Cialis

What is Cialis?

• Cialis (tadalafil) is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED), benign prostatic hyperplasia (BPH).

Tadalafil skeletal

What are the uses of this medicine?

Cialis (tadalafil) is a prescription medicine taken by mouth for the treatment of:

• men with erectile dysfunction (ED)
• men with symptoms of benign prostatic hyperplasia (BPH)
• men with both ED and BPH

Erectile dysfunction (ED):

• ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection.
• A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him.
• CIALIS helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity.
• Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.

Benign prostatic hyperplasia (BPH):

• BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.

How does this medicine work?

• Tadalafil is an inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
• Inhibition of PDE5 by tadalafil increases the concentrations of cGMP.
• Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle.
• This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells.
• Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum.
• The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP.
• Tadalafil inhibits PDE5.
• Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• take any medicines called “nitrates”.
• use recreational drugs called “poppers” like amyl nitrite and butyl nitrite.
• take any medicines called guanylate cyclase stimulators, such as riociguat.
• are allergic to CIALIS or ADCIRCA ®, or any of its ingredients.

What drug interactions can this medicine cause?

• CIALIS and other medicines may affect each other.
• Especially tell your healthcare provider if you take any of the following:
• medicines called nitrates. Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.
• medicines called guanylate cyclase stimulators, such as riociguat (Adempas ®), used to treat pulmonary hypertension is contraindicated.
• medicines called alpha blockers. These include Hytrin ® (terazosin HCl), Flomax ® (tamsulosin HCl), Cardura ® (doxazosin mesylate), 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. If CIALIS is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
• other medicines to treat high blood pressure (hypertension)
• medicines called HIV protease inhibitors, such as ritonavir (Norvir ®, Kaletra ®)
• some types of oral antifungals such as ketoconazole (Nizoral ®), itraconazole (Sporanox ®)
• some types of antibiotics such as clarithromycin (Biaxin ®), telithromycin (Ketek ®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).
• other medicines or treatments for ED.
• CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both CIALIS and ADCIRCA. Do not take sildenafil citrate (Revatio ®) with CIALIS.

Is this medicine FDA approved?

• Tadalafil was approved for medical use in the United States in 2003.

How should this medicine be used?

Recommended dosage: 'CIALIS for Use as Needed for Erectile Dysfunction:

• The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.

CIALIS for Once Daily Use for Erectile Dysfunction:

• The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
• The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

CIALIS for Once Daily Use for Benign Prostatic Hyperplasia:

• The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day.
• When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia:

• The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Administration:

• Take CIALIS exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you.
• Some men can only take a low dose of CIALIS or may have to take it less often, because of medical conditions or medicines they take.
• Do not change your dose or the way you take CIALIS without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to CIALIS and your health condition.
• CIALIS may be taken with or without meals.
• If you take too much CIALIS, call your healthcare provider or emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg

This medicine is available in fallowing brand namesː

• CIALIS

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose

Uncommon side effects include:

• priapism
• Color vision changes
• decrease or loss of vision
• Sudden loss or decrease in hearing

What special precautions should I follow?

• Do not use other ED medicines or ED treatments while taking CIALIS.
• Do not drink too much alcohol when taking CIALIS (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.
• Patients should not use CIALIS if sex is inadvisable due to cardiovascular status.
• Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension.
• CIALIS is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers.
• 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. Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism.
• Patients should stop CIALIS and seek medical care 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). CIALIS should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION.
• Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing.
• Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Adverse events were similar to those seen at lower doses.

Treatment of overdosage:

• In cases of overdose, standard supportive measures should be adopted as required.
• Hemodialysis contributes negligibly to tadalafil elimination.

Can this medicine be used in pregnancy?

• CIALIS (tadalafil) is not indicated for use in females.

Can this medicine be used in children?

• CIALIS is not indicated for use in pediatric patients.
• Safety and efficacy in patients below the age of 18 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: tadalafil
• Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

• CIALIS ® (tadalafil) is a registered trademark of Eli Lilly and Company.

Marketed by: Lilly USA, LLC Indianapolis, IN , USA

What should I know about storage and disposal of this medication?

• Store CIALIS at room temperature between 59° and 86°F (15° and 30°C).

• Dailymed label info on Cialis
• FDA Cialis

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