Staxyn

Staxyn (Vardenafil Hydrochloride)

What is Staxyn (Vardenafil Hydrochloride)?

Staxyn is a medication prescribed for adult males to treat sexual function problems (impotence or erectile dysfunction). Staxyn belongs to the drug class, Phosphodiesterase-5 Enzyme Inhibitors. Along with sexual stimulation, these medications work by increasing the blood flow to the penis to help a man get and stay erect.

Staxyn is not recommended:

• If you are allergic or have had an allergic reaction to Staxyn or ingredients in Staxyn.
• If you have severe hepatic or end-stage renal disease and rely on dialysis.
• For patients under 18 years of age.

What are the Indications for Staxyn?

Staxyn is approved for the treatment of erectile dysfunction.

How is Staxyn used?

Storage

Staxyn should be stored in the original package at 77°F (25°C and 25°C) away from heat, light and moisture.

Keep it out of reach of children.

Instruction

Take Staxyn by mouth, as directed by your doctor, with or without food one hour before sexual activity. Place the tablet on your tongue immediately after removing it from the blister pack. Let it dissolve completely. Do not crush or split the tablet. Do not take this medication with liquid.

Do not take more than one tablet in 24 hours.

Staxyn disintegrating tablets are absorbed differently to the film-coated tablets. Do not switch from one to the other without consulting with your doctor. Do not change your dosage and take more than what is prescribed. If you took more than the prescribed dosage, contact your doctor immediately or seek emergency medical care.

Dosage

Staxyn is available in a 10 mg strength white, round, orally disintegrating tablet. It comes in a 4-tablet unit blister pack.

One Staxyn tablet should be taken 60 minutes before sexual intercourse.

If you require a lower or higher dose, please speak to your doctor to prescribe you the film-coated tablets instead.

Side Effects

It’s important to understand that although Staxyn is FDA approved, it comes with side effects that may or may not affect you.

Before starting Staxyn, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. Tell your doctor if you experience the following symptoms, they become severe or do not go away on their own.

• Hot flushes
• Stuffy nose and/or sinus pain
• Headache
• Dizziness
• Upset stomach
• Back pain

Serious Side Effects

Severe adverse reactions while taking Staxyn may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Cardiovascular effects: symptoms of heart attack, including chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.
• Effects on eyes: vision changes or sudden vision loss
• Sudden hearing loss: ringing in ears and dizziness
• Painful erection or it lasts longer than 4 hours: it can cause damage to the penis
• Severe allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Staxyn, tell your doctor or pharmacist:

• If you are allergic to Staxyn or any ingredients in Staxyn
• If you have any other allergies
• If you are having any surgeries
• If you are taking any other medication containing vardenafil
• If you have any heart, liver or kidney problems
• If you have had a stroke
• If you have stomach ulcers
• If you have low blood pressure or uncontrolled high blood pressure
• If you have prostate problems

Alpha-blockers

If you are currently using alpha blocker medication, such as doxazosin or tamsulosin, to treat an enlarged prostate or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting.  Speak to your doctor about how to minimize your risk.

Heart conditions

If you suffer from heart disease or have had a heart attack or stroke, please speak to your doctor before taking Staxyn. If you take Staxyn and experience any chest pains, dizziness or nausea during sex, please stop immediately and let your doctor know.

Liver function

If you suffer from any liver problems, like liver disease or reduced liver function, it can cause this medication to build up in the body, and cause side effects. If you have liver conditions, please speak to your doctor before taking Staxyn.

Penis deformation

Please let your doctor know if you have any anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie’s disease. Your doctor will have to closely monitor you while using Staxyn.

Combination with Other Erectile Dysfunction Therapies

Do not use other erectile dysfunction medication or therapies while using Staxyn. The safety and efficacy in combination with other treatments have not been studied.

Sexually Transmitted Diseases

Staxyn does not protect you against sexually transmitted diseases (STIs) such as HIV, Hepatitis B and Syphilis. You should continue to take the necessary precautions to protect yourself against STIs.

Alcohol

Staxyn can make you dizzy or cause vision changes. Using alcohol at the same time as Staxyn can increase your dizziness. Limit your alcohol intake while using this medication, and talk to your doctor if you are using marijuana.

Pregnancy and Breastfeeding

Staxyn is not intended for use by women and it is therefore not recommended during pregnancy and breastfeeding.

Elderly patients

You may require a lower dose of Staxyn if you are older than 65 years, so speak to your doctor about a dosage that is safe for you.

Interactions & Contraindications

Before using Staxyn, tell your doctor or pharmacist if you take any:

• Medicine, especially antibiotics, medicines for antifungal medicine, high blood pressure, prostate disorder, heart rhythm or HIV/Aids medication
• herbal supplements
• vitamins

Nitrates or nitrate therapy

Patients currently on nitrate/nitrite therapy in any form should not use Staxyn as it may cause abnormally low blood pressure, already associated with organic nitrates and nitrites. This can lead to dizziness, fainting, and rarely a heart attack or stroke.

Guanylate Cyclase (GC) Stimulators

Patients who are using a GC stimulator, such as riociguat, should not use Staxyn as it may cause abnormally low blood pressure, already associated with the use of GC stimulators. This can lead to dizziness, fainting, and rarely a heart attack or stroke.

Grapefruit

Eating grapefruit or drinking grapefruit juice while using Staxyn may increase the amount of vardenafil in your body and lead to unwanted side effects. Grapefruit should be avoided while using Staxyn unless otherwise directed.

CYP3A4 inhibitors

Taking a CYP3A inhibitor with Staxyn increases the potency of Staxyn which can lead to an increased risk in side effects. CYP3A inhibitors should be avoided while taking Staxyn unless otherwise directed.

CYP3A inhibitors include itraconazole, ketoconazole, clarithromycin, voriconazole, telaprevir, nelfinavir and ritonavir.

Frequently Asked Questions