Zealthy Hardies

Zealthy Hardies are compounded medications. Federal law permits the sale of compounded medications, but they do not undergo FDA safety, effectiveness, or manufacturing.  Zealthy only works with US-based, compounding pharmacies with National Association of Boards of Pharmacy Accreditation that uphold state regulations.

Do not take Sildenafil (generic Viagra) if you:

• take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
• are allergic to Sildenafil, as contained in Sildenafil and REVATIO, or any of the ingredients in Sildenafil

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate medical help

Sildenafil can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). 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
• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Sildenafil and call your healthcare provider right away if you have any sudden vision loss
• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Sildenafil and contact a doctor right away

Before you take Sildenafil, tell your healthcare provider if you:

• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
• have had heart surgery within the last 6 months
• have pulmonary hypertension
• have had a stroke
• have low blood pressure, or high blood pressure that is not controlled
• have a deformed penis shape
• have had an erection that lasted for more than 4 hours
• have problems with your blood cells such as sickle call anemia, multiple myeloma, or leukemia
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including an eye problem called NAION
• have bleeding problems
• have or have had stomach ulcers
• have liver problems
• have kidney problems or are having kidney dialysis have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil may affect the way other medicines work, and other medicines may affect the way Sildenafil works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators such as Adempas (riociguat)
• medicines called alpha-blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosinmesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Sildenafil with alpha-blockers can lead to a drop in blood pressure or to fainting
• medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase), or atazanavir sulfate (Reyataz)
• some types of oral antifungal medicines, such as ketoconazole (Nizoral) and itraconazole (Sporanox)
• some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
• other medicines that treat high blood pressure
• other medicines or treatments for ED
• Sildenafil contains Sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil should not be used with REVATIO or with other PAH treatments containing Sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])

Sildenafil does not protect against sexually transmitted diseases, including HIV.

The most common side effects of Sildenafil: headache; flushing; upset stomach; abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.

Sildenafil (generic Viagra) is prescription medicine used to treat erectile dysfunction (ED).

Sildenafil is not for women or children.

1.  What is tadalafil used to treat?

Tadalafil is approved for the treatment of men who experience difficulty having and maintaining an erection (impotence).

2.  How does tadalafil work?

Tadalafil works by enhancing the effects of one of the chemicals the body normally releases into the penis during sexual arousal. This allows an increase of blood flow into the penis. An erection is the result of an increase in blood flow into certain internal areas of the penis.

3.  How is tadalafil different from the currently approved products for erectile dysfunction (ED)?

Tadalafil is different from other currently approved products for ED in that it stays in the body longer. However, there were no studies that directly compared the clinical efficacy and safety of tadalafil to other products.

4.  How do I take tadalafil?

Tadalafil is taken orally before sexual activity, not more than once daily. Cialis may be taken with or without food. In some patients, the dose strength and maximum frequency of use may be adjusted. For more detailed information consult with your health care provider.

5.  Are there any side effects with tadalafil?

As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with Tadalafil during the testing of the product were: 

• headache
• indigestion
• back pain
• muscle pain
• flushing
• stuffy nose 

Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking tadalafil and these usually go away by themselves within 48 hours. A small number of patients taking tadalafil also reported abnormal vision.

6.  What important information should you know about tadalafil?

• tadalafil can cause your blood pressure to drop suddenly to an unsafe level if it is taken with any nitrate medication. You could get dizzy, faint or have a heart attack or stroke.
• Tell your healthcare provider that you take tadalafil. If you need emergency medical care for a heart problem, it will be important for your health care provider to know when you last took tadalafil.
• After taking a single tablet, some of the active ingredient of tadalafil remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.
• Physicians should discuss with patients the potential for tadalafil to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications.

7.  What should I talk to my doctor about when considering if tadalafil is right for me?

Because sexual activity can increase the work of the heart, your doctors should talk to you about your heart’s general condition and if tadalafil is right for you. Patients who have a condition called "left ventricular outlet obstruction" from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with tadalafil, tadalafil is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.

8.  Who should not take tadalafil?

Tadalafil should not be used by patients taking nitrates (such as nitroglycerin tablets or patches) because the combination of these with tadalafil could significantly lower blood pressure and lead to fainting or even death in some men.

9.  Can tadalafil be used with other treatments for impotence?

The safety and effectiveness of tadalafil when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. 

10. What if I am taking other drugs?

Always discuss with your health care practitioner ALL of the medications you are taking (prescription and over-the-counter) that way, you can receive the best advice for your own situation. Tadalafil is not recommended for people taking any form of nitroglycerin because the combination may lower blood pressure to an unsafe level.

11.  How will tadalafil be supplied?

Tadalafil will be available as oral tablets in 5mg, 10mg and 20mg strengths.

12. Is tadalafil by prescription or OTC (over-the-counter)?

Tadalafil is available by prescription only.

13.  How can I report a serious side effect with tadalafil to FDA?

FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.

You can report an adverse event either online, by regular mail or by fax, using the contact information at the bottom of this page.