TM Owner Metuchen Pharmaceuticals
Stendra 200mg Tablet
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Indications & Clinical Uses
- Stendra 200 mg tablets contain avanafil, a phosphodiesterase type 5 (PDE5) inhibitor manufactured for Metuchen Pharmaceuticals, LLC, approved for the treatment of erectile dysfunction in adult men.
- It is taken as needed rather than daily, starting around 15 to 30 minutes before sexual activity, which is faster than some older PDE5 inhibitors, with a recommended starting dose of 100 mg that can be adjusted between 50 mg and 200 mg based on effectiveness and side effects, up to once daily.
- It works by enhancing the effect of nitric oxide during sexual stimulation to increase blood flow to the penis, and does not cause an erection without stimulation.
- Stendra is not approved for use in women or children, and has no approved use for pulmonary hypertension or any indication other than erectile dysfunction.
Side Effects
- Stendra's label carries no boxed warning.
- The most common side effects, each affecting up to about 1 in 10 men, are headache, flushing, nasal congestion, cold-like symptoms (nasopharyngitis) and back pain.
- Priapism, a painful erection lasting more than 4 hours, is a medical emergency requiring immediate treatment to avoid permanent damage.
- Stop taking Stendra and get urgent medical attention for any sudden decrease or loss of vision in one or both eyes, or sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness.
- Seek emergency care rather than taking a nitrate at home if you develop chest pain, severe dizziness or fainting during or after sexual activity, since these may signal a serious drop in blood pressure.
Precautions & Warnings
- Stendra is contraindicated with any form of organic nitrate, because the combination can cause a dangerous, sudden fall in blood pressure.
- Your healthcare provider assesses whether sexual activity poses a cardiac risk before prescribing it.
- If you take an alpha-blocker for prostate symptoms or blood pressure, your provider will usually start you on the lowest 50 mg dose of Stendra because of additive blood-pressure-lowering effects.
- Use is not recommended with severe liver or kidney impairment.
- Stendra has no approved use in women and should never be given to children.
- There is no specific driving restriction, but avoid driving if you feel dizzy or lightheaded after taking it.
- Discuss any history of stroke, heart attack, irregular heartbeat or retinitis pigmentosa with your healthcare provider before starting.
Avoid Interactions
- Tell your healthcare provider about every medicine you take before starting Stendra.
- Never combine it with nitrates, in any form, including recreational nitrites, because of the risk of severe hypotension.
- Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir and clarithromycin should not be used with Stendra, and moderate CYP3A4 inhibitors limit the dose to 50 mg in any 24-hour period.
- Alpha-blockers and other blood-pressure-lowering medicines can add to Stendra's blood-pressure-lowering effect, so your provider may start you on a lower dose or adjust timing.
- Large amounts of alcohol can add to the blood-pressure-lowering effect and may reduce sexual performance, so limit intake around dosing.
- Always tell your pharmacist about supplements and over-the-counter medicines too.
References
Frequently Asked Questions
Stendra (avanafil) is a PDE5 inhibitor used to treat erectile dysfunction in adult men. It works with sexual stimulation to increase blood flow to the penis; it does not cause an erection on its own and has no other approved use.
Stendra is a tablet taken by mouth as needed, about 15 to 30 minutes before sexual activity, with or without food. The usual starting dose is 100 mg, adjustable between 50 mg and 200 mg, and no more than one dose in 24 hours.
The most common side effects of Stendra (avanafil) are headache, flushing, nasal congestion, cold-like symptoms and back pain. Get emergency care for an erection lasting more than 4 hours, or for sudden vision or hearing loss, rather than waiting to see if it passes.
Never take Stendra with nitrate medicines or recreational nitrites, as this combination is contraindicated and can cause a dangerous drop in blood pressure. Limit alcohol, and tell your provider about ketoconazole, ritonavir, clarithromycin or other CYP3A4 inhibitors, which change how much avanafil you can safely take.
Stendra (avanafil) can work faster than some older PDE5 inhibitors, starting as early as 15 minutes before sexual activity for some men, compared with about an hour for others. Its 50 mg, 100 mg and 200 mg strengths let your provider adjust the dose to your response.
Talk to your provider first. If you take an alpha-blocker for blood pressure or prostate symptoms, Stendra is usually started at the lowest 50 mg dose, because combining PDE5 inhibitors with alpha-blockers can lower blood pressure further, sometimes causing dizziness or fainting.
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