PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Phentermine hydrochloride 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., 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
Product summary:
Phentermine hydrochloride capsules are supplied as: 15 mg powder-filled capsules, gray/orange; imprinted logo LANNETT on the cap and 1742 on the body, in bottles of 100 and 1000 psules, natural/blue; imprinted logo LANNETT on the cap and 1308 on the body, in bottles of 100 and 1000 capsules. 30 mg powder-filled capsules, yellow/yellow; imprinted logo LANNETT on the cap and 1310 on the body, in bottles of 100 and 1000 capsules. 30 mg powder-filled capsules, black/black; imprinted logo LANNETT on the cap and logo 0597 logo on the body, in bottles of 100 and 1000 capsules. 30 mg pellet-filled capsules, natural/blue; imprinted logo LANNETT on the cap and 1438 on the body, in bottles of 100 and 1000 capsules. 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 out of the reach of children.
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-557-30

PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride capsule

Direct_Rx

----------

PHENTERMINE HYDROCHLORIDE

Phentermine hydrochloride 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., 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.

Exogenous Obesity

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

The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after

breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate

in depression of the appetite for 12 to 14 hours.

Phentermine is not recommended for use in pediatric patients ≤ 16 years of age.

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

Phentermine hydrochloride capsules USP, 15 mg (equivalent to 12 mg phentermine base): powder-filled

capsules, gray/orange; imprinted logo LANNETT on the cap and 1742 on the body.

Phentermine hydrochloride capsules USP, 30 mg (equivalent to 24 mg phentermine base): powder-filled

capsules, natural/blue; imprinted logo LANNETT on the cap and 1308 on the body.

Phentermine hydrochloride capsules USP, 30 mg (equivalent to 24 mg phentermine base): powder-filled

capsules, yellow/yellow; imprinted logo LANNETT on the cap and 1310 on the body.

Phentermine hydrochloride capsules USP, 30 mg (equivalent to 24 mg phentermine base): powder-filled

capsules, black/black; imprinted logo LANNETT on the cap and logo 0597 logo on the body.

Phentermine hydrochloride capsules USP, 30 mg (equivalent to 24 mg phentermine base): pellet-filled

capsules, natural/blue; imprinted logo LANNETT on the cap and 1438 on the body.

History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart

failure, uncontrolled hypertension)

During or within 14 days following the administration of monoamine oxidase inhibitors

Hyperthyroidism

Glaucoma

Agitated states

History of drug abuse

Pregnancy [see Use in Specific Populations (8.1)]

Nursing [see Use in Specific Populations (8.3)]

Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

5.1 Coadministration with Other Drug Products for Weight Loss

Phentermine hydrochloride capsules are indicated only as short-term (a few weeks) 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 prescribed drugs, over-the-counter preparations,

and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g.,

fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration

of phentermine and these drug products is not recommended.

5.2 Primary Pulmonary Hypertension

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; there have been rare cases of PPH in patients who reportedly have taken

phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may 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, and patients

should be evaluated for the possible presence of pulmonary hypertension.

5.3 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 possible role of phentermine in the etiology

of these valvulopathies has not been established and their course in individuals after the drugs are

stopped is not known. The possibility of an association between valvular heart disease and the use of

phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients

who reportedly have taken phentermine alone.

5.4 Development of Tolerance, Discontinuation in Case of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an

attempt to increase the effect; rather, the drug should be discontinued.

5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks

Phentermine 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.

5.6 Risk of Abuse and Dependence

Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and

other related stimulant drugs that have been extensively abused. The possibility of abuse of phentermine

should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction

program. See Drug Abuse and Dependence (9) and Overdosage (10).

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

possibility of overdosage.

5.7 Usage with Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

5.8 Use in Patients with Hypertension

Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in

blood pressure).

5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be

required.

5.1 Coadministration with Other Drug Products for Weight Loss

Phentermine hydrochloride capsules are indicated only as short-term (a few weeks) 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 prescribed drugs, over-the-counter preparations,

and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g.,

fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration

of phentermine and these drug products is not recommended.

5.2 Primary Pulmonary Hypertension

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; there have been rare cases of PPH in patients who reportedly have taken

phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may 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, and patients

should be evaluated for the possible presence of pulmonary hypertension.

5.3 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 possible role of phentermine in the etiology

of these valvulopathies has not been established and their course in individuals after the drugs are

stopped is not known. The possibility of an association between valvular heart disease and the use of

phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients

who reportedly have taken phentermine alone.

5.4 Development of Tolerance, Discontinuation in Case of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an

attempt to increase the effect; rather, the drug should be discontinued.

5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks

Phentermine 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.

5.6 Risk of Abuse and Dependence

Phentermine is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and

other related stimulant drugs that have been extensively abused. The possibility of abuse of phentermine

should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction

program. See Drug Abuse and Dependence (9) and Overdosage (10).

