pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic Receptor Interactions; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.

Monoamine OxidaseNorepinephrine Uptake

Indications

Sourced from openFDA
  • Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct 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.ICD-10: E66.9

Contraindications

Sourced from openFDA
  • Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.contraindicated

Dosage & administration

Sourced from openFDA

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient’s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 17 years of age.

Warnings & precautions

Sourced from openFDA

Benzphetamine hydrochloride tablets 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 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. It should be noted that benzphetamine was not specifically studied in this case-control study. 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, Benzphetamine hydrochloride tablets 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 benzphetamine has been used alone.

Adverse reactions

Sourced from openFDA

The following have been associated with the use of benzphetamine hydrochloride: Cardiovascular Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use. 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 cases of this valvulopathy have been reported when benzphetamine hydrochloride tablets have been used alone. CNS Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug. Gastrointestinal Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances. Allergic Urticaria and other allergic reactions involving the skin. Endocrine Changes in libido.

Use in specific populations

Sourced from openFDA

Pregnancy Benzphetamine hydrochloride tablets are contraindicated in pregnancy.

Overdosage

Sourced from openFDA

Manifestations of Overdosage Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness 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. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma. Treatment of Overdosage (See WARNINGS )--- Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following is based on experience with other anorexiants. Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases amphetamine excretion.

Approval history

Sourced from openFDA
  • Jul 20, 2010ANDAANDA090968Kvk Tech
  • Dec 15, 2015ANDAANDA090346Epic Pharma Llc

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.
11 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 Ineffective436%
  2. 2Pyrexia218%
  3. 3Abdominal Pain19.1%
  4. 4Adverse Reaction19.1%
  5. 5Cerebrovascular Accident19.1%
  6. 6Decreased Appetite19.1%
  7. 7Drug Screen False Positive19.1%
  8. 8Energy Increased19.1%
  9. 9Fall19.1%
  10. 10Fluid Retention19.1%
  11. 11Hypokalaemia19.1%
  12. 12Malaise19.1%
  13. 13Monoplegia19.1%
  14. 14Phobia19.1%
  15. 15Product Availability Issue19.1%

Literature

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Recent PubMed references pinned to Benzphetamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Benzphetamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Benzphetamine work?
Mechanism-of-action classes: Adrenergic Receptor Interactions; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.
What is Benzphetamine used for?
According to FDA labeling, Benzphetamine carries indications including: Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Benzphetamine?
Benzphetamine is classified as Sympathomimetic Amine Anorectic, Adrenergic Receptor Interactions, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Appetite Suppression, Bronchodilation, Increased Norepinephrine Activity, Increased Sympathetic Activity.
What are the contraindications for Benzphetamine?
Benzphetamine labeling lists contraindications including: Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.. Always consult the full prescribing information and a clinician.
Note. Data for benzphetamine 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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