FDA Approves Cialis ( R ) ( tadalafil ) For Once Daily Use For The Treatment Of Erectile Dysfunction

Eli Lilly and Company ( NYSE: LLY ) announced that U. S. Food and Drug Administration ( Food and Drug Administration ) has approved Cialis ( R ) ( tadalafil ) ( 1 ) for once daily use ( 2. 5 mg and 5 mg ) , an oral medication taken once per day to treat erectile dysfunction ( ED ) . When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses.

Currently available in parts of Europe, this low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity ( e. g. twice weekly ) . For other men, Cialis taken as needed - previously approved dosing regimen - may be most appropriate.

In clinical trials, when taken without restrictions on timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy.

" ED can be a chronic condition like diabetes or high blood pressure, " said Ridwan Shabsigh, M. D. , Director of the Division of Urology at Maimonides Medical Center in New York. " As a urologist, I know couples like to have choices and will appreciate the availability of Cialis for once daily use. '

Cialis for use as needed transformed U. S. ED market when it was approved in 2003 as first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Cialis for once daily use provides a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity. In consultation with their physician, patients now have the freedom to choose dosing regimen that's appropriate for them.

" We strive to provide patients with solutions that fit their needs and Cialis for once daily use delivers on this promise, " said Shawn Heffern, Cialis U. S. Director of Brand Marketing at Lilly. " Now, patients have two options - some may prefer up to 36 hours of efficacy provided by Cialis for use as needed while others may want unique benefit provided by this daily dosing option. '

Additionally, Lilly's wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed such that patients who currently use two or more pills per week of Cialis for use as needed shouldn't experience higher treatment costs with Cialis for once daily use.

The FDA's approval of Cialis for once daily use was based upon the evaluation of comprehensive data package for the daily dosing option. The data include results from three phase III randomized, double-blind, placebo- controlled studies. Men with ED who participated in these clinical studies and who took tadalafil 2. 5 mg and 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function compared with those taking placebo. ( 2 ) Cialis 5 mg, 10 mg and 20 mg have been approved in United States for as-needed treatment of ED since November 2003.

The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing and pain in limb. Most adverse events reported with tadalafil were transient and generally mild or moderate.

About ED

ED is defined as consistent inability to attain and maintain an erection sufficient for sexual intercourse. Experts believe that 80 percent to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 percent to 20 percent are predominantly due to psychological causes. ( 3, 4 ) In many cases, however, both psychological and physical factors contribute to the condition. ( 5 )

About Cialisz

Cialis ( R ) ( tadalafil ) is approved for treatment of erectile dysfunction on an as-needed basis or in a daily regimen. 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. As part of a daily regimen, Cialis may be taken as 2. 5 mg or increased to 5 mg, based on individual efficacy and tolerability.

Important Safety Information for Cialis

Cialis is available by prescription only and isn't for everyone. Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they're healthy enough for sexual activity. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. Cialis for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating potential for interactions with certain medications ( e. g. , nitrates, alpha-blockers, anti- hypertensives and potent inhibitors of CYP3A4 ) and with substantial amounts of alcohol. The most common side effects with Cialis were headache, upset stomach, delayed backache or muscle ache.

As with any ED tablet, in rare event of priapism ( an erection lasting more than four hours ) , men should seek immediate medical attention 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 is not possible to determine if these events are related directly to ED tablets or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet and seek medical attention right away.

Cialis doesn't protect a man or his partner from sexually transmitted diseases, including HIV. Men should not drink alcohol in excess with Cialis. Individual results may vary. Cialis hasn't been studied for multiple attempts per dose.

Individual results may vary. Cialis hasn't been studied for multiple attempts per dose. For full patient information and/or full prescribing information, visit http: //www. cialis. com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying latest research from its own world-wide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind. , Lilly provides answers - through medicines and information - for some of world's most urgent medical needs. Additional information about Lilly is available at http: //www. lilly. com. P-LLY

Certain of matters discussed herein with respect to clinical studies and Lilly's products may constitute forward-looking statements within meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward- looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in respective filings with Securities and Exchange Commission, which may affect business and prospects of Lilly. More specifically, there can be no assurance that this product will achieve commercial success or that competing products won't pre-empt any market opportunity that might exist for product.

References

( 1 ) Cialis is a registered trademark of Eli Lilly.

( 2 ) Cialis prescribing information, updated January 2008.

( 3 ) Shabsigh, R. ( 2002 ) . Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York: Kensington.

( 4 ) Erectile Dysfunction, http: //kidney. niddk. nih. gov/kudiseases/pubs/impotence. Data accessed 09/28/07.

( 5 ) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.

