Sildenafil Citrate Tablets For Men To Regain The Essence Of Life
SOULFIL : The solution for men erectile dysfunction
|Frequently Asked Questions|
|MECHANISM OF ACTION|
|PRECAUTION & WARNINGS|
|DOSAGE AND ADMINISTRSTION|
|ROUTE OF ADMINISTRATION|
|1||What is SOULFIL ?|
|2||What is Erectile Dysfunction ?|
|3||How does SOULFIL work ?|
|4||How early should I take SOULFIL before the sexual activity ?|
|5||How much SOULFIL can I take ?|
|6||Who should not take SOULFIL ?|
|7||Can I take SOULFIL with alcohol ?|
|8||Can I take SOULFIL after food?|
|9||What are the side effects of SOULFIL ?|
|10||What if SOULFIL does not work ?|
|What is SOULFIL ?
SOULFIL is a convenient oral pill for the treatment of Erectile Dysfunction in men.
|What is Erectile Dysfunction ?
Erectile Dysfunction or ED is an inability to get and/or maintain penile erection sufficient for satisfactory sexual activity.
|How does SOULFIL work ?
SOULFIL dilates arteries in the penis and thus allows filling of blood into sinusoids. This leads to erection of the penis. As the penis hardens the veins are compressed restricting the blood flow out of the penis. Thus it maintains the penile erection. It does not increase the sexual desire itself.
|How early should I take SOULFIL before the sexual activity ?
SOULFIL should be taken about 1 hour before sexual activity. However it can be taken 30 minutes to 4 hours before sexual intercourse.
|How much SOULFIL can I take ?
The most convenient dose is decided by your doctor.SOULFIL comes in different doses (50mg & 100mg)For most men dose is 50mg one hour before sexual activity. Do not take more SOULFIL than your doctor prescribes and do not take SOULFIL more than once a day.
|Who should not take SOULFIL ?
SOULFIL is only for men suffering from ED. It is not recommended for children and women. Patients who are on any cardiac medicine should consult the doctor regarding the use of SOULFIL . SOULFIL should not be taken by patients who are on any form of nitrates.
|Can I take SOULFIL with alcohol ?
You are advised not to take alcohol before taking SOULFIL .It may alter the response of the drug.
|Can I take SOULFIL after food?
Yes, but avoid fat meal before taking SOULFIL to have better response.
|What are the side effects of SOULFIL ?
SOULFIL may cause side effects such as headache, flushing, stomach upset or blurring of vision.
|What if SOULFIL does not work ?
SOULFIL may not be effective for every one ,if it does not work for you, consult your doctor for other treatment options.
|SOULFIL - 50
Each film coated tablet contains:
equivalent to Sildenafil …...50 mg
Each film coated tablet contains:
equivalent to Sildenafil ….. 100 mg
|SOULFIL , an oral therapy for erectile dysfunction, is the citrate salt of Sildenafil.|
|The physiologic mechanism of erection of the penis involves release of nitric oxide(NO) in the corpus cavernosum during sexual stimulation.
NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate(cGMP),producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of Nitric Oxide (NO) by inhibiting phosphodiesterase types 5(PDE5), which is responsible for degradation of cGMP in the corpus cavernosum .
When sexual stimulation causes local release of NO, inhibition of PDE5 by Sildenafil causes increased levels of cGMP in the corpus cavernosum resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
Sildenafil at recommended doses has no effect in the absence of sexual stimulation. Studies in vitro have shown that Sildenafil is selective for PDE5.Its effect is more potent on PDE5 than on other known phosphodiesterase (>80-fold for PDE1,>1,000-fold for PDE2,PDE3 and PDE4).
The approximately 4,000-fold selectively for PDE5versus PDE3 is important because that PDE is involved in control of cardiac contractility Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina.
This lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels.
|SOULFIL is rapidly absorbed after oral administration with an absolute bioavailability of about 40 % .
Its pharmacokinetic profile is dose dependent over the recommended dose range . Maximum observed plasma concentrations are reached within 30-120 minutes of oral dosing on an empty stomach.
When SOULFIL is taken with a high fat meal, the rate of absorption is reduced with a mean delay in 60 minutes and mean reduction of 29%.
The mean steady state volume of distribution (Vss ) for Sildenafil is 150L, indicating distribution into the tissues.
Sildenafil is metabolised by hepatic microsomal enzyme system to an active metabolite which has 50% of the invitro potency of the parent drug for inhibition of PDE5.
After oral or IV administration sildenafil is excreted as metabolites predominantly in the faeces and to a lesser extent in the urine.
|Consistent with its known effects on the nitric oxide /cGMP pathway,SOULFIL potentiates the hypotensive effects of nitrates and its administration to the patients who are using organic nitrates either regularly and/or intermittently in any form, is therefore contraindicated.
SOULFIL is also contraindicated in patients with a known hypersensitivity to any component of the tablet.
|There is a potential for cardiac risk of sexual activity in patients with pre-existing
Therefore treatments for erectile dysfunction including SOULFIL , should not be generally used in men whom sexual activity is inadvisable , because of their underlying cardiaovascular status.
Similarly SOULFIL should be prescribed with caution in the following group of patients since there is no controlled clinical trial data on the safety or efficacy of the drug in these patients.
Patients who have suffered a myocardial infarction stroke or life - threatening arrhythmia with last 6 months.
Patients with resting hypertension ( BP < 90/50) or hypertension ( BP > 170/110) Patients with cardiac failure or coronary artery disease causing unstable angina. Prolonged erection greater than 4 hours and priapism ( painful erection greater than 6 hours in duration ) have been reported infrequently with Sildenafil. In the event of an erection that persists longer than 4 hours , the patients should seek immediate medical assistance.
If priapism is not treated immediately penile tissue damage and permanent loss of potency could result.
The safety of SOULFIL is unknown in patients with bleeding disorders and patients with active peptic ulceration.
SOULFIL should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or peryronie’s disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia,multiple myeloma or leukemia).
The safety and efficacy of combinations of SOULFIL with other treatments for erectile dysfunction have not been studied.
Therefore the use of such combinations is not recommended.
|A reduction in Sildenafil clearance occurs when it is coadministered with CYP-3A4 inhibitors such as Ketoconazole, Erythromycin or Cimetidine.
It can be expected that concomitant administration of CYP3A4 inducers such as Rifampicin will decrease the plasma levels of Sildenafil.
|For most patients the recommended dose is 50 mg taken approximately one hour before sexual activity.
The daily dose ranges from 25 mg to a maximum of 100mg and should be administered only once daily or as prescribed only by a Urologist , Psychiatrist or an Endocrinologist. The following factors are associated with increased plasma levels of Sildenafil : age > 65 (40% increase ) hepatic impairment ( e.g. Cirrhosis , 80% ) severe renal impairement ( creatinine clearance < 30ml/min , 100% ) and concomitant use of potent cytochrome P450 3A4 inhibitor ( Ketoconazole , Itraconazole ,Erythromycin (182%) , Saquinavir ( 210%) .
Since higher plasma levels may increase both the efficacy and incidence of adverse events a starting dose of 25mg should be considered in these patients.
|SOULFIL is generally well tolerated.
Commonly reported adverse effects are light and temporary . The most common side effects are headache and facial reddening. Other side effects reported but rarely seen are indigestion , dizziness, clogged nose ,effects on vision and skin rash.
|Store below 25 Degree Celcius in a dry place.
Protect from light .
Keep out of reach of children.
|Each film coated tablet containing Sildenafil Citrate equivalent to Sildenafil 50mg/100mg is available in a strip of 4 tablets.
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