NDC 63629-7319 Phendimetrazine Tartrate

Phendimetrazine Tartrate

NDC Product Code 63629-7319

NDC CODE: 63629-7319

Proprietary Name: Phendimetrazine Tartrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phendimetrazine Tartrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
3;5
Score: 4

NDC Code Structure

NDC 63629-7319-0

Package Description: 120 TABLET in 1 BOTTLE

NDC 63629-7319-1

Package Description: 30 TABLET in 1 BOTTLE

NDC 63629-7319-2

Package Description: 135 TABLET in 1 BOTTLE

NDC 63629-7319-3

Package Description: 180 TABLET in 1 BOTTLE

NDC 63629-7319-4

Package Description: 15 TABLET in 1 BOTTLE

NDC 63629-7319-5

Package Description: 90 TABLET in 1 BOTTLE

NDC 63629-7319-6

Package Description: 7 TABLET in 1 BOTTLE

NDC 63629-7319-7

Package Description: 21 TABLET in 1 BOTTLE

NDC 63629-7319-8

Package Description: 60 TABLET in 1 BOTTLE

NDC 63629-7319-9

Package Description: 45 TABLET in 1 BOTTLE

NDC Product Information

Phendimetrazine Tartrate with NDC 63629-7319 is a a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Phendimetrazine Tartrate is phendimetrazine tartrate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Bryant Ranch Prepack

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.

Phendimetrazine Tartrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENDIMETRAZINE TARTRATE 35 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Appetite Suppression - [PE] (Physiologic Effect)
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
  • Sympathomimetic Amine Anorectic - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bryant Ranch Prepack
Labeler Code: 63629
FDA Application Number: ANDA089452 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-26-2001 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Phendimetrazine Tartrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

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:C12H17NO·C4H6O6 M.W. 341.36Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene.Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and FD&C Blue #1 Lake as coloring.

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 phendimetrazine 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.

Indications And Usage

Phendimetrazine tartrate 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 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. 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 × 0.0254 = meters.BODY MASS INDEX (BMI), kg/m2WeightHeight (feet, inches)(pounds)5'0"5'3"5'6"5'9"6'0"6'3"140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129240474339363330250494440373431Phendimetrazine tartrate is indicated for use as monotherapy only.

Contraindications

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.

Warnings

Phendimetrazinetartrate 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 phendimetrazinetartrate 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 phendimetrazine treatment. Phendimetrazine tartrate is 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 phendimetrazine tartrate 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).Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded.Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine tartrate 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.Phendimetrazine tartrate is not recommended for patients who used any anorectic agents within the prior year.

Precautions

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.

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

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.

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.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

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 cases of this valvulopathy have 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.

Controlled Substance

Phendimetrazine tartrate tablets are a Schedule III controlled substance.

Dependence

Phendimetrazine tartrate is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phendimetrazine should be kept in mind when evaluating the desirability of 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 the 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 intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

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.

Dosage And Administration

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.

How Supplied

Product: 63629-7319NDC: 63629-7319-1 30 TABLET in a BOTTLENDC: 63629-7319-2 135 TABLET in a BOTTLENDC: 63629-7319-3 180 TABLET in a BOTTLENDC: 63629-7319-4 15 TABLET in a BOTTLENDC: 63629-7319-5 90 TABLET in a BOTTLENDC: 63629-7319-6 7 TABLET in a BOTTLENDC: 63629-7319-7 21 TABLET in a BOTTLENDC: 63629-7319-8 60 TABLET in a BOTTLENDC: 63629-7319-9 45 TABLET in a BOTTLE

Storage

Store at 20º to 25ºC (68º to 77ºF); [see USP Controlled Room Temperature].Dispense in tight containers with child-resistant closures.

Other

Rx onlyManufactured forTruxton, Inc.Bellmawr, NJ 08031Manufactured byMikart, Inc.Atlanta, GA 30318Code 369A00Rev. 09/13

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