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Regimex
Overview
What is Regimex?
Regimex™
d
The structural formula (dextro form) is represented below:
Each tablet for oral administration contains 25 mg of benzphetamine hydrochloride.
In addition, both strengths contain calcium stearate, corn starch, D&C Red #30 Aluminum Lake and sorbitol.
What does Regimex look like?
What are the available doses of Regimex?
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What should I talk to my health care provider before I take Regimex?
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How should I use Regimex?
Regimex™
Regimex™
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 12 years of age.
What interacts with Regimex?
Regimex™
Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. tablets should not be used concomitantly with other CNS stimulants.
Regimex™
Regimex™
What are the warnings of Regimex?
The 10 mL multiple-dose vials of cisatracurium besylate injection contain benzyl alcohol, which is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solution containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources.
Regimex™
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, 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.
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 pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. tablets are 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. To limit unwarranted exposure and risks, treatment with tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).
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.
Regimex™
Regimex™
What are the precautions of Regimex?
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 even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Information for Patients
Amphetamines 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.
Drug Interactions
Efficacy of tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.
Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. tablets should not be used concomitantly with other CNS stimulants.
Amphetamines may decrease the hypotensive effect of antihypertensives. 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.
Pregnancy
(see section).
Nursing Mothers
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.
Geriatric Use
Clinical studies of benzphetamine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Regimex?
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 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.
What should I look out for while using Regimex?
Regimex™
Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. tablets should not be used concomitantly with other CNS stimulants.
Regimex™
Regimex™
Regimex™
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, 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.
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 pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. tablets are 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. To limit unwarranted exposure and risks, treatment with tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).
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.
Regimex™
Regimex™
What might happen if I take too much Regimex?
How should I store and handle Regimex?
SUSTIVA capsules and SUSTIVA tablets should be stored at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature].Regimex™25 mg:Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Regimex™25 mg:Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Regimex™25 mg:Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
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.
Pharmacokinetic data in humans are not available.
Non-Clinical Toxicology
Regimex™Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. tablets should not be used concomitantly with other CNS stimulants.
Regimex™
Regimex™
Regimex™
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, 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.
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 pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. tablets are 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. To limit unwarranted exposure and risks, treatment with tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).
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.
Regimex™
Regimex™
Efficacy of tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.
Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. tablets should not be used concomitantly with other CNS stimulants.
Amphetamines may decrease the hypotensive effect of antihypertensives. 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.
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 even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
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 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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