Benzphetamine: Difference between revisions
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|indicationType=treatment | |indicationType=treatment | ||
|indication=[[Obesity|exogenous obesity]] | |indication=[[Obesity|exogenous obesity]] | ||
|adverseReactions=[[Hypertension|Increased blood pressure]], [[Palpitations]], [[Tachyarrhythmia]], [[Urticaria]], [[Diarrhea]], [[Nausea]], Unpleasant taste in mouth, [[Xerostomia]], Central nervous system stimulation, [[Overstimulation]], [[Dizziness]], [[Headache]], [[Insomnia]], [[Tremor]], [[Depression | |adverseReactions=[[Hypertension|Increased blood pressure]], [[Palpitations]], [[Tachyarrhythmia]], [[Urticaria]], [[Diarrhea]], [[Nausea]], [[Parageusia|Unpleasant taste in mouth]], [[Xerostomia]], Central nervous system stimulation, [[Overstimulation]], [[Dizziness]], [[Headache]], [[Insomnia]], [[Tremor]], [[Depression|Depression following drug withdrawal]], [[Restlessness]], [[Libido|Changes in libido]] | ||
| Line 47: | Line 47: | ||
<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications=* 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. | |contraindications=* 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. | ||
Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants. | * [[Hypertensive crises]] have resulted when [[sympathomimetic amines]] have been used concomitantly or within 14 days following use of [[monoamine oxidase inhibitors]]. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants. | ||
Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. | * Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. | ||
<!--Warnings--> | <!--Warnings--> | ||
| Line 58: | Line 58: | ||
====Precautions==== | ====Precautions==== | ||
General | =====General===== | ||
Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions. | * [[Insulin]] requirements in [[diabetes mellitus]] may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions. | ||
Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime. | * Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime. | ||
Caution is to be exercised in prescribing amphetamines for patients with mild hypertension. The least amount feasible | * Caution is to be exercised in prescribing amphetamines for patients with mild [[hypertension]]. The least amount feasible | ||
should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. | should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. | ||
| Line 69: | Line 69: | ||
<!--Clinical Trials Experience--> | <!--Clinical Trials Experience--> | ||
|clinicalTrials=The following have been associated with the use of benzphetamine hydrochloride: | |clinicalTrials=* The following have been associated with the use of benzphetamine hydrochloride: | ||
Cardiovascular: | =====Cardiovascular:===== | ||
Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. | * [[Palpitation]], [[tachycardia]], [[hypertension|elevation of blood pressure]]. There have been isolated reports of [[cardiomyopathy]] associated with chronic amphetamine use. | ||
CNS: | =====CNS:===== | ||
Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at | * [[Overstimulation]], [[restlessness]], [[dizziness]], [[insomnia]], [[tremor]], [[sweating]], [[headache]]; rarely, [[Psychosis|psychotic episodes at | ||
recommended doses; depression following withdrawal of the drug. | recommended doses]]; [[Depression|depression following withdrawal of the drug]]. | ||
Gastrointestinal: | =====Gastrointestinal:===== | ||
Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances. | * Dryness of the mouth, [[Parageusia|unpleasant taste]], [[nausea]], [[diarrhea]], other gastrointestinal disturbances. | ||
Allergic: | =====Allergic:===== | ||
Urticaria and other allergic reactions involving the skin. | * [[Urticaria]] and other allergic reactions involving the skin. | ||
Endocrine: | =====Endocrine:===== | ||
Changes in libido. | * [[Libido|Changes in libido]]. | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
<!--Drug Interactions--> | <!--Drug Interactions--> | ||
|drugInteractions=* Hypertensive crises have resulted when sympathamimetic amines have been used concomitantly or within 14 days following use of | |drugInteractions=* [[Hypertensive crises]] have resulted when sympathamimetic amines have been used concomitantly or within 14 days following use of | ||
monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants. | monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants. | ||
Amphetamines may enhance the effects of tricyclic antidepressants. | * [[Amphetamines]] may enhance the effects of [[tricyclic antidepressants]]. | ||
Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying | * Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying | ||
agents decrease blood levels and increase excretion of amphetamines. | agents decrease blood levels and increase excretion of amphetamines. | ||
| Line 169: | Line 120: | ||
<!--Overdosage--> | <!--Overdosage--> | ||
|overdose=Manifestations of Overdosage: | |overdose======Manifestations of Overdosage:===== | ||
Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states. | * Acute overdosage with amphetamines may result in [[restlessness]], [[tremor]], [[tachypnea]], [[confusion]], [[assaultiveness]] and [[panic states]]. | ||
Fatigue and depression usually follow the central stimulation. Cardiovasculas effects include arrhythmias, | * [[Fatigue]] and [[depression]] usually follow the central stimulation. Cardiovasculas effects include [[arrhythmias]], | ||
hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, | [[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 | [[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 convulsion and coma. | of associated complications. Fatal poisoning is usually preceded by [[convulsion]] and [[coma]]. | ||
Treatment of Overdosage: | =====Treatment of Overdosage:===== | ||
Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following | * Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following | ||
is based on experience with other anorexiants. | is based on experience with other anorexiants. | ||
Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension | * 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. | 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. | * Experience with [[hemodialysis]] or [[peritoneal dialysis]] is inadequate to permit recommendations in this regard. | ||
Acidification of the urine increases amphetamine excretion. The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitioneal LD50 in mice is 153 mg/kg. | * Acidification of the urine increases amphetamine excretion. The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitioneal LD50 in mice is 153 mg/kg. | ||
DRUG ABUSE AND DEPENDENCE | =====DRUG ABUSE AND DEPENDENCE===== | ||
Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III | * Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III | ||
Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and | * Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and | ||
related stimulant drugs have been extensively abused, and the possibility of abuse of benzphetamine Hydrochloride Tablets | related stimulant drugs have been extensively abused, and the possibility of abuse of benzphetamine Hydrochloride Tablets | ||
should be kept in mind when evaluating the desirabilityof including a drug as part of a weight reduction program. | should be kept in mind when evaluating the desirabilityof including a drug as part of a weight reduction program. | ||
Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social | * Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social | ||
dysfunction. There are reports of patients who have increased dosage to many times that recommended. | dysfunction. There are reports of patients who have increased dosage to many times that recommended. | ||
Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; | Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; | ||
changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include | changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include | ||
severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation | severe [[dermatoses]], marked [[insomnia]], [[irritability]], [[hyperactivity]], and personality changes. The most severe manifestation | ||
of chronic intoxication is psychosis, often clinically indistinguishable from schizophirenia. | of chronic intoxication is [[psychosis]], often clinically indistinguishable from [[schizophirenia]]. | ||
|drugBox={{drugbox2 | |drugBox={{drugbox2 | ||
| Verifiedfields = changed | | Verifiedfields = changed | ||
| Line 256: | Line 207: | ||
<!--Mechanism of Action--> | <!--Mechanism of Action--> | ||
|mechAction=* Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. | |mechAction=* Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and [[Hypertension|elevation of blood pressure]]. [[Tachyphylaxis]] and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. | ||
Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved. | * Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved. | ||
<!--Structure--> | <!--Structure--> | ||
| Line 269: | Line 220: | ||
: [[File:Benzphetamine Str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | : [[File:Benzphetamine Str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | ||
Each Benzphetamine hydrochloride tablets 50 mg, for oral administration, contains 50 mg of benzphetamine hydrochloride. | * Each Benzphetamine hydrochloride tablets 50 mg, for oral administration, contains 50 mg of benzphetamine hydrochloride. | ||
Inactive ingredients: Calcium Stearate, Polyethylene Glycol, FD and C Yellow No. 6, Lactose Anhydrous, Sorbitol. | Inactive ingredients: Calcium Stearate, Polyethylene Glycol, FD and C Yellow No. 6, Lactose Anhydrous, Sorbitol. | ||
| Line 276: | Line 227: | ||
<!--Pharmacokinetics--> | <!--Pharmacokinetics--> | ||
|PK=Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. | |PK=* Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. | ||
The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. | * The magnitude of increased [[weight loss]] of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. | ||
The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited. | * The natural history of [[obesity]] is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited. | ||
<!--Nonclinical Toxicology--> | <!--Nonclinical Toxicology--> | ||
|nonClinToxic=Carcinogenesis, Mutagenesis, Impairment of Fertility | |nonClinToxic======Carcinogenesis, Mutagenesis, Impairment of Fertility===== | ||
Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed. | * Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed. | ||
<!--Clinical Studies--> | <!--Clinical Studies--> | ||
| Line 309: | Line 260: | ||
<!--Patient Counseling Information--> | <!--Patient Counseling Information--> | ||
|fdaPatientInfo=Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or | |fdaPatientInfo=* Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or | ||
driving a vehicle; the patient should therefore be cautioned accordingly. | driving a vehicle; the patient should therefore be cautioned accordingly. | ||
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
| Line 318: | Line 269: | ||
<!--Look-Alike Drug Names--> | <!--Look-Alike Drug Names--> | ||
|drugShortage= | |drugShortage= | ||
}} | }} | ||
<!--Pill Image--> | <!--Pill Image--> | ||
Revision as of 14:48, 17 March 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Benzphetamine is a Sympathomimetic amine that is FDA approved for the treatment of exogenous obesity. Common adverse reactions include Increased blood pressure, Palpitations, Tachyarrhythmia, Urticaria, Diarrhea, Nausea, Unpleasant taste in mouth, Xerostomia, Central nervous system stimulation, Overstimulation, Dizziness, Headache, Insomnia, Tremor, Depression following drug withdrawal, Restlessness, Changes in libido.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Benzphetamine Hydrochloride Tablets 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. The limited usefulness of agents of this class should be weighed against possible risks inherent in their use such as those described below.
