Building consensus on off-label uses of sildenafil

Health Care Comments Off

We are building consensus on the off-label uses of sildenafil. The current indications approved by DCGI are as follows:




Date of Approval

Sildenafil citrate film coated 25/50/100 mg

By urologist, psychiatrist, endocrinologist in erectile dysfunction in men.


Cardiologists decide about contraindications but cannot prescribe.

Sildenafil Citrate Orally Disintegrating Strips: 25mg / 50mg

Erectile dysfunction.


Quick acting. Does not mention about restrictions of prescribers. 100 mg will be off label use.

Sildenafil Citrate 20mg

Pulmonary arterial hypertension (WHO group I) to improve exercise ability.


Approved only for primary PPH. For others it will be off label use. Does not mention about prescribing restrictions.

Sildenafil Citrate Injection 0.8mg/ml

Pulmonary arterial hypertension (PAH) (WHO Group-1) to improve exercise ability and delay clinical worsening.


(Source: New Drugs Approved by CDSCO at

Sildenafil can be prescribed by all. This discrepancy in indications should be taken out.

The responses received so far for off label use of tadalafil are as below:

Dr Pai: Insert in the vagina before or after embryo transfer and continue it for 15 days till pregnancy test is done, to find out whether patient is pregnant. Sildenafil is used in patients with poor endometrial growth or with recurrent IVF failures.
Dr Prashant Tanna: Newborn in persistent pulmonary hypertension
Dr Gian Chand Rana: Only by MBBS
Viraj Suvarna: Sildenafil with nintedanib versus nintedanib alone is currently being examined in severe idiopathic pulmonary fibrosis. Earlier study where sildenafil was tried in such patients and while it did not improve the 6-minute walk test (primary endpoint), it did improve certain QOL measures (secondary endpoints) – the STEP trial.
o Women with clitoral erectile dysfunction.

o Hypoactive sexual desire disorder

o All types of pulmonary hypertension (like tadalafil is approved)

Drug Name


Date of Approval

Tadalafil Tablet2.5mg/5mg

1. Erectile dysfunction.

2. Erectile dysfunction with benign prostatic hyperplasia


Tadalafil tablet 20 mg(Additional Indication)

Pulmonary arterial hypertension


Tadalafil Orally Disintegrating Strip10mg & 20mg (Additional dosage form)

Erectile dysfunction


Tadalafil 10mg/20mgTablets

Erectile dysfunction in adult men


(Source: New Drugs Approved by CDSCO at

Off label use of tadalafil

Benign prostatic hyperplasia (BPH) without erectile dysfunction

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

Chronic kidney disease can be debilitating in the longer term

Health Care, Heart Care Foundation of India, Medicine Comments Off

Babies born preterm may stand the risk of developing the condition later in life New Delhi, 2nd May 2019: Preterm and early term birth are strong risk factors for the development of chronic kidney disease (CKD) from childhood into mid-adulthood, suggests a study published in the BMJ. Preterm birth (before 37 weeks of pregnancy) interrupts kidney development and maturity during late-stage pregnancy, resulting in fewer nephrons forming (filters that remove waste and toxins from the body). Of all the patients who develop end stage kidney failure in India, only 10% to 15% get proper treatment. About 6000 undergo kidney transplant, 60,000 undergo hemodialysis, and another 6000 prefer to take peritoneal dialysis in a year. About six-lakh people die for want of renal replacement therapy. Of all the patients who develop end stage kidney disease, over 90% needing renal replacement therapy die because of inability to afford care and 60% of those who start on treatment drop midway due to financial reasons. As of May 2017, there are over 130, 000 patients receiving dialysis and the number is increasing by about 232 per million population! Speaking about this, Padma Shri Awardee, Dr KK Aggarwal, President, HCFI, said, “CKD is characterized by a gradual loss of kidney function over time and may eventually lead to kidney failure, leading patients to undergo dialysis or a kidney transplant. The signs and symptoms are not noticeable until the disease is fairly well advanced, and the condition has become severe. By this time, most of the damage is irreversible. At an advanced stage of CKD, dangerous levels of fluid, electrolytes, and wastes can build up in the body. Those with underlying conditions such as diabetes, high blood pressure, cardiovascular disease, abnormal kidney structure, and a family history of the disease are at more risk. Additionally, those who smoke and are obese can also be potential candidates for CKD over the longer term.” Some symptoms of this condition include nausea, vomiting, loss of appetite, fatigue and weakness, sleep problems, decreased mental sharpness, muscle twitches and cramps, edema, persistent itching, chest pain, shortness of breath, and hypertension. Adding further, Dr Aggarwal, who is also the Group Editor-in-Chief of IJCP, said, “Some key measures to keep kidney diseases at bay is to monitor and treat conditions and diseases like obesity and Dyslipidemia, respectively. If blood pressure and blood sugar can be kept under control, more than 50% of CKD can be prevented.” Some tips from HCFI.

  • Keep fit and active, it helps reduce your blood pressure and on the move for kidney health.
  • Keep regular control of your blood sugar level as about half of people who have diabetes develop kidney damage.
  • Monitor your blood pressure. It is also the most common cause of kidney damage. The normal blood pressure level is 120/80. Between this level and 129/89, you are considered prehypertensive and should adopt lifestyle and dietary changes.
  • Eat healthy and keep your weight in check as this can help prevent diabetes, heart disease and other conditions associated with CKD. Reduce your salt intake. The recommended sodium intake is 5 to 6 grams of salt per day. In order to reduce your salt intake, try and limit the amount of processed and restaurant food.
  • Maintain a healthy fluid intake. Traditional wisdom has long suggested drinking 1.5 to 2 liters (3 to 4 pints) of water per day. Consuming plenty of fluid helps the kidneys clear sodium, urea and toxins from the body which, in turn, results in a “significantly lower risk” of developing CKD.
  • Do not smoke as it slows the flow of blood to the kidneys. Smoking also increases the risk of kidney cancer by about 50%.
  • Do not take over-the-counter pills on a regular basis: drugs like ibuprofen are known to cause kidney damage and disease if taken regularly.