Sildenafil Injection Review: From a Company with Great Stability

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Sildenafil Injection from Aurobindo Pharma/AuroMedics Pharma is an unconventional way of delivering Sildenafil Citrate in patients. The common route of administration for PDE5 inhibitors (phosphodiesterase type 5 inhibitors) such as Sildenafil Citrate is via the oral route and this injection (administered intravenously) is not the conformist way of giving patients Sildenafil.

According to the information available for injectable Sildenafil Citrate products, IV-administered Sildenafil is usually given to patients with pulmonary arterial hypertension (PAH) [1]. Drug monographs for Sildenafil injectable products like Revatio from Pfizer have the primary indication for pulmonary hypertension and not erectile dysfunction. Although the Sildenafil content of injectable Sildenafil products is also efficacious in helping patients overcome erectile dysfunction, the IV route for Sildenafil may be for urgent delivery of the drug for patients with PAH.

Sildenafil Injection from Aurobindo only comes in the IV drug form and the content of the product is 10 mg of Sildenafil per 12.5mg/mL or 0.8 mg/mL, which is actually a low dose of Sildenafil which may be ineffective if used for erectile dysfunction, since Sildenafil for impotence is usually dosed at 50-100 mg per intake [2].

Aurobindo Pharma Information

Another Pharma company situated in India is the business company Aurobindo Pharma. Like the other Pharma companies, Aurobindo can be found in the “HITEC City”, India’s Hyderabad [3]. The enterprise began in 1986 (which is as early as the other pharmaceutical companies in India) and was founded by PV Ramaprasad Reddy, K Nityananda Reddy and their team [4]. However, the company only started manufacturing in the year 1988 and produced their first product, the SSP or semi-synthetic Penicillin [4].

Today, the company manufactures more than Penicillin—Aurobindo Pharma is now reproducing pharmaceutical goods in the vast areas of cardiovascular, HIV/AIDS/Hepa antiretrovirals, diabetic medicine, neuroscience, cephalosporins, and gastroenterology [4].

Aurobindo Pharma

Aurobindo Pharma

The data on Aurobindo Pharma’s website states that it belongs to the top 10 Pharma business names in India when it comes to revenues [4]. It is indeed a manufacturer operating on a massive scale, as Aurobindo is known to export to 125 countries of the world [4]. For the manufacture of active pharmaceutical ingredients (APIs) alone, the company dedicated 9 manufacturing units, which signposts the company’s dedication for the manufacture even of its raw materials for its Pharma goods [4].

Aurobindo is not only a large-scale operator, it is also a well-accredited supplier of pharmaceutical products. The United States FDA, United Kingdom MRHA, Europe GMP, Health Canada, South Africa MCC, and ANVISA by Brazil are the ones accrediting Aurobindo, which means that the company takes its quality manufacturing seriously [4].

Scientific Studies on Sildenafil

Sildenafil Citrate’s primary use is for the management of erectile dysfunction in males. However, there are studies which included the use of Sildenafil in the probable treatment modalities for premature ejaculation. The study of Salonia et al, “A Prospective Study Comparing Paroxetine Alone Versus Paroxetine Plus Sildenafil in Patients With Premature Ejaculation” tested Sildenafil’s efficacy when it comes to managing premature ejaculation symptoms and compared the results with the singular SSRI treatment [5]. Healthy, potent males were who were suffering from premature ejaculation (with no known cause) were recruited for the study and were given either Paroxetine 10mg every day (21 days and another 20 mg on-demand, before intercourse) or the same 10mg daily Paroxetine and the same 20mg as needed dose of Paroxetine, but this time, the patients were also administered with 50 mg on-demand Sildenafil Citrate (1 hour prior to coitus) [5]. According to the authors, the combination of Sildenafil and Paroxetine in patients was able to elicit good results, which are more significant than the Paroxetine-only dose [5]. The only downside to this combination is the increased side effects such as more headaches and flushing [5]. In the end, both groups were willing to continue with their treatments again (Paroxetine only-82.5% ad Paroxetine-Sildenafil-90%) [5].