Dosage
- Benzphetamine Hydrochloride Tablets are supplied as follows:
- 50 mg (peach, round, imprinted with BP 650, scored)
- 12634-118-56 Bottle of 56
- 12634-118-44 Bottle of 84
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Benzphetamine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzphetamine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Benzphetamine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Benzphetamine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzphetamine in pediatric patients.
Contraindications
- 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.
- Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants.
- Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Warnings
- When tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued
Precautions
General
- Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.
- Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.
- Caution is to be exercised in prescribing amphetamines for patients with mild hypertension. The least amount feasible
should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Adverse Reactions
Clinical Trials Experience
- 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 associated with chronic amphetamine use.
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:
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Benzphetamine in the drug label.
Drug Interactions
- Hypertensive crises have resulted when sympathamimetic amines have been used concomitantly or within 14 days following use of
monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.
- Amphetamines may enhance the effects of tricyclic antidepressants.
- Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying
agents decrease blood levels and increase excretion of amphetamines.
Use in Specific Populations
Pregnancy
- Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzphetamine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Benzphetamine during labor and delivery.
Nursing Mothers
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Pediatric Use
- Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.
Geriatic Use
There is no FDA guidance on the use of Benzphetamine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Benzphetamine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Benzphetamine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Benzphetamine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Benzphetamine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Benzphetamine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Benzphetamine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
There is limited information regarding Monitoring of Benzphetamine in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Benzphetamine in the drug label.
Overdosage
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. Cardiovasculas 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 convulsion and coma.
Treatment of Overdosage:
- 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. The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitioneal LD50 in mice is 153 mg/kg.
DRUG ABUSE AND DEPENDENCE
- Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III
- Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and
related stimulant drugs have been extensively abused, and the possibility of abuse of benzphetamine Hydrochloride Tablets should be kept in mind when evaluating the desirabilityof including a drug as part of a weight reduction program.
- Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social
dysfunction. There are reports of patients who have increased dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophirenia.
Pharmacology
| |
| |
Benzphetamine
| |
| Systematic (IUPAC) name | |
| (2S)-N-benzyl-N-methyl-1-phenylpropan-2-amine | |
| Identifiers | |
| CAS number | |
| ATC code | none |
| PubChem | |
| DrugBank | |
| Chemical data | |
| Formula | Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox |
| Mol. mass | 239.355 g/mol |
| SMILES | & |
| Synonyms | N-benzyl-N-methylamphetamine |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Protein binding | 75–99% |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
X(US) |
| Legal status | |
| Routes | ? |
Mechanism of Action
- Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.
- Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved.
Structure
- Benzphetamine hyrochloride tablets 50 mg contain the anorectic agent benzphetamine hydrochloride.Benzephet-
amine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benaphetamine hydrochloride is d-N,a-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its moleculas weight is 275.82. The structural formula (dextro form) is represented as follows below:
This image is provided by the National Library of Medicine.
- Each Benzphetamine hydrochloride tablets 50 mg, for oral administration, contains 50 mg of benzphetamine hydrochloride.
Inactive ingredients: Calcium Stearate, Polyethylene Glycol, FD and C Yellow No. 6, Lactose Anhydrous, Sorbitol.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Benzphetamine in the drug label.
Pharmacokinetics
- Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.
- The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.
- The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
- Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.
Clinical Studies
There is limited information regarding Clinical Studies of Benzphetamine in the drug label.
How Supplied
- Benzphetamine Hydrochloride Tablets are supplied as follows:
- 50 mg (peach, round, imprinted with BP 650, scored)
- 12634-118-56 Bottle of 56
- 12634-118-44 Bottle of 84
Storage
- Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
- Dispense in a tight, light-resistant container as defined in the USP.
- A Schedule CS-III controlled drug substance.
Images
Drug Images
{{#ask: Page Name::Benzphetamine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
PACKAGE LABEL,PRINCIPAL DISPLAY PANEL
This image is provided by the National Library of Medicine.
Ingredients and Appearance
This image is provided by the National Library of Medicine.
{{#ask: Label Page::Benzphetamine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
- Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or
driving a vehicle; the patient should therefore be cautioned accordingly.
Precautions with Alcohol
- Alcohol-Benzphetamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Didrex®[1]
Look-Alike Drug Names
There is limited information regarding Benzphetamine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.