al 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. body mass index (bmi), kg/m 2 height(feet , inches) header$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 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 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.

tant alcohol use may result in an adverse drug reaction. ( 5.7 ) use caution in patients with even mild hypertension (risk of increase in blood pressure). ( 5.8 ) a reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. ( 5.9 ) 5.1 coadministration with other drug products for weight loss phentermine hydrochloride orally disintegrating tablets are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. the safety and efficacy of combination therapy with phentermine hydrochloride orally disintegrating tablets and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. therefore, coadministration of phentermine hydrochloride orally disintegrating tablets and these drug products is not recommended. 5.2 primary pulmonary hypertension primary pulmonary hypertension (pph) a rare, frequently fatal disease of the lungs-has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. the possibility of an association between pph and the use of phentermine hydrochloride alone cannot be ruled out; there have been rare cases of pph in patients who reportedly have taken phentermine alone. the initial symptom of pph is usually dyspnea. other initial symptoms may include angina pectoris, syncope or lower extremity edema. patients should be advised to report immediately any deterioration in exercise tolerance. treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension. 5.3 valvular heart disease serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. the possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. the possibility of an association between valvular heart disease and the use of phentermine hydrochloride alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone. 5.4 development of tolerance, discontinuation in case of tolerance when tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. 5.5 effect on the ability to engage in potentially hazardous tasks phentermine hydrochloride 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. 5.6 risk of abuse and dependence phentermine hydrochloride is related chemically and pharmacologically to amphetamine (d- and d l l-amphetamine) and to other related stimulant drugs that have been extensively abused. the possibility of abuse of phentermine hydrochloride should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. see drug abuse and dependence ( 9 ) and overdosage ( 10 ) . the least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. 5.7 usage with alcohol concomitant use of alcohol with phentermine hydrochloride may result in an adverse drug reaction. 5.8 use in patients with hypertension use caution in prescribing phentermine hydrochloride for patients with even mild hypertension (risk of increase in blood pressure). 5.9 use in patients on insulin or oral hypoglycemic medications for diabetes mellitus a reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

swallow with or without water.

imulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. gastrointestinal dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. allergic urticaria. endocrine impotence, changes in libido.

e. 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. 8.3 nursing mothers it is not known if phentermine hydrochloride is excreted in humanmilk; however, other amphetamines are present in humanmilk. 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. 8.4 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 this product, approved for short-term therapy, is not recommended. 8.5 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. 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. 8.6 renal impairment phentermine hydrochloride was not studied in patients with renal impairment. based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. use caution when administering phentermine hydrochloride to patients with renal impairment [see clinical pharmacology ( 12.3 ) ].

ng the administration of the oral disintegrating tablet (odt), phentermine reaches peak concentrations (c max ) after 3 to 4.4 hours. swallowing the odt after disintegration with or without water did not affect the extent (auc) of phentermine exposure. administration of the orally disintegrating tablet (odt) after a high fat/high calorie breakfast decreased the c max of phentermine by approximately 5% and the auc by approximately 12%. despite the decrease in c max and auc, phentermine hydrochloride orally disintegrating tablet can be administered with or without food. swallowing the orally disintegrating tablet (odt) without prior disintegration decreased the c max of phentermine by approximately 7% and the auc by approximately 8% compared to swallowing the odt after disintegration. drug interactions in a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. however in the presence of topiramate, phentermine c max and auc increase 13% and 42%, respectively. specific populations renal impairment phentermine hydrochloride was not studied in patients with renal impairment. the literature reported cumulative urinary excretion of phentermine under uncontrolled urinary ph conditions is 62% to 85%. exposure increases can be expected in patients with renal impairment. use caution when administering phentermine hydrochloride to patients with renal impairment.

egration. drug interactions in a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. however in the presence of topiramate, phentermine c max and auc increase 13% and 42%, respectively. specific populations renal impairment phentermine hydrochloride was not studied in patients with renal impairment. the literature reported cumulative urinary excretion of phentermine under uncontrolled urinary ph conditions is 62% to 85%. exposure increases can be expected in patients with renal impairment. use caution when administering phentermine hydrochloride to patients with renal impairment.

as to the relative importance of the drug and non-drug factors on weight loss. the natural history of obesity is measured over several 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.

7 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets phentermine hydrochloride orally disintegrating tablets, 37.5 mg are white to off- white, round, beveled, biconvex, uncoated tablets, debossed with '670' on one side and plain on other side and are supplied as follows: ndc 68382-670-06 in bottle of 30 tablets ndc 68382-670-16 in bottle of 90 tablets ndc 68382-670-01 in bottle of 100 tablets ndc 68382-670-05 in bottle of 500 tablets ndc 68382-670-10 in bottle of 1000 tablets ndc 68382-670-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets 16.1 storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a tightly closed container with a child-resistant closure (as required). protect from moisture. keep out of the reach of children.

include, but are not limited to: development of primary pulmonary hypertension [see warnings and precautions ( 5.2 ) ] development of serious valvular heart disease [see warnings and precautions ( 5.3 ) ] effects on the ability to engage in potentially hazardous tasks [see warnings and precautions ( 5.5 ) ] the risk of an increase in blood pressure [see warnings and precautions ( 5.8 ) and adverse reactions ( 6 ) ] the risk of interactions [see contraindications ( 4 ) , warnings and precautions ( 5 ) and drug interactions ( 7 ) ] see also, for example, adverse reactions ( 6 ) and use in specific populations ( 8 ) . the patients must also be informed about the potential for developing tolerance and actions if they suspect development of tolerance [see warnings and precautions ( 5.4 ) ] and the risk of dependence and the potential consequences of abuse [see warnings and precautions ( 5.6 ) , drug abuse and dependence ( 9 ) , and overdosage ( 10 ) ]. tell patients to keep phentermine hydrochloride orally disintegrating tablets in a safe place to prevent theft, accidental overdose, misuse or abuse. selling or giving away phentermine hydrochloride orally disintegrating tablets may harm others and is against the law. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088 , or by visiting www.fda.gov/medwatch. *are the registered trademark of their respective owners.