The information provided below corresponds to the official product information from Patient Information Leaflet provided by the manufacturer.
The text does not contain any of medical advices, mode of administration and prescription plans.
Before beginning any treatment, we kindly advise you to consult your healthcare provider.
Sildenafil citrate is one of the first pharmaceutical agents which acts very effectively in men who are suffering from erection disorder. Activity of Sildenafil citrate based only on increase of local blood circulation in the penis. But Sildenafil citrate does not increase sexual desire, does not increase libido and does not act as a stimulating agent. Sildenafil citrate could be used by men if they are suffering from erectile dysfunctions of different origin also in vessel or penis nerves dysfunctions.
Most of men over 40 years old have question what is the cause of erectile dysfunction and how to fix it? The answer to this question is that arteries which are leading to the penis could not be opened properly. This is the reason why men cannot achieve an erection.
Since the launch of the preparation on the market in 1998 it has been used by other 16 millions of men and is still considered very effective and safe for use. The preparation can be used to treat elderly patients and even patients with impaired renal function in low dosages starting form 25 mg. The preparation may help people with psychological problems as well as with physiological disorders which cause erectile dysfunction..
The preparation does not affect the hormonal system nor does it increase libido. The preparation helps a person to achieve and maintain a steady erection when he is aroused for 4 hours after intake. The only restriction which is applied to Sildenafil citrate is that it must be taken only once a day.
Sildenafil citrate has 3 standard dosages: 25mg, 50 mg and 100mg. Usually the medication is prescribed in 50 mg dosage and then depending on the achieved effect the dosage is corrected. Another method of treatment may also apply - the treatment begins with a minimal dose of the medicine and then increase until a stable effect is achieved.
Other well-known manufacturer of Sildenafil citrate is Aurochem Laboratories (India) Pvt. Limited. The company is on the market over 10 years. Pharmaceutical products of Aurochem Laboratories (India) Pvt. are imported to 25 countries over the world and their assortment includes up to 450 types of safe and qualitative medicines. The products are produced in the forms of ointments, creams, powders, liquid orals, capsules, syrups and tablets. Among them are not only medications used to treat erectile dysfunction like Sildenafil citrate but also antacids, cardiovascular, antiulcers, antibiotics, antiallergic, anti fungals.
Generic Sildenafil citrate is a medication which consists the same active ingredient as Sildenafil citrate. Generic Sildenafil citrate is not produced by Pfizer, it is usually is produced by the manufactures which are specialized in production of generic preparations. Sildenafil citrate is usually much cheaper than brand preparation. This is usually related to the fact that companies which produce the generic version of the preparation do not pay for clinical laboratory and clinical trials. The difference between generic and brand Sildenafil citrate is usually consists in different form, shape, color of the tablets, and the amount of adjuvant substances. Generic Sildenafil citrate which is provided by dx-health is manufactured by Aurochem Laboratories (India) Pvt. Limited and is sometimes is called as Mygra.
Sildenafil citrate is prescribed to treat men over 18 years of age which suffer from erectile dysfunction. Sildenafil citrate is prescription medication meaning that is available only with a doctors prescription.
Sildenafil citrate works by selectively inhibiting phosphodiesterase-5, which normally affects the degradation of cyclic guanosine monophosphate in the penises cavernous body. The preparation actively increases the relaxing effect on the smooth muscle of the cavernous body and increases blood flow to the penis. Activation of the NO-cGMP chain starts when a patient is sexually aroused, the inhibition of PDE-5 leads to increased concentrations of cGMP in the cavernous body thus leading to a better erection. The pharmacological effect is achieved only in cases of sexual stimulation.
The effectiveness of the preparation depends strongly on the degree of erectile dysfunction and on the cause of the disorder. As an example the in treatment of vascular erectile dysfunction by the medicine has shown high efficacy. On the other hand treatment of venous drainage induced ED the positive effects are achieved in a moderate number of cases.
After extensive clinical trials the medicine is approved to be safe in males starting form age of 18 to 87. With a percentage of side effects appearance below 2.5%. These side effects were described as transient to mild in nature, some occurring only in the beginning of the treatment. One thing a man can feel good about is that Sildenafil citrate has been tested in more than 130 controlled studies (completed and ongoing) including over a dozen thousands of men. These studies and real-world experience of Sildenafil citrate has shown to have a strong safety profile.
Generic Sildenafil citrate cautions, warnings and precautions
Generic Sildenafil citrate is contraindicated in known allergy or reactions of hypersensitivity to any of the preparations ingredients.
