Tenuate Dospan (Oral)

Diethylpropion is used as part of a short-term plan, along with a low calorie diet, to help with weight loss. It is for obese patients who have not been able to lose weight just by dieting and exercising. Diethylpropion is part of 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 make sure this medicine is working properly and does not cause any unwanted effects.

Do not use diethylpropion if you are also using similar medicines such as benzphetamine, mazindol, phendimetrazine, phentermine, Bontril®, 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.

This medicine may be habit-forming. If you think this medicine is not working properly after taking it for 4 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 in 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.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures (such as barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

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.

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, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

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 about any other types of allergies, such as those 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 diethylpropion affects children younger than 17 years of age. Safety and effectiveness have not been established for this age group.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of diethylpropion. However, older patients are more likely to have kidney problems related to aging, which may require caution and a dose adjustment for those taking diethylpropion.

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 not be used together at all, while in other cases, two different medicines may be used together even if there is a risk of interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are significant and may not be all-inclusive.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Iobenguane I 131
• Venlafaxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtimes or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any additional medical problems, especially:

• Agitated state or
• Advanced arteriosclerosis (hardening of the arteries) or
• History of drug abuse or dependence or
• Glaucoma or
• Heart problems (e.g., heart murmur, valvular heart disease) or
• Severe hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Pulmonary hypertension (increased blood pressure in the lungs)—This medicine should not be used in patients with these conditions.

• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Mild to moderate hypertension (high blood pressure) or
• Mental illness or
• Seizures or epilepsy—Use with caution. This medicine may exacerbate these conditions.

• Kidney disease—Use with caution. Higher blood levels of diethylpropion can occur, increasing the risk of serious side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

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

Rare

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

Incidence not known

• Black, tarry stools
• blurred vision
• burning while urinating
• chest pain
• chills
• convulsions
• cough or hoarseness
• decreased ability to exercise
• depression
• difficult or labored breathing
• difficult or painful urination
• dizziness
• fainting
• false or unusual sense of well-being
• fast, slow, pounding, or irregular heartbeat or pulse
• fear or nervousness
• fever with or without chills
• frequent urination
• general feeling of tiredness or weakness
• headache
• inability to speak
• increased volume of pale, dilute urine
• lower back or side pain
• nosebleeds
• numbness or tingling in the face, arms, or legs
• restlessness
• severe or sudden headache
• shakiness in the legs, arms, hands, or feet
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the feet or lower legs
• swollen glands
• temporary blindness
• tightness in the chest
• trembling or shaking of the hands or feet
• trouble with breathing
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision problems
• weakness in the arm or leg on one side of the body, sudden and severe
• wheezing

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

Symptoms of overdose

• Abdominal or stomach cramps
• bigger, dilated, or enlarged pupils (black part of the eye)
• change in consciousness
• confusion
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• increased sensitivity of the eyes to light
• loss of consciousness
• nausea
• overactive reflexes
• panic
• physical attempt to injure
• restlessness
• sweating
• violent actions
• vomiting

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 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 or are bothersome or if you have any questions about them:

Incidence not known

• Abdominal or stomach discomfort
• bruising
• difficulty having a bowel movement (stool)
• drowsiness
• dry mouth
• general feeling of discomfort or illness
• hair loss
• headache
• hives or welts
• indigestion
• itching
• large, flat, blue, or purplish patches in the skin
• loss of appetite
• muscle pain
• passing of gas
• redness of the skin
• skin rash
• sleeplessness
• stomach fullness or discomfort
• trouble sleeping
• unable to sleep
• unpleasant taste

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.

• Tenuate
• Tenuate Dospan

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Diethylpropion

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 two forms: the immediate-release tablets and the controlled-release tablets. Ask your doctor which dosage form is right for you.

Swallow the controlled-release tablets whole. Do not break, crush, 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 treatment of obesity:For oral dosage form (immediate-release tablets): Adults and teenagers 17 years of age and older—25 milligrams (mg) three times a day, taken one hour before meals, and in mid evening to overcome night hunger. Children 16 years of age and younger—Use is not recommended. For oral dosage form (controlled-release tablets): Adults and teenagers 17 years of age and older—75 milligrams (mg) once a day, taken usually in mid morning. Children 16 years of age and younger—Use is not recommended.

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.