Important Safety Information for StaminaRx
Warning for antidepressant medications (Dapoxetine):
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of dapoxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Dapoxetine and other antidepressant medicines
may cause serious side effects, including suicidal thoughts or actions:
- Dapoxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
- Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when dapoxetine is started or when the dose is changed.
Contraindications for using Sildenafil or Tadalafil medications:
- Do not take if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking with a nitrate medicine can cause a sudden and serious decrease in blood pressure.
- Some medicines can cause unwanted or dangerous effects when used with tadalafil. Tell your doctor about all your current medicines, especially riociguat (Adempas). Do not take tadalafil with riociguat.
- 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.
- Do not use if you have an allergy or hypersensitivity to Sildenafil, Tadalafil, or other medications in the same class.
- Patients should not use if sex is inadvisable due to cardiovascular status.
- Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).
Contraindications for using Dapoxetine medications:
- Do not use Dapoxetine if you have an allergy or hypersensitivity to Dapoxetine or other SSRIs.
- Do not use Dapoxetine if you have heart problems including heart rhythm problems or heart failure
- History of fainting
- Severe depression or mania
- Severe or moderate liver problems
- You are taking medications that interact with Dapoxetine
Contraindications for using Apomorphine medications:
- Do not use Apomorphine if you have an allergy or hypersensitivity to Apomorphine.
- This medication contains Apomorphine. Apomorphine cannot be used along with 5HT3 antagonists like ondansetron, granisetron, and dolasetron.
Before taking this medication:
You should not use Sildenafil or Tadalafil if you are allergic to them, or:
- If you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).
- If you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.
- If you take alpha-blocker medications.
You should not use Apomorphine if you are allergic to it, or:
- If you take a 5HT3 antagonist medication including ondansetron, granisetron, and dolasetron.
- If you have congenital QT syndrome or are taking class IA or III antiarrhythmics.
You should not use Dapoxetine if you are allergic to it, or:
- If you have a history of heart problems, fainting, mania, severe depression, or liver problems.
To make sure StaminaRx is safe for you, tell your doctor if you have ever had:
- Heart problems (chest pain, a heart rhythm disorder, congenital QT syndrome or QT prolongation, heart attack, heart disease, heart failure)
- Pulmonary hypertension
- High or low blood pressure
- Previous stroke
- Blood circulation problems
- Retinitis pigmentosa (an inherited condition of the eye)
- Severe vision problems
- Blindness in one or both eyes
- Hearing problems
- Bleeding problems
- A stomach ulcer
- Pulmonary veno-occlusive disease (PVOD)
- Liver problems or kidney disease or require dialysis
- A blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia
- A physical deformity of the penis (such as Peyronie's disease)
- If you have been told you should not have sexual intercourse for health reasons
- If you have ever had an erection lasting 4 hours or longer
- An electrolyte imbalance
- Vascular dysfunction
- Volume overload disorders or sensitivity
- Psychotic or mental health issues including mania or severe depression
- Impulse control issues
- Disorders of the oral mucosa
- Fainting history or dizziness from low blood pressure
- History of or current recreational drug use
Potential Drug Interactions:
- Nitrates: Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking a nitrate medicine with tadalafil can cause a dangerous decrease in blood pressure.
- Guanylate cyclase stimulators: Adempas® (riociguat)
- Alpha-blockers: Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin)
- Monoamine oxidase inhibitors (MAOIs)
- HIV protease inhibitors: ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
- Oral antifungal medicines: ketoconazole (Nizoral®) and itraconazole (Sporanox®)
- Antibiotics: clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
- Antidiuretics: May increase the risk of volume overload or electrolyte imbalances.
- Antihypertensive or vasodilator medications: May increase the risk of heart issues including heart attack, low blood pressure, falls, and injuries.
- Thioridazine
- Lithium
- Linezolid
- Tryptophan
- St.John’s Wort
- Tramadol
- Medications that treat migraines
- Other medicines that treat depression
- Other medicines that treat high blood pressure
- Other dopamine antagonists
- Other medicines or treatments for ED
- Other medications that can cause arrhythmias
- Pain medications or Naltrexone
- Cialis and generic Cialis also contain tadalafil, tadalafil is also found in a drug called Adcirca used for pulmonary arterial hypertension (PAH). Do not use this medication with Cialis, Adcirca, or with any other PDE5 inhibitor or erectile dysfunction treatment.
- Viagra and generic versions of this medication also contain sildenafil. Do not use this medication with any other PDE5 inhibitor or erectile dysfunction treatment.
Note: If you have taken some of these medications in the past but plan on stopping taking them before using StaminaRx, talk with your doctor. Some of these medications may need to be stopped at least 2 weeks before starting on StaminaRx to avoid dangerous interactions.
Side Effects:
Get emergency medical help if you have signs of an allergic reaction to this medication:
- Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
Stop taking this medication and get emergency medical help if you have these less common but more severe side effects:
- heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating
- vision changes or sudden vision loss, blurred vision
- erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis)
- ringing in your ears, or sudden decrease or loss of hearing
- irregular heartbeat, signs of an arrhythmia, or QT prolongation
- swelling in your hands, ankles, or feet
- shortness of breath
- seizure (convulsions)
- a light-headed feeling, like you might pass out
- a slow, fast, or uneven heart rate
- high blood pressure -- severe headache, pounding in your neck and ears
- confusion, severe weakness, unsteady feeling
- severe or ongoing nausea
- signs of volume overload or electrolyte imbalance
- hallucinations, confusion, disorientation, psychotic-like behaviors, and new or worsening impulse control issues
- falls
- mood changes, including thoughts of suicide or harming yourself
Dapoxetine side effects may include:
- Dizziness
- Headache
- Nausea, bloating, or upset stomach
- Irritability, anxiousness, or agitation
- “Pins and needles” or numbness
- Trouble achieving or maintaining an erection
- Sweating, flushing
- Constipation, gassiness, diarrhea
- Sleeping problems or strange dreams
- Sleepiness
- Congestion
- Increased blood pressure
- Trouble concentrating
- Shakiness
- Reduced libido
- Ringing in the ears
- Blurred vision, vision changes
- Dry mouth
- Mood changes, paranoia
- Confusion, disorientation
- Heart rate changes
- Blood pressure changes
- Fatigue or weakness
- Jitteriness
- Itchiness or cold sweat
- Spinning sensation
- Teeth grinding
- Altered taste
Common Sildenafil and Tadalafil side effects may include:
- flushing (warmth, redness, or tingly feeling)
- headache, dizziness
- heartburn, nausea, or upset stomach
- abnormal vision (blurred vision, changes in color vision, vision with a blue tinge)
- runny or stuffy nose, nosebleeds
- rash
- nausea
- muscle pain, back pain
Common Apomorphine side effects may include:
- Nausea
- Dizziness
- Sleepiness
- Mouth and throat soft tissue swelling, pain, tinging, or numbness
Heart attack, irregular heartbeat, stroke, and death have occurred rarely in men taking Cialis (the brand-name medication containing Tadalafil). The majority of these men had severe cardiac problems before taking Cialis. It is not known if Cialis caused these problems. Let your doctor know about any existing cardiac issues, or any new symptoms.
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 the FDA at 1-800-FDA-1088.
.png){kind=icon}
.png){kind=icon}
.svg){kind=icon}
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)