Malegra FXT Plus is one of the generic treatment options containing sildenafil (100mg) for erectile dysfunction (plus 60 mg fluoxetine for premature ejaculation). Since the discovery of the Sildenafil Citrate for improving the male sexual response by the improvement of the erectile function of Erectile Dysfunction (ED) patients, Sildenafil became the first line of treatment for a number of ED cases of various etiologies (“Treating erectile dysfunction and central neurological diseases with oral phosphodiesterase type 5 inhibitors. Review of the literature” by Lombardi et.al. and “Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus” by Vardi and Nini) .
Sildenafil has been developed by various pharmaceutical companies since the approval of the manufacturing of the generic forms in the market as the need for cheaper alternatives to brand-name medication arose. One of the companies which joined in the production of generic Sildenafil in the market is Sunrise Remedies, and it is the producer of the Malegra products containing Sildenafil as its active ingredient. There is a number of Malegra product variants that the company produces and one of these Malegra products is the one with Sildenafil and Fluoxetine, which is called Malegra-FXT Plus. The product contains 100 mg of Sildenafil and 60 mg of Fluoxetine in every pill and targets both ED and Premature Ejaculation (PE). It is widely available in the market, especially on the Internet pharmacy market, where a great number of patients obtain their prescription medication for ED and PE.
Sunrise Remedies Pvt. Ltd. Information
Sunrise Remedies is a company well-known for its Ayurvedic remedies, and especially known for its Jesibi Cream made for back and joint pain . Aside from Ayurvedic and traditional Indian medicine, the company is also known for manufacturing products with active pharmaceutical ingredients (API), and according to its information, manufactures these products in accordance with the WHO-GMP standards .
Unfortunately, there is not much information regarding the US FDA approval of the company, as it was not indicated anywhere on its website. It may be assumed though that the company has been locally approved by the local Indian FDA, as the company has been in operation for two decades to-date. Pharmaceutical companies would not last that long when still unapproved by their country’s FDA. Still, the company manufactures generic products which are well-known among the Internet consumers and its products are also famous for being both physiologically and cost-effective.
Scientific Studies on Sildenafil and Fluoxetine
Erectile Dysfunction and Premature ejaculation have been common for male part of the population for a long time. Just because patients are not willing to speak openly about their conditions due to the fear of being socially stigmatized, there is no sufficient information recorded, especially for PE, in the past years.
According to the study by Stanley, et. al. entitled “An Update of the International Society of Sexual Medicine’s Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE)” , since the society is starting to open up and since the discovery of a number of treatments for both PE and ED, the treatment modalities continue to improve over the years. Since most of ED and PE cases are comorbid, treatments involving Sildenafil for both the conditions were tested, and Sildenafil Citrate proved to be more effective in ED cases than for both. Therefore, it has been recommended that further studies need to be conducted for Sildenafil Citrate concerning PE . One of the discovered treatments for PE is the SSRI (selective serotonin reuptake inhibitors) like dapoxetine, fluoxetine, sertraline, and others, since the etiology of PE has been determined as not only from psychological factors but also that it exists caused by neurological factors, genetic factors, and other underlying medical conditions . Dapoxetine is considered an effective treatment for PE as it causes a significant delay in the ejaculation response of the patients. Fluoxetine and the other off-label SSRIs are effective and well-tolerated but the results indicated that these SSRIs as a treatment for PE are more effective taken as a daily treatment than on-demand/as-needed .
As for Sildenafil Citrate for ED, the effects are already known, as Sildenafil has been the first line of treatment for most ED cases and even in cases of varying etiologies ,. Because Sildenafil proved effective in treating ED, research concerning it are gearing towards its medical application for other medical concerns and exploring its use in patients with neurological-disorder-etiologies than proving its effectiveness in the healthy male population, as its efficacy has already been established. But, not all the research involving Sildenafil Citrate use discover only positive effects of the drug; there are some, like the research “Sildenafil use and increased risk of incident melanoma in US men: a prospective cohort study” by Li et.al., which linked Sildenafil Citrate to an increased risk of melanoma, although Sildenafil use was not significantly linked to squamous cell carcinoma or basal cell carcinoma .
Also, a case study presented by Cakmak et.al., “An unusual adverse effect of sildenafil citrate: Acute myocardial infarction in a nitrate-free patient”, linked Sildenafil use to myocardial infarction (MI) in a patient without any history of a coronary artery disease and who is not taking any nitrate medication . The case, though, did not make a definite association with Sildenafil and acute MI, and the authors deemed that the incidence was an isolated case . But still, caution is to be practiced regarding the intake of Sildenafil for ED even for patients who have clean medical histories.
