Staxyn

Name: Staxyn

Staxyn Usage

  • Take Staxyn exactly as your doctor prescribes.  
  • Take 1 Staxyn orally disintegrating tablet about 1 hour (60 minutes) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with Staxyn. 
  • Do not change your dose of Staxyn without talking to your doctor. Your doctor may lower your dose or raise your dose, depending on how your body reacts to this medication.
  • Take Staxyn no more than once a day. Doses should be taken at least 24 hours apart. 
  • Staxyn can be taken with or without food. 
  • Staxyn is not interchangeable with the regular release tablet (Levitra).
  • Staxyn should be placed on the tongue where it will disintegrate. It should be taken without liquid.

Staxyn Dosage

Take Staxyn exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

For most patients, the recommended dose of Staxyn (vardenafil) is 10 mg, taken by mouth approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. 

Staxyn Overdose

If you take too much Staxyn (more than the prescribed amount) call your doctor or local Poison Control Center right away or seek emergency medical attention.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect vardenafil?

Do not take vardenafil with similar medicines such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). These medicines also have other brand names (Adcirca, Revatio) that are used to treat a condition called pulmonary arterial hypertension.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with vardenafil, especially:

  • all other medications you use for erectile dysfunction;

  • an antibiotic--clarithromycin, erythromycin, telithromycin, and others;

  • antifungal medicine--itraconazole, ketoconazole, and others;

  • drugs to treat high blood pressure or a prostate disorder--alfuzosin, doxazosin, prazosin, silodosin, terazosin, tamsulosin;

  • heart rhythm medicine--amiodarone, dofetilide, disopyramide, dronedarone, procainamide, quinidine, sotalol; or

  • HIV/AIDS medicine--atazanavir, indinavir, ritonavir, saquinavir, and others.

This list is not complete. Other drugs may interact with vardenafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Staxyn Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Arm, back, or jaw pain
  • blindness
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cold sweats
  • confusion
  • decreased vision
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • eye pain
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • hives, itching, or skin rash
  • nausea
  • nervousness
  • pain or discomfort in the arms, jaw, back, or neck
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • slow or fast heartbeat
  • sweating
  • tearing
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Hearing loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
  • sneezing
  • stuffy nose
Less common
  • Abnormal ejaculation
  • abdominal or stomach pain
  • abnormal vision
  • acid or sour stomach
  • back pain
  • belching
  • bloody nose
  • body aches or pain
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in color vision
  • changes in vision
  • congestion
  • cough
  • diarrhea
  • difficulty seeing at night
  • difficulty with moving
  • difficulty with swallowing
  • dim vision
  • dry mouth
  • dryness or soreness of the throat
  • excessive muscle tone
  • eye pain
  • face swelling
  • fast heartbeat
  • feeling of constant movement of self or surroundings
  • fever
  • general feeling of discomfort or illness
  • heartburn
  • hoarseness
  • increased redness of the eye
  • increased sensitivity of the eyes to sunlight
  • indigestion
  • joint pain
  • lack or loss of strength
  • loss of appetite
  • muscle aches and pains
  • muscle cramping
  • muscle stiffness
  • muscle tension or tightness
  • neck pain
  • pain or burning in the throat
  • runny nose
  • sensation of spinning
  • shivering
  • sleepiness or unusual drowsiness
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stomach discomfort, upset, or pain
  • swollen joints
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • trouble with sleeping
  • trouble with swallowing
  • voice changes
  • watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Uses of Staxyn

  • It is used to treat erectile dysfunction (ED).
  • It may be given to you for other reasons. Talk with the doctor.

What are some other side effects of Staxyn?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Flushing.
  • Headache.
  • Stuffy nose.
  • Runny nose.
  • Upset stomach.
  • Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Staxyn (vardenafil orally disintegrating tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Staxyn. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Adverse Reactions

The following serious adverse reactions with the use of Staxyn (vardenafil) are discussed elsewhere in the labeling:

• Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)] • Priapism [see Warnings and Precautions (5.3)] • QT Prolongation [see Warnings and Precautions (5.7)] • Effects on eye [see Warnings and Precautions (5.4)] • Sudden hearing loss [see Warnings and Precautions (5.5)]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Staxyn: Safety of Staxyn was evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥65 years old. Approximately 8% (n=29) were ≥75 years old. An integrated analysis of both studies included a total of 355 subjects that received Staxyn compared to 340 subjects that received placebo (mean age was 61.7, range 21.0 to 88.0; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other). The discontinuation rates due to adverse reactions were 1.4% for Staxyn compared to 0.6% for placebo. Table 1 below details the most frequently reported adverse reactions.

Table 1: Adverse drug reactions reported by ≥2% of the patients treated with Staxyn and more frequent on drug than placebo in controlled trials

Adverse Drug Reaction

Staxyn

(n=355)

Placebo

(n=340)

Headache

14.4%

1.8%

Flushing

7.6%

0.6%

Nasal Congestion

3.1%

0.3%

Dyspepsia

2.8%

0%

Dizziness

2.3%

0%

Back Pain

2%

0.3%

 

Adverse drug reactions reported in the Staxyn placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.

All Vardenafil Studies: Vardenafil film-coated tablets and Staxyn has been administered to over 17,000 men (mean age 54.5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.

In the placebo-controlled clinical trials for vardenafil film-coated tablets and Staxyn, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.

Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.

The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil film-coated tablets and Staxyn. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:

Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain

Auditory: tinnitus, vertigo

Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension

Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases

Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia

Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure

Respiratory: dyspnea, sinus congestion

Skin and appendages: erythema, rash

Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis

Urogenital: increase in erection, priapism

Postmarketing Experience

The following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Ophthalmologic: Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].

Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of vardenafil.

Neurologic: Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.

Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information (17.9)].

How should I take Staxyn?

Take Staxyn orally disintegrating tablets exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Staxyn can be taken with or without food.

Staxyn is usually taken only when needed, about 60 minutes before sexual activity. The medicine can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

To take the Staxyn orally disintegrating tablet:

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

  • Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

  • Swallow several times as the tablet dissolves. Do not take Staxyn with liquid.

Do not take Staxyn more than once a day. Allow 24 hours to pass between doses.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Store at room temperature away from moisture and heat.

What should I avoid while taking Staxyn?

Grapefruit and grapefruit juice may interact with vardenafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking vardenafil.

Drinking alcohol can increase certain side effects of Staxyn.

Do not use any other drug to treat impotence unless your doctor tells you to.

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