PHENDIMETRAZINE TARTRATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

PHENDIMETRAZINE TARTRATE (UNII: 6985IP0T80) (PHENDIMETRAZINE - UNII:AB2794W8KV)

Dostupné s:

Apotheca Inc.

INN (Mezinárodní Name):

PHENDIMETRAZINE TARTRATE

Složení:

PHENDIMETRAZINE TARTRATE 35 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Phendimetrazine tartrate tablets 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 who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (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 ÷ 2.2 = kg; inches × 0.0254 = meters. Weight Height (feet, inches) (pounds) 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 Phendimetrazine tartrate is indicated

Přehled produktů:

Each yellow, round tablet contains 35 mg phendimetrazine tartrate, and is debossed "T" on one side and "3" score "5" on the other side. Tablets are supplied in bottles of: NDC 12634-539-00 Bottles of 10 NDC 12634-539-01 Bottles of 100 NDC 12634-539-09 Bottles of 35 NDC 12634-539-40 Bottles of 40 NDC 12634-539-42 Bottles of 42 NDC 12634-539-45 Bottles of 45 NDC 12634-539-50 Bottles of 50 NDC 12634-539-52 Blister Pack of 12 NDC 12634-539-54 Blister Pack of 14 NDC 12634-539-57 Blister Pack of 20 NDC 12634-539-58 Blister Pack of 28 NDC 12634-539-59 Blister Pack of 30 NDC 12634-539-60 Bottles of 60 NDC 12634-539-61 Blister Pack of 10 NDC 12634-539-63 Blister Pack of 3 NDC 12634-539-66 Blister Pack of 6 NDC 12634-539-67 Blister Pack of 7 NDC 12634-539-69 Blister Pack of 9 NDC 12634-539-71 Bottles of 30 NDC 12634-539-74 Bottles of 24 NDC 12634-539-78 Bottles of 28 NDC 12634-539-79 Bottles of 25 NDC 12634-539-80 Bottles of 20 NDC 12634-539-81 Bottles of 21 NDC 12634-539-82 Bottles of 12 NDC 12634-539-84 Bottles of 14 NDC 12634-539-85 Bottles of 15 NDC 12634-539-90 Bottles of 90 NDC 12634-539-91 Blister Pack of 1 NDC 12634-539-92 Bottles of 2 NDC 12634-539-93 Bottles of 3 NDC 12634-539-94 Bottles of 4 NDC 12634-539-95 Bottles of 5 NDC 12634-539-96 Bottles of 6 NDC 12634-539-97 Bottles of 7 NDC 12634-539-98 Bottles of 8 NDC 12634-539-99 Bottles of 9

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

PHENDIMETRAZINE TARTRATE- PHENDIMETRAZINE TARTRATE TABLET
APOTHECA INC.
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DESCRIPTION
Phendimetrazine tartrate, as the dextro isomer, has the chemical name
of (2 _S_, 3 _S_)-3, 4-Dimethyl-2-
phenylmorpholine L-(+)-tartrate (1:1).
The structural formula is:
Phendimetrazine tartrate is a white, odorless crystalline powder. It
is freely soluble in water; sparingly
soluble in warm alcohol, insoluble in chloroform, acetone, ether and
benzene.
Each tablet, for oral administration, contains 35 mg of
phendimetrazine tartrate. In addition, each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, croscarmellose sodium, dibasic
calcium phosphate dihydrate, magnesium stearate, microcrystalline
cellulose and FD&C Yellow #6,
D&C Yellow #10 as coloring.
CLINICAL PHARMACOLOGY
Phendimetrazine tartrate is a sympathomimetic amine with
pharmacological activity similar to the
prototype drugs of this class used in obesity, the amphetamines.
Actions include central nervous system
stimulation and elevation of blood pressure. Tachyphylaxis and
tolerance have 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. Other central nervous system actions or metabolic
effects, may be involved for example.
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 is only a
fraction of a pound a week. 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