Diethylpropion (oral route)


    Brand Name

    US Brand Name

    Tenuate

    Tenuate Dospan


    Description

    Diethylpropion is used for weight reduction in patients with obesity. This medicine works by suppressing your appetite.

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

    This product is available in the following dosage forms:

    • Tablet, Extended Release
    • Tablet

    Before Using

    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.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of diethylpropion in children 16 years of age and younger. Safety and efficacy have not been established.

    Geriatric

    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, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving diethylpropion.

    Breastfeeding

    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.

    Drug Interactions

    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:

    • Agitation or anxiety, severe or
    • Arteriosclerosis (hardening of the arteries), advanced or
    • Drug use disorder or dependence, history of or
    • Glaucoma or
    • Heart or blood vessel disease or
    • Heart problems (eg, 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.
    • Hypertension (high blood pressure), mild to moderate—Use with caution. May make these conditions worse.

    Proper Use

    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 extended-release tablets. Ask your doctor which dosage form is right for you.

    Take the immediate-release tablets 1 hour before meals.

    Swallow the extended-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 weight loss:
      • For oral dosage form (immediate-release tablets):
        • Adults and children 17 years of age and older—25 milligrams (mg) 3 times a day.
        • Children 16 years of age and younger—Use is not recommended.
      • For oral dosage form (extended-release tablets):
        • Adults and children 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

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    Do not use this medicine if you are also using similar medicines including benzphetamine, mazindol, phendimetrazine, phentermine, Bontril®, or Didrex®. Do not use this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), linezolid (Zyvox®), phenelzine (Nardil®), selegiline (Eldepryl®), tranylcypromine (Parnate®) within the past 14 days.

    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.

    This medicine may cause pulmonary hypertension (increased blood pressure in the lungs). Serious heart or blood vessel problems (eg, valvular heart disease) may also occur if you take more of it, if you take it for a longer time, or if you are taking other medicine that reduces appetite (eg, dexfenfluramine (Redux®), fenfluramine (Fintepla®)). Check with your doctor right away if you have chest pain, decreased ability to exercise, fainting, swelling of the feet or lower legs, or trouble breathing.

    If you will be taking this medicine for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

    This medicine may cause some people to become dizzy, lightheaded, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    This medicine may increase the risk of seizures. Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of extremities, or sudden loss of consciousness.

    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 (including 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.

    Symptoms of an overdose include: dilated or enlarged pupils, confusion, panic, restlessness, seeing, hearing, or feeling things that are not there, trembling or shaking in the legs, arms, hands, or feet.

    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

    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
    • trouble breathing

    Incidence not known

    • Black, tarry stools
    • blurred vision
    • burning while urinating
    • chest pain or tightness
    • chills
    • 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
    • seizures
    • 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
    • trembling or shaking of the hands or feet
    • 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

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

    Symptoms of overdose

    • 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
    • stomach cramps
    • 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

    • 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.






    CON-XXXXXXXX

    Your gift holds great power – donate today!

    Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine.