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FDA NEWS RELEASE

FDA approves Cialis to treat benign prostatic hyperplasia

The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.

In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

“BPH can have a big impact on a patient’s quality of life,” said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men.”

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

About ED & BPH (erectile dysfunction & benign prostatic hyperplasia)

About ED

ED is a medical condition that causes problems getting or maintaining an erection. It affects approximately 18 million men in the United States, but is treatable in most cases. ED is more common in older men, but can happen at almost any age.

Not all men experience ED in the same way. ED may be mild in severity, resulting in occasional problems, or more severe, with erection problems that happen often—or always. Problems may include:

  • You can't get an erection at all
  • You get an erection, but it's not hard enough for penetration
  • You get an erection, but you can't maintain it until sexual activity is over

Increased risk factors for ED

  • High blood pressure (hypertension)
  • Diabetes (high blood sugar)
  • High cholesterol
  • Nerve diseases (such as Parkinson's disease A disorder that kills or damages nerve cells in a part of the brain that controls how muscles move. Symptoms may include shaking, stiffness, slow movement, and poor balance and coordination. or multiple sclerosis)
  • Surgery or injury (especially prostate A gland in a man’s body located near the base of his penis. The prostate secretes a fluid that makes up the main portion of the fluid (semen) that a man ejaculates during an orgasm. bladder, or rectal surgery)
  • Abnormal hormone levels (testosterone or thyroid)
  • Lifestyle factors (like smoking, drinking alcohol in excess, being overweight, not being physically active, or using recreational drugs)
  • Side effect of some medications (including high blood pressure medication and antihistamines)
  • Emotional or personal issues (such as ongoing stress or relationship problems, depression, or anxiety about sexual performance)

About BPH

BPH is a medical condition in which the prostate A gland in a man’s body located near the base of his penis. The prostate secretes a fluid that makes up the main portion of the fluid (semen) that a man ejaculates during an orgasm. becomes enlarged and can cause problems associated with urination. ED and BPH are separate conditions, but they often coexist, and both are treatable .

Symptoms of BPH* can increase with age and may include:

  • Needing to go frequently or urgently
  • Stopping or starting during urination
  • Needing to push or strain during urination
  • Having a weak urine stream
  • Incomplete emptying of the bladder
  • Needing to go excessively at night

*Treatment of individual symptoms may vary.

Causes of the urinary symptoms of BPH

When everything is working normally, the bladder stores urine until it is full, then empties all of the urine at once. The urine leaves the body through a thin tube called the urethra, which is surrounded by the prostate gland.

With BPH, the prostate gland enlarges and can eventually interfere with urination by partially blocking the urethra.

Talk to your doctor & partner

If you're experiencing either or both of these common conditions, the key to getting help is to make an appointment with your doctor. That’s the only way to know if you need treatment.

Start the conversation

It may not be easy for you to talk to your doctor about certain issues. But the more information you are able to share about yourself, the easier it will be for your doctor to properly diagnose your condition.

Download and fill out the symptom checklists below to help start the conversation at your next appointment.

Talking to your partner

About ED

How do I talk about ED
with my partner? My partner has ED.
What should I know?

About BPH

How do I talk about BPH Enlargement of the prostate gland that can lead to urination and bladder problems if the enlarged gland begins to press on the urethra.
with my partner? My partner also has BPH
symptoms. What should I know?

Want more information?

To help you learn more about ED and BPH, here’s a list of well-respected associations and Web sites that provide important information you can use when deciding how to treat your condition.

Urology Care Foundation National Institute of Diabetes
and Digestive and Kidney
Diseases (NIDDK) Sexual Medicine Society
of North America (SMSNA)

TD92261 11/2014 В©2014, LILLY USA, LLC. ALL RIGHTS RESERVED.

Indications: CIALIS is approved to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Taking CIALIS with finasteride when starting BPH treatment has been studied for 26 weeks. CIALIS is not for women or children.

IMPORTANT SAFETY INFORMATION FOR CIALIS

What Is The Most Important Information I Should Know About CIALIS?

Do not take CIALIS if you:take medicines called “nitrates” such as nitroglycerin or other medications like isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure; or use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. take medicines called guanylate cyclase stimulators such as riociguat (Adempas ® ),* a medicine used to treat pulmonary hypertension as the combination may cause an unsafe drop in blood pressure. are allergic to CIALIS or ADCIRCA ® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing.

After taking a single tablet, some of the active ingredient of CIALIS 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.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if it is already weak from a heart attack or heart disease.

What Should I Tell My Healthcare Provider Before Taking CIALIS?

CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. Do not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking CIALIS, tell your healthcare provider about all your medical problems, particularly if you have or ever had: heart problems such as chest pain (angina), heart failure, irregular heartbeats, or heart attack pulmonary hypertensionlow blood pressure or high blood pressure that is not controlled strokeliver or kidney problems or require dialysisretinitis pigmentosa. a rare genetic (runs in families) eye disease severe vision loss, including a condition called NAIONstomach ulcers or a bleeding problema deformed penis shape or Peyronie’s disease an erection that lasted more than 4 hoursblood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect CIALIS?

Tell your healthcare provider about all the medicines you take, especially: medicines called "nitrates" which are often prescribed for chest pain medicines called guanylate cyclase stimulators, such as riociguat (Adempas ® ), used to treat pulmonary arterial hypertension and chronic-thromboembolic hypertension alpha-blockers often prescribed for prostate problems blood pressure medications medicines for HIV or some types of oral antifungal medications some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine) other medicines or treatments for erectile dysfunction (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.

How Should I Take CIALIS?

CIALIS should not be taken more than one time each day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Take CIALIS exactly as your healthcare provider prescribes it.

What Should I Avoid While Taking CIALIS?

Do not use other ED medicines or ED treatments. Do not drink too much alcohol (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.

What Are The Possible Side Effects Of CIALIS?

The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include:
An erection that won’t go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets, including CIALIS, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call a healthcare provider right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 .

CIALIS does not:
Cure ED, increase a man's sexual desire, protect a man or his partner from sexually transmitted diseases, including HIV or serve as a male form of birth control.

CIALIS is available by prescription only.

*The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

TD CON ISI 16SEP2015

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* See warnings and precautions about use with antihypertensives and in patients with cardiovascular disease.

Drug Interactions

Cialis is a vasodilator and it is extensively metabolized by CYP3A4 liver enzymes. Therefore, combining Cialis with other vasodilators will increase the incidence of hypotension, and CYP3A4 inhibitors will increase the blood levels of Cialis.

Table 2. Cialis Drug Interactions

Nitrates for example, isosorbide, nitroglycerin

Alpha adrenergic blockers

Caution. Do not combine with alpha blockers for treatment of BPH. For ED, patients should be stable on alpha blocker prior to Cialis, and lowest Cialis dose should be used

Do not combine with substantial amounts of alcohol

Antacids (magnesuim hydroxide/aluminum hydroxide)

Reduced rate of absorption of Cialis, but total absorption is the same.

Ketoconazole, ritonavir, erythromycin, itraconazole, grapefruit juice, other HIV protease inhibitors

Inhibits CYP3A4 metabolism increasing blood levels of Cialis

Avoid combination of Cialis with CYP3A4 inhibitors if possible. Maximum dose is 10 mg every 72 hours as needed or 2.5 mg daily regardless of sexual activity

Rifampin, carbamazepine, phenytoin, phenobarbital

Increased metabolism via CYP3A4 liver enzymes with reduced blood levels of Cialis

Dosage adjustment is not required

Efficacy of Cialis (tadalafil)

Erectile Dysfunction

  • Lasts up to 36 hours and starts working within 15-30 minutes after ingestion.
  • 62%-77% of patients taking 20 mg Cialis were able to initiate intercourse (insert penis) compared to 39%-43% of patients who received placebo. Change from baseline was 2% for placebo and 26%-32% for Cialis users.
  • 50%-64% of Cialis users maintained their erection compared to 23%-25% of patients taking placebo. Change from baseline was 4%-5% for placebo and 34%-44% for Cialis users.
  • Cialis versus Viagra: Cialis works within 15-30 minutes and lasts 36 hours while Viagra works within 30-60 minutes and lasts about 4 hours.

BPH (Benign Prostatic Hyperplasia)

After 12 weeks of treatment changes in total symptom score were -3.6 for placebo and -5.6 for patients taking Cialis 5 mg daily. Cialis was significantly better than placebo in reducing symptoms of BPH.

Pharmacology (Mechanism of Action)

Cialis is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. How Cialis relieves symptoms of BPH is not understood. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 may increase CGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

Cialis Pill Identification and Imprint Code

Cialis 2.5 mg tablet is a yellow, almond film-coated tablet, with imprint "C 2 1/2".

Cialis 5 mg tablet is a yellow, almond film-coated tablet, with imprint "C 5".

Cialis 10 mg tablet is a yellow, almond film-coated tablet, with imprint "C 10".

Cialis 20 mg tablet is a yellow, almond film-coated tablet, with imprint "C 20".

REFERENCE: FDA Prescribing Information.

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