PFIZER'S CHANTIX(TM) (varenicline) NOW AVAILABLE TO HELP SMOKERS QUIT
NEW YORK, August 7 -- THIS IS A MULTIVU SPECIAL REPORT. THERE'S IMPORTANT NEWS FOR MILLIONS OF ADULT SMOKERS IN THE UNITED STATES. A NEW PRESCRIPTION AID TO SMOKING CESSATION TREATMENT CALLED CHANTIX IS NOW AVAILABLE IN U.S. PHARMACIES.
CHANTIX WAS DEVELOPED BY PFIZER AND IT IS THE FIRST NEW PRESCRIPTION AID TO SMOKING CESSATION APPROVED BY THE FDA IN NEARLY A DECADE. IN TWO HEAD-TO-HEAD, PLACEBO-CONTROLLED STUDIES, ABOUT 44 PERCENT OF PATIENTS WHO TOOK CHANTIX QUIT SMOKING BY THE END OF 12 WEEKS OF TREATMENT. ABOUT 30 PERCENT OF PATIENTS WHO TOOK BUPROPRION SR AND ABOUT 18 PERCENT WHO TOOK A SUGAR PILL QUIT BY THE END OF THE SAME 12-WEEK TREATMENT PERIOD.
DR. MITCHELL NIDES, A SMOKING CESSATION SPECIALIST, COMMENTS ON CHANTIX: "Quitting smoking is tough, largely due to nicotine addiction. [It] often takes smokers several times before they're successful. The approval of CHANTIX offers new hope to those who've tried unsuccessfully in the past, as well as those who've never tried before. My hope is that it will successfully help many people quit smoking."
FOR INDIVIDUALS WHO ARE MOTIVATED TO QUIT SMOKING, LITERATURE HAS SHOWN THAT A COMBINATION OF MEDICATION AND BEHAVIOR MODIFICATION CAN INCREASE QUITTING SUCCESS RATES.
PATIENTS PRESCRIBED CHANTIX WILL BE OFFERED ENROLLMENT IN THE GETQUITTM SUPPORT PLAN, A UNIQUE PROGRAM TO HELP SMOKERS THROUGH THE QUITTING PROCESS. THE PLAN WAS DEVELOPED BY PFIZER WITH INPUT FROM SMOKING CESSATION EXPERTS AND WILL BE AVAILABLE AT NO ADDITIONAL COST.
THE MOST FREQUENTLY REPORTED ADVERSE EVENTS WITH CHANTIX WERE NAUSEA, HEADACHE, INSOMNIA, AND ABNORMAL DREAMS.
NAUSEA WAS REPORTED BY APPROXIMATELY 30 PERCENT OF PATIENTS TREATED WITH CHANTIX WITH APPROXIMATELY A 3 PERCENT DISCONTINUATION RATE DURING 12 WEEKS OF TREATMENT. NAUSEA WAS GENERALLY DESCRIBED AS MILD OR MODERATE AND OFTEN TRANSIENT. FOR SOME SUBJECTS, IT WAS PERSISTENT OVER THE COURSE OF TREATMENT.
IT'S IMPORTANT FOR PEOPLE WHO WANT TO QUIT SMOKING TO DISCUSS AN APPROPRIATE TREATMENT PLAN WITH THEIR DOCTORS.
FOR FULL PRESCRIBING INFORMATION, PATIENTS AND HEALTH CARE PROVIDERS CAN VISIT WWW.CHANTIX.COM OR CALL 1-877-CHANTIX TO RECEIVE MORE INFORMATION ABOUT CHANTIX.
I'M DANIELLE ADDAIR.
SAFETY INFORMATION:
CHANTIX is indicated as an aid to smoking cessation treatment in adults.
The most frequently reported adverse events (>10 percent) with CHANTIX were nausea, headache, insomnia, and abnormal dreams.
Nausea was reported by approximately 30 percent of patients treated with CHANTIX (1 mg twice a day), with approximately a 3 percent discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient, although for some patients it persisted over the course of treatment.
Please see prescribing information below. Patients and health care providers can visit www.CHANTIX.com or call 1-877-CHANTIX to receive more information about CHANTIX.
PATIENT INFORMATION
CHANTIX(TM) (varenicline) Tablets
Read the patient information that comes with CHANTIX before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your condition or treatment.
WHAT IS CHANTIX?
CHANTIX is a prescription medicine to help adults stop smoking.
