Cialis: Package Insert and Label Information (Page 7 of 7)
14.4 CIALIS 5 mg for Once Daily Use for ED and BPH
The efficacy and safety of CIALIS for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either CIALIS 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.
In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took CIALIS.
The efficacy results for patients with both ED and BPH, who received either CIALIS 5 mg for once daily use or placebo (N=408) are shown in Tables 20 and 21 and Figure 7.
CIALIS 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. CIALIS 5 mg for once daily use also resulted in statistically significant improvement in SEP3. CIALIS 2.5 mg did not result in statistically significant improvement in the total IPSS.
| Placebo | CIALIS 5 mg | p-value | |
| Total Symptom Score (IPSS) | |||
| (N=193) | (N=206) | ||
| Baseline | 18.2 | 18.5 | |
| Change from Baseline to Week 12 | -3.8 | -6.1 | <.001 |
| EF Domain Score (IIEF EF) | |||
| (N=188) | (N=202) | ||
| Baseline | 15.6 | 16.5 | |
| Endpoint | 17.6 | 22.9 | |
| Change from Baseline to Week 12 | 1.9 | 6.5 | <.001 |
| Placebo | CIALIS 5 mg | ||
| (N=187) | (N=199) | p-value | |
| Maintenance of Erection (SEP3) | |||
| Baseline | 36% | 43% | |
| Endpoint | 48% | 72% | |
| Change from Baseline to Week 12 | 12% | 32% | <.001 |
CIALIS for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 7).
Figure 7: Mean IPSS Changes in ED/BPH Patients by Visit in Study L
In this study, the effect of CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (CIALIS 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
CIALIS (tadalafil) is supplied as follows:
Strengths of film-coated, almond-shaped tablets (not scored) are available in different sizes and different shades of yellow, and supplied in the following package sizes:
| Bottles of 30 | NDC 54868-5956-0 |
| Bottles of 3 | NDC 54868-4665-3 |
| Bottles of 5 | NDC 54868-4665-1 |
| Bottles of 6 | NDC 54868-4665-4 |
| Bottles of 10 | NDC 54868-4665-2 |
| Bottles of 30 | NDC 54868-4665-0 |
| Bottles of 3 | NDC 54868-4968-0 |
| Bottles of 4 | NDC 54868-4968-6 |
| Bottles of 5 | NDC 54868-4968-2 |
| Bottles of 6 | NDC 54868-4968-3 |
| Bottles of 10 | NDC 54868-4968-5 |
| Bottles of 15 | NDC 54868-4968-4 |
| Bottles of 20 | NDC 54868-4968-7 |
| Bottles of 30 | NDC 54868-4968-1 |
16.2 Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
17 PATIENT COUNSELING INFORMATION
“See FDA-approved Patient Labeling (Patient Information)”
17.1 Nitrates
Physicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of CIALIS with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.
Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS 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 CIALIS should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)].
17.2 Cardiovascular Considerations
Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].
17.3 Concomitant Use with Drugs Which Lower Blood Pressure
Physicians should discuss with patients the potential for CIALIS to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].
17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use
Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing CIALIS for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [See Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].
17.5 Priapism
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. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.
17.6 Vision
Physicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, 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 Clinical Studies (6.2)].
17.7 Sudden Hearing Loss
Physicians should advise patients to stop taking PDE5 inhibitors, including CIALIS, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].
17.8 Alcohol
Patients should be made aware that both alcohol and CIALIS, 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 CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].
17.9 Sexually Transmitted Disease
The use of CIALIS offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.
17.10 Recommended Administration
Physicians should instruct patients on the appropriate administration of CIALIS to allow optimal use.
For CIALIS for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.
For CIALIS for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Cialis is effective at improving erectile function over the course of therapy.
For CIALIS for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.
Revision Date October 2011
Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA
www.cialis.com
Copyright © 2003, 2011, Eli Lilly and Company. All rights reserved.
PV 6604 AMP
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Patient Information
CIALIS® (See-AL-iss)
(tadalafil) tablets
Read this important information before you start taking CIALIS and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about CIALIS when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.
What Is The Most Important Information I Should Know About CIALIS?
CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke.
Do not take CIALIS if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
- Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
- Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.
(See “Who Should Not Take CIALIS?”)
Tell all of your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS.
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 (see “Can Other Medicines Affect CIALIS?”).
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 your heart is already weak from a heart attack or heart disease.
See also “What Are The Possible Side Effects Of CIALIS?”
What Is CIALIS?
CIALIS 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
CIALIS for the Treatment of 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.
Some form of sexual stimulation is needed for an erection to happen with CIALIS.
CIALIS does not:
- cure ED
- increase a man’s sexual desire
- protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.
