FDA prescribing information, side effects and uses. Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2. S,3. S)- 3,4- dimethyl- 2- phenylmorpholine L- (+)- tartrate (1: 1). No No Yes No Black JNC 8 Hypertension Guideline Algorithm Lifestyle changes: FAA / DOT Medical Certification requires that pilots /drivers take no medication which is likely to interfere with safe performance of. These medicines lower high blood pressure by opening up (dilating) the blood vessels. This allows blood to flow more easily, which lowers blood pressure. Diagnosis is made after measuring BP > 140/90 mmHg three times. Kaplan’s clinical hypertension. Philadelphia, PA: Lippincott Williams & Wilkins. Stages of hypertension. Hypertension is a condition where blood pressure in the arteries is elevated. A number of factors are responsible for Hypertension and if not checked and brought. The structural formula is as follows: Phendimetrazine 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 capsule, for oral administration, contains 1. Phendimetrazine tartrate manufactured in a special base designed for prolonged release. Inactive ingredients: FD& C Blue No. Phendimetrazine - Clinical Pharmacology. Phendimetrazine tartrate is a phenylalkylamine 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 . 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 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 clinically limited. The active drug, 1. Phendimetrazine tartrate in each capsule of this special extended- release dosage form approximates the action of three 3. 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. The absorption half- life of the drug from the immediate release 3. Phendimetrazine tablets is appreciably more rapid than the absorption rate of the drug from the extended- release formulation. Indications and Usage for Phendimetrazine. Phendimetrazine tartrate extended- release capsules 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 greater than or equal to 3. 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 . The use of anorectic agents for longer than three months was associated with a 2. 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. Valvularheart disease associated with the use of some anorectic agents such asfenfluramineand 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. 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 preexisting 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. 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 1. Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, Phendimetrazine 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. General. Caution is to be exercised in prescribing Phendimetrazine tartrate for patients with even mild hypertension. Insulin or oral hypoglycemic medication requirements in diabetes mellitus may be altered in association with the use of Phendimetrazine and the concomitant dietary regimen. Phendimetrazine 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. Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with Phendimetrazine tartrate sustained release have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy. Pregnancy Category XPhendimetrazine tartrate is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phendimetrazine tartrate, a phenylalkylamine sympathomimetic amine has pharmacological activity similar to amphetamines (see CLINICAL PHARMACOLOGY). Animal reproduction studies have not been conducted in Phendimetrazine tartrate. 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 a fetus. Nursing Mothers. It is not known if Phendimetrazine tartrate is excreted in human milk. Phendimetrazine tartrate, a phenylalkylamine sympathomimetic amine, has pharmacological activity similar to the amphetamines (see CLINICAL PHARMACOLOGY), and other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Drug Interactions. Monoamine Oxidase Inhibitors. Use of Phendimetrazine tartrate is contraindicated during or within 1. Alcohol. Concomitant use of alcohol with Phendimetrazine tartrate may result in an adverse drug reaction. Insulin and Oral Hypoglycemic Medications. Requirements may be altered. Adrenergic Neuron Blocking Drugs. Phendimetrazine tartrate may decrease the hypotensive effect of adrenergic neuron blocking drugs. Pediatric Use. Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long- term treatment, the use of Phendimetrazine tartrate ER approved for short- term therapy, is not recommended in patients less that 1. Renal Impairment. Phendimetrazine tartrate extended- release capsules were not studied in patients with renal impairment. As Phendimetrazine tartrate is excreted in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering Phendimetrazine tartrate to patients with renal impairment. Geriatric Use. 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. The major route of elimination is via the kidney where most of the drug and metabolites are excreted. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Adverse Reactions. The following adverse reactions are described, or described in greater detail, in other sections: - Primary pulmonary hypertension (see Warnings)- Valvular heart disease (see Warnings)- Effect on the ability to engage in potentially hazardous tasks (see Warnings)- Withdrawal effects following prolonged high dosage administration (see Drug Abuse and Dependence)The following adverse reactions to Phendimetrazine have been identified: Cardiovascular. High Blood Pressure - Heart and Blood Vessel Disorders. High blood pressure (hypertension) is persistently high pressure in the arteries. Often no cause for high blood pressure can be identified, but sometimes it occurs as a result of an underlying disorder of the kidneys or a hormonal disorder. Obesity, a sedentary lifestyle, stress, smoking, and excessive amounts of alcohol or sodium (salt) in the diet all can play a role in the development of high blood pressure in people who have an inherited tendency to develop it. In most people, high blood pressure causes no symptoms. Doctors make the diagnosis after measuring blood pressure on two or more occasions. People are advised to lose weight, stop smoking, and decrease the amounts of sodium and fats in their diet. Antihypertensive drugs are given. To many people, the word hypertension suggests excessive tension, nervousness, or stress. In medical terms, hypertension refers to persistently high blood pressure, regardless of the cause. Because it usually does not cause symptoms for many years—until a vital organ is damaged—high blood pressure has been called the silent killer. Uncontrolled high blood pressure increases the risk of problems such as stroke,aneurysm, heart failure, heart attack, and kidney damage. About 7. 5 million Americans are estimated to have high blood pressure. High blood pressure occurs more often in blacks—in 4. Mexican Americans. It also occurs with high frequency in people whose ancestors are from China, Japan, and other East Asian or Pacific areas (such as Koreans,Thais, Polynesians, Micronesians, Filipinos, and Maori). The consequences of high blood pressure are worse for blacks and those of Asian descent. High blood pressure occurs more often in older people—in about two thirds of people aged 6. People who have normal blood pressure at age 5. High blood pressure is twice as common among people who are obese as among those who are not. In the United States, only an estimated 8. Of people with a diagnosis of high blood pressure, about 7. When blood pressure is checked, two values are recorded. The higher value reflects the highest pressure in the arteries, which is reached when the heart contracts (during systole). The lower value reflects the lowest pressure in the arteries, which is reached just before the heart begins to contract again (during diastole). Blood pressure is written as systolic pressure/diastolic pressure—for example, 1. Hg (millimeters of mercury). This reading is referred to as . However, the higher the blood pressure, the greater the risk of complications—even within the normal blood pressure range—so these limits are somewhat arbitrary. In most young people with high blood pressure, both systolic and diastolic pressures are high. In contrast, many older people with high blood pressure have high systolic pressure (1. Hg or more) with normal or low diastolic pressure (less than 9. Hg). This disorder is called isolated systolic hypertension. A hypertensive urgency is blood pressure that is more than 1. Hg but has not yet caused any organ damage that is apparent to people or their doctors. A hypertensive urgency usually does not cause symptoms. A hypertensive emergency is a particularly severe form of high blood pressure. Blood pressure is at least 1. Hg, and there is evidence of progressive damage in one or more vital organs (typically the brain, heart, and kidneys), often accompanied by a variety of symptoms. Hypertensive emergencies are uncommon, but they are several times more common among blacks than among whites, among men than among women, and among people in lower socioeconomic groups than among those in higher socioeconomic groups. If untreated, a hypertensive emergency can be fatal.
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