New-gra® 25
New-gra® 25
An effective treatment for erectile dysfunction

Indication

  • New-gra® is indicated for the treatment of erectile dysfunction.  

Composition

Each film-coated tablet of  New-gra®  25 contains: 

  • Sildenafil 25 mg (as Sildenafil Citrate) 

Each film-coated tablet of  New-gra®  50 contains: 

  • Sildenafil 50 mg (as Sildenafil Citrate)

Each film-coated tablet of  New-gra® 100 contains: 

  • Sildenafil 100 mg (as Sildenafil Citrate)

Dosage

* The tablet should be swallowed whole with water. 
* Sexual stimulation is required for New-gra®  to be effective.
-Adults:

  • The usual dose is 50 mg per day about one hour before sexual intercourse.  
  • Depending on response, the dose may be increased to 100 mg or decreased to 25 mg once a day. 
  • An initial dose of 25 mg is recommended in healthy elderly people (65 years or over). 
  • New-gra®  is not indicated for use in children. 
  • Sildenafil a novel effective oral therapy for male erectile dysfunction, is the citrate salt of Sildenafil, a selective inhibitor of phosphodiestrase type 5 (PDE5), that enhances the effect of nitric oxide during sexual stimulation which results in increased levels of cyclic guanosine monophosphate producing smooth muscle relaxation in the corpus cavernosum, allowing inflow of blood and hence increasing the pressure in the penis and leading to tumescence.  
  • The erectile response generally increased with increasing sildenafil dose and plasma concentration.
  • The time course of effect for up to 4 hours but the response may be diminished compared to 2 hours. 
  • Sildenafil at recommended doses has no effect in the absence of sexual stimulation. 
  • The decrease in blood pressure was most notable approximately 1- 2 hours after single oral dose of sildenafil, this effect is not releated to dose or plasma levels. 
  • Sildenafil is rapidly absorbed following administration by mouth, with a bioavailability of approximately 40%. Peak plasma concentrations are attained within 30 to 120 minutes; the rate of absorption is reduced when administered with food. It is widely distributed into tissues and is approximately 96% bound to plasma proteins.
  • Sildenafil is metabolized in the liver primarily by cytochrome P450 3A4 and  P450 2C9 isoforms. The major metabolite N-desmethylsildenafil has the same activity of Sildenafil , The major metabolite has a potency for PDE5 approximately 50% of the parent drug. 
  • Excretion is predominantly as metabolites in the faeces and  to a lesser extent in the urine. 

Each film-coated tablet of  New-gra®  25 contains: 

  • Sildenafil 25 mg (as Sildenafil Citrate) 

Each film-coated tablet of  New-gra®  50 contains: 

  • Sildenafil 50 mg (as Sildenafil Citrate)

Each film-coated tablet of  New-gra® 100 contains: 

  • Sildenafil 100 mg (as Sildenafil Citrate)
  • New-gra® is indicated for the treatment of erectile dysfunction.  
  • New-gra®  is contraindicated in anyone taking Organic Nitrates as it may potentiate their hypotensive effects. 
  • Hypersensitivity Sildenafil to this product.
  • Hepatic microsomal isoenzyme inhibitors (such as: Cimetidine, Erythromycin, HIV protease inhibitors, Ketoconazole and Itraconazole) increase Sildenafil levels in the plasma. 
  • Concomitant administration of Rifampicin with New-gra® will decrease plasma levels of Sildenafil. 
  • Sildenafil do not potentiate the hypotensive effect of Alcohol. 
  • New-gra®  is not indicated for use in women. 

* As with other drugs, New-gra®  may cause mild to moderate and transient (not exceed several hours) side effects and some of them usually due to overdosage:

  • Headache
  • flushing
  • dyspepsia
  • visual disturbances
  • dizziness
  • nasal congestion
  • rash 
  • urinary or respiratory tract infection.  

* The tablet should be swallowed whole with water. 
* Sexual stimulation is required for New-gra®  to be effective.
-Adults:

  • The usual dose is 50 mg per day about one hour before sexual intercourse.  
  • Depending on response, the dose may be increased to 100 mg or decreased to 25 mg once a day. 
  • An initial dose of 25 mg is recommended in healthy elderly people (65 years or over). 
  • New-gra®  is not indicated for use in children. 
  • The cardiovascular risks of sexual activity should be considered before beginning therapy with New-gra® . 
  • It should be used with caution in patients who have suffered a  myocardial infarction, stroke, resting hypotension (BP < 90/50), cardiac failure or coronary artery disease causing unstable angina and retinitis pigmentosa.
  • Caution is required in patients with renal or hepatic impairment, and dosage reduction may be necessary. 
  • New-gra® should be used with caution in patients with anatomical deformation of the penis.
  • In case of an erection that persists longer than 4 hours, immediate medical assistance should be sought. 
     
  • Blister of 4 tablets, Pack of one blister. 
  •  Store in a dry place at a temperature below 30°C, protect from light.