WHO SHOULD NOT TAKE CHANTIX?
CHANTIX has not been studied in children under 18 years of age.
CHANTIX is not recommended for children under 18 years of age.
Do not take CHANTIX if you are allergic to anything in it. See a complete
list of ingredients at the end of this leaflet.
WHAT SHOULD I TELL MY DOCTOR BEFORE STARTING CHANTIX?
Tell your doctor about all of your medical conditions including if you:
* have kidney problems or get kidney dialysis. Your doctor may
prescribe a lower dose of CHANTIX for you.
* are pregnant or plan to become pregnant. CHANTIX has not been
studied in pregnant women. It is not known if CHANTIX will harm
your unborn baby. It is best to stop smoking before you get pregnant.
* are breast-feeding. Although it was not studied, CHANTIX may pass
into breast milk. You and your doctor should discuss alternative
ways to feed your baby if you take CHANTIX.
Tell your doctor about all your other medicines including prescription
and nonprescription medicines, vitamins and herbal supplements.
Especially, tell your doctor if you take:
* insulin
* asthma medicines
* blood thinners.
When you stop smoking, there may be a change in how these and other
medicines work for you.
Know the medicines you take. Keep a list of them with you to show your
doctor and pharmacist.
HOW DO I TAKE CHANTIX?
1. Choose a quit date when you will stop smoking.
2. Start taking CHANTIX 1 week (7 days) before your quit date. This
lets CHANTIX build up in your body. You can keep smoking
during this time. Make sure that you try and stop smoking on
your quit date. If you slip, try again. Some people need a few
weeks for CHANTIX to work best.
3. Take CHANTIX after eating and with a full glass (8 ounces) of
water.
4. Most people will keep taking CHANTIX for up to 12 weeks. If you
have completely quit smoking by 12 weeks, ask your doctor if
another 12 weeks of CHANTIX may help you stay cigarette-free.
You start with the white tablet and then usually go to the blue tablet.
See the chart below for dosing instructions.
Day 1 to Day 3 ? White tablet (0.5 mg), 1 tablet each day
Day 4 to Day 7 ? White tablet (0.5 mg), twice a day
* 1 in the morning and 1 in the evening
Day 8 to end of treatment ? Blue tablet (1 mg) twice a day
* 1 in the morning and 1 in the evening
* This dosing schedule may not be right for everyone. Talk to your
doctor if you are having side effects such as nausea or sleep
problems. Your doctor may want to reduce your dose.
* If you miss a dose, take it as soon as you remember. If it is close to
the time for your next dose, wait. Just take your next regular dose.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF CHANTIX?
The most common side effects of CHANTIX include:
* nausea
* changes in dreaming
* constipation
* gas
* vomiting
Tell your doctor about side effects that bother you or that do not go
away.
These are not all the side effects of CHANTIX. Ask your doctor or
pharmacist for more information.
HOW SHOULD I STORE CHANTIX?
* Store CHANTIX at room temperature, 59 to 86?F (15 to 30?C).
* Safely dispose of CHANTIX that is out of date or no longer needed.
* Keep CHANTIX and all medicines out of the reach of children.
GENERAL INFORMATION ABOUT CHANTIX
Medicines are sometimes prescribed for conditions other than those
described in patient information leaflets. Do not use CHANTIX for a
condition for which it was not prescribed. Do not give your CHANTIX to
other people, even if they have the same symptoms that you have. It
may harm them.
This leaflet summarizes the most important information about
CHANTIX. If you would like more information, talk with your doctor. You
can ask your doctor or pharmacist for information about CHANTIX that
is written for healthcare professionals.
To find out more about CHANTIX and tips on how to quit smoking:
* Go to the CHANTIX website at www.CHANTIX.com.
* Call 1-877-CHANTIX (877-242-6849).
WHAT IS IN CHANTIX?
Active ingredient: varenicline tartrate
Inactive ingredients: microcrystalline cellulose (NF), anhydrous dibasic
calcium phosphate (USP), croscarmellose sodium (NF), colloidal silicon
dioxide (NF), magnesium stearate (NF), Opadry(R) White (for 0.5 mg),
Opadry(R) Blue (for 1 mg), and Opadry(R) Clear (for both 0.5 mg and 1 mg)
Rx only
Distributed by
Pfizer Labs
Division of Pfizer Inc, NY, NY 10017
LAB-0328-3.0
May 2006
Data Source : Pfizer Inc
ป้ายกำกับ:
Chantix
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