Cialis

What Is Cialis?

Cialis (tadalafil) is a prescription medication belonging to the phosphodiesterase type 5 (PDE5) inhibitor class of drugs. Zyvex Pharma Cialis is formulated as almond-shaped tablets for oral administration available in 25mg strengths. Each tablet contains the active ingredient tadalafil along with inactive ingredients including croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and other pharmaceutical excipients.

A critical point to understand is that tadalafil has no effect in the absence of sexual stimulation. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil does not produce an erection spontaneously—it simply enhances the natural erectile response when sexual arousal occurs.

Key Distinction from Other PDE5 Inhibitors: Tadalafil is highly selective for PDE5. In vitro studies have shown that tadalafil is >10,000-fold more potent for PDE5 than for PDE1, PDE2, PDE3, PDE4, and PDE7 enzymes. It is 700-fold more potent for PDE5 than for PDE6 (the enzyme found in the retina responsible for phototransduction), which explains its lower incidence of visual side effects compared to some other PDE5 inhibitors. Tadalafil is 14-fold more potent for PDE5 than for PDE11A1 and 40-fold more potent for PDE5 than for PDE11A4, two forms of PDE11 found in human prostate, testes, skeletal muscle, and other tissues.

Cialis Uses

Erectile Dysfunction (ED): 

Cialis is indicated for the treatment of erectile dysfunction in adult men—the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

Benign Prostatic Hyperplasia (BPH): 

Cialis is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. The mechanism for reducing BPH symptoms has not been established, though the effect of PDE5 inhibition on cGMP concentration is observed in the smooth muscle of the prostate, the bladder, and their vascular supply.

ED and BPH (Combined): 

Cialis is indicated for the treatment of both erectile dysfunction and the signs and symptoms of BPH in men who have both conditions. When used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.

Off-Label Uses: 

Tadalafil is occasionally used off-label for pulmonary arterial hypertension (marketed as Adcirca for this indication), Raynaud phenomenon, and other vascular conditions.

How to Maximize Cialis Efficiency

Dosage Options:

Zyvex Pharma Cialis offers two distinct dosing regimens:

As-Needed Dosing (for ED): The recommended starting dose is 10 mg taken prior to anticipated sexual activity. Based on efficacy and tolerability, the dose may be increased to 20 mg or decreased to 5 mg. The maximum dosing frequency is once per day. Cialis improves erectile function compared to placebo for up to 36 hours post-dose—a significantly longer window than other PDE5 inhibitors.

Once-Daily Dosing (for ED, BPH, or ED/BPH): The recommended dose is 2.5 mg taken once daily, without regard to the timing of sexual activity. May be increased to 5 mg based upon efficacy and tolerability. For BPH alone or ED/BPH combined, the recommended dose is 5 mg taken at approximately the same time every day.

Timing and Administration:

• Cialis may be taken without regard to food—unlike some other PDE5 inhibitors, food does not significantly affect its absorption or effectiveness.
• For as-needed use, take the dose at least 30 minutes beforeanticipated sexual activity. Peak blood concentration is typically reached between 30 minutes and 6 hours after dosing.
• For once-daily use, take at the same time every day to maintain consistent plasma levels.
• The effects last for up to 36 hours, providing a flexible window for spontaneous sexual activity.

Important Considerations:

• Sexual stimulation is requiredfor the medication to work.
• Do not take more than one dose in 24 hoursfor as-needed use.
• Alcohol consumption:Substantial amounts of alcohol (≥5 units) may increase the risk of hypotension when taken with Cialis.
• Cialis is effective across a wide range of patient populations, including those with diabetes, spinal cord injury, and following prostate surgery.

Cialis Side Effects

Common Side Effects (occurring in ≥2% of users):

The most common adverse reactions reported with Zyvex Pharma Cialis include headache, dyspepsia (indigestion), back pain, myalgia (muscle pain), flushing, nasal congestion, and pain in extremity. Back pain and myalgia are typically mild to moderate and usually resolve within 48 hours.

Cardiovascular Effects:

Tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In clinical pharmacology studies, tadalafil 20 mg administered to healthy subjects produced a mean maximal decrease in supine blood pressure of 1.6/0.8 mm Hg relative to placebo. There was no significant effect on heart rate. However, patients with severely impaired autonomic control of blood pressure may be particularly sensitive to these vasodilatory effects.

Serious Side Effects Requiring Immediate Medical Attention:

• Priapism:An erection that persists for more than 4 hours requires emergency medical treatment. Prolonged erection can damage the penis.
• Sudden Vision Loss:Patients should stop Cialis and seek immediate medical attention if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
• Sudden Hearing Loss:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Cialis.
• Serious Cardiovascular Events:Myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia have been reported postmarketing in temporal association with the use of tadalafil.
• Hypersensitivity Reactions:Including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis.

Who Shouldn't Use It

Absolute Contraindications:

Zyvex Pharma Cialis is absolutely contraindicated (must not be used) in the following situations:

1. Patients using organic nitrates:Administration of Cialis to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. Cialis potentiates the hypotensive effect of nitrates, which can cause a dangerous and potentially life-threatening drop in blood pressure. In clinical studies, tadalafil (5 to 20 mg) was shown to potentiate the hypotensive effect of nitrates. If nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapseafter the last dose of Cialis before nitrate administration is considered.
2. Patients using guanylate cyclase (GC) stimulators:Co-administration with riociguat or other GC stimulators is contraindicated.
3. Known hypersensitivity:Cialis is contraindicated in patients with a known serious hypersensitivity to tadalafil. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.

Patients Who Should Not Use Cialis (Cardiovascular Considerations):

The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Cialis. Until further information is available, Cialis is not recommended for:

• 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
• Stroke within the last 6 months

Cialis should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

Patients Who Should Use Caution:

• 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.
• Patients with severely impaired autonomic controlof blood pressure may be particularly sensitive to the actions of vasodilators.
• Patients taking alpha-blockers or antihypertensives:Use of Cialis with alpha-blockers, antihypertensives, or substantial amounts of alcohol may lead to hypotension. Caution is advised when Cialis is used as a treatment for ED in men taking alpha-blockers.
• Patients with severe renal or hepatic impairment:Dose adjustments may be necessary.

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