Prelu-2 (Oral)

Phendimetrazine is used as part of a short-term plan, together with a low calorie diet, for weight loss. It is for obese patients who have not been able to lose weight through diet and exercise alone. Phendimetrazine is in a group of medicines called appetite suppressants.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and does not cause any unwanted effects.

Do not use phendimetrazine if you are also taking similar medicines, such as benzphetamine, diethylpropion, mazindol, phentermine, Didrex®, or Suprenza™. Also, do not use this medicine if you have taken an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® in the past 14 days. Using these medicines together may cause serious unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use effective birth control to avoid getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor immediately.

This medicine may be habit-forming. If you think this medicine is not working properly after taking it for a few weeks, do not increase the dose. Instead, talk to your doctor.

Stop using this medicine and contact your doctor right away if you notice a decrease in your ability to exercise, if you faint, or if you experience chest pain, swelling of your feet or lower legs, or trouble breathing. These may be signs of a very serious heart or lung problem.

This medicine may cause some people to feel dizzy, lightheaded, or less alert than usual. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert.

Do not stop using this medicine unless your doctor instructs you to. If you suddenly stop using this medicine, you may feel very tired and depressed.

For diabetic patients: This medicine may affect blood sugar levels. If you notice a change in your blood or urine sugar test results or if you have any questions, consult your doctor.

Avoid drinking alcohol while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.

In deciding to use this medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how phendimetrazine extended-release capsules affect children younger than 17 years of age. Its safety and effectiveness have not been established.

There have not been appropriate studies on how phendimetrazine tablets affect children. Its safety and effectiveness have not been established.

Phendimetrazine slow-release capsules are not recommended for children younger than 12 years of age.

Geriatric

Current studies have not shown any specific problems for elderly patients that would limit the usefulness of phendimetrazine extended-release capsules. However, older adults are more likely to have kidney issues related to aging, which may require caution and dosage adjustments for those taking phendimetrazine extended-release capsules.

There is no information available on how phendimetrazine slow release capsules and tablets affect older patients.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are chosen for their potential significance and are not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication for you or change some of the other medicines you are taking.

• Brofaromine
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Sibutramine
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Iobenguane I 131
• Venlafaxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Agitated state or
• Advanced arteriosclerosis (hardening of the arteries) or
• History of drug abuse or dependence or
• Glaucoma or
• Heart or blood vessel disease (e.g., arrhythmia, congestive heart failure, coronary artery disease, stroke) or
• Heart problems (e.g., heart murmur, valvular heart disease) or
• Uncontrolled hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• History of pulmonary hypertension—Should not be used in patients with these conditions.

• Diabetes or
• Controlled hypertension (high blood pressure)—Use with caution. May worsen these conditions.

• Kidney disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its benefits, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need to see a doctor.

Check with your doctor right away if you experience any of the following side effects:

Rare

• Seeing, hearing, or feeling things that are not real
• severe changes in mental state

Incidence not known

• Anxiety
• burning sensation while urinating
• chest pain or discomfort
• reduced ability to exercise
• difficult or painful urination
• dizziness
• dry mouth
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling warm
• headache
• breathing rapidly
• increased urge to urinate
• irritability
• nausea
• numbness or tingling in arms or legs
• pain or discomfort in arms, jaw, back, or neck
• urinating more often
• redness of the face, neck, arms, and sometimes upper chest
• restlessness
• shaking in legs, arms, hands, or feet
• shortness of breath
• sweating
• swelling in feet or lower legs
• trembling or shaking hands or feet
• difficulty breathing
• trouble sleeping
• difficulty thinking, speaking, or walking
• vomiting
• weakness

Get emergency help immediately if you notice any of the following symptoms of overdose:

Symptoms of overdose

• Abdominal or stomach cramps
• blurred vision
• change in consciousness
• convulsions
• diarrhea
• feeling discouraged
• dizziness, faintness, or lightheadedness when getting up quickly from lying or sitting
• fast, slow, or irregular heartbeat
• feeling sad or empty
• loss of appetite
• lightheadedness
• loss of consciousness
• loss of interest or pleasure
• overactive reflexes
• panic
• physical attempts to harm oneself
• pounding sound in the ears
• rapid breathing
• sweating
• tiredness
• difficulty concentrating
• unusual tiredness or weakness
• violent behavior

Some side effects may occur that usually do not require medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional may also have ways to help prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

Incidence not known

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• trouble having or maintaining an erection
• increased sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• decreased sexual ability, desire, drive, or performance
• sleeplessness
• stomach pain
• inability to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Bontril
• Bontril PDM
• Bontril Slow-Release
• Melfiat
• Obezine
• Phendiet
• Phendiet-105
• Prelu-2

Available Dosage Forms:

• Capsule, Extended Release
• Tablet

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Phendimetrazine

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine is available in 3 forms: extended-release capsules, slow-release capsules, and tablets. Ask your doctor which dosage form is right for you.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For weight loss: For oral dosage form (extended-release capsules): Adults and teenagers 17 years of age and older—One capsule or 105 milligrams (mg) once a day, taken 30 to 60 minutes before the morning meal. Children younger than 17 years of age—Use and dose must be determined by your doctor. For oral dosage form (slow-release capsules): Adults and teenagers—One capsule or 105 milligrams (mg) once a day, taken 30 to 60 minutes before the morning meal. Children younger than 12 years of age—Use is not recommended. For oral dosage form (tablets): Adults—One tablet or 35 milligrams (mg) two or three times a day, taken one hour before meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2 tablets three times a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.