DIETHYLPROPION HYDROCHLORIDE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Diethylpropion hydrochloride tablets USP, 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/m2 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. 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 USP, 25 mg are indicated for use as monotherapy only. Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sy
Product summary:
Product: 63629-8215 NDC: 63629-8215-1 30 TABLET in a BOTTLE NDC: 63629-8215-2 90 TABLET in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
63629-8215-1, 63629-8215-2

DIETHYLPROPION HYDROCHLORIDE- diethylpropion hydrochloride tablet

Bryant Ranch Prepack

----------

Diethylpropion Hydrochloride Tablets USP, 25 mg

CIV

Rx only

DESCRIPTION

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:

CLINICAL PHARMACOLOGY

Diethylpropion hydrochloride is a sympathomimetic amine with some pharmacologic activity similar to

that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central

nervous system stimulation and elevation of blood pressure. Tolerance has been demonstrated with all

drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not

been established, however, that the action of such drugs in treating obesity is primarily one of appetite

suppression. For example, other central nervous system actions or metabolic effects may be involved.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more

weight on the average than those treated with placebo and diet, as determined in relatively short-term

clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients averages

some fraction of a pound a week. However, individual weight loss may vary substantially from patient to

patient. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo

subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss

due to the various drug effects are not established. The amount of weight loss associated with the use

of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in

part to variables other than the drug prescribed, such as the physician/investigator relationship, the

population treated, and the diet prescribed. Studies do not permit conclusions as to the relative

importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas most studies cited are restricted to a few

weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone is unknown.

Diethylpropion is rapidly absorbed from the GI tract after oral administration and is extensively

metabolized through a complex pathway of biotransformation involving N-dealkylation and reduction.

Many of these metabolites are biologically active and may participate in the therapeutic action of

diethylpropion hydrochloride tablets USP, 25 mg. Due to the varying lipid solubilities of these

metabolites, their circulating levels are affected by urinary pH. Diethylpropion and/or its active

metabolites are believed to cross the blood-brain barrier and the placenta.

Diethylpropion and its metabolites are excreted mainly by the kidney. It has been reported that between

75-106% of the dose is recovered in the urine within 48 hours after dosing. Using a phosphorescence

assay that is specific for basic compounds containing benzoyl group, the plasma half-life of the

aminoketone metabolites is estimated to be between 4 to 6 hours.

INDICATIONS AND USAGE

Diethylpropion hydrochloride tablets USP, 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 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

Weight

(pounds )

Height (feet, inches)

5'0"

5'3"

5'6"

5'9"

6'0"

6'3"

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 USP, 25 mg are indicated for use as monotherapy only.

CONTRAINDICATIONS

Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or

2

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.

WARNINGS

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.

PRECAUTIONS

General

Caution is to be exercised in prescribing diethylpropion hydrochloride tablets USP, 25 mg for patients

with hypertension or with symptomatic cardiovascular disease, including arrhythmias. Diethylpropion

hydrochloride tablets USP, 25 mg should not be administered to patients with severe hypertension.

Reports suggest that diethylpropion hydrochloride may increase convulsions in some epileptics.

Therefore, epileptics receiving diethylpropion hydrochloride tablets USP, 25 mg should be carefully

monitored. Titration of dose or discontinuance of diethylpropion hydrochloride tablets USP, 25 mg may

be necessary.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the

possibility of overdosage.

Information for Patient

The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and

diethylpropion hydrochloride tablets USP, 25 mg (See WARNINGS). The patient should be advised to

observe caution when driving or engaging in any potentially hazardous activity.

Laboratory Tests

None

Drug Interactions

Because diethylpropion hydrochloride tablets USP, 25 mg are monoamines, hypertension may result

when either agent is used with monoamine oxidase (MAO) inhibitors (See CONTRAINDICATIONS).

Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may

have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic

agents is contraindicated.

Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics

may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be

additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with

antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may

antagonize the anorectic effect of diethylpropion.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

No long-term animal studies have been done to evaluate diethylpropion hydrochloride for

carcinogenicity. Mutagenicity studies have not been conducted. Animal reproduction studies have

revealed no evidence of impairment of fertility (See Pregnancy).

Pregnancy

Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at

doses up to 1.6 times the human dose (based on mg/m ) and have revealed no evidence of impaired

fertility or harm to the fetus due to diethylpropion hydrochloride. There are, however, no adequate and

well-controlled studies in pregnant women. Because animal reproduction studies are not always

predictive of human response, this drug should be used during pregnancy only if clearly needed.

Spontaneous reports of congenital malformations have been recorded in humans, but no causal

relationship to diethylpropion has been established.

Non-Teratogenic Effects. Abuse with diethylpropion hydrochloride during pregnancy may result in

withdrawal symptoms in the human neonate.

Nursing Mothers

Since diethylpropion hydrochloride and/or its metabolites have been shown to be excreted in human

milk, caution should be exercised when diethylpropion hydrochloride tablets USP, 25 mg are

administered to a nursing woman.

Geriatric Use

Clinical studies of diethylpropion hydrochloride tablets USP, 25 mg did not include sufficient numbers

of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and

younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at

the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac

function, and of concomitant disease or other drug therapy.

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.

Pediatric Use

Since safety and effectiveness in pediatric patients below the age of 16 have not been established,

diethylpropion hydrochloride tablets USP, 25 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 tablets USP, 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.

DRUG ABUSE AND DEPENDENCE

Diethylpropion hydrochloride tablets USP, 25 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 LD 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 tablets USP, 25 mg overdosage.

DOSAGE AND ADMINISTRATION

Diethylpropion Hydrochloride Tablets USP, 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).

HOW SUPPLIED

Product: 63629-8215

NDC: 63629-8215-1 30 TABLET in a BOTTLE

NDC: 63629-8215-2 90 TABLET in a BOTTLE

DIETHYLPROPION HCL 25MG(CIV) TAB

DIETHYLPROPION HYDROCHLORIDE

diethylpropion hydrochloride tablet

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -

8 215(NDC:0 527-1475)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIETHYLPRO PIO N HYDRO CHLO RIDE (UNII: 19 V2PL39 NG) (DIETHYLPROPION -

UNII:Q9 4YYU22B8 )

DIETHYLPROPION

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

TARTARIC ACID (UNII: W48 8 8 I119 H)

MANNITO L (UNII: 3OWL53L36 A)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

TALC (UNII: 7SEV7J4R1U)

ZINC STEARATE (UNII: H9 2E6 QA4FV)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

ROUND (flat-faced beveled edge)

S iz e

10 mm

Flavor

Imprint Code

LCI;1475

Contains

Packag ing

Bryant Ranch Prepack

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 215-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /13/20 19

2

NDC:6 36 29 -8 215-2

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /13/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 0 177

0 7/18 /20 11

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 215) , RELABEL(6 36 29 -8 215)

Revised: 9/2019

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