Phendimetrazine Tartrate

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Overview

What is Phendimetrazine Tartrate?

Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1).

The structural formula is:

In addition, the following inactive ingredients are present: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose.

What does Phendimetrazine Tartrate look like?

What are the available doses of Phendimetrazine Tartrate?

Sorry No records found.

What should I talk to my health care provider before I take Phendimetrazine Tartrate?

Sorry No records found

How should I use Phendimetrazine Tartrate?

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 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 follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

Phendimetrazine tartrate is indicated for use as monotherapy only.

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, ½ tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.

What interacts with Phendimetrazine Tartrate?

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.

What are the warnings of Phendimetrazine Tartrate?

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.

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What are the precautions of Phendimetrazine Tartrate?

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine tartrate and the concomitant dietary regimen.

Phendimetrazine tartrate may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Studies with Phendimetrazine Tartrate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with phendimetrazine tartrate. It is also not known whether phendimetrazine tartrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

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.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, phendimetrazine tartrate should not be taken by women who are nursing unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Safety and effectiveness in pediatric patients have not been established.

What are the side effects of Phendimetrazine Tartrate?

Cardiovascular:

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What should I look out for while using Phendimetrazine Tartrate?

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.

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.

What might happen if I take too much Phendimetrazine Tartrate?

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.

How should I store and handle Phendimetrazine Tartrate?

Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.White to Off-white round shaped tablets, bisected and embossed with “EL” on the left side of the bisect and “11” on the right. Phendimetrazine tartrate tablets, USP containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 64850-900-01) and 1,000 (NDC 64850-900-10). DEA Order Form Required.Manufactured by: Elite Laboratories, Inc. 165 Ludlow Avenue Northvale, NJ 07647 ID # IN0502 Rev. 08/17 Manufacturer’s Code: 64850White to Off-white round shaped tablets, bisected and embossed with “EL” on the left side of the bisect and “11” on the right. Phendimetrazine tartrate tablets, USP containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 64850-900-01) and 1,000 (NDC 64850-900-10). DEA Order Form Required.Manufactured by: Elite Laboratories, Inc. 165 Ludlow Avenue Northvale, NJ 07647 ID # IN0502 Rev. 08/17 Manufacturer’s Code: 64850White to Off-white round shaped tablets, bisected and embossed with “EL” on the left side of the bisect and “11” on the right. Phendimetrazine tartrate tablets, USP containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 64850-900-01) and 1,000 (NDC 64850-900-10). DEA Order Form Required.Manufactured by: Elite Laboratories, Inc. 165 Ludlow Avenue Northvale, NJ 07647 ID # IN0502 Rev. 08/17 Manufacturer’s Code: 64850White to Off-white round shaped tablets, bisected and embossed with “EL” on the left side of the bisect and “11” on the right. Phendimetrazine tartrate tablets, USP containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 64850-900-01) and 1,000 (NDC 64850-900-10). DEA Order Form Required.Manufactured by: Elite Laboratories, Inc. 165 Ludlow Avenue Northvale, NJ 07647 ID # IN0502 Rev. 08/17 Manufacturer’s Code: 64850White to Off-white round shaped tablets, bisected and embossed with “EL” on the left side of the bisect and “11” on the right. Phendimetrazine tartrate tablets, USP containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 64850-900-01) and 1,000 (NDC 64850-900-10). DEA Order Form Required.Manufactured by: Elite Laboratories, Inc. 165 Ludlow Avenue Northvale, NJ 07647 ID # IN0502 Rev. 08/17 Manufacturer’s Code: 64850

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Phendimetrazine tartrate is a sympathomimetic amine with pharmacological 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 for example.

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 greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origin of the increased weight loss due to the various drug effects is 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 clinically limited.

The major route of elimination is via the kidneys where most of the drug and metabolites are excreted. Some of the drug is metabolized to phenmetrazine and also phendimetrazine-N-oxide. The average half-life of elimination when studied under controlled conditions is about 3.7 hours for both the extended-release and immediate release forms. The absorption half-life of the drug from the immediate release 35 mg phendimetrazine tablets is appreciably more rapid than the absorption rate of the drug from the extended-release formulation.

Non-Clinical Toxicology

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.

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.

Although Timolol Maleate Ophthalmic Solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with Timolol Maleate Ophthalmic Solution and epinephrine has been reported occasionally.

Beta-adrenergic blocking agents:

Calcium antagonists:

Catecholamine-depleting drugs:

Digitalis and calcium antagonists:

CYP2D6 inhibitors:

Clonidine:

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine tartrate and the concomitant dietary regimen.

Phendimetrazine tartrate may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Studies with Phendimetrazine Tartrate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with phendimetrazine tartrate. It is also not known whether phendimetrazine tartrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

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.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, phendimetrazine tartrate should not be taken by women who are nursing unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Safety and effectiveness in pediatric patients have not been established.

Cardiovascular:

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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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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