Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Diethylpropion Hydrochloride Tablets, USP, 25 mg are supplied in bottles of 90 (NDC 62135-488-90). 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. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71297 Revised 03/2023; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Diethylpropion Hydrochloride Tablets USP, 25mg- NDC 62135-488-90- 90's Bottle Label image description
- HOW SUPPLIED Diethylpropion Hydrochloride Tablets, USP, 25 mg are supplied in bottles of 90 (NDC 62135-488-90). 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. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71297 Revised 03/2023
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Diethylpropion Hydrochloride Tablets USP, 25mg- NDC 62135-488-90- 90's Bottle Label image description
Overview
Diethylpropion Hydrochloride Tablets, USP, 25 mg are available for oral administration as tablets containing 25 mg diethylpropion hydrochloride, USP. The inactive ingredients in each tablet are: microcrystalline cellulose, lactose monohydrate, mannitol, tartaric acid, povidone, talc, and zinc stearate. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride. Its chemical structure is: image description
Indications & Usage
Diethylpropion hydrochloride tablets, 25 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches × 0.0254 = meters. Body Mass Index (BMI), kg/m 2 Weight (pounds) Height (feet, inches) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The usefulness of agents of this class (See CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride tablets, 25 mg are indicated for use as monotherapy only.
Dosage & Administration
Diethylpropion Hydrochloride Tablets, 25 mg: One 25 mg tablet three times daily, one hour before meals, and in midevening if desired to overcome night hunger. Geriatric use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See PRECAUTIONS , Geriatric Use ).
Warnings & Precautions
WARNINGS Diethylpropion hydrochloride tablets, 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, 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, 25 mg treatment. Diethylpropion hydrochloride tablets, 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, 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, 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, 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.
Contraindications
Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension (See PRECAUTIONS ). Agitated states. Patients with a history of drug abuse. Use in combination with other anorectic agents is contraindicated. During or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crises may result.
Adverse Reactions
Cardiovascular: Precordial pain, arrhythmia (including ventricular), ECG changes, tachycardia, elevation of blood pressure, palpitation and rare reports of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination, have been reported. Valvulopathy has been very rarely reported with diethylpropion hydrochloride tablets, 25 mg monotherapy, but the causal relationship remains uncertain. Central Nervous System: In a few epileptics an increase in convulsive episodes has been reported; rarely psychotic episodes at recommended doses; dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and cerebrovascular accident Gastrointestinal: Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation, other gastrointestinal disturbances Allergic: Urticaria, rash, ecchymosis, erythema Endocrine: Impotence, changes in libido, gynecomastia, menstrual upset Hematopoietic System: Bone marrow depression, agranulocytosis, leukopenia Miscellaneous: A variety of miscellaneous adverse reactions has been reported by physicians. These include complaints such as dysuria, dyspnea, hair loss, muscle pain, increased sweating, and polyuria.
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