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Sildenafil Citrate Solution for injection [Pulmonary Hypertension]

It is used to treat pulmonary arterial hypertension

Generic Name: sildenafil

Brand Names: Revatio, Viagra

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: [Web], [Web], [Web], [Web], [Web], [Web] and [Web].

What is this medicine?

SILDENAFIL (sil DEN a fil) is used to treat pulmonary arterial hypertension. This is a serious heart and lung condition. This medicine helps to improve symptoms and quality of life.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

-anatomical deformation of the penis, Peyronie's disease, or history of priapism (painful and prolonged erection)
-bleeding disorders
-eye disease, vision problems
-heart disease
-high or low blood pressure
-history of blood diseases, like sickle cell anemia or leukemia
-kidney disease
-liver disease
-pulmonary veno-occlusive disease (PVOD)
-stomach ulcer
-an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
-breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

-cisapride
-cobicistat; elvitegravir; emtricitabine; tenofovir
-methscopolamine nitrate
-nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
-nitroprusside
-other sildenafil products (Viagra)
-telaprevir
This medicine may also interact with the following medications:

-antiviral medicines for HIV or AIDS
-bosentan
-certain medicines for benign prostatic hyperplasia (BPH)
-certain medicines for blood pressure
-certain medicines for fungal infections like ketoconazole and itraconazole
-cimetidine
-erythromycin

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Tell your doctor or health care professional right away if you have any change in your eyesight or hearing.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcoholic drinks; they can make you more dizzy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-breathing problems
-changes in vision
-chest pain
-decreased hearing
-fast, irregular heartbeat
-men: prolonged or painful erection (lasting more than 4 hours)
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

-facial flushing
-headache
-nosebleed
-trouble sleeping
-upset stomach

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: September 06, 2012
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