Brand(s): Fildena® XXX
Manufacturer: Fortune Health Care
Generic name: Sildenafil Citrate
Pharmacologic Classifications: Type 5 Inhibitor
Fildena XXX is one of Fortune Healthcare products containing Sildenafil Citrate and indicated for patients with erectile dysfunction (ED). Fildena XXX is the company’s version of chewable or orodispersible tablets, which are ideal for patients having difficulty in taking in the hard pill version. This product contains 100 mg of Sildenafil in every pill, which is considered an effective dosage for ED treatment.
Orodispersible tablets, one of the fast dissolving delivery systems (FDDs) was made to overcome problems related to the oral delivery of the conventional hard pill type. The research by Sagban and Ismail, “Formulation and evaluation of orodispersible film of sildenafil citrate”, presented the effectiveness of orodispersible/fast dissolving tablets in the oral administration of Sildenafil citrate in patients. Companies like Fortune Healthcare were able to formulate their own generic version of fast dissolving tablets like Fildena XXX.
Fildena XXX is not only a chewable pill, it also has flavors like orange, pineapple, strawberry, and banana. According to the manufacturer information, FildenaXXX is not only intended for patients suffering from ED, it is also used in treating Pulmonary Arterial Hypertension (PAH). Aside from the chewable products, Fortune Healthcare also manufactures other Fildena products like the conventional tablets (comes in 25, 50, and 100 mg), Fildena Strong (120 mg), oral jelly, combination pills, and others.
|Generic Name||Sildenafil Citrate Chewable Tablets|
|Composition||Sildenafil Citrate equivalent to Sildenafil 100mg|
|Hardness||19’53” Minutues in water|
|Color||Multi color (yellow, Orange, Pink and golden yellow)|
|Flavour||Banana, Orange, Strawberry and Pineapple|
|Validity||30 Months from the Mftd. Date|
|Minimum Order Quantity||8|
Fortune Healthcare India is one of the ISO 9001:2000 certified pharmacies located in India. It is based in Gujarat, and since 2004 has been operating in the pharmaceutical business. The company specializes in manufacturing generic medications with identical active pharmaceutical ingredients as the original meds. But, Fortune Healthcare has most of its products qualified under Men and Women’s Health Medications.
There are only a few known pharmaceutical companies in India which are certified by the US Food and Drug Administration. Unfortunately, Fortune Healthcare is not one of these companies. The company, though, is WHO-GMP approved for its good manufacturing process.
The company is only small, though. Fortune Healthcare employs only about 25 people, and almost half of its employees are dedicated to quality control, and the other half for research and development. Compared to its competitors, the company is small, but since it was already WHO-GMP certified, it can be said that it really upholds the quality of its medications.
There are several studies exploring other oral administrations for Sildenafil Citrate, as there are certain patient populations which are not able to proceed with the Sildenafil treatment due to their physical limitations. According to the research by Ismail et.al. in 2016, “Innovative trends and perspectives for erectile dysfunction treatment: A systematic review”, the current treatments for erectile dysfunction (ED) is still far from ideal, so there are still more innovations in ED treatment to look out for in the coming years.
The oral disintegrating formulations for ED are one of the areas being studied for the oral administration of sildenafil in patients. One study, “A nanohybrid system for taste masking of sildenafil” by Lee et.al., made a nanohybrid made from montmorillonite (MMT), an inorganic clay material to improve or mask the taste of sildenafil in fast disintegrating formulations. MMT was then covered with a basic polymer, polyvinylacetal diethylaminoacetate (AEA). The study concluded that given the properties of the AEA and the sildenafil-MMT nanohybrid, the MMT-based nanohybrid is a promising oral administration taste-masking system for orally dispersible SC products.
Another study, “Optimized nano-transfersomal films for enhanced sildenafil citrate transdermal delivery: ex vivo and in vivo evaluation” by Badr-Eldin et.al. explored other methods of delivery for the administration of Sildenafil in erectile dysfunction patients. The research’s objective was to formulate Sildenafil into nano-transfersomal transdermal films, with improved bioavailability, as the traditional oral route of administration faced poor bioavailability problems and short duration of action which require the patients to administer the drug frequently. Aside from the goal of creating and optimized Sildenafil nano-transfersomal transdermal films, the research also aimed to solve the problem regarding the bioavailability and the short effect duration. The results of the study showed that there is indeed enhanced bioavailability and extended absorption exhibited by the Sildenafil nano-transfersomal films. Therefore, the authors concluded that there is indeed potential for the optimized SLD nano-transfersomal films to reduce future dose administration and frequency of Sildenafil Citrate in ED patients.
The study “Comparison of fasting bioavailability among 100-mg commercial, 100-mg generic, and 50-mg chewable generic sildenafil tablets in healthy male Mexican volunteers: a single-dose, 3-period, crossover study” by Marcelín-Jiménez et.al., on the other hand, studied the relative tolerability of the 50-mg chewable tablet available. As for the results of the study, the authors concluded that based on the clinical data obtained from the study, the chewable tablets were well-tolerated by the study participants.
