What Is REDACT?

How does REDACT work?

How long does it take for REDACT to work?

Who should take REDACT?

How and when should I take REDACT?

What if I miss a dose?

How long should I take REDACT?

Who should not take REDACT?

What medical conditions or information should I tell my doctor?

What about physician follow-up visits?

What medications can cause problems if taken at the same time I take REDACT?

When should I call my doctor?

Is REDACT a controlled substance?

What weight-loss results have been observed with REDACT?

What are some of the more common side effects of REDACT?

Can REDACT affect blood pressure or heart rate?

Are there any severe side effects?

Does REDACT cause damage to the heart valves?

Will REDACT change the way I need to take my nutritional supplements?

What about drinking alcoholic beverages?

What about drinking coffee, tea and caffeinated beverages?

What if I develop allergic reactions?

What if I am pregnant or nursing?

What about sexual activity and potential pregnancy?

Will REDACT affect the effectiveness of birth control pills?

What about driving a car or dangerous work activities?

How should I keep and use REDACT?

What Is REDACT?

REDACT is an oral prescription medication used for the medical management of obesity, including weight loss and the maintenance of weight loss, and should be used in conjunction with a reduced-calorie diet.

REDACT can only be prescribed by a medical doctor. REDACT comes in three different strength capsules (5 mg, 10 mg, and 15 mg). The recommended initial starting dose of REDACT is one 10 mg capsule per day. Your doctor will determine the starting dose that is best for you.

How does REDACT work?

REDACT works by affecting appetite control centers in the brain.

In medical studies in overweight people, REDACT, along with a reduced calorie diet, produced significant reductions in body weight.

REDACT should be used as part of a comprehensive weight-loss program, supervised by your doctor, that includes a reduced calorie diet and appropriate physical activity.

How long does it take for REDACT to work?

Every person will respond differently to REDACT when used as part of a comprehensive weight-loss program. You may be able to lose 4 or more pounds. of body weight in the first month you take REDACT. If you find that you do not lose at least 4 pounds. during the first month, you should notify your doctor so he or she can re-evaluate your situation. Your doctor may wish to change your dose of REDACT.

Most people who lose weight on REDACT lose it in the first 6 months of treatment. Scientific studies that lasted two years have shown that many people who lost weight and remained on REDACT therapy maintained their weight loss.

Who should take REDACT?

A weight-loss program that includes a reduced calorie diet and appropriate physical activity may be adequate in some patients. You should discuss with your doctor whether REDACT should be added to such a program.

REDACT is recommended for overweight people with an initial body mass index (BMI) of 30 or higher, or for overweight people with a BMI of 27 or higher if they have medical risk factors such as high blood pressure, diabetes, or high cholesterol. Your doctor can determine your BMI and will decide if you meet these criteria.

How and when should I take REDACT?

Follow your doctor’s instructions on how and when to take REDACT.

Your doctor will recommend that you take one (1) REDACT capsule a day.

You can take REDACT on an empty stomach or after a meal.

What if I miss a dose?

If you forget to take a dose of REDACT, do not take an extra capsule to “make up” for the dose you forgot.

How long should I take REDACT?

Your doctor will determine how long you should take REDACT. Follow your doctor's advice.

The safety and effectiveness of REDACT have not been determined beyond two (2) years at this time.

Who should not take REDACT?

REDACT should not be taken by people who:

- HAVE UNCONTROLLED OR POORLY CONTROLLED HIGH BLOOD PRESSURE BECAUSE REDACT SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS.

- Are taking prescription medicines called monoamine oxidase inhibitors (MAOIs) for depression, Parkinson’s Disease, or any other disorder (for example: Eldepryl®(selegiline hydrochoride), Parnate®(tranylcypromine sulfate), Nardil®(phenelzine sulfate)).

- Are taking other weight loss medications that act on the brain (for example: phentermine). This includes prescription and over-the-counter medications and herbal products.

- Have had prior allergic reactions to REDACT or sibutramine.

- Have a diagnosis of coronary artery disease and/or who have angina pectoris (heart-related chest pain).

