sildenafil (pulmonary hypertension)
Sildenafil belongs to the family of medications known as phosphodiesterase type 5 inhibitors. It is used to treat pulmonary hypertension (high blood pressure in the blood vessels between the heart and lungs) when people have not responded to conventional treatment.
It helps reduce pulmonary blood pressure by widening blood vessels.
Each white, film-coated, round tablet marked “RVT20” on one side and “PFIZER” on the other side, contains sildenafil 20 mg. Nonmedicinal ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; film coating: hypromellose, lactose, titanium dioxide (E-171), and triacetin.
0.8 mg/mL solution for injection
Each mL of clear, sterile solution for injection contains 0.8 mg sildenafil as sildenafil citrate. Nonmedicinal ingredients: glucose and water for injection.
The recommended adult dose of sildenafil for pulmonary hypertension is 20 mg 3 times daily. Doses should be taken approximately 6 to 8 hours apart.
Sildenafil may be taken with or without food.
The solution for injection is used to continue treatment with sildenafil when a person with pulmonary hypertension is temporarily unable to take sildenafil by mouth. The maximum dose of this form of sildenafil is 10 mg given by intravenous (into a vein) injection 3 times a day. This dose of sildenafil is approximately equal in activity to 20 mg of sildenafil taken by mouth.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not take sildenafil if you:
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Bleeding problems: Sildenafil may cause your body to take longer to stop bleeding. If you have bleeding problems or a bleeding disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Blood pressure: Sildenafil can cause a rapid decrease in blood pressure that may add to the blood pressure-lowering effect of other medications. Tell your doctor if you are taking medications to treat high blood pressure. If you are taking medication for high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Grapefruit juice: Grapefruit juice can increase the amount of sildenafil in your blood. Do not drink grapefruit juice while taking this medication.
Heart or blood vessel problems: Sildenafil can make heart or blood vessel problems worse. If you have had a heart attack, stroke, or life-threatening abnormal heart rhythm within the last 6 months, or have angina, chest pain, an irregular heartbeat, or high or low blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Lung problems: Sildenafil is not recommended for people with a form of high blood pressure in the lungs called pulmonary veno-occlusive disease. If you have pulmonary veno-occlusive disease or experience sudden cough, shortness of breath, chest pain, or rapid breathing, talk to your doctor before taking this medication.
Nitrate-containing medications: Sildenafil should never be taken with any medications that contain nitrates. Blood pressure may suddenly drop to life-threatening levels if sildenafil is taken with any nitrate-containing medication (e.g., nitroglycerin tablets, spray, or patches) or any other nitrates (e.g., isosorbide dinitrate or amyl nitrite “poppers”). Dizziness, fainting spells, heart attack, or stroke may be experienced.
Penis deformation: Men with an anatomical deformation of the penis such as angulation, cavernosal fibrosis, or Peyronie’s disease should be closely monitored by their doctor while taking this medication.
Prolonged erection: Tell your doctor if you have ever had an erection that lasted longer than 4 hours, or have sickle cell anemia or leukemia, before taking this medication.
Prostate problems: Tell your doctor if you are taking medications to treat prostate problems, such as alpha-blockers (e.g., doxazosin), as sildenafil combined with these medications may cause dangerously low blood pressure.
Vision problems: If you have or have had a temporary decrease or permanent loss of vision in one or both eyes, including a condition called non-arteritic anterior ischemic optic neuropathy (NAION), or if you have retinitis pigmentosa, tell your doctor before taking this medication.
This medication can cause partial or complete vision loss that may be temporary or permanent. If you experience a sudden loss of vision in one or both eyes or other vision-related problems, contact your doctor immediately. If you do experience vision changes, do not drive or operate machinery until your vision returns to normal.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if sildenafil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication have not been established for children with pulmonary hypertension.
There may be an interaction between sildenafil and any of the following:
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