The role of Sildenafil citrate in the erectile dysfunction treatment revolves around in the drug being the potent and selective inhibitor of PDE5 or phosphodiesterase type 5. Sildenafil acts to suppress PDE5 from degrading the cGMP (cyclic guanosine monophosphate). The cGMP is the one responsible for the vasodilation and the smooth muscle relaxation of the corpus cavernosum in the penis, so without the PDE5 degrading it, the erectile response will continue. But this erectile response enhancement by Sildenafil in ED patients is also mediated by the NO (nitric oxide), which is released upon sexual stimulation. Without the sexual stimuli, Sildenafil will not work as it does not cause erections spontaneously, contrary to the common knowledge on SC function.
Given the identified effects of Sildenafil in the erectile response, patients under Sildenafil treatment can expect improvement in their sexual response to sexual stimuli. ED patients seemingly lost their ability to have erections even if they desired to, and Sildenafil treatment can significantly improve the sexual functioning of these individuals.
The same effect can be expected for Fildena XXX, as it is a product which contains 100 mg Sildenafil, and Sildenafil, regardless of its orodispersible form in Fildena XXX, or brand, is effective in treating ED in almost all of the patients. Since the active content of Fildena XXX is the same/identical with the other branded Sildenafil products, patients can expect that the drug will work for them, provided that they do not have other medical or physiological considerations that might affect the drug’s bioavailability and effect in general.
Recommended dose for Sildenafil is anywhere between 25 to 100 mg, but in some cases, the doctor may prescribe higher doses (200 mg) for those unresponsive to the low dose treatments, as the 200 mg dose is also deemed effective and still safe for patient use (“Effect of sildenafil in patients with erectile dysfunction taking antihypertensive therapy” by Kloner et.al.).
As for Fildena-XXX, the manufacturer and vendor information indicates that the intake of the drug is limited to one dose (100 mg) of the chewable tablet per day. But, this dosing is still under the scrutiny of the patients’ respective physicians, as the Sildenafil doses for ED treatment is customized depending on the patient history.
Regarding the treatment duration for Sildenafil, there is no recommendation on how long the treatment would take, but researchers are studying the long-term effect or chronic use of the drug for ED (“Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial” by Rendell et.al.).
Side effects reported by patients using the drug commonly include facial flushing and headaches. The side effects reported by patients are usually mild and transient, and they go away on their own. But, there are cases in which patients react differently and adversely to the drug, especially on higher doses, and cause other side effects that may be disruptive and also affect their activities of daily living. In these cases, the patients should discontinue Sildenafil and call their doctors immediately.
Drug interactions for Sildenafil include a long list of medications, but the meds on top of the contraindicated drug list are the nitrate-containing drugs in all forms, as their interaction is potentially harmful to the patient (“Overall cardiovascular profile of sildenafil citrate” by Zusman et.al).
Caution is also to be exercised by patients taking various medications such as blood pressure medications, cardiovascular drugs, antibiotics, antifungal medication, isosorbides, and others. Recreational drugs, vitamins, herbal medications, supplements, and the like should also be disclosed to the attending physicians upon the assessment as these drugs are also known to interact with Sildenafil.
Clients are happy with the Fildena XXX products they bought from Cheapamericandrugstore.com, as indicated by their 5-star ratings for the product. One client from the site, Efrain, rated Fildena XXX 5 stars due to its fruity flavor. The other buyer, Kevin, appreciated the fact that Fildena XXX was fruity flavored too, and recommended Fildena XXX’s use to other buyers. Apparently, the users liked the fruity formulation of the product.
Buyers from Usrushed.com, too, gave good ratings for Fildena XXX. There is no detail for the flavor of the product here, but the buyers commented on how the product was effective upon use. The other user’s rating was only 3 out of 5, but his “wow” comment suggests that he was also pleased with the results. There was no elaboration for the low rating, however.
Since clients seem to like the fruity formulation of Fildena XXX, the product seems fitting for those who want to try Sildenafil, as the flavors of the product seem to make the product tolerable to take.
As expected of generic formulations, online stores sell Fildena XXX for a fraction of its brand-name counterparts’ prices. Buyers can have Fildena XXX for at $32 (8 pills), and the prices change depending on the number of products to be bought by buyers. When buyers get more of the pills, the price per pill decreases.
Since the main supply of Fildena XXX products are only found in India, the online suppliers provide a way for these products to reach most parts of the world. Shipping charges are courier-preference-dependent, and the clients are the one to choose which courier suits them well. Internet pharmacies ship to the USA, Canada, and Australia, plus most countries in Asia and the Middle East.
New methods of administration for Sildenafil have been a subject of a number of studies, as they aim to provide more efficient methods for systemic Sildenafil delivery. These studies are positive that in the future, there will be more methods of administration for Sildenafil in treating ED and involving not only the oral route.
Fildena XXX is one drug administered orally also, but it is different from its Sildenafil counterparts as it is in an orodispersible tablet form, which makes it more tolerable than the other Sildenafil types. Also, the product comes in different flavors, which the users seemed to enjoy. The effectiveness of Fildena XXX is the same with the other Sildenafil products, though, as its chewable form did not seem to affect its bioavailability.
As for my rating, since the product Fildena XXX was well-received, I think it deserves 4 out of 5. I left out a point as it is reserved for products which are approved by the US FDA. Fildena XXX, aside from being effective, is also great-tasting, which makes it interesting to try. Although generic, since it’s manufactured by an ISO/WHO-GMP accredited maker, users are assured they are taking a high-quality (yet affordable) ED treatment.