Eli Lilly and Company http: //www. lilly. com

Medical advises for your health improvement

Nitrazepam: helpful modern medicine.

uses of Nitrazepam Nitrazepam is used in adults for short-term treatment of trouble sleeping ( insomnia ) . It may help we fall asleep faster and decrease number of times we awaken during night. It may also help we sleep for a longer time. Nitrazepam is also used in children and infants to treat a certain type of seizure ( myoclonic ) .

Nitrazepam belongs to a class of drugs called benzodiazepines, which act on brain to produce a calming effect. It works by enhancing effects of a certain natural chemical in the body ( GABA ) .

how to use of Nitrazepam To treat insomnia, take Nitrazepam by mouth with or without food, before bedtime as directed by your doctor. Nitrazepam can be chewed or dissolved in liquid if we are unable to swallow it whole.

Don't use Nitrazepam if we have less than 7 to 8 hours to sleep. Doing so increases the risk of daytime drowsiness and temporary memory loss.

To treat seizures in infants and children, give medication by mouth, usually 3 times a day or as directed by doctor.

Dosage is based on your medical condition and response to treatment. Nitrazepam isn't usually used for more than 7 to 10 days when treating insomnia. Long-term use can cause the medication to build up in your body, increase side effects, and cause dependence. It can make your insomnia worse after you stop taking medication ( rebound insomnia ) .

Nitrazepam may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, if you suddenly stop Nitrazepam, withdrawal reactions ( e. g. , depressed/anxious mood, stomach/muscle cramps, vomiting, sweating, shakiness, seizures ) may occur while use Nitrazepam. Report any such reactions to your doctor immediately. When stopping extended, regular treatment with Nitrazepam, gradually reducing dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Rarely, use of Nitrazepam can also result in abnormal drug-seeking behavior ( addiction ) . Don't increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, Nitrazepam mayn't work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if you continue to have trouble sleeping or your child's seizures persist or worsen.

side effects of Nitrazepam Drowsiness, dizziness, loss of coordination, headache, lightheadedness, nightmares, trouble walking, or falling may occur while use Nitrazepam. To reduce risk of injury from falling, take Nitrazepam right before going to bed. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Nitrazepam may make we sleepy during day. Tell your doctor if we have daytime drowsiness. Your dose may need to be adjusted. Some people, particularly children, may experience excitability rather than drowsiness.

Remember that your doctor has prescribed Nitrazepam because he or she has judged that benefit to we is greater than risk of side effects. Many people using Nitrazepam do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Tell your doctor immediately if any of these rare but very serious side effects occur:

A very serious allergic reaction to Nitrazepam is rare. However, seek immediate medical attention if we notice any symptoms of a serious allergic reaction, including:

This isn't a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

precautions of Nitrazepam Before taking Nitrazepam, tell your doctor or pharmacist if we are allergic to it; or to other benzodiazepines ( e. g. , diazepam, temazepam ) ; or if we have any other allergies.

Nitrazepam shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if we have:

Before using Nitrazepam, tell your doctor or pharmacist your medical history, especially of:

Nitrazepam may make we dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that we are taking Nitrazepam.

Caution is advised when using Nitrazepam in the elderly because they may be more sensitive to effects of the drug, especially memory problems and increased risk of falls due to drowsiness, dizziness, and loss of coordination.

Caution is advised when using Nitrazepam in infants/young children because they may be at risk for lung infection due to difficulty swallowing that leads to saliva getting in lungs ( aspiration ) .

During pregnancy, Nitrazepam should be used only when clearly needed. Nitrazepam may cause harm to an unborn baby. Infants born to mothers who used similar medications for a long time during pregnancy have had withdrawal symptoms. Infants born to mothers who used similar medications near or at the time of delivery have had unusual drowsiness, feeding problems, slow breathing, liver problems, and floppy muscles. Consult your doctor for more details and to discuss reliable forms of birth control.

Nitrazepam may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding isn't recommended while using Nitrazepam. Consult your doctor before breast-feeding.

interactions of Nitrazepam Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for them. Do not start, stop, or change dosage of any medicine before checking with your doctor or pharmacist first.

Nitrazepam shouldn't be used with the following medication because very serious interactions may occur while use Nitrazepam:

If you're currently using medication listed above, tell your doctor or pharmacist before starting Nitrazepam.

Before using Nitrazepam, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines ( e. g. , diphenhydramine ) , anti-seizure drugs ( e. g. , carbamazepine ) , medicine for sleep or anxiety ( e. g. , alprazolam, diazepam, zolpidem ) , muscle relaxants, narcotic pain relievers ( e. g. , codeine ) , psychiatric medicines ( e. g. , chlorpromazine, risperidone, amitriptyline, trazodone ) .

Check labels on all your medicines ( e. g. cough-and-cold products ) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using these products safely.

This document doesn't contain all possible interactions. Therefore, before using Nitrazepam, tell your doctor or pharmacist of all the products we use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

FDA approved Nitrazepam

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