The Action of Sildenafil Citrate and Fluoxetine
Sildenafil Citrate works by inducing vasodilation and promoting a blood flow in the penile tissue by acting as a phosphodiesterase type 5 (PDE5) inhibitor. As PDE5 is inhibited, cGMP presence is encouraged (neurotransmitter released during stimulation of the patient sexually), since PDE5 acts primarily to disintegrate cGMP. Since cGMP is allowed and not broken down, the erection response is prolonged.
Fluoxetine, as a SSRI acts to delay the ejaculatory response of the patient by blocking the axonal reuptake of serotonin (hence the name SSRI), which is responsible for facilitating the ejaculatory response in the male body .
Effects of Sildenafil and Fluoxetine
Patients may expect having improved erectile response and delayed ejaculatory response when taking any medication with a combination of Sildenafil and Fluoxetine. Sildenafil is potent in eliciting and sustaining erections (presence of sexual stimuli is required, though). Since Malegra-FXT Plus contains both Sildenafil and Fluoxetine as active pharmaceutical ingredients, patients may expect alleviation of ED and PE effects. There is no known drug interaction between Sildenafil and Fluoxetine, so there should not be any adverse interactions present upon taking the meds. But, since Fluoxetine is proven to be more effective in daily treatments than when used as-needed, there is a small concern on how long it can delay PE .
Recommended Doses and Length of Therapy
Malegra FXT is recommended to be taken with a full glass of water about an hour before the sexual activity . The 100 mg Sildenafil/60 mg Fluoxetine Malegra FXT Plus intake is only limited to one dose within a 24-hour period. Although the recommended intake for Fluoxetine to be effective is daily , Malegra FXT Plus being a compound drug is a different story. Sildenafil is also allowable for long-term therapy like Fluoxetine, but there is no present prescribed length of treatment for the compound drug.
Side effects and Warnings
Side effects commonly exhibited by ED patients on long-term treatment using sildenafil are headaches, flushing, indigestion, rhinitis, nausea, and vomiting, to name just a few. As an isolated drug, fluoxetine has commonly reported side effects including drowsiness, insomnia, nervousness, tremor, weakness, anorexia, and decreased appetite . But as a compound drug, Malegra FXT Plus’ side effects mimic those exhibited by patients in purely Sildenafil therapy . More side effects have yet to be determined, though, since there are insufficient studies involving the drug and its presumed side effects.
Nitrates, blood-pressure-lowering medication, antibiotics, vitamins, and more are the ones contraindicated for sildenafil intake, especially the drugs belonging to the nitrate family, as the interaction between Sildenafil and nitrates may be detrimental or catastrophic.
As for fluoxetine, commonly contraindicated meds for it are other anti-depressant medication, benzodiazepines, and more. Since there is actually a long list of contraindicated meds for sildenafil and fluoxetine use, patients should get assessed by their physicians before taking Malegra FXT Plus or any ED treatment containing either Sildenafil of fluoxetine or both.
Reviewing the client testimonials given for Malegra FXT Plus, it can be said that buyers/patients taking the medication are generally pleased with Malegra FXT Plus’ effect. Various online pharmacies carried reviews for the product from patients who were able to try out the product.
A buyer, Marshall, from Cheapgenericeddrug.com, shared how he found the product convenient as he wanted to target both ED and PE but was unsure in taking separate meds for ED and PE. Marshall mentioned that when he took his friend’s suggestion to take Malegra FXT, he was able to treat his ED/PE and without experiencing any side effect.
One reviewer from Malegra.biz commented how he appreciated the product and how impressed he was. According to him, even if Malegra FXT was just generic, it had proven effective in improving his erectile response, and he was able to enjoy it without complications and side effects.
Though there was an initial question regarding the effectiveness of fluoxetine as an as-needed PE medication, it is surprising that patients were able to find Malegra FXT for their comorbid ED/PE condition an effective treatment. It seems that the drug is recommendable for patients with both sexual dysfunctions present.