Generic Sildenafil citrate should not be taken in patients which take nitrates of nitrogen oxide donors.
Generic Sildenafil citrate is contraindicated for use in patients under 18 years of age. The medication is not intended to use in women.
Generic Sildenafil citrate should be used with caution in:
- Anatomical deformations of the penis (angulation, cavernous fibrosis)
- Diseases which predispose priapism
- Diseases manifested with bleedings, tendency to bleedings
- Aggravation of the stomach and duodenal ulcers
- Hereditary pigment retinitis
Coronary heart disease, unstable stenocardia, a history of heart attack, stroke, life-threatening arrhythmia, high blood pressure, low blood pressure
The medication is not intended to use in women that is why there is no data if the medication is safe in pregnant women or during breastfeeding.
The medication is taken orally. The recommended daily dose for the most patients is 50mg 1 hour before the sexual intercourse. According the efficiency and tolerability of the preparation the dose of the medication can be increased up to 100mg or decreased up to 25mg. The maximal recommended dose is 100mg once daily.
In patients with kidney failure (creatinine clearance 30-80ml/min) the correction of the dose is not required. In patients with creatinine clearance less than 30ml/min the dose of sildenafil citrate is 25mg daily.
In patients with liver failure the dose of sildenafil citrate should be 25mg daily.
If Sildenafil citrate is taken in combination with ritonavir the maximal dose of Sildenafil citrate is 25mg once in 48 hours (2 days). In concomitant application with CYP3A4 inhibitors (erythromycin, ketoconazole, itraconazole) the beginning dose of Sildenafil citrate is 25mg daily. Sildenafil citrate dose in patients with take alpha-blockers should be corrected as well. It is not recommended to take generic Sildenafil citrate without medical approval.
Generic Sildenafil citrate works nearly 4 hours. There are a group of factor which may change the duration of Sildenafil citrate effects. These factors include: liver or kidney diseases, ages, other products taking.
Sildenafil citrate like brand preparation is usually well tolerated and generic Sildenafil citrate side effects are not common. During the clinical trials the following side effects were observed:
Nervous system: headache (10.8%), dizziness, blurred vision, vision changes, chromatopsia
Cardiovascular system: vasodilation, hot flashes, increased heart rate
Respiratory system: rhinitis, nasal congestion
Digestive system: dyspepsia, upset stomach
The less common Sildenafil citrate side effects include:
General health disorders: reactions of hypersensitivity
Central nervous system: seizures
Cardiovascular system: tachycardia, decreased blood pressure, faint, nasal bleedings
Gastrointestinal system vomiting
Vision organs: eye pain, eye redness
In patients which take Sildenafil citrate in very rare cases it was observed a conditions which is called nonarteritic anterior ischemic optic neuropathy (NAION). This condition manifests in sudden loss of vision. This condition is probably may occur in the patients with the following risk factors:
- Age over 60 years
- Other cardiovascular diseases
- Alcohol abuse
Sildenafil citrate can interact with the amount of medicines:
1.Cimetidine which h2 histamine receptor blockers which is used is used to treat stomach and duodenal ulcer. Cimetidine may significantly increase the blood levels of Sildenafil citrate leading to increased risk of Sildenafil citrate side effects.
2. Protease inhibitors like Ritonavir or Indinavir. This type of medication can significantly increase the blood levels of Sildenafil citrate in the organism.
3.Norvasc(amodipine) when used with Sildenafil citrate can cause extremely low blood pressure
4.Alpha blockers when used with Sildenafil citrate can cause significant drop in blood pressure
5. Erythromycin - a macrolide antibiotic which may change the way how your organism metabolizes Sildenafil citrate
6.Antifungals - change the way how your organism metabolizes Sildenafil citrate.
7.Nitrates - Sildenafil citrate should never be taken with nitrate or nitrogen oxide donors. Patients may experience extremely low blood pressure.
8. When generic Sildenafil citrate is taken with alcohol - certain health problems may occur. These are: dizziness, tachycardia, low blood pressure
Are herbal Sildenafil citrate and generic Sildenafil citrate are the same medications?
No. Herbal Sildenafil citrate is usually called herbal supplements which work works in different ways. Herbal Sildenafil citrate does not contain Sildenafil citrate. The activity of herbal Sildenafil citrate is lower than generic Sildenafil citrate.
This info corresponds to official PIL provided by legal manufacturer and reviewed by: Dr. Rohit Bansali N.