Diethylpropion

The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and TENUATE or TENUATE DOSPAN. (See WARNINGS.) The patient should be advised to observe caution when driving or engaging in any potentially hazardous activity.

Taking diethylpropion in combination with other diet pills or appetite suppressants can cause serious or life threatening medical problems. Do not use any other diet medications while taking diethylpropion, unless your doctor tells you to.

You should not take this medication if you are allergic to diethylpropion or if you have pulmonary hypertension, severe coronary artery disease, glaucoma, overactive thyroid, uncontrolled high blood pressure, a history of drug or alcohol addiction, if you are agitated, or if you are taking any other diet pills.

Do not use diethylpropion if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before you take diethylpropion, tell your doctor if you have a heart murmur, heart valve disorder, heart rhythm disorder, epilepsy, or if you have taken other diet pills within the past 12 months.

This medication may cause blurred vision and may impair your thinking or reactions. Diethylpropion may also cause restless feelings that can hide the symptoms of extreme tiredness. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Diethylpropion may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not stop using diethylpropion suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using diethylpropion.

Taking diethylpropion in combination with other diet pills or appetite suppressants can cause serious or life threatening medical problems. Do not use any other diet medications while taking diethylpropion, unless your doctor tells you to.

You should not take this medication if you are allergic to diethylpropion or if you have pulmonary hypertension, severe coronary artery disease, glaucoma, overactive thyroid, uncontrolled high blood pressure, a history of drug or alcohol addiction, if you are agitated, or if you are taking any other diet pills.

Do not use diethylpropion if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before you take diethylpropion, tell your doctor if you have a heart murmur, heart valve disorder, heart rhythm disorder, epilepsy, or if you have taken other diet pills within the past 12 months.

This medication may cause blurred vision and may impair your thinking or reactions. Diethylpropion may also cause restless feelings that can hide the symptoms of extreme tiredness. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Diethylpropion may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not stop using diethylpropion suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using diethylpropion.

Tell your doctor about all other medicines you use, especially:

• insulin or oral diabetes medication;

• blood pressure medication; or

• stimulants, cold or allergy medicines, ADHD (attention deficit hyperactivity disorder) medicine such as Adderall or Ritalin.

This list is not complete and other drugs may interact with diethylpropion. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

In the U.S.

• Tenuate
• Tenuate Dospan

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Diethylpropion

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.

diethylpropion is available only with your doctor's prescription.

Diethylpropion hydrochloride tablets USP, 25 mg should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products.

In a case-control epidemiological study, the use of anorectic agents, including Diethylpropion, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than 3 months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Diethylpropion hydrochloride tablets USP, 25 mg should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. Valvulopathy has been very rarely reported with Diethylpropion hydrochloride tablets USP, 25 mg monotherapy, but the causal relationship remains uncertain. The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect preexisting valvular heart diseases or pulmonary hypertension prior to initiation of Diethylpropion hydrochloride tablets USP, 25 mg treatment. Diethylpropion hydrochloride tablets USP, 25 mg are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur.

To limit unwarranted exposure and risks, treatment with Diethylpropion hydrochloride tablets USP, 25 mg should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds, or as determined by the physician and patient).

Diethylpropion hydrochloride tablets USP, 25 mg are not recommended for patients who used any anorectic agents within the prior year.

If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. Diethylpropion hydrochloride tablets USP, 25 mg may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Prolonged use of Diethylpropion hydrochloride may induce dependence with withdrawal syndrome on cessation of therapy. Hallucinations have occurred rarely following high doses of the drug. Several cases of toxic psychosis have been reported following the excessive use of the drug and some have been reported in which the recommended dose appears not to have been exceeded. Psychosis abated after the drug was discontinued.

When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.

Diethylpropion Hydrochloride Tablets USP, 25 mg are supplied in bottles of 100 (NDC 0527-1475-01).

Each white to off-white round flat-faced beveled edge tablet is debossed "LCI" on one side and "1475" on the other side.

Keep tightly closed. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

Protect from excessive heat.

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19154

CIB70602C
Rev. 08/17

(dye eth il PROE pee on)

• Anorexiant
• Central Nervous System Stimulant
• Sympathomimetic

Diethylpropion is a sympathomimetic amine with pharmacologic properties similar to the amphetamines. It is also structurally similar to bupropion. The mechanism of action in reducing appetite appears to be secondary to CNS effects, including stimulation of the hypothalamus to release norepinephrine

Metabolism

Forms active metabolites via N-dealkylation and reduction

Excretion

Urine

Half-Life Elimination

Aminoketone metabolites: ∼4-6 hours

Most effective when combined with a low calorie diet and behavior modification counseling. Take immediate release tablet 1 hour before meals or food.

IMMEDIATE-RELEASE: 25 mg orally 3 times a day, 1 hour before meals, and in mid-evening if desired to overcome night hunger.

CONTROLLED-RELEASE: 75 mg orally once a day in mid-morning, swallowed whole.

Comments:
-Indicated for monotherapy use only.
-Treatment should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds or as determined by the physician and patient).
-Discontinue treatment if tolerance develops; do not exceed the recommended dose in an attempt to increase the effect.

Use: Management of exogenous obesity as a short-term adjunct (a few weeks) on a regimen of weight reduction based on caloric restriction in patients with an initial BMI of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Data not available

General:
-The possibility of abuse should be kept in mind when evaluating the desirability of including this drug as part of a weight reduction program. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, personality changes, and psychosis.
-Management of acute overdosage is largely symptomatic and includes lavage and sedation with a barbiturate. IV phentolamine may be considered if severe hypertension occurs. Experience with hemodialysis and peritoneal dialysis is inadequate in this regard.
-Prolonged use may induce dependence with withdrawal syndrome once treatment is discontinued.

Monitoring:
-Cardiovascular: Cardiac evaluation (baseline/prior to treatment initiation). echocardiogram (during and after treatment), blood pressure
-Metabolic: Weight, waist circumference
-Renal: Renal function (in elderly patients and patients with renal impairment)

Patient advice:
-This drug may cause symptoms including dizziness, drowsiness, and vision problems; avoid driving and other activities such as operating machinery until you know how this drug affects you.
-Avoid drinking alcohol while taking this drug.