United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 15 mg - phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2 , or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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.  body mass index (bmi), kg/m2 height (feet, inches) weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3"  140  27  25  23  21  19  18  150  29  27  24  22  20  19  160  31  28  26  24  22  20  170  33  30  28  25  23  21  180  35  32  29  27  25  23  190  37  34  31  28  26  24  200  39  36  32  30  27  25  210  41  37  34  31  29  26  220  43

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. •history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail

United States - English - NLM (National Library of Medicine)

kvk-tech, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) - during or within 14 days following the administration of monoamine oxidase inhibitors - hyperthyroidism - glaucoma - agitated states - history of drug abuse - pregnancy [see use in specific populations ( 8.1) ] - nursing [see use in specific populations ( 8.3) ] - known hypersensitivity, or idiosyncrasy to the sympathomimetic amines pregnancy category x phentermine 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. phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [ see clinical pharmacology ( 12.1) ]. animal reproduction studies have not been conducted with phentermine. 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. it is not known if phentermine is excreted in human milk; however, 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. safety and effectiveness in pediatric patients have not been established. because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. 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. this drug is known to be substantially excreted by the kidney, and 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. based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [ see clinical pharmacology ( 12.3) ]. use caution when administering phentermine hydrochloride to patients with renal impairment. in patients with severe renal impairment (egfr 15 to 29 ml/min/1.73 m 2 ), limit the dosage of phentermine hydrochloride to 15 mg daily [see dosage and administration ( 2.2)]. phentermine hydrochloride has not been studied in patients with egfr less than 15 ml/min/1.73 m 2 , including end-stage renal disease requiring dialysis; avoid use in these populations. phentermine is a schedule iv controlled substance. phentermine is related chemically and pharmacologically to the amphetamines. amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine 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 of these drugs 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. a severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

United States - English - NLM (National Library of Medicine)

blenheim pharmacal, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. •history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2 , or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride tablets usp, [see clinical pharmacology (12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride, usp 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those describ

United States - English - NLM (National Library of Medicine)

directrx - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride, usp 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. bmi index the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. history of cardiovascular disease (e.g., coronary arter

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. •history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail

United States - English - NLM (National Library of Medicine)

sunrise pharmaceutical, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2 , or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine, [see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. • history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hyper

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) - during or within 14 days following the administration of monoamine oxidase inhibitors - hyperthyroidism - glaucoma - agitated states - history of drug abuse - pregnancy [see use in specific populations ( 8.1) ] - nursing [see use in specific populations ( 8.3) ] - known hypersensitivity, or idiosyncrasy to the sympathomimetic amines pregnancy category x phentermine 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. phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [ see clinical pharmacology ( 12.1) ]. animal reproduction studies have not been conducted with phentermine. 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. it is not known if phentermine is excreted in human milk; however, 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. safety and effectiveness in pediatric patients have not been established. because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. 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. this drug is known to be substantially excreted by the kidney, and 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. based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [ see clinical pharmacology ( 12.3) ]. use caution when administering phentermine hydrochloride to patients with renal impairment. in patients with severe renal impairment (egfr 15 to 29 ml/min/1.73 m 2 ), limit the dosage of phentermine hydrochloride to 15 mg daily [see dosage and administration ( 2.2)]. phentermine hydrochloride has not been studied in patients with egfr less than 15 ml/min/1.73 m 2 , including end-stage renal disease requiring dialysis; avoid use in these populations. phentermine is a schedule iv controlled substance. phentermine is related chemically and pharmacologically to the amphetamines. amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine 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 of these drugs 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. a severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.