Pronunciation:

dye-eth-il-PROE-pee-on hye-droe-KLOR-ide

Brand Names:

• Tenuate
• Tenuate Dospan

Dosage Forms:

• Tablet, Extended Release
• Tablet

Classifications:

Therapeutic—

Appetite Suppressant, Centrally Acting

Chemical—

Diethylpropion

Uses of This Medicine:

Diethylpropion is used as part of a short-term plan, along with a low calorie diet, for weight reduction. It is used in obese patients who have not been able to lose weight with diet and exercise alone. Diethylpropion belongs to the group of medicines known as appetite suppressants.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of diethylpropion in children younger than 17 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diethylpropion in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving diethylpropion.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iobenguane I 131
• Venlafaxine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Agitated state or
• Arteriosclerosis (hardening of the arteries), advanced or
• Drug abuse or dependence, history of or
• Glaucoma or
• Heart problems (e.g., heart murmur, valvular heart disease) or
• Hypertension (high blood pressure), severe or
• Hyperthyroidism (overactive thyroid) or
• Pulmonary hypertension (increased blood pressure in the lungs)—Should not be used in patients with these conditions.

• Heart or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure), mild to moderate or
• Mental illness or
• Seizures or epilepsy—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that 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 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.

This medicine may be habit-forming. If you think this medicine is not working properly after you have taken 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 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 are normally. 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.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine 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 the results of your blood or urine sugar tests 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.

Side Effects of This Medicine:

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

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 immediately 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.