PHENDIMETRAZINE TARTRATE 35 mg/1
PHENDIMETRAZINE TARTRATE · TABLET · Bryant Ranch Prepack
PHENDIMETRAZINE TARTRATE is a tablet containing phendimetrazine tartrate at 35 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- PHENDIMETRAZINE TARTRATE
- Generic Name
- PHENDIMETRAZINE TARTRATE
- NDC Code (Product)
63629-2489- Manufacturer
- Bryant Ranch Prepack
- Strength
- 35 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA085588
- Marketing Start
- 07/01/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 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 follow: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” (pounds) 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 for the use as monotherapy only
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual Adult Dosage: 1 tablet (35 mg) twice a day or three times a day one hour before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, 1/2 tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.
Warnings
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 ti…
Contraindications
CONTRAINDICATIONS Known hypersensitivity or idiosyncratic reactions to sympathomimetics. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma. Highly nervous or agitated patients. Patients with a history of drug abuse. Patients taking other CNS stimulants, including monoamine oxidase inhibitors
Drug Interactions
Interactions Drug Interactions Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems. Drug/Laboratory Test Interactions
Adverse Reactions
ADVERSE REACTIONS Cardiovascular: Palpitation, tachycardia, elevated blood pressure, ischemic events. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no case of this valvulopathy has been reported when phendimetrazine tartrate has been used alone. Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain. Genitourinary: Urinary frequency, dysuria, changes in libido.
Frequently Asked Questions
What is PHENDIMETRAZINE TARTRATE used for?
PHENDIMETRAZINE TARTRATE contains PHENDIMETRAZINE TARTRATE. It is a tablet taken oral. Consult your doctor for specific uses.
Is PHENDIMETRAZINE TARTRATE a controlled substance?
Yes, PHENDIMETRAZINE TARTRATE is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for PHENDIMETRAZINE TARTRATE?
The generic name for PHENDIMETRAZINE TARTRATE is PHENDIMETRAZINE TARTRATE. There are 7 other brand versions of PHENDIMETRAZINE TARTRATE.
What is the NDC code for PHENDIMETRAZINE TARTRATE 35 mg/1?
The NDC (National Drug Code) for PHENDIMETRAZINE TARTRATE 35 mg/1 is 63629-2489, listed by Bryant Ranch Prepack.