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Sildenafil Citrate

Erectile Dysfunction

VEGA ASIA - 50

Each film coated tablet contains:
Sildenafil Citrate
eq. to Sildenafil 50 mg
Colour:Titanium Dioxide BP & Indigo Carmine

Tablet

VEGA ASIA - 100

Each film coated contains:
Sildenafil Citrate
eq. to Sildenafil 100 mg
Colour:Titanium Dioxide BP & Indigo Carmine

Tablet

Sildenafil Citrate Tablets -50 mg	Each film coated tablet contains: Sildenafil Citrate eq. to Sildenafil 50 mg Colour:Titanium Dioxide BP & Carmine	Tablet
Sildenafil Citrate Tablets -100 mg	Each film coated tablet contains: Sildenafil Citrate eq. to Sildenafil 100 mg Colour:Titanium Dioxide BP & Carmine	Tablet
VEGA ASIA - 50	Each film coated tablet contains: Sildenafil Citrate eq. to Sildenafil 50 mg Colour:Titanium Dioxide BP & Indigo Carmine	Tablet

VEGA ASIA - 100

Each film coated contains:
Sildenafil Citrate
eq. to Sildenafil 100 mg
Colour:Titanium Dioxide BP & Indigo Carmine

Tablet

Sildenafil Citrate Tablets -50 mg	Each film coated tablet contains: Sildenafil Citrate eq. to Sildenafil 50 mg Colour:Titanium Dioxide BP & Carmine	Tablet
Sildenafil Citrate Tablets -100 mg	Each film coated tablet contains: Sildenafil Citrate eq. to Sildenafil 100 mg Colour:Titanium Dioxide BP & Carmine	Tablet

      INFORMATION FOR USE OF A MEDICAL
PRACTITIONER, HOSPITAL OR LABORATORY

SILDENAFIL TABLETS

Available Composition

VEGA ASIA-100

Each film coated tablet contains: Sildenafil Citrate eq. to Sildenafil…100 mg

IMPORTANT WARNING:

Do not take VEGA ASIA if you are taking or have recently taken nitrates (medications for chest pain) such as Isosorbide dinitrate, Isosorbide mononitrate, and Nitroglycerin

PHARMACOLOGICAL CLASSIFICATION

Erectile Dysfunction

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 type 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.
PHARMACOKINETICS
VEGA ASIA (Sildenafil) is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When Sildenafil is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%. The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Protein binding is independent of total drug concentrations.Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0.001% of the administered dose may appear in the semen of patients.Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized. 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 sildenafils pharmacologic effects.
INDICATIONS

VEGA ASIA (Sildenafil) is indicated for the treatment of:

· Male erectile dysfunction

PATIENT INFORMATION:

BEFORE YOU TAKE VEGA ASIA

Make sure you have told your doctor if you:
If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildenafil.
If you have a severe heart or liver problem.
If you have recently had a stroke or a heart attack, or if you have low blood pressure.
If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
If you have ever had loss of vision because of non-arteritic anterior ischaemic optic neuropathy (NAION)

HOW TO TAKE VEGA ASIA

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VEGA ASIA may be taken anywhere from 4 hours to half hour before sexual activity. Based on effectiveness and toleration, 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.

IF YOU MISS A DOSE

If you are taking VEGA ASIA for erectile dysfunction, you are unlikely to miss a dose since this medication is taken as needed, not on a regular dosing schedule.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning.

TAKING OTHER MEDICINE

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of Sildenafil if you are taking:
· Alfuzosin
· Terazosin· Itraconazole· Ketoconazole· Anticoagulants such as warfarin· Certain barbiturates such as butalbital· Atenolol· Propranolol· Erythromycin

SIDE EFFECTS

Common side effects of VEGA ASIA include:

headache
heartburn
diarrhea
flushing (feeling of warmth)
nosebleeds
difficulty falling asleep or staying asleep
numbness, burning, or tingling in the arms, hands, feet, or legs
muscle aches

Serious side effects which may require medical attention include:
· sudden severe loss of vision (see below for more information) · blurred vision · sudden decrease or loss of hearing · ringing in ears · erection that is painful or lasts longer than 4 hours · dizziness or lightheadedness · fainting · chest pain · worsening shortness of breath

STORING

· Keep all medicines out of the reach of children.

· Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice.