Phentermine (Page 4 of 4)

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

Phentermine Hydrochloride Capsules USP, 15 mg are white to off-white powder filled in Size ‘3’ gray opaque/yellow opaque capsules, imprinted with “U47” on cap and body in black ink.

Bottles of 7 NDC 68788-7691-01
Bottles of 30 NDC 68788-7691-03
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

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

Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

Patients must be informed that phentermine hydrochloride 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 phentermine to take, and when and how to take it [see Dosage and Administration (2)].

Advise pregnant women and nursing mothers not to use phentermine [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 phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law.
Revised:03/2017

Repackaged by Preferred Pharmaceuticals, Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL –Phentermine Hydrochloride Capsules, USP 15 mg

NDC 68788-7691
Phentermine Hydrochloride Capsules, USP CIV
15 mg
Rx only

Repackaged by Preferred Pharmaceuticals, Inc.

Phentermine HCI Capsules USP 15mg CIV
(click image for full-size original)
PHENTERMINE phentermine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7691(NDC:13107-105)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FD&C RED NO. 40
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C YELLOW NO. 5
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color GRAY (Gray Opaque) , YELLOW (Yellow Opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code U;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7691-1 7 CAPSULE in 1 BOTTLE None
2 NDC:68788-7691-3 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204318 04/01/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7691)

Revised: 04/2020 Preferred Pharmaceuticals, Inc.

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