Adipex-P (Page 3 of 3)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

14 CLINICAL STUDIES

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

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 drugs 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 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, speckled, scored tablet is debossed with “ADIPEX-P” and “9”-“9”. The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with “ADIPEX-P” — “37.5” on the cap and two stripes on the body using dark blue ink.

Tablets are packaged in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).

Capsules are packaged in bottles of 100 (NDC 57844-019-01).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

Patients must be informed that ADIPEX-P® is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5)].

Patients must be instructed on how much ADIPEX-P® to take, and when and how to take it [see Dosage and Administration (2) ].

Advise pregnant women and nursing mothers not to use ADIPEX-P® [see Use in Specific Populations (8.1, 8.3)].

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:

  • 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 ADIPEX-P® in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away ADIPEX-P® may harm others and is against the law.

All trademarks are the property of their respective owners.

Manufactured by:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Manufactured for:

Teva Select Brands , Horsham, PA 19044

Division of Teva Pharmaceuticals USA

Rev. X 1/2013

PRINCIPAL DISPLAY PANEL

NDC 54569-1718-0

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048

//medlibrary.org/lib/images-rx/adipex-p-3/1718-0-300x125.jpg
(click image for full-size original)
ADIPEX-P
phentermine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-1718(NDC:57844-009)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SUCROSE
FD&C BLUE NO. 1
Product Characteristics
Color BLUE, WHITE Score 2 pieces
Shape OVAL (oblong) Size 10mm
Flavor Imprint Code ADIPEX;P;9;9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54569-1718-0 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085128 09/30/1990
Labeler — A-S Medication Solutions LLC (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions LLC 830016429 repack (54569-1718)

Revised: 06/2013 A-S Medication Solutions LLC

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