Phendiet-105 (Oral)

Phendimetrazine is used as part of a short-term plan, along with a low-calorie diet, to help with weight loss. It is meant for obese patients who have not been able to lose weight with diet and exercise by themselves. 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 using 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 pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using the medicine, tell your doctor right away.

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, consult your doctor.

Stop using this medicine and check with your doctor right away if you notice a decrease in your ability to exercise, if you faint, or if you have chest pain, swelling of your feet or lower legs, or trouble breathing. These may be symptoms 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 you react to this medicine 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 tells 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, check with your doctor.

Avoid drinking alcohol while using this medicine.

Do not take other medicines unless your doctor has discussed them with you. 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 a medicine, it is important to consider the risks against the benefits. This is a decision you will make with your doctor. For this medicine, you should think about the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you have, 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. Safety and effectiveness have not been established.

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

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

Geriatric

Current studies have not shown any geriatric-specific problems that would limit the usefulness of phendimetrazine extended-release capsules in older adults. However, elderly patients are more likely to have kidney issues related to aging, which may require caution and a dose adjustment 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 adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the following medicines while using this medicine. The following interactions are significant and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of your other medicines.

• 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 adjust the dose or how often you use one or both medicines.

• Iobenguane I 131
• Venlafaxine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Agitated state or
• Arteriosclerosis (hardening of the arteries), advanced or
• History of drug abuse or dependence or
• Glaucoma or
• History of 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 increased because the medicine may be removed from the body more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Rare

• Seeing, hearing, or feeling things that are not there
• severe mental changes

Incidence not known

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

Get emergency help right away if any of the following overdose symptoms occur:

Symptoms of overdose

• Abdominal or stomach cramps
• blurred vision
• change in consciousness
• convulsions
• diarrhea
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, or irregular heartbeat
• feeling sad or empty
• lack of appetite
• lightheadedness
• loss of consciousness
• loss of interest or pleasure
• overactive reflexes
• panic
• physical attempt to injure
• pounding in the ears
• rapid breathing
• sweating
• tiredness
• trouble with concentrating
• unusual tiredness or weakness
• violent actions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• inability to have or keep an erection
• increased sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• loss of sexual ability, desire, drive, or performance
• sleeplessness
• stomach pain
• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with 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.