- Have arrhythmias (irregular heart beats).

- Have had a prior heart attack.

- Have a diagnosis of congestive heart failure.

- Have severe liver or kidney disease.

- Have had a stroke or symptoms of a stroke (transient ischemic attacks [TIAs]).

- Are pregnant or planning to become pregnant.

- Are breast-feeding their infants.

- Are suffering from major eating disorder anorexia nervosa or bulimia nervosa.

 -Are under 16 years of age.

If you have any concerns or questions about whether or not you should take REDACT, talk to your doctor.

IMPORTANT: It is very important that you make sure that your primary care doctor and all your other healthcare providers know what medications you take and what medical conditions and allergies you have.

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What medical conditions or information should I tell my doctor?

It is important that you tell your doctor all about your medical history, whether you are taking or have taken weight loss drugs in the past, current medical problems, current symptoms, what other medications you take or have taken (prescription and over-the-counter medicines and herbal products) and any prior allergies to medicines.

It is important to make sure your doctor knows if you have heart disease of any kind, high blood pressure, migraine headaches, Parkinson’s Disease, prior strokes, prior transient ischemic attacks (TIAs), thyroid disorders, osteoporosis, gallstones, liver disease, kidney disease, history of a major eating disorder (anorexia nervosa or bulimia nervosa) or any other medical problem.

It is important to make sure your doctor knows if you have had depression or are taking prescription medications for depression. The use of REDACT in a patient with depression may require extra caution.

You should tell your doctor if you are taking medications that regulate the neurotransmitter serotonin in the brain (for example: Prozac®, Zoloft®, Effexor®, Luvox®, Paxil®, or Zyban®).

It is important to tell your doctor if you have had seizures (epilepsy or convulsions). The use of REDACT in a patient with seizures may require extra caution.

It is important to tell your doctor if you have glaucoma. The use of REDACT in a patient with glaucoma may require extra caution.

It is important to tell your doctor if you are taking any medications that may increase your risk of bleeding (e.g. aspirin, clopidogrel, ticlopidine, warfarin). The use of REDACT in patients taking medications that may increase the risk of bleeding may require extra caution. Signs of bleeding may include bruising, nose bleeds, and gum bleeding.

What about physician follow-up visits?

You should make sure you see your doctor as directed for regular follow-up visits, during which your doctor can follow your body weight, and carefully monitor your overall health as you try to lose weight and maintain weight loss.

What medications can cause problems if taken at the same time I take REDACT?

You cannot take REDACT if you are taking prescription medicines called monoamine oxidase inhibitors (MAOIs). It is especially important to make sure you tell your doctor if you are taking MAOIs which are sometimes used to treat depression or Parkinson’s Disease (for example: Eldepryl®(selegiline hydrochoride), Nardil®(phenelzine sulfate), Parnate®(tranylcypromine sulfate)). This is very important because serious, sometimes even fatal, reactions can occur if REDACT is taken at the same time MAOIs are taken.

If you are currently taking an MAOI, your doctor will want you to stop taking it for at least two (2) full weeks before starting you on REDACT.

If you are currently taking MERIDlA, your doctor will want you to stop taking it for at least two (2) full weeks before starting you on an MAOI.

REDACT should not be taken if you are taking other weight-loss medications that act on the brain (for example: phentermine). This includes both prescription and over-the-counter medications and herbal products.

