Obezine (Oral)

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

You can only get this medicine with a prescription from your doctor.

It is very important that your doctor checks your progress at regular visits to make sure 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 used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within 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 an effective form of birth control to avoid getting pregnant. 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 you have taken it for a few weeks, do not increase the dose. Instead, check with 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 with breathing. These may be symptoms of a very serious heart or lung problem.

This medicine may cause some people to become dizzy, lightheaded, or less alert than they normally are. Make sure you know how you react to this medicine before you drive, use machines, or do 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 the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Avoid drinking alcohol while you are 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 a medicine, it's important to weigh the risks against the benefits. This is a decision you will make with your doctor. For this medicine, consider the following:

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 over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how effective phendimetrazine extended-release capsules are in children under 17 years old. Safety and effectiveness have not been established.

Studies have not been done to determine how effective phendimetrazine tablets are in children. Safety and effectiveness have not been established.

Phendimetrazine slow-release capsules are not recommended for children under 12 years old.

Geriatric

Studies so far have not shown any specific problems for elderly patients that would limit the use of phendimetrazine extended-release capsules. However, older adults are more likely to have kidney problems related to aging, which may need careful monitoring and dose adjustments for those taking phendimetrazine extended-release capsules.

There is no information about 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 during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be taken together even if interactions could happen. In these cases, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been chosen based on their potential importance and are not necessarily comprehensive.

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

• 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 needed in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Iobenguane I 131
• Venlafaxine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to 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. Be sure to tell 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
• 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 stronger because the body may remove the medicine more slowly.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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 occasionally, 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 immediately if any of the following symptoms of overdose 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. Your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.