Diethylpropion Hydrochloride ER (Page 3 of 3)

Pediatric Use

Since safety and effectiveness in pediatric patients below the age of 16 have not been established, diethylpropion hydrochloride extended release tablets, 75 mg is not recommended for use in pediatric patients 16 years of age and under.

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 extended release tablets, 75 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.

DRUG ABUSE AND DEPENDENCE

Diethylpropion hydrochloride extended release tablets, 75 mg are schedule IV controlled substances. Diethylpropion hydrochloride has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused. There have been reports of subjects becoming psychologically dependent on diethylpropion. The possibility of abuse should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with varying degrees of psychologic dependence and social dysfunction which, in the case of certain drugs, may be severe. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

OVERDOSAGE

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, and mydriasis. Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include tachycardia, arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdose of pharmacologically similar compounds has resulted in convulsions, coma and death.

The reported oral LD50 for mice is 600 mg/kg, for rats is 250 mg/kg and for dogs is 225 mg/kg.

Management of acute diethylpropion hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Intravenous phentolamine has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates diethylpropion hydrochloride extended release tablets, 75 mg overdosage.

DOSAGE AND ADMINISTRATION

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg:

One extended-release 75 mg tablet daily, swallowed whole, in midmorning.

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).

HOW SUPPLIED

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are supplied in bottles of 28 (NDC 17224-360-10). Each white to off-white capsule-shaped tablet is debossed “LCI” on one side and “1477” on the other side. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed and protect from excessive heat.

Distributed by:

CALVIN, SCOTT AND COMPANY, INCORPORATED

209 Eubank Blvd NE # B, Albuquerque, NM 87123, USA

PRINCIPAL DISPLAY PANEL

NDC 17224-360-10

Diethylpropion Hydrochloride Extended Release Tablets

CIV

75 mg

Rx Only

28 TABLETS

Diethylpropion
(click image for full-size original)

DIETHYLPROPION HYDROCHLORIDE ER
diethylpropion hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17224-360(NDC:0527-1477)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIETHYLPROPION HYDROCHLORIDE (DIETHYLPROPION) DIETHYLPROPION HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CARBOMER HOMOPOLYMER TYPE A
TARTARIC ACID
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
POVIDONE K30
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code LCI;1477
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17224-360-10 28 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091680 10/24/2011
Labeler — CALVIN, SCOTT AND COMPANY, INCORPORATED (073404626)
Registrant — CALVIN, SCOTT AND COMPANY, INCORPORATED (073404626)
Establishment
Name Address ID/FEI Operations
CALVIN, SCOTT AND COMPANY, INCORPORATED 073404626 repack (17224-360)

Revised: 11/2019 CALVIN, SCOTT AND COMPANY, INCORPORATED

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