Revatio

DRUG DESCRIPTION

REVATIO (sildenafil citrate) , a therapy for pulmonary arterial hypertension, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5). Sildenafil is also marketed as VIAGRAź for erectile dysfunction.

Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:

Revatio (sildenafil) Structural Formula Illustration

Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.

REVATIO (sildenafil citrate) Tablets: REVATIO (sildenafil citrate) is formulated as white, film-coated round tablets equivalent to 20 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.

REVATIO (sildenafil citrate) Injection: REVATIO (sildenafil citrate) is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg (12.5 mL) of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and water for injection.

What are the possible side effects of sibutramine (Meridia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

  • flu symptoms;
  • fast or pounding heartbeats;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, uneven heartbeats);
  • new or worsening shortness of breath;
  • seizure (convulsions)
  • ...

Read All Potential Side Effects and See Pictures of Revatio »

What are the precautions when taking sildenafil citrate (Revatio)?

Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, high or low blood pressure, a severe loss of body water (dehydration), history of painful/prolonged erection (priapism), eye problems (such as decreased vision in one or both eyes, retinitis pigmentosa), heart problems (such as heart attack or irregular heartbeat in the past 6 months, heart failure, chest pain/angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), kidney disease, liver...

Read All Potential Precautions of Revatio »


Revatio Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, headache, flushing, heartburn, nosebleeds, trouble sleeping, or swollen hands/ankles/feet (edema) may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, a sudden loss of eyesight in one or both eyes (NAION) may occur. This may or may not be due to sildenafil. Stop taking sildenafil and get medical help right away if this occurs. You have a slightly greater chance of developing this serious eye problem if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), or high blood pressure, or if you smoke or are over 50.

Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop taking sildenafil and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.

In the unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away or permanent problems could occur.

Rarely, sildenafil may cause sudden hearing problems (such as decrease/loss of hearing in one or both ears, ringing in the ears). Stop taking sildenafil and get medical help right away if these effects occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, high or low blood pressure, a severe loss of body water (dehydration), history of painful/prolonged erection (priapism), eye problems (such as decreased vision in one or both eyes, retinitis pigmentosa), heart problems (such as heart attack or irregular heartbeat in the past 6 months, heart failure, chest pain/angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), kidney disease, liver disease, fluid in the lungs (pulmonary edema), problem with shape of penis (such as angulation, fibrosis/scarring, Peyronie's disease), stroke in the past 6 months.

This drug may make you dizzy or cause vision problems. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug. Your doctor may start you on a lower dose.

This brand of the drug is usually not used in women. During pregnancy, sildenafil should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Revatio Patient Information Including Side Effects

Brand Names: Meridia

Generic Name: sibutramine (Pronunciation: si BUE tra meen)

  • What is sibutramine (Revatio)?
  • What are the possible side effects of sibutramine (Revatio)?
  • What is the most important information I should know about sibutramine (Revatio)?
  • What should I discuss with my healthcare provider before taking sibutramine (Revatio)?
  • How should I take sibutramine (Revatio)?
  • What happens if I miss a dose (Revatio)?
  • What happens if I overdose (Revatio)?
  • What should I avoid while taking sibutramine (Revatio)?
  • What other drugs will affect sibutramine (Revatio)?
  • Where can I get more information?

What is sibutramine (Revatio)?

Sibutramine affects chemicals in the brain that affect weight maintenance.

Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.

Sibutramine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sibutramine (Revatio)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

  • flu symptoms;
  • fast or pounding heartbeats;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, uneven heartbeats);
  • new or worsening shortness of breath;
  • seizure (convulsions)
  • easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);
  • blood in your urine or stool;
  • weakness, restless feeling, confusion, anxiety, agitation, fever, overactive reflexes, joint pain, sweating, vomiting, tremors; or
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out.

Less serious side effects may include:

  • dry mouth, upset stomach;
  • loss of appetite;
  • dizziness;
  • runny or stuffy nose, sore throat, cough;
  • headache, back pain;
  • trouble sleeping (insomnia),
  • constipation.
  • hunger;
  • mild skin rash; or
  • changes in your menstrual period.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sibutramine (Revatio)?

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body.

You should not take sibutramine if you are allergic to ir, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), or if you are taking stimulant diet pills.

Before taking sibutramine, tell your doctor if you have glaucoma, high blood pressure, heart disease, a history of heart attack or stroke, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16.

Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, narcotic pain medicine, or migraine headache medicines.

Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.

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