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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.
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.
Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine , CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.
Systemic exposure of phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see Dosage and Administration ( 2.2) and Use in Specific Populations ( 8.6)].
Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:
Suprenza is an orally disintegrating tablet (ODT) ofphentermine hydrochloride, USP. Phentermine hydrochloride is a sympathomimeticamine anorectic. Its chemical name is α,α,dimethylphenethylaminehydrochloride. The structural formula is as follows:
Suprenza contains the inactiveingredients mannitol powder, citric acid powder, Povidone CL, Povidone K 30,sucralose, magnesium stearate, peppermint flavor, talc, sodium lauryl sulfate,and mannitol pregranulated. Suprenza 15 mg ODT also contains FD&C Blue # 1lake and FD&C Yellow # 5 lake. Suprenza 30 mg ODT also contains FD&CYellow # 5 lake. Suprenza 37.5 mg ODT also contains FD&C Blue # 1 lake.
With dry hands, gently remove the Suprenza (phenterminehydrochloride ODT) tablet from the bottle. Immediately place the Suprenzatablet on top of the tongue where it will dissolve, then swallow with orwithout water.
Available as orally disintegrating tablets (ODT)containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are notscored. The 15 mg ODT is a yellow with blue spots round tablet embossed withAX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 onone side. The 37.5 mg ODT is a white with blue spots round tablet embossed withAX8 on one side.
Phentermine is related chemically and pharmacologicallyto the amphetamines. Amphetamines and other stimulant drugs have beenextensively abused and the possibility of abuse of phentermine should be keptin mind when evaluating the desirability of including a drug as part of aweight reduction program.
Serious regurgitant cardiac valvular disease,primarily affecting the mitral, aortic and/or tricuspid valves, has beenreported in otherwise healthy persons who had taken a combination ofphentermine with fenfluramine or dexfenfluramine for weight loss. The possiblerole of phentermine in the etiology of these valvulopathies has not beenestablished and their course in individuals after the drugs are stopped is notknown. The possibility of an association between valvular heart disease and theuse of Suprenza alone cannot be ruled out; there have been rare cases ofvalvular heart disease in patients who reportedly have taken phentermine alone.
Suprenza is contraindicated during pregnancy because weightloss offers no potential benefit to a pregnant woman and may result in fetalharm. A minimum weight gain, and no weight loss, is currently recommended forall pregnant women, including those who are already overweight or obese, due toobligatory weight gain that occurs in maternal tissues during pregnancy.Phentermine has pharmacologic activity similar to amphetamine (d- and dllamphetamine)[see CLINICAL PHARMACOLOGY]. Animal reproduction studies have not beenconducted with phentermine. If this drug is used during pregnancy, or if thepatient becomes pregnant while taking this drug, the patient should be apprisedof the potential hazard to a fetus.
Suprenza was not studied in patients with renalimpairment. Based on the reported excretion of phentermine in urine, exposureincreases can be expected in patients with renal impairment. Use caution whenadministering Suprenza to patients with renal impairment [see CLINICALPHARMACOLOGY].
Management of acute phentermine hydrochlorideintoxication is largely symptomatic and includes lavage and sedation with abarbiturate. Experience with hemodialysis or peritoneal dialysis is inadequateto permit recommendations in this regard. Intravenous phentolamine (Regitine,CIBA) has been suggested on pharmacologic grounds for possible acute, severehypertension, if this complicates overdosage.
Following the administration ofthe oral disintegrating tablet (ODT), phentermine reaches peak concentrations(Cmax) after 3.0 to 4.4 hours. Swallowing the ODT after disintegration with orwithout water did not affect the extent (AUC) of phentermine exposure.
Administration of the ODT aftera high fat/high calorie breakfast decreased the Cmax of phentermine byapproximately 5% and the AUC by approximately 12%. Despite the decrease in Cmaxand AUC, phentermine ODT can be administered with or without food.
In a single-dose study comparing the exposures after oraladministration of a combination capsule of 15 mg phentermine and 92 mgtopiramate to the exposures after oral administration of a 15 mg phenterminecapsule or a 92 mg topiramate capsule, there is no significant topiramateexposure change in the presence of phentermine. However in the presence oftopiramate, phentermine Cmax and AUC increase 13% and 42%, respectively.
Suprenza was not studied in patients with renalimpairment. The literature reported cumulative urinary excretion of phentermineunder uncontrolled urinary pH conditions is 62%-85%. Exposure increases can beexpected in patients with renal impairment. Use caution when administeringSuprenza to patients with renal impairment.
The natural history of obesity is measured over severalyears, 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 beconsidered clinically limited.
Patients must be informed thatSuprenza is a short-term (a few weeks) adjunct in a regimen of weight reductionbased on exercise, behavioral modification and caloric restriction in themanagement of exogenous obesity, and that coadministration of phentermine withother drugs for weight loss is not recommended [see INDICATIONS AND USAGEand WARNINGS AND PRECAUTIONS].
Patients must be informed aboutthe risks of use of phentermine (including the risks discussed in Warnings andPrecautions), about the symptoms of potential adverse reactions and when tocontact a physician and/or take other action. The risks include, but are notlimited to:
The Preamble arranges basic information on the "who, what, where, when, and why" of a document for the reader's convenience. For Rules and Proposed Rules it explains the basis and purpose of the regulatory text, but contains no regulatory text. 041b061a72