pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Dopamine Uptake Inhibitors; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.

Dopamine UptakeMonoamine OxidaseNorepinephrine Uptake

Indications

Sourced from openFDA
  • 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.ICD-10: E66.9

Contraindications

Sourced from openFDA
  • Known hypersensitivity or idiosyncratic reactions to sympathomimetics. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma.contraindicated

Dosage & administration

Sourced from openFDA

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 & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category C Studies with Phendimetrazine Tartrate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Usage in Pregnancy Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Overdosage

Sourced from openFDA

Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death. The management of overdosage is largely symptomatic. It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

Approval history

Sourced from openFDA
  • Aug 19, 1977ANDAANDA085588Acertis Pharms
  • Apr 16, 1979NDANDA018074Acertis Pharms
  • Jan 28, 2008ANDAANDA040762Elite Labs Inc
  • Aug 31, 2010ANDAANDA091042Kvk Tech

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
57 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective916%
  2. 2Pain712%
  3. 3Headache611%
  4. 4Weight Increased611%
  5. 5Back Pain58.8%
  6. 6Wrong Technique In Product Usage Process58.8%
  7. 7Choroidal Effusion47.0%
  8. 8Dyspnoea47.0%
  9. 9Fatigue47.0%
  10. 10Myopia47.0%
  11. 11Ocular Hypertension47.0%
  12. 12Off Label Use47.0%
  13. 13Arthralgia35.3%
  14. 14Fall35.3%
  15. 15Hunger35.3%

Clinical trials

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The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Phendimetrazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Phendimetrazine work?
Mechanism-of-action classes: Dopamine Uptake Inhibitors; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.
What is Phendimetrazine used for?
According to FDA labeling, Phendimetrazine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Phendimetrazine?
Phendimetrazine is classified as Sympathomimetic Amine Anorectic, Dopamine Uptake Inhibitors, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Appetite Suppression, Increased Cerebral Cortex Dopamine Activity, Increased Cerebral Cortex Norepinephrine Activity, Increased Sympathetic Activity.
What are the brand names for Phendimetrazine?
Phendimetrazine is marketed under brand names including Melfiat.
What are the contraindications for Phendimetrazine?
Phendimetrazine labeling lists contraindications including: Known hypersensitivity or idiosyncratic reactions to sympathomimetics. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma.. Always consult the full prescribing information and a clinician.
Note. Data for phendimetrazine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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