PHENTERMINE RESIN ER – phentermine capsule, extended release 
Lannett Company, Inc.

———-

Phentermine Resin
Extended-Release Capsules

CIV

Rx Only

DESCRIPTION

Phentermine Resin Extended-Release Capsules contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is α, α-dimethyl phenethylamine (phenyl-tertiary-butylamine).

Inactive Ingredients: Dibasic Calcium Phosphate, Talc, and Magnesium Stearate. The 15 mg capsule shell consists of D&C Yellow #10, FD&C Yellow # 6, Titanium Dioxide, Gelatin, FD&C Blue #1, FD&C Red #40, FDA /E172 Black Iron Oxide. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol and Methanol. The 30 mg capsule shell consists of D&C Yellow #10, FD&C Yellow # 6, Titanium Dioxide, and Gelatin. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol and Methanol.

CLINICAL PHARMACOLOGY

Phentermine Resin Extended-Release Capsules are sympathomimetic amines with pharmacologic activity similar to the prototype drug of this class used in obesity, amphetamine (d- and dl-amphetamine). Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects may be involved.

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

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 in years, whereas the studies cited are restricted to a few weeks’ or months’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

The bioavailability of Phentermine Resin Extended-Release Capsules has been studied in humans in which blood levels of phentermine were measured by a gas chromatography method. Blood levels obtained with the 15 mg and 30 mg resin complex formulations indicated slower absorption with a reduced but prolonged peak concentration and without a significant difference in prolongation of blood levels when compared with the same doses of phentermine hydrochloride. The clinical significance of these differences is not known. In clinical trials establishing the efficacy of Phentermine Resin Extended-Release Capsules, a single daily dose produced an effect comparable to that produced by other regimens of “anorectic” drug therapy.

INDICATIONS AND USAGE

Phentermine Resin Extended-Release Capsules 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., 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
Weight (pounds) Height (feet, inches)
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 (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.

CONTRAINDICATIONS

Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

WARNINGS

Phentermine Resin Extended-Release Capsules are indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, the coadministration of these drug products for weight loss is not recommended.

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 alone cannot be ruled out. The initial symptom of PPH is usually dyspnea. Other initial symptoms 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.

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 etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known.

If tolerance to the “anorectic” effect develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued.

Phentermine Resin Extended-Release Capsules 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.

When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol.

Drug Abuse and Dependence

Phentermine Resin Extended-Release Capsules are related chemically and pharmacologically to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of Phentermine Resin Extended-Release Capsules should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d- and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Usage in Pregnancy

Safe use in pregnancy has not been established. Use of Phentermine Resin Extended-Release Capsules by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant.

Pediatric Use

Phentermine Resin Extended-Release Capsules are not recommended for use in pediatric patients under 16 years of age.

PRECAUTIONS

Caution is to be exercised in prescribing Phentermine Resin Extended-Release Capsules for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Phentermine Resin Extended-Release Capsules and the concomitant dietary regimen.

Phentermine Resin Extended-Release Capsules may decrease the hypotensive effect of adrenergic neuron blocking drugs.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Geriatric Use

Clinical studies of Phentermine Resin Extended-Release Capsules did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.

ADVERSE REACTIONS

Cardiovascular: Primary pulmonary hypertension (see WARNINGS), palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses with some drugs in this class.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic: Urticaria.

Endocrine: Impotence, changes in libido.

OVERDOSAGE

Manifestations of acute overdosage may include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions and coma.

Management of acute Phentermine Resin Extended-Release Capsules intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Intravenous phentolamine (Regitine) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

DOSAGE AND ADMINISTRATION

One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, Phentermine Resin Extended-Release Capsules, 15 mg, will usually suffice. Phentermine Resin Extended-Release Capsules, 30 mg, are recommended for less responsive patients. Phentermine Resin Extended-Release Capsules are not recommended for use in pediatric patients under 16 years of age.

Phentermine Resin Extended-Release Capsules should be swallowed whole.

HOW SUPPLIED

Phentermine Resin Extended-Release Capsules are available in two strengths:

15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body.

NDC 0527-1398-01 Bottle of 100’s

30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body.

NDC 0527-1366-01 Bottle of 100’s

Dispense in a tight, well-closed container as defined in the USP with a child resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured By:
Lannett Company, Inc.
Philadelphia, PA 19136

Rev. 08/09

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 0527-1398-01

Lannett

PHENTERMINE RESIN  CIV
EXTENDED-RELEASE
CAPSULES

15 mg*

Rx Only

100 CAPSULES

PRINCIPAL DISPLAY PANEL — 30 mg

NDC 0527-1366-01

Lannett

PHENTERMINE RESIN  CIV
EXTENDED-RELEASE
CAPSULES

30 mg*

Rx Only

100 CAPSULES


PHENTERMINE RESIN  ER
phentermine resin  capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0527-1398
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE (PHENTERMINE) PHENTERMINE 15 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
TALC  
MAGNESIUM STEARATE  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
TITANIUM DIOXIDE  
GELATIN  
SHELLAC  
ALCOHOL  
FERROSOFERRIC OXIDE  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
FD&C RED NO. 40  
FD&C BLUE NO. 1  
METHYL ALCOHOL  
Product Characteristics
Color GRAY, YELLOW (gray opaque/maize opaque capsules) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LCI;1398
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0527-1398-01 100 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040872 07/28/2011

PHENTERMINE RESIN  ER
phentermine resin  capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0527-1366
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENTERMINE (PHENTERMINE) PHENTERMINE 30 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
TALC  
MAGNESIUM STEARATE  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
TITANIUM DIOXIDE  
GELATIN  
SHELLAC  
ALCOHOL  
FERROSOFERRIC OXIDE  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
FD&C RED NO. 40  
FD&C BLUE NO. 1  
METHYL ALCOHOL  
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LCI;1366
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0527-1366-01 100 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040872 07/28/2011

Labeler – Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 002277481 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 829757603 ANALYSIS, LABEL, MANUFACTURE, PACK
Revised: 07/2011Lannett Company, Inc.