication is contraindicated to sildenafil.
Fluoxetine is generally interactive with other antidepressants, benzodiazepines, and barbiturates, so these medicines should not be taken with fluoxetine.
Because Malegra FXT contains both fluoxetine and sildenafil, the mentioned drugs should not be taken along with it. Sildenafil and fluoxetine, however, have no known interactions so it’s generally safe to take pills with both the active pharmaceutical ingredients (API).
Patient comments for Malegra FXT were generally good, as most of them are satisfied regarding the drug’s effect. Users commented on being able to have sexual activity for extended periods of time. Aside from effectiveness, users also admired how the drug was able to fight ED and PE in just one pill, saving them the cost for separate treatments. Aside from that, the patients also were well-pleased at how the product was a very affordable option for treating ED or PE.
There was a recommendation by a client who gave his review for Malegra FXT on Pharmaexpressrx.com. The user noticed that he had a delay in his usual sexual response while using Malegra FXT. He found out that it was due to his fatty food consumption.
Since the users were all out in recommending the drug, Malegra FXT may indeed be a viable choice for treating co-morbid ED/PE conditions.
Price for Malegra FXT, Available Forms and Dosage
The pricing for Malegra FXT is based on the Internet seller’s prerogative, as the market for ED drugs is not quite price-regulated. Still, the prices for the drugs are affordable, as Malegra FXT is a generic drug which is price-optimized for patients looking for affordable ED/PE treatment.
Canada-pharmacy-24h.com and Drug-24h.com had the same price for 60 pills of Malegra FXT. They both sell the 60-pill set for $92.28. As the quantity purchased gets higher, patients are able to get the products for a cheaper amount for each pill, as reflected by the table above.
There are some Internet drugstores which are shipping the products for free as they have included the shipping cost on the product prices already. However, these examples presented were from online drugstores which do not have free shipping. The fees, however, of these two internet pharmacies are the same; both Internet pharmacies charge $9.95 for Airmail shipping (takes 2-3 weeks), while they both charge $19.95 for EMS (takes 3-8 days).
Online drugstores are able to ship to the USA, Canada, Australia, Europe, Asia (basically worldwide) for the same rates mentioned. There are only a handful of pharmacies charging the items for their weight. Usually, the shipping rates are courier-dependent.
Conclusion and Rating
Combination drugs like Malegra FXT which contains sildenafil (100 mg) and fluoxetine (40 mg) have been formulated for patients with conditions of both Premature Ejaculation and Erectile Dysfunction. Manufacturers may have developed compound drugs with both APIs to target the condition cost-effectively since the drugs were viable to be put together as they did not have known negative interactions.
As for the side effects, users were not exactly open to the Malegra FXT side effects as most of the comments available on Internet pharmacy sites were positive and were not reflective of the negatives concerning their ED/PE drug use. Still, patients and medical practitioners alike are cautioned regarding the side effects of the drugs, especially fluoxetine, as it has sperm quality/semen altering effects.
It is important for consumers to be sure of the quality of the medications they are taking, especially regarding sensitive conditions like PE and ED. Sunrise Remedies Pvt. Ltd.is a prominent India-based company which manufactures Ayurvedic remedies and generic drugs, but its GMP approval was only meant for its Ayurvedic medications. Since that is the case, I can award Malegra FXT only with 3 stars out of 5 for being effective (based on user comments) but lacking in evidence and the substantial approvals that it’s generally safe to use. It is plausible for ED and PE treatment, but it is safer if patients are to consult their GPs for assessment before taking the medication.
Malegra FXT Wiki Facts
- Brand: Malegra FXT
- Active Ingredient: Sildenafil and Fluoxetine
- Treatment: Erectile Dysfunction and Premature Ejaculation
- Manufacturer: Sunrise Remedies Pvt. Ltd.
- Country of Manufacture: India
- Availability: UK, USA, EU, New Zealand, India ++
- Montorsi F, Althof SE. Partner responses to sildenafil citrate (Viagra) treatment of erectile dysfunction. Urology. 2004 Apr 30;63(4):762-7. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~TbXFkr:2
- Smith KJ, Roberts MS. The cost-effectiveness of sildenafil. Annals of internal medicine. 2000 Jun 20;132(12):933-7. Available from: http://annals.org/aim/article/713538/cost-effectiveness-sildenafil
- Malegra FXT for the treatment of the erectile dysfunction. Available from: http://www.malegra-fxt.com/
- SUNRISE REMEDIES PVT. LTD. Available from: http://saenterprise.en.ecplaza.net/
- Moreland AJ, Makela EH. Selective serotonin-reuptake inhibitors in the treatment of premature ejaculation. Annals of Pharmacotherapy. 2005 Jul 1;39(7-8):1296-301. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~SJ8nRs:4:@od@@/cgi-bin/sis/search2/d?./temp/~Iua7Zq:0@
- Mattos RM, Marmo Lucon A, Srougi M. Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study. Urologia internationalis. 2008 Mar 19;80(2):162-5. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~Iua7Zq:1
- Semen abnormalities with SSRI antidepressants. Prescrire Int. 2015, Jan; 24(156):16-7. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~Iua7Zq:2
- Spitzer M, Bhasin S, Travison TG, Davda MN, Stroh H, Basaria S. Sildenafil increases serum testosterone levels by a direct action on the testes. Andrology. 2013 Nov 1;1(6):913-8. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~TbXFkr:2
- Webb DJ, Freestone S, Allen MJ, Muirhead GJ. Sildenafil citrate and blood-pressure–lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist. The American journal of cardiology. 1999 Mar 4;83(5):21-8. Available from: http://www.sciencedirect.com/science/article/pii/S0002914999000442