Gioxil-36 is indicated for the treatment of erectile dysfunction. Its composition is formulated from natural products Maca Root 200mg (Lepidium meyenii)and Muira puama 20mg(Ptychopetalum olacoides ) , Hydroxyhomosildenafil 20mg

WARNINGS

No warnings are currently listed for Gioxil-36 ® due to the botanical nature of the principal ingredients used in the formulation.  Evaluation of erectile dysfunction should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing Gioxil-36, it is important to note the following:

Cardiovascular
Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including Gioxil-36, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of Gioxil-36. In such a patient, who has taken Gioxil-36, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of Gioxil-36 before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking Gioxil-36 should seek immediate medical attention. [See Contraindications].

Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Gioxil-36, and therefore until further information is available, Gioxil-36 is not recommended for the following groups of patients:

• myocardial infarction within the last 90 days

• unstable angina or angina occurring during sexual intercourse

• New York Heart Association Class 2 or greater heart failure in the last 6 months

• uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg)

• stroke within the last 6 months.

As with other PDE5 inhibitors, Gioxil-36 has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, Gioxil-36 420 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects [see Clinical Pharmacology (12.2)]. While this effect should not be of consequence in most patients, prior to prescribing Gioxil-36, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

Prolonged Erection

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Gioxil-36 should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease).

Eye

Physicians should advise patients to stop use of all PDE5 inhibitors, including Gioxil-36, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors [see Adverse Reactions].

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Alpha blockers and Antihypertensives

Physicians should discuss with patients the potential for Gioxil-36 to augment the blood-pressure-lowering effect of alpha blockers and antihypertensive medications [see Drug Interactions] and Clinical Pharmacology]. Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. PDE5 inhibitors, including Gioxil-36, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Pharmacology) and Drug Interactions], which may lead to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:

• Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic.

instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.

• In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose.
• In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
• Safety of combined use of PDE5 inhibitors and alpha blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.

Counseling Patients About Sexually Transmitted Diseases

The use of Gioxil-36 offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

PRECAUTIONS

Alcohol

Patients should be made aware that both alcohol and Gioxil-36, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with Gioxil-36 can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache

Combination With Other Erectile Dysfunction Therapies

The safety and efficacy of combinations of Gioxil-36 and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

MISUSE POTENTIAL

Reports of recreational use and misuse of similar products for erectile dysfunction appear in the medical literature and the media. Increasing access to these products via the Internet may facilitate such misuse. Use in social settings has gained popularity, both in young, healthy patients, as well as those with chronic medical conditions, including human immunodeficiency virus infections. In these settings, the PDE5 inhibitors are sometimes used concomitantly with "club drugs" such as ketamine and amyl nitrite, leading to potentially harmful or fatal drug interactions. Pharmacists should be cognizant of the potential for PDE5 inhibitors to be misused, particularly in patients who are at greater risk of cardiovascular complications, and should advise patients and other health care professionals accordingly.

SPECIAL POPULATIONS

Pregnancy

No adequate and well controlled studies with Gioxil-36 have been conducted in pregnant women.  Because animal reproductive studies are not always predicative of human response Gioxil-36 during pregnancy is not recommended.  Gioxil-36 IS INTENTED FOR MALE USE ONLY.

Nursing Mothers

It is not known if Gioxil-36 is secretes in human milk.  Therefore, Gioxil-36 should not be taken by nursing women.  Gioxil-36 IS INTENTED FOR MALE USE ONLY.

Pediatric Use

Gioxil-36 has not been studied in pediatric patients below the age of 12 years.

Geriatric Use

Clinical studies of Gioxil-36 did not include significant number of patients aged 65 years and older to determine whether the respond differently from younger patients.