Sildenafil (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sildenafil for Oral Suspension 10 mg/mL is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.

Sildenafil for Oral Suspension 10 mg/mL

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(click image for full-size original)

Recommended storage for Sildenafil for oral suspension 10 mg/mL: Store below 30°C (86°F) in the original package in order to protect from moisture.
Reconstituted Oral Suspension

Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information).

  • Inform patients of contraindication of Sildenafil with regular and/or intermittent use of organic nitrates.
  • Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking Sildenafil not to take VIAGRA or other PDE-5 inhibitors.
  • Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking Sildenafil. Such an event may be a sign of NAION.
  • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking Sildenafil. These events may be accompanied by tinnitus and dizziness.

Distributed By:

Virtus Pharmaceuticals, LLC

Langhorne, PA 19047

1-888-848-3593

Revised: 05/2021

PATIENT INFORMATION

Sildenafil (Sil den’ a fil) for Oral Suspension

Read this Patient Information before you start taking Sildenafil for oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Sildenafil for oral suspension, ask your doctor or pharmacist.

What is the most important information I should know about Sildenafil for oral suspension?

Never take Sildenafil for oral suspension with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level.

Nitrate medicines include:

  • Medicines that treat chest pain (angina)
  • Nitroglycerin in any form including tablets, patches, sprays, and ointments
  • Isosorbide mononitrate or dinitrate
  • Street drugs called “poppers” (amyl nitrate or nitrite)

Guanylate cyclase stimulators include:

  • Riociguat (Adempas)

Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.

What is Sildenafil for oral suspension?

Sildenafil for oral suspension is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.

Sildenafil for oral suspension improves the ability to exercise and can slow down worsening changes in your physical condition.

  • Sildenafil for oral suspension is not for use in children
  • Adding Sildenafil for oral suspension to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.

Sildenafil for oral suspension contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take Sildenafil for oral suspension with VIAGRA or other PDE-5 inhibitors.

Who should not take Sildenafil for oral suspension?

Do not take Sildenafil for oral suspension if you:

  • take nitrate medicines. See “What is the most important information I should know about Sildenafil for oral suspension?”
  • take guanylate cyclase stimulator medicines. See “What is the most important information I should know about Sildenafil for oral suspension?”
  • are allergic to sildenafil or any other ingredient in Sildenafil for oral suspension. See “What are the ingredients in Sildenafil for oral suspension?” at the end of this leaflet.

What should I tell my doctor before taking Sildenafil for oral suspension?

Tell your doctor about all of your medical conditions, including if you

  • have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack
  • have a disease called pulmonary veno-occlusive disease (PVOD)
  • have high or low blood pressure or blood circulation problems
  • have an eye problem called retinitis pigmentosa
  • have or had loss of sight in one or both eyes
  • have any problem with the shape of your penis or Peyronie’s disease
  • have any blood cell problems such as sickle cell anemia
  • have a stomach ulcer or any bleeding problems
  • are pregnant or planning to become pregnant. It is not known if Sildenafil for oral suspension could harm your unborn baby.
  • are breastfeeding. Sildenafil for oral suspension passes into your breast milk, it is not known if it could harm your baby.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil for oral suspension and certain other medicines can cause side effects if you take them together.

The doses of some of your medicines may need to be adjusted while you take Sildenafil for oral suspension.

Especially tell your doctor if you take

  • Nitrate medicines. See “What is the most important information I should know about Sildenafil for oral suspension?”
  • Riociguat (Adempas). See “What is the most important information I should know about Sildenafil for oral suspension?”
  • Ritonavir (Norvir®) or other medicines used to treat HIV infection
  • Ketoconazole (Nizoral®)
  • Itraconazole (Sporanox)
  • High blood pressure medicine

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Sildenafil for oral suspension?

  • Take Sildenafil for oral suspension exactly as your doctor tells you.

Sildenafil for oral suspension may be prescribed to you as

  • Sildenafil for oral suspension
  • Take Sildenafil for oral suspension 3 times a day about 4 to 6 hours apart.
  • Take Sildenafil for oral suspension at the same times every day.
  • Sildenafil for oral suspension will be mixed for you by your pharmacist. Do not mix Sildenafil for oral suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
  • Do not take more than one dose of Sildenafil for oral suspension at a time.
  • Do not change your dose or stop taking Sildenafil for oral suspension on your own. Talk to your doctor first.
  • If you take too much Sildenafil for oral suspension, call your doctor or go to the nearest hospital emergency room.

What are the possible side effects of Sildenafil for oral suspension?

  • low blood pressure. Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.
  • more shortness of breath than usual. Tell your doctor if you get more short of breath after you start Sildenafil for oral suspension. More shortness of breath than usual may be due to your underlying medical condition.
  • decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.
  • sudden decrease or loss of hearing. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including Sildenafil for oral suspension, or to other diseases or medicines, to other factors, or to a combination of factors.
  • heart attack, stroke, irregular heartbeats, and death. Most of these happened in men who already had heart problems.
  • erections that last several hours. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.

The most common side effects with Sildenafil for oral suspension include:

Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.

Tell your doctor if you have any side effect that bothers you or doesn’t go away.

These are not all the possible side effects of Sildenafil for oral suspension. For more information, ask your doctor or pharmacist.

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

How should I store Sildenafil for oral suspension?

  • Store Sildenafil for oral suspension reconstituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F).
  • Do not freeze Sildenafil for oral suspension.
  • Throw away Sildenafil for oral suspension after 60 days.
  • Keep Sildenafil for oral suspension and all medicines away from children.

General information about Sildenafil for oral suspension

Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use Sildenafil for oral suspension for a condition for which it was not prescribed. Do not give Sildenafil for oral suspension to other people, even if they have the same symptoms you have. It could harm them.

This patient leaflet summarizes the most important information about Sildenafil for oral suspension. If you would like more information about Sildenafil for oral suspension talk with your doctor. You can ask your doctor or pharmacist for information about Sildenafil for oral suspension that is written for health professionals. For more information call 1-888-848-3593.

What are the ingredients in Sildenafil for oral suspension?

Sildenafil for oral suspension

Active ingredients: sildenafil citrate

Inactive ingredients: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous and grape flavor

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