Phendimetrazine Tartrate

Phendimetrazine Tartrate

Phendimetrazine Tartrate Recall

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Questions & Answers

Side Effects & Adverse Reactions

Phendimetrazine tartrate 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 phendimetrazine tartrate, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three 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, phendimetrazine tartrate 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. However, no cases of this valvulopathy have been reported when phendimetrazine tartrate has been used alone.

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 pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of phendimetrazine treatment. Phendimetrazine tartrate is 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 phendimetrazine tartrate should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded.

Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.

Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine tartrate 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.

Phendimetrazine tartrate is not recommended for patients who used any anorectic agents within the prior year.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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/m2 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/m2 Height (feet, inches)
Weight(pounds) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3”
140272523211918
150292724222019
160312826242220
170333028252321
180353229272523
190373431282624
200393632302725
210413734312926
220433936333028
230454137343129
240474339363330
250494440373431

Phendimetrazine tartrate is indicated for use as monotherapy only.

History

There is currently no drug history available for this drug.

Other Information

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:Documents and SettingsavyasDesktopphend-outsertSPLphendimetrazine-image-a.jpg

C12H17NO•C4H6O6                                                     M.W. 341.36

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 Manufacturers


  • A-s Medication Solutions Llc
    Phendimetrazine Tartrate Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Phendimetrazine Tartrate Tablet [A-s Medication Solutions Llc]
  • A-s Medication Solutions Llc
    Phendimetrazine Tartrate Capsule, Extended Release [A-s Medication Solutions Llc]
  • Apotheca, Inc.
    Phendimetrazine Tartrate Tablet [Apotheca, Inc.]
  • Apotheca, Inc.
    Phendimetrazine Tartrate Capsule [Apotheca, Inc.]
  • Physicians Total Care, Inc.
    Phendimetrazine Tartrate Tablet [Physicians Total Care, Inc.]
  • Bryant Ranch Prepack
    Phendimetrazine Tartrate Tablet [Bryant Ranch Prepack]
  • Rebel Distributors Corp
    Phendimetrazine Tartrate Tablet [Rebel Distributors Corp]
  • Stat Rx Usa Llc
    Phendimetrazine Tartrate Tablet [Stat Rx Usa Llc]
  • Solco Healthcare Us Llc
    Phendimetrazine Tartrate Tablet [Solco Healthcare Us Llc ]
  • H.j. Harkins Company, Inc.
    Phendimetrazine Tartrate Tablet [H.j. Harkins Company, Inc.]
  • Eon Labs, Inc.
    Phendimetrazine Tartrate Capsule, Extended Release [Eon Labs, Inc.]
  • Life Line Home Care Services, Inc.
    Phendimetrazine Tartrate Tablet [Life Line Home Care Services, Inc.]
  • Physicians Total Care, Inc.
    Phendimetrazine Tartrate Capsule, Extended Release [Physicians Total Care, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Phendimetrazine Tartrate Capsule, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Aidarex Pharmaceuticals Llc
    Phendimetrazine Tartrate Tablet [Aidarex Pharmaceuticals Llc]
  • Bryant Ranch Prepack
    Phendimetrazine Tartrate Capsule, Extended Release [Bryant Ranch Prepack]
  • Actavis, Inc.
    Phendimetrazine Tartrate Tablet [Actavis, Inc.]
  • A-s Medication Solutions Llc
    Phendimetrazine Tartrate Tablet [A-s Medication Solutions Llc]
  • Mikart, Inc.
    Phendimetrazine Tartrate Tablet [Mikart, Inc.]
  • A-s Medication Solutions Llc
    Phendimetrazine Tartrate Capsule, Extended Release [A-s Medication Solutions Llc]
  • Preferred Pharmaceuticals, Inc.
    Phendimetrazine Tartrate Tablet [Preferred Pharmaceuticals, Inc.]
  • Mikart, Inc.
    Phendimetrazine Tartrate Tablet [Mikart, Inc.]
  • C.o. Truxton, Inc.
    Phendimetrazine Tartrate Tablet [C.o. Truxton, Inc.]
  • C.o. Truxton, Inc.
    Phendimetrazine Tartrate Tablet [C.o. Truxton, Inc.]
  • C.o. Truxton, Inc.
    Phendimetrazine Tartrate Tablet [C.o. Truxton, Inc.]
  • Aidarex Pharmaceuticals Llc
    Phendimetrazine Tartrate Capsule, Extended Release [Aidarex Pharmaceuticals Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Phendimetrazine Tartrate Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Elite Laboratories, Inc
    Phendimetrazine Tartrate Tablet [Elite Laboratories, Inc]
  • Eon Labs, Inc.
    Phendimetrazine Tartrate Tablet [Eon Labs, Inc.]
  • A-s Medication Solutions Llc
    Phendimetrazine Tartrate Tablet [A-s Medication Solutions Llc]

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