On the other hand, the study of Ali Atan et al in 2005, “Comparison of efficacy of sildenafil-only, sildenafil plus topical EMLA cream, and topical EMLA-cream-only in treatment of premature ejaculation” reviewed the efficacy of Sildenafil or EMLA (topical anaesthetic) cream only or the combination of both drugs in males with PE [6]. 84 patients were subdivided into 4 groups; group 1 had placebo only, group 2 had Sildenafil (50mg) only, group 3 were given Sildenafil (50mg) plus EMLA cream, while group 4 used the cream only treatment [6[. Of all the treatment groups, the EMLA-cream-only and the EMLA + Sildenafil group were able to yield the highest percentage when it comes to efficacy (77.3% and 86.4%, respectively) although there is no significant difference between these two’s results [6]. In the culmination of their investigation, the authors concluded that using only Sildenafil only as effective as placebo (55% to 40%) and the combination of the cream + Sildenafil and the anesthetic cream-only treatment have similar effectiveness [6].

Another study focused on determining whether Sildenafil has the potential in aiding patients ailing from premature ejaculation and erectile dysfunction is the study from Li et al in 2003, with a title, “[Clinical study of sildenafil in the treatment of premature ejaculation complicated by erectile dysfunction]” [7]. Li’s study included 45 patients and allocated them with 50 to 100 mg of Sildenafil for 3 months [7]. The results indicated an 88.88% of efficacy in the patients’ erectile function, while the data gathered suggests that 60% of the patients were improved of their PE condition [7]. Due to the positive results, the researchers concluded that Sildenafil use in patients with both ED and PE is effective in improving both conditions [7].

Description and Mechanism of Action of Sildenafil

It is known by patients all over the world that Sildenafil Citrate is an efficacious agent for erectile dysfunction. Some of the impotence patients know that Sildenafil stimulates the upsurge of blood in the spongy penile tissues, leading to an erection. Although that is true, the stimulating effect is not the actual action of Sildenafil in patients.

In truth, Sildenafil Citrate’s mechanism is fairly simple—it prevents PDE5 from doing its job. Patients suffering from impotence have their hormonal/chemical transmitter systems in disarray, causing PDE5 to precipitately destroy the chemical signal which enables the erection in patients. Since is selective, its only task is to keep PDE5 from degrading the chemical signal initiating the erectile response. As Sildenafil is able to accomplish its job, the erectile function is once more reinstated in patients with ED.

Sildenafil Injection Effects for Erectile Dysfunction

Although it was mentioned earlier that Sildenafil Citrate injections are not really indicated for erectile dysfunction, the Sildenafil content of the drug can benefit patients for their erectile problems. Patients suffering from chronic ED can expect significant improvements in their erectile function on the outset of Sildenafil use. However, patient response to the drug is varied; not all patients may find the drug efficacious, especially those patients with other/underlying clinical illnesses. In these cases, however, patients are given adjuvant therapies which include other ED drugs or sometimes ED apparatuses.

Sildenafil injections are primarily utilized for patients with PAH. Sildenafil is used in both pediatric and adult PAH patients. Surprising as it may seem, PAH and erectile dysfunction are not the only conditions that Sildenafil is able to treat. As studies for various medical applications for Sildenafil are underway, patients can expect more clinical relevance for Sildenafil in the near future.

Recommended Doses and Duration of Therapy

Oral Sildenafil tablets/products are initially given in 50 mg, though patients are typically responsive to the 100 mg dose of the drug. Patients with ED are requested to take the Sildenafil tablets 1 hour before sexual activity, as the drug takes up about an hour to get integrated into the patients’ system. Alcohol is prohibited to be consumed along with Sildenafil, as Sildenafil and alcohol’s interaction is not in any way beneficial for the patients.

Patients with pulmonary hypertension are given with an initial dose of 2.5-10mg of IV Sildenafil three times a day. Oral Sildenafil for PAH, on the other hand, is recommended 5 to 20 mg for 3 times a day [2]. These are not the only dosages for Sildenafil use, as depending on the condition of the patients, the dose may still be adjusted to fit the patients’ needs (hepatic and renal impaired patients have dose adjustments) [2].

