DIETHYLPROPION HYDROCHLORIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)

Dostępny od:

NuCare Pharmaceuticals,Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Diethylpropion hydrochloride is 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 x 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 is indicated for use as monotherapy only. 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. Diethylpropion hydrochloride is a schedule IV controlled substance. 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.

Podsumowanie produktu:

25 mg immediate-release tablets in bottles of 30, 60 and 100. Bottles of 30, NDC 68071-3400-3 Bottles of 28 , NDC 68071-3400-8 Bottles of 21 , NDC 68071-3400-1 Bottles of 14 , NDC 68071-3400-7 Bottles of 112 , NDC 68071-3400-0 Bottles of 84 , NDC 68071-3400-8 Each white to off white, round flat tablets debossed “K 44” on one side and plain on the other side. Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx only Manufactured by: KVK-TECH, INC. 110 Terry Dr. Suite 200 Newtown, PA 18940-1850 Item ID # 6129/03 01/11 Manufacturer’s Code: 10702

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DIETHYLPROPION HYDROCHLORIDE- DIETHYLPROPION HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
DIETHYLPROPION HCL USP CIV25 MG TABLETS
RX ONLY
DESCRIPTION
Diethylpropion hydrochloride is available for oral administration in
immediate-release
tablets containing 25 mg diethylpropion hydrochloride. The inactive
ingredients in each
immediate-release tablet are: crospovidone, lactose anhydrous,
magnesium stearate,
starch pregelatinized and tartaric acid. Diethylpropion hydrochloride
is a
sympathomimetic agent. The chemical name for diethylpropion
hydrochloride is 1-
phenyl-2-diethylamino-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 amo