Malegra FXT Plus Price, Available Forms and Dosage
Buyers may avail of Malegra FXT Plus containing 100 mg sildenafil and 60 mg fluoxetine on online pharmacies for at least $1.50 per pill and depending on the number of pills required. There are a lot of Internet pharmacies with this product available and they have differing prices for the same product for some unknown reason. But, pricing for Malegra FXT remains reasonable and quite affordable, considering the brand-name treatment for ED and PE are very expensive. Patients may buy from trusted Internet pharmacies generic ED meds for a far lower price, saving cost but getting the same high-quality medication.
As for the delivery, most of the online pharmacies offer two shipping options for their clients. AirMail and EMS shipping are offered and they vary in price and in transit times. Only a few sites charge differently for each destination country, as the rates are more often than not based on whether the clients will choose AirMail or EMS delivery. Prices for these options also vary from one site to another; for instance, Pharmshoponline.com charges $9.95 for the AirMail option while Viagraonline-rxpharmacy.com charges $14.95 for the same courier option.
Internet pharmacies are able to ship the products worldwide (the USA, Australia, Canada, Europe, and others). The usual charges are not location-dependent, so buyers can expect to pay the same rate no matter where they would like to ship their orders to.
Conclusion and Rating
Since Erectile Dysfunction and Premature Ejaculation are socially stigmatized in the past few years, studies regarding them were not able to progress as they should, until recently, more and more patients started participating in studies which led to discovering the multi-etiology characteristic of these sexual dysfunctions. Knowing the underlying cause of ED and PE led also into discovering treatments appropriate for the specific ED and PE cases per patient.
ED and PE are at times co-morbid, which probably led several companies to develop generic medications which target both ED and PE conditions with one pill. Sunrise Remedies made Malegra FXT Plus, a pill containing both sildenafil (100 mg) and fluoxetine (60 mg) specially made for patients with both ED and PE. Separate studies for Sildenafil and Fluoxetine exist and both were proven to treat the conditions they are meant for, although there seems to be a lack of studies for compound meds like Malegra FXT which specializes in alleviating ED and PE at the same time. Sildenafil and fluoxetine, having their own specific pathways, do not interact with each other negatively, though, the adverse reactions due to Sildenafil-fluoxetine incompatibility may be ruled out.
Although well-acclaimed by users, I can only give 3 out of 5 for Malegra FXT Plus since compound meds, like Malegra, still don’t have an approval the US FDA. It was also a concern that the company manufacturing it did not have the necessary approvals from the US FDA and WHO-GMP yet. Although a famous company, it may be more specialized in making Ayurvedic preparations than manufacturing high-quality drugs, although we can’t discount the fact that its long track record may indicate good quality for its products and a good popularity among the buyers as well.
Malegra FXT Plus Wiki Facts
- Brand: Malegra FXT Plus
- Active Ingredient: Sildenafil Citrate and Fluoxetine
- Treatment: Erectile Dysfunction
- Manufacturer: Sunrise Remedies Pvt. Ltd.
- Country of Manufacture: India
- Availability: USA, India, EU, UK, Asian Countries +
- Vardi M, Nini A. Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus. Cochrane Database of Systematic Reviews. 2007, Issue 1. Art. No.: CD002187. Available from: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0011451/.
- Lombardi G, Nelli F, Celso M, Mencarini M, Del Popolo G. Treating erectile dysfunction and central neurological diseases with oral phosphodiesterase type 5 inhibitors. Review of the literature. Journal of Sexual Medicine. 2012; 9(4): 970-985. Available from: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0047078/
- AYURVEDIC PRODUCTS. Available from: http://www.sunriseremedies.in/ayurvedic-product.html
- About Us. Available from: http://www.sunriseremedies.in/about-us.html
- Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AI, Adaikan PG, et.al. An Update of the International Society of Sexual Medicine’s Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun; 2(2): 60–90. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4184677/
- Li WQ, Qureshi AA, Robinson K, Han J. Sildenafil use and increased risk of incident melanoma in US men: a prospective cohort study. JAMA Intern Med. 2014 Jun; 174(6): 964–970. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4178948/
- Cakmak HA, Ikitimur B, Karadag B, Ongen Z. An unusual adverse effect of sildenafil citrate: Acute myocardial infarction in a nitrate-free patient. BMJ Case Rep. 2012; 2012: bcr2012006504. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4543919/
- Malegra FXT. Available from: http://www.malegra-fxt.com/malegra-fxt-pro.html
- Fluoxetine Side Effects. Available from: https://www.drugs.com/sfx/fluoxetine-side-effects.html [Accessed 1st December 2016].