Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NDC 72989-409-30 - bottle of 30 capsules NDC 72989-409-11 - bottle of 1,000 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. DISPENSE IN A TIGHT CONTAINER AS DEFINED IN THE USP. To report SUSPECTED ADVERSE REACTIONS, contact Acertis Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by Acertis Pharmaceuticals, LLC Raleigh, NC 27601 Rev. 05/2025 MF5254REV05/25 OE2820; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 30-count Bottle Label NDC 72989-409-30 Phendimetrazine Tartrate Extended-Release Capsules CIII 105 mg Rx Only 30 Capsules acertis™ PHARMACEUTICALS 30-count Bottle Label
- HOW SUPPLIED NDC 72989-409-30 - bottle of 30 capsules NDC 72989-409-11 - bottle of 1,000 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. DISPENSE IN A TIGHT CONTAINER AS DEFINED IN THE USP. To report SUSPECTED ADVERSE REACTIONS, contact Acertis Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by Acertis Pharmaceuticals, LLC Raleigh, NC 27601 Rev. 05/2025 MF5254REV05/25 OE2820
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 30-count Bottle Label NDC 72989-409-30 Phendimetrazine Tartrate Extended-Release Capsules CIII 105 mg Rx Only 30 Capsules acertis™ PHARMACEUTICALS 30-count Bottle Label
Overview
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 as follows: 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 capsule, for oral administration, contains 105 mg phendimetrazine tartrate manufactured in a special base designed for prolonged release. Inactive ingredients: FD&C Blue No. 1, FD&C Red No. 40, gelatin, pharmaceutical glaze, povidone, silica gel, sodium lauryl sulfate, corn starch, sucrose, talc and trace amounts of red imprinting ink. chemical-structure
Indications & Usage
Phendimetrazine tartrate extended-release capsules 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 greater than or equal to 30 kg/m 2 or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) 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 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. Phendimetrazine tartrate is indicated for use as monotherapy only. Body Mass Index Table
Dosage & Administration
Since the product is an extended-release dosage form, limit to one extended-release capsule (105 mg phendimetrazine tartrate) in the morning (30 to 60 minutes before morning meal). Each extended-release capsule contains 105 mg phendimetrazine tartrate in a Brown/Clear capsule imprinted E 5254.
Warnings & Precautions
WARNINGS 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. 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 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. 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 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.
Contraindications
• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension, pulmonary hypertension) • During or within 14 days following the administration of monoamine oxidase inhibitors • Hyperthyroidism • Glaucoma • Agitated states • History of drug abuse • Pregnancy (see PRECAUTIONS, Pregnancy ) • Nursing • Use in combination with other anorectic agents or CNS stimulants • Known hypersensitivity or idiosyncratic reactions to sympathomimetics
Adverse Reactions
The following adverse reactions are described, or described in greater detail, in other sections: • Primary pulmonary hypertension (see WARNINGS ) • Valvular heart disease (see WARNINGS ) • Effect on the ability to engage in potentially hazardous tasks (see WARNINGS ) • Withdrawal effects following prolonged high dosage administration (see DRUG ABUSE AND DEPENDENCE ) The following adverse reactions to phendimetrazine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevated blood pressure, ischemic events. Central Nervous System Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal Dryness of the mouth, nausea, stomach pain, diarrhea, constipation. Genitourinary Urinary frequency, dysuria, changes in libido.
Drug Interactions
Monoamine Oxidase Inhibitors Use of phendimetrazine tartrate is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. Alcohol Concomitant use of alcohol with phendimetrazine tartrate may result in an adverse drug reaction. Insulin and Oral Hypoglycemic Medications Requirements may be altered. Adrenergic Neuron Blocking Drugs Phendimetrazine tartrate may decrease the hypotensive effect of adrenergic neuron blocking drugs.
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