- serve as a male form of birth control
CIALIS is only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.
CIALIS for the Treatment of Symptoms of BPH
BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.
CIALIS for the Treatment of ED and Symptoms of BPH
ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take CIALIS for the treatment of both conditions.
CIALIS is not for women or children.
CIALIS must be used only under a healthcare provider’s care.
Who Should Not Take CIALIS?
Do not take CIALIS if you:
- take any medicines called “nitrates”.
- use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About CIALIS?”)
- are allergic to CIALIS or ADCIRCA ® , or any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS. Symptoms of an allergic reaction may include:
- rash
- hives
- swelling of the lips, tongue, or throat
- difficulty breathing or swallowing
Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.
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. Before taking CIALIS, tell your healthcare provider about all your medical problems, including if you:
- have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems.
- have low blood pressure or have high blood pressure that is not controlled
- have had a stroke
- have liver problems
- have kidney problems or require dialysis
- have retinitis pigmentosa, a rare genetic (runs in families) eye disease
- have ever had severe vision loss, including a condition called NAION
- have stomach ulcers
- have a bleeding problem
- have a deformed penis shape or Peyronie’s disease
- have had an erection that lasted more than 4 hours
- have blood 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 including prescription and non-prescription medicines, vitamins, and herbal supplements. CIALIS and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following*:
- medicines called nitrates (see “What Is The Most Important Information I Should Know About CIALIS?”)
- 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.
How Should I Take CIALIS?
- 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.
How Should I Take CIALIS for Symptoms of BPH?
For symptoms of BPH, CIALIS is taken once daily.
- Do not take CIALIS more than one time each day.
- Take one CIALIS tablet every day at about the same time of day.
- If you miss a dose, you may take it when you remember but do not take more than one dose per day.
How Should I Take CIALIS for ED?
For ED, there are two ways to take CIALIS — either for use as needed OR for use once daily.
CIALIS for use as needed:
- Do not take CIALIS more than one time each day.
- Take one CIALIS tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking CIALIS and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take CIALIS before sexual activity. Some form of sexual stimulation is needed for an erection to happen with CIALIS.
- Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.
OR
CIALIS for once daily use is a lower dose you take every day.
- Do not take CIALIS more than one time each day.
- Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
- If you miss a dose, you may take it when you remember but do not take more than one dose per day.
Some form of sexual stimulation is needed for an erection to happen with CIALIS. - Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition.
How Should I Take CIALIS for Both ED and the Symptoms of BPH?
For both ED and the symptoms of BPH, CIALIS is taken once daily.
- Do not take CIALIS more than one time each day.
- Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
- If you miss a dose, you may take it when you remember but do not take more than one dose per day.
- Some form of sexual stimulation is needed for an erection to happen with CIALIS.
What Should I Avoid While Taking CIALIS?
- 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.
What Are The Possible Side Effects Of CIALIS?
See “What Is The Most Important Information I Should Know About 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 side effects include:
An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.
Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS, and call a healthcare provider right away.
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS and contact a healthcare provider right away.
These are not all the possible side effects of CIALIS. For more information, ask your healthcare provider or pharmacist.
How Should I Store CIALIS?
Store CIALIS at room temperature between 59° and 86°F (15° and 30°C).
Keep CIALIS and all medicines out of the reach of children.
General Information About CIALIS:
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use CIALIS for a condition for which it was not prescribed. Do not give CIALIS to other people, even if they have the same symptoms that you have. It may harm them.
This is a summary of the most important information about CIALIS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIALIS that is written for health providers. For more information you can also visit www.cialis.com, or call 1-877-CIALIS1 (1-877-242-5471).
What Are The Ingredients In CIALIS?
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.
This Patient Information has been approved by the U.S. Food and Drug Administration
Rx only
CIALIS® (tadalafil) is a registered trademark of Eli Lilly and Company.
*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.
Revision Date October 2011
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
www.cialis.com
Copyright © 2003, 2011, Eli Lilly and Company. All rights reserved.
PV 5227 AMP
PACKAGE LABEL – Cialis 5mg tablets
Cialis®
(tadalafil) tablets
5mg
Tablets should not be split.
Entire dose should be taken.
Rx only
PACKAGE LABEL – Cialis 10mg tablets
Cialis®
(tadalafil) tablets
10mg
Tablets should not be split.
Entire dose should be taken.
Rx only
PACKAGE LABEL – Cialis 20 mg tablets
Cialis®
(tadalafil) tablets
20mg
Tablets should not be split.
Entire dose should be taken.
Rx only
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| Labeler — Physicians Total Care, Inc. (194123980) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Physicians Total Care, Inc. | 194123980 | relabel, repack | |
Revised: 12/2011 Physicians Total Care, Inc.
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.