In addition to the above, a rare, but serious, medical syndrome called the “serotonin syndrome” has been reported in patients when medications like REDACT are taken along with other drugs that may alter serotonin activity such as: drugs for depression (for example: Desyrel® (trazodone hydrochloride) , Effexor® (venlafaxine hydrochloride), Eldepryl® (selegiline hydrochoride), Remeron® (mirtazapine), Serzone® (nefazodone hydrochloride), Wellbutrin® (bupropion hydrochloride), Nardil® (phenelzine sulfate), Parnate® (tranylcypromine sulfate), Paxil® (paroxetine hydrochloride), Prozac® (fluoxetine hydrochloride), Zoloft® (sertraline), Ludiomil® (maprotiline hydrochloride), Adapin® (doxepin hydrochloride), Asendin® (amoxapine), Elavil® (amitriptyline hydrochloride), Etrafon® (amitriptyline hydrochloride, perphenazine), Limbitrol® (chlordiazepoxide, amitriptyline hydrochloride), Norpramin® (desipramine hydrochloride), Pamelor® (nortriptyline hydrochloride), Sinequan® (doxepin hydrochloride), Surmontil® (trimipramine maleate), Tofranil® (imipramine hydrochloride), Triavil® (amitriptyline hydrochloride, perphenazine), Vivactil® (protriptyline hydrochloride), Luvox® (fluvoxamine maleate), Anafranil® (clomipramine hydrochloride)), drugs for migraine headache therapy (Imitrex® [sumatriptan succinate]) and dihydroergotamine, certain pain medications such as Demerol® (meperidine), Duragesic® (fentanyl), and Talwin® (pentazocine); the cough suppressant dextromethorphan found in many cough medicines; lithium; and the amino acid tryptophan. The syndrome requires immediate medical attention and may include one or more of the following symptoms: restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, weakness, tremor, incoordination, fever, shivering, sweating, vomiting and increased heart rate.

The metabolism of REDACT may be inhibited by ketoconazole (an anti-fungal medicine) and to a lesser degree erythromycin (an antibiotic medicine). You need to make sure your doctor knows you are taking these medicines before you take REDACT. If, while taking REDACT, your doctor decides to put you on ketoconazole or erythromycin, you should remind him or her that you are also on REDACT.

Many over-the-counter cough and cold remedies, as well as certain allergy products and decongestants, contain medicines such as phenylpropanolamine, ephedrine, or pseudoephedrine that may increase blood pressure or heart rate. Before taking these medications on your own, you should check with your doctor to make sure it is all right to take these medicines if you are already taking REDACT.

Your doctor may advise you to take a certain type of cough, cold, decongestant or allergy medicine that will not interact with REDACT.

When should I call my doctor?

It is important that you call your doctor immediately if you experience any symptoms or feelings that make you concerned about your health or a possible drug side effect. Let your doctor advise you on your concerns. If you experience any of the following symptoms, stop taking REDACT and notify your doctor immediately: trouble breathing, shortness of breath, chest pain, angina, rapid heart beats over 100 beats a minute, pounding or irregular heart beats, restlessness, lightheadedness, blackout spells, disorientation, depression, mental confusion, anxiety, nervousness, tremors, loss of muscle coordination, muscle stiffness or muscle rigidity, high fever, pain in the eyes, dilated pupils, shivering, sweating, abdominal pain, nausea or vomiting, or other symptoms that concern you.

Is REDACT a controlled substance?

Yes, REDACT is a controlled substance in Schedule IV of the Controlled Substances Act (CSA).

What weight-loss results have been observed with REDACT?

Patients treated with REDACT while on a reduced calorie diet, showed a significant weight loss during the first 6 months of treatment, and significant weight loss was maintained for one year. In one 12-month study, the average weight loss in patients taking REDACT, 10 mg daily, was about 10 lb. and in those taking 15 mg daily was about 14 lb. The average weight loss in persons on only a reduced calorie diet was 3½ lb.

What are some of the more common side effects of REDACT?

REDACT, like all medications, may cause side effects. In studies the most common side effects were: dry mouth, constipation, and insomnia (inability to fall asleep). Other side effects that may occur include: headache, increased sweating, an increase in blood pressure, and an increase in heart rate. These side effects are generally mild, and have usually not caused people to stop taking REDACT. If you develop a symptom that you think might be a side effect, stop taking REDACT and notify your doctor immediately so he or she can advise you on what to do.

Can REDACT affect blood pressure or heart rate?

REDACT SUBSTANTIALLY INCREASES BLOOD PRESSURE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE IS REQUIRED WHEN TAKING REDACT.

On average, small increases in blood pressure and small increases in heart rate were seen in overweight people who took REDACT in scientifically controlled studies. You should make sure you see your doctor as directed for regular follow-up visits. Your blood pressure and pulse should be measured prior to starting therapy with REDACT and should be monitored at regular intervals thereafter. If you experience an increase in blood pressure or heart rate while taking REDACT, your doctor may decide to decrease the dose or discontinue REDACT.

