Kamagra, Generic Viagra Patient Information Sheet

Sildenafil Citrate Tablets
KAMAGRA GOLD
What is KAMAGRA GOLD ?
Ans KAMAGRA GOLD is a convenient oral pill for the treatment of Erectile Dysfunction (ED) in men.
What is ED?
Ans. Erectile Dysfunction or ED, is an inability to gel and/or maintain penile erection sufficient for satisfactory sexual activity. It is often termed as impotence, a common sexual problem.
How does KAMAGRA GOLD work?
Ans KAMAGRA GOLD dilates arteries in the penis and thus allows filling of blood into sinusoids (small spaces in the penis). 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 KAMAGRA GOLD before sexual activity ?
Ans KAMAGRA GOLD should be taken about 1 hour before sexual activity However it can be taken 30 minutes to 4 hours before sexual intercourse.
How much KAMAGRA GOLD can I take ? Ans. The most convenient dose is decided by your doctor. KAMAGRA GOLD comes in different doses (25mg. 50mg & 100mg). For most men dose is 50mg one hour before sexual activity. Do not take more KAMAGRA GOLD than your doctor prescribes and do not take KAMAGRA GOLD more than once a day.
Who should not take KAMAGRA GOLD ? Ans KAMAGRA GOLD 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 KAMAGRA GOLD
KAMAGRA GOLD should not be taken by patients who are on any form of nitrates
Can I take KAMAGRA GOLD with alcohol?
Ans. You are advised not to take alcohol before taking
KAMAGRA GOLD It may alter the response of the drug.
Can I take KAMAGRA GOLD after food?
Ans Yes, but avoid fat meal before taking KAMAGRA GOLD
to have better response.
What are the side effects of KAMAGRA GOLD ?
Ans KAMAGRA GOLD may cause side effects such as
headache, flushing, stomach upset or blurring of vision
What if KAMAGRA GOLD does not work ? Ans KAMAGRA GOLD may not be effective for everyone, if it does not work for you. consult your doctor, for other treatment options.

Sildenafil Citrate Tablets
KAMAGRA* GOLD
COMPOSITION
KAMAGRA GOLD - 25 Tablets: Each film coated tablet contains: Sildenafil Citrate
equivalent to Sildenafil 25 mg KAMAGRA GOLD - 50 Tablets: Each film coated tablet contains: Sildenafil Citrate
equivalent to Sildenafil 50 mg
KAMAGRA GOLD -100 Tablets: Each film coated tablet contains: Sildenafil Citrate
equivalent to Sildenafil 100mg DESCRIPTION
KAMAGRA GOLD, an oral therapy for erectile dysfunction, is the citrate salt of Sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5(PDE5). Sildenafil citrate is designated chemically as 1-[{3-(6.7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrozolo [4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfony1]-4- melhylpiperazine citrate and has a molecular weight of 666.7.
MECHANISM OF ACTION
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. It's effect is more potent on PDE5 than on other known phosphodiesterases (>80-fold for PDE1. > 1,000-fold for PDE2, PDE3 and PDE4). The approximately 4,000-fold selectivity for PDE5 versus 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.
PHARMACOKINETICS
KAMAGRA GOLD is rapidly absorbed after oral administration, with an absolute bioavailability of about 40%. Its pharmacokinetics are dose-proportional over the recommended dose range. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When KAMAGRA GOLD is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and mean reduction in Cmax of 29% . The mean steady state volume of distribution (Vss) for Sildenafil is 150 L. indicating distribution into the tissues. It is eliminated predominantly by hepatic metabolism (mainly cytochrome P450 3A4) and is converted to an active metabolite with properties similar to the parent, Sildenafil. This metabolite has a PDE selectivity profile similar to parent Sildenafil. This metabolite has a PDE selectivity profile similar to Sildenafil and an in vitro potency for PDE5 approximately 50% of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for Sildenafil, so that the metabolite accounts for about 20% of Sildenafil's pharmacological effects. Sildenafil and its major circulating N-desmethyl metabolite are both
approximately 96% bound to plasma proteins. Both Sildenafil and the metabolite have terminal half lives of about 4 hours. After entire oral or intravenous administration. Sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
INDICATIONS
KAMAGRA GOLD is indicated for the treatment of erectile dysfunction in men.
CONTRAINDICATIONS
Consistent with its known effects on the nitric oxide/cGMP pathway, KAMAGRA GOLD potentiates the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated. KAMAGRA GOLD is also contraindicated in patients with a known hypersensitivity to any component of the tablet.
PRECAUTIONS AND WARNINGS
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including KAMAGRA GOLD, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. Similarly, KAMAGRA GOLD 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 within the last 6 months;
Patients with resting hypotension (BP<90/50) or hypertension (BP>170/110);
Patients with cardiac failure or coronary artery disease causing unstable angina;
Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Prolonged erection greater than 4 hours and priapism ( painful erections 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 patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. The safety of KAMAGRA GOLD is unknown in patients with bleeding disorders and patients with active peptic ulceration. KAMAGRA GOLD should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosa! fibrosis or Peyronie'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 KAMAGRA

not been studied. Therefore, the use of such combinations is not recommended
DRUG INTERACTIONS
A reduction in Sildenafil clearance occurs when it was coadministered with CYP 3A4 inhibitors such as Ketoconazole, Erythromycin, or Cimetidine. It can be expected that concomitant administration of CYP 3A4 inducers, such as Rifampicin, will decrease the plasma levels of Sildenafil
PREGNANCY, NURSING MOTHERS AND PAEDIATRIC USE
KAMAGRA GOLD is not indicated for use in newborns, children, orwomen.
DOSAGE AND ADMINISTRATION
For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, KAMAGRA GOLD may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and tolerance, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
The following factors are associated with increased plasma level of Sildenafil; age>65 (40% increase in AUC). hepatic impairment (e.g. cirrhosis, 80%) severe renal impairment (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 25 mg should be considered in these patients.
ADVERSE REACTIONS
KAMAGRA GOLD is generally well tolerated. Commonly reported adverse events to Sildenafil include the following; headache (16%), dyspepsia (7%) nasal congestion (4%) , abnormal vision (3%) diarrhoea (3%), dizziness (2%) and skin rash (2%).
OVERDOSAGE
In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as Sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.