Super Fildena is a combination therapy of 100 mg of sildenafil citrate and 60 mg of dapoxetine hydrochloride. It is used to improve ejaculation time and erection quality in patients with both erectile dysfunction (ED) and premature ejaculation (PE).
This article addresses the basic pharmacological profile of Super Fildena, including its mechanism of action, dose, usage, safety profile, and drug interactions.
Keep reading to know more about the drug.
Super Fildena is manufactured by the Indian pharmaceutical company Fortune Healthcare. It is a tablet containing a combination of sildenafil and dapoxetine.
Sildenafil is a phosphodiesterase 5 (PDE-5) inhibitor, the most common group of drugs used in ED. It helps to achieve an erection. Viagra, the drug which revolutionized the treatment of ED, has the same chemical composition.
Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) that increases the ejaculation time. It is the first and the only product licensed for use in PE . Studies on the efficacy and safety of the combination of sildenafil and dapoxetine have reported significant improvement in ejaculation time .
Dapoxetine does not interact with sildenafil; hence, this combination brings maximum sexual benefits .
Super Fildena is a brilliant blue and tartrazine-colored triangular tablet. It is not an aphrodisiac, nor does it contain hormones. The drug is available for purchase only upon a valid medical prescription. It offers no protection against sexually transmitted diseases. Use only as directed by your healthcare provider. Do not use this in combination with other drugs for ED.
Super Fildena is composed of 100 mg of sildenafil along with 60 mg of dapoxetine. The maximum recommended dose is once daily before sexual activity. A combination of sildenafil and dapoxetine is also available in half-strength.
Super Fildena is a film-coated tablet that should be swallowed whole with a glass of water. It should be taken one to three hours before sexual activity. The tablet should not be crushed or chewed.
It can be taken either on an empty stomach or after a meal. However, it is recommended that you take a light meal beforehand. Avoid taking the drug with fatty meals since this can delay the effect of sildenafil. When the tablet is taken with food, it also decreases the chances of an upset stomach.
Take this medication as it is instructed. Do not stop the drug without consulting your healthcare provider.
Super Fildena has a short onset of action. Both sildenafil and dapoxetine are rapidly absorbed following oral administration. The maximum plasma concentration is achieved within 60 minutes after a single oral dose [2, 4].
Super Fildena can provide effects for up to 6 hours. Due to the high dosage of the active ingredient and dual composition of the drug, longer and better intercourse can be achieved.
The price of the Super Fildena tablet ranges from $85 to $130 per strip. Each strip contains four tablets. Prices depend upon the availability of the drug and the type of insurance coverage.
Sildenafil, one of the active ingredients of Super Fildena, was originally discovered by Pfizer in 1989. The drug was patented as Viagra .
It was originally studied for use in pulmonary arterial hypertension and angina. However, it was less effective in its treatment. It then gained widespread commercial popularity when its side effect (penile erection) was marketed for the treatment of impotence which was then a major concern for older men.
Sildenafil was patented in 1996 and approved by the US Food and Drug Administration (FDA) in 1998 [4, 6]. The approval of sildenafil for ED was followed by the discovery of several other drugs with similar chemical compositions.
The patent obtained by Pfizer expired in 2017, after which sildenafil became available as a generic medication. This generic version of the ‘little blue pill’ is cheaper and widely available around the globe.
Dapoxetine was created by the pharmaceutical company Eli Lilly. It was a drug that was initially manufactured as an antidepressant. The drug was not effective in the treatment of depression. Dapoxetine was subsequently developed to treat PE.
It was later sold to Johnson & Johnson’s subsidiary Alza in 2003. It has not yet been approved by the US FDA. However, it has been approved by medical authorities of Germany, Finland, Sweden, Portugal, Austria, Italy, Mexico, Spain, South Korea, and New Zealand [7, 8].
Sildenafil and dapoxetine are rapidly eliminated from the body. This leads to lower chances of severe or toxic effects. Nevertheless, Super Fildena may have the following side effects:
- Back pain
- Blurred vision
- Dry mouth
- Excessive sweating
- Fall in blood pressure
- Gastrointestinal side effects
- Impaired color vision
- Lack of energy and strength
- Muscle pain
- Nasal congestion
- Upper respiratory tract infection
- Hearing loss
- Heart attack
- Sudden loss of vision
Super Fildena should not be used in pregnant women, nursing mothers, and pediatric patients. It should be used with caution in men older than sixty-five years. Dose adjustments are required in patients with liver and kidney impairments.
