Label: ADIPEX-P- phentermine hcl 37.5mg tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 4, 2020

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  • Dosage and Administration Section

    2 DOSAGE AND ADMINISTRATION

    2.1 Exogenous Obesity

    Dosage should be individualized to obtain an adequate response with the lowest effective dose.

    The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day. Phentermineis not recommended for use in pediatric patients ≤ 16 years of age.

    Late evening medication should be avoided because of the possibility of resulting insomnia.

    2.2 Dosage in Patients With Renal Impairment

    The recommended maximum dosage of phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Avoid use of phentermine in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

    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.

    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 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, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

  • Principal Display Panel

    Phentermine HCl 37.5mg

  • INGREDIENTS AND APPEARANCE
    ADIPEX-P 
    phentermine hcl 37.5mg tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0118(NDC:0527-1445)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE HYDROCHLORIDE37.5 mg
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code LCI;1445
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0118-128 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04055504/15/2005
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0118)