PHENDIMETRAZINE TARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EPM Packaging Inc

INN (International Name):

PHENDIMETRAZINE TARTRATE

Composition:

PHENDIMETRAZINE TARTRATE 35 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phendimetrazine tartrate 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 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 x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m Height (feet, inches ) Weight(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 3

Product summary:

Phendimetrazine Tartrate Tablets , USP 35 mg are available as White, round, biconvex tablets debossed “K” above bisect “45” on one side and plain on the other side. Bottles of 30 NDC 10702-045-03 Bottles of 100 NDC 10702-045-01 Bottles of 1000 NDC 10702-045-10 Yellow, round, biconvex tablets debossed “K” above bisect “77” on one side and plain on the other side. Bottles of 30 NDC 10702-077-03 Bottles of 100 NDC 10702-077-01 Bottles of 1000 NDC 10702-077-10 Blue, round, biconvex tablets debossed “K” above bisect “78” on one side and plain on the other side. Bottles of 30 NDC 10702-078-03 Bottles of 100 NDC 10702-078-01 Bottles of 1000 NDC 10702-078-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. DEA Order Form Required. Manufactured by: KVK-TECH, INC. 110 Terry Drive Suite 200 Newtown, PA 18940-1850 Item ID # 006080/05 09/10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENDIMETRAZINE TARTRATE- PHENDIMETRAZINE TARTRATE TABLET
EPM PACKAGING INC
----------
PHENDIMETRAZINE
TARTRATE TABLETS,
USP 35 mg, CIII
Rx Only
Phendimetrazine tartrate, as the dextro isomer, has the chemical name
of (2S,3S)-3,4-Dimethyl-2-
phenylmorpholine L-(+)- tartrate (1:1).
The structural formula is:
C H NO•C H O M.W. 34 1.36
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 white tablet, for oral administration, contains 35 mg of
phendimetrazine tartrate. In addition, the
following inactive ingredients are present: Colloidal Silicon Dioxide,
Lactose Monohydrate,
Magnesium Stearate, Microcrystalline Cellulose 102 and Sodium Starch
Glycolate. The yellow tablet
also contains FD&C Yellow # 5 Aluminum Lake (15-17%). The blue tablet
also contains FD&C Blue #
1 Aluminum Lake (11-13%).
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.
12 17 4 6 6
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