If you have high blood pressure that is controlled by medication or diet, your doctor may choose to prescribe REDACT for you as part of a comprehensive weight-management program. REDACT should not be taken by people who have uncontrolled or poorly controlled high blood pressure.

Are there any severe side effects?

Certain weight-loss drugs have been associated with pulmonary hypertension (PPH), a rare but sometimes fatal disease. In clinical studies, no cases of PPH have been reported with REDACT. Because this disease is so rare, however, it is not known whether or not REDACT may cause this disease.

The first symptom of PPH is usually shortness of breath. If you experience new or worsening shortness of breath, or if you experience chest pain, fainting, or swelling of your feet, ankles, or legs, stop taking REDACT, and notify your doctor immediately.

Does REDACT cause damage to the heart valves?

Certain weight-loss drugs have been associated with cardiac valve dysfunction (heart valve disease). Patients in two studies were examined by doctors who used cardiac ultrasound testing to carefully look at heart valve structure and function. In one study, 25 patients were examined before treatment with REDACT and again after three months of treatment. None of the patients had heart valve disease. In another study, patients who had received either REDACT or placebo (sugar pills) for periods of two weeks to 16 months were examined. Three out of 132 patients (2.3%) who had taken REDACT and two out of 77 patients (2.6%) who had taken placebo were found to have heart valve disease. You should discuss this further with your doctor.

Will REDACT change the way I need to take my nutritional supplements?

Non-drug nutritional supplements, like vitamins, minerals and amino acids (with the exception of tryptophan) can be used along with REDACT. You should make sure your doctor knows what nutritional supplements you are taking and why you are taking them. You should not take REDACT if you are taking tryptophan. You should not use herbal or over-the-counter weight-loss products while taking REDACT.

What about drinking alcoholic beverages?

REDACT may increase the sedative effects of alcohol. It is important that you let your doctor know how often, and what type of alcoholic beverages you drink. Your doctor can advise you best as to whether you should drink alcoholic beverages while on REDACT.

What about drinking coffee, tea and caffeinated beverages?

REDACT can be safely taken with moderate use of coffee, tea or caffeinated beverages. You should check with your doctor to make sure that you do not have a medical condition that can be aggravated by these beverages independent of being on REDACT. You should check with your doctor if you consume a great deal of caffeinated beverages or use over-the-counter pills that contain caffeine.

What if I develop allergic reactions?

Stop taking REDACT and notify your doctor immediately if you develop a skin rash, hives or other allergic reactions.

What if I am pregnant or nursing?

REDACT should not be used by pregnant women or nursing mothers. You should notify your doctor immediately if you become pregnant or plan to become pregnant.

What about sexual activity and potential pregnancy?

Women of child bearing potential should use an effective birth control method while taking REDACT. Check with your doctor to make sure you are on a medically safe and effective birth control method while taking REDACT.

Will REDACT affect the effectiveness of birth control pills?

No.

What about driving a car or dangerous work activities?

REDACT should not interfere with your ability to drive your car. However, you should be on the alert for any signs of fatigue, sedation, or lack of alertness. You should be very careful about using alcohol before you drive as REDACT may increase the sedative effects of alcohol.

REDACT was studied in healthy people and did not affect their coordination or impair their judgment. However, REDACT has the potential to impair judgment, thinking, coordination or motor skills. You should check with your doctor if you have any questions with regard to your work and the use of REDACT.

How should I keep and use REDACT?

REDACT should be stored at normal room temperature (about 60 to 85°F). Never leave REDACT in hot or moist places.

It is important to keep REDACT in a safe area where children cannot get it.

If your child swallows REDACT, immediately speak with your doctor and/or take your child to the emergency room for immediate medical attention. If you are unable to reach a doctor or emergency room, call the poison control center at 1-800-222-1222.

Never take more REDACT than prescribed by your doctor.

You should never share REDACT with a friend.