Side Effects and Warnings

Although most patients are asymptomatic, there are Sildenafil-treated patients who are bound to have side effects as a result of the use of the medication. In clinical studies meant for the discovery of Sildenafil’s efficacy, patients perceived side effects as a repercussion of Sildenafil utility for their condition. Side effects included gastric pain, changes in eyesight (particularly the blue color), and the extremely common facial flushing and redness [5]. Until now, however, there are no scientific proofs which can determine a patient’s predisposition to side effects of the drug. But, clues lie in the patients’ underlying medical conditions; it is thought that the patients’ current illnesses contribute to the presence of side effects due to Sildenafil use.

Albeit headaches and flushing are trifling, serious side effects may also occur. Patients are warned about side effects such as blindness, hearing loss, chest pain indicative of an impending heart attack, myocardial infarction, seizures, death, and other dire consequences [8]. FDA and the manufacturers make the patients aware of these possibilities to warrant the safety of Sildenafil use in patients.

Drug Interactions

Besides the potential side effects as a result of using Sildenafil for any condition, Sildenafil also has adverse reactions ascertained for it when combined with several drug groups. Patients are advised to be cautious when it comes to using Sildenafil Citrate, as there are maintenance medications which are known to have deleterious effects when co-administered with Sildenafil Citrate. Nitrates, for one, are restricted to be used concomitantly with Sildenafil due to the danger of having an extremely low blood pressure. In addition to the nitrate drug warning, patients are also asked to stay away from the drugs for fungal infections, bacterial infections, and even household products such as grapefruit juice.

Customer Reviews

It is rather arduous to locate reviews for Sildenafil injection, primarily because it is not used by the patients themselves. Since Sildenafil injection is an IV-only drug, its use is restricted to the medical health professionals. However, regarding Sildenafil reviews, there is actually a glut of reviews for Sildenafil tablets—most of them have good reports about the efficacy of the drug for their ED. We can say that because Sildenafil injection is manufactured by an exceedingly reputable agency, it can be assumed that Sildenafil injection functions well for the use it is intended for.

Also, the fact that the drug is still available in the market is a testament to its safety and efficacy. No bad reports about Sildenafil injection were given out online, so we can deduce that the drug is functioning well for its indications.

Price, Available Forms and Dosage

Due to the IV nature of Sildenafil injection, there is no online store vending the drug. Unlike the Sildenafil tablets, Sildenafil injection is sternly sold and with various restrictions to its use. The patients do not have much utility for Sildenafil in IV form, so the product may not actually be profitable for online shops to sell. Also, with the surplus of other oral Sildenafil products, the injectable form of Sildenafil is not actually an option for the patients due to its difficult administration which actually requires medical expertise.

Conclusion and Rating

Sildenafil injection is a product indicated for the condition Pulmonary Arterial Hypertension in patients. Although the same Sildenafil Citrate ingredient found in the ED pills is the main active ingredient of Sildenafil injection, the product is not actually indicated for ED use. The drug is actually one of the hard-to-procure items, as the drug is not sold anywhere online and is may be strictly for medical professionals’ use only. Still, due to the impressive manufacturer portfolio for Sildenafil injection, the drug may be rated 4 out of 5, although it is not too recommendable as it is not easy to procure and is not really meant for ED use.

Reference List

  1. https://www.drugs.com/pro/sildenafil-injection.html
  2. https://www.drugs.com/dosage/sildenafil.html
  3. https://en.wikipedia.org/wiki/Aurobindo_Pharma
  4. http://www.aurobindo.com/about-us/overview
  5. http://www.sciencedirect.com/science/article/pii/S0022534705641742
  6. http://www.sciencedirect.com/science/article/pii/S0090429505013063
  7. http://europepmc.org/abstract/med/12931367
  8. https://www.drugs.com/sfx/sildenafil-side-effects.html
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