Medications that should not be mixed with Super Fildena include:
Co-administration of Super Fildena and nitrates is contraindicated as it causes additive blood pressure-lowering effects.
Super Fildena can increase the blood-pressure-lowering effects of some antihypertensives.
Dapoxetine can interact with monoamine oxidase (MAO) inhibitors such as isocarboxazid, phenelzine, and selegiline. Combination therapy should be avoided as there are reports of serious and lethal reactions.
Co-administration of Super Fildena and antipsychotics such as thioridazine can lead to serious ventricular arrhythmias. Dapoxetine inhibits CYP2D6 isoenzymes. This in turn inhibits the metabolism of thioridazine, which leads to elevated levels of the drug. This causes ventricular arrhythmias.
Alcohol and sildenafil are mild vasodilators. When taken together, it causes additive blood pressure-lowering effects. Another effect of alcohol is that it temporarily impairs the ability to attain an erection. It can also cause headaches, dizziness, and increased heart rate. It is best not to consume alcohol while taking this drug.
Antacids such as aluminum hydroxide or magnesium lead to reduced absorption of sildenafil. Hence, enhanced effects of Super Fildena can occur.
The CYP3A4 group of drugs includes ketoconazole, itraconazole, erythromycin, carbamazepine, and barbiturates. These drugs decrease the metabolism of Super Fildena and hence can abnormally potentiate its clinical effects.
Super Fildena should not be used in combination with other SSRIs. Herbal products such as St. John’s wort contain serotonin. Combining drugs with these medicinal and herbal products may increase serotonin levels, causing diarrhea, shivering, and seizures [4, 8].
This drug is not recommended for use by:
- Pregnant or breastfeeding women
- Pediatric population
- Patients with known hypersensitivity to sildenafil and/or dapoxetine
- Patients who have been advised to refrain from sexual activity due to underlying heart disease
- Individuals with renal impairments
- Individuals with severe hepatic impairment
- Patients using Nitrates
- Patients with a previous history of non-arteritic anterior ischemic optic neuropathy (NAION)
- Patients on drugs that can potentially interact with sildenafil and/or dapoxetine
- Patients with a history of priapism (prolonged erection)
What is the Mechanism of Action of Super Fildena?
Super Fildena helps to achieve an erection and prolongs sexual intercourse duration. Penile erection is caused by increased blood flow to the penis. This is due to the relaxation of the penile arteries and the smooth muscle corpus cavernosum.
The endothelial cells and nerve endings release nitric oxide (NO), which mediates vasodilation. NO stimulates the synthesis of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum, leading to smooth muscle relaxation and increased blood flow. Sildenafil is an inhibitor of the cGMP-specific PDE-5 enzyme. Inhibition of PDE-5 increases the amount of cGMP, which enhances erectile function.
Dapoxetine is a serotonin reuptake inhibitor. The inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin’s action at the synaptic receptors aids in the prolongation of ejaculation [2, 4, 8].
The clinical efficacy and safety of the sildenafil and dapoxetine combination therapy have been evaluated in a few clinical studies. The combination therapy significantly improved the intravaginal ejaculatory latency time. Mild and transient side effects were reported .
Another randomized multicenter study reported an improved premature ejaculation profile with a low risk of adverse effects .
Super Fildena is not recommended for pregnant and lactating mothers .
Many other drugs help with ED and PE due to similar ingredients or their effects on the body.
All these drugs work to improve the penile blood flow and prolong ejaculation time. Discuss with your physician before switching medications.
Alternative prescription medications include:
- Avanafil (Avaforce, Stendra, Avana)
- Mirodenafil (Mvix)
- Sildenafil (Viagra, Fildena, P-Force, Vygex)
- Tadalafil (Cialis, Tadagra, Tadovas, Tadact,Tadacip, Tadalip)
Herbal and natural formulations can be an alternative to Super Fildena. These should be used with caution and must not be used with Super Fildena.
- Foods that increase serotonin (eggs, cheese, pineapples, tofu, salmon, nuts, and seeds)
- Horny goat weed
- Vitamin E
Super Fildena is a prescription-only medicine. The drug can be purchased online or in your local pharmacies. Purchasing the drug online maintains privacy. It is also time and cost-saving.
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