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

possibility of overdosage.

5.7 Usage with Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

5.8 Use in Patients with Hypertension

Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in

blood pressure).

5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be

required.

7.1 Monoamine Oxidase Inhibitors

Use of phentermine is contraindicated during or within 14 days following the administration of

monoamine oxidase inhibitors because of the risk of hypertensive crisis.

7.2 Alcohol

Concomitant use of alcohol with phentermine may result in an adverse drug reaction.

7.3 Insulin and Oral Hypoglycemic Medications

Requirements may be altered [see Warnings and Precautions (5.9)].

7.4 Adrenergic Neuron Blocking Drugs

Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

8.1 Pregnancy

Teratogenic Effects

Pregnancy Category X

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 dll-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.

8.3 Nursing Mothers

It is not known if phentermine is excreted in human milk; however, other amphetamines are present in

human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should

be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of

the drug to the mother.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a

chronic condition requiring long-term treatment, the use of this product, approved for short-term

therapy, is not recommended.

8.5 Geriatric Use

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.

8.6 Renal Impairment

Phentermine was not studied in patients with renal impairment. Based on the reported excretion of

phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution

when administering phentermine to patients with renal impairment [see Clinical Pharmacology (12.3)].

9.1 Controlled Substance

Phentermine is a Schedule IV controlled substance.

9.2 Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other

stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept

in mind when evaluating the desirability of including a drug as part of a weight reduction program.

9.3 Dependence

Abuse of amphetamines 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 these drugs

to many times than 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. A severe manifestation of chronic

intoxication is psychosis, often clinically indistinguishable from schizophrenia.

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

possibility of overdosage.

10.1 Acute Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration,

confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the

central stimulation. Cardiovascular effects include arrhythmia, 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

terminates in convulsions and coma.

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.

10.2 Chronic Intoxication

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. See Drug Abuse and

Dependence (9.3).

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-

dimethylphenethylamine hydrochloride. The structural formula is as follows:

[Phentermine HCl Molecular Structure]

C10H15N HCl M.W. 185.7

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in

water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Phentermine hydrochloride capsules, USP are available as:

a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg

phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and

inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules

contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium

dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous,

gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose

anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black

capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40.

The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg

yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene

glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C

Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg

black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene

glycol, strong ammonia solution, yellow iron oxide, and dimethicone.

b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine

base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide,

FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow

No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the

pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene

glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C

Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.

12.1 Mechanism of Action

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of

this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are

commonly known as "anorectics" or "anorexigenics." It has not been established that the primary action

of such drugs in treating obesity is one of appetite suppression since other central nervous system

actions, or metabolic effects, may also be involved.

12.2 Pharmacodynamics

Typical of amphetamines 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.

12.3 Pharmacokinetics

Following the administration of phentermine, phentermine reaches peak concentrations (Cmax) after 3 to

4.4 hours.

Specific Populations

Renal Impairment

Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary

excretion of phentermine under uncontrolled urinary pH conditions is 62%-85%. Exposure increases

can be expected in patients with renal impairment. Use caution when administering phentermine to

patients with renal impairment.

Drug Interactions

In a single-dose study comparing the exposures after oral administration of a combination capsule of 15

mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine

capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the

presence of phentermine. However in the presence of topiramate, phentermine Cmax and AUC increase

13% and 42%, respectively.

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.

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.

Phentermine hydrochloride capsules are supplied as:

15 mg powder-filled capsules, gray/orange; imprinted logo LANNETT on the cap and 1742 on the

body, in bottles of 100 and 1000 psules, natural/blue; imprinted logo LANNETT on the cap and 1308 on

the body, in bottles of 100 and 1000 capsules.

30 mg powder-filled capsules, yellow/yellow; imprinted logo LANNETT on the cap and 1310 on the

body, in bottles of 100 and 1000 capsules.

30 mg powder-filled capsules, black/black; imprinted logo LANNETT on the cap and logo 0597 logo

on the body, in bottles of 100 and 1000 capsules.

30 mg pellet-filled capsules, natural/blue; imprinted logo LANNETT on the cap and 1438 on the body,

in bottles of 100 and 1000 capsules.

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 out of the reach of children.

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 (5.1)].

Patients must be instructed on how much phentermine to take, and when and how to take it [see Dosage

and Administration (3)].

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 (5.7, 5.9) 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.

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19154

Made in the USA

CIB70554B

Rev. 05/2016

PHENTERMINE HYDROCHLORIDE

phentermine hydrochloride capsule

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code (Source )

NDC:6 19 19 -

557(NDC:0 527-1742)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENTERMINE HYDRO CHLO RIDE (UNII: 0 K2I50 5OTV) (PHENTERMINE -

PHENTERMINE

PHENTERMINE HYDRO CHLO RIDE (UNII: 0 K2I50 5OTV) (PHENTERMINE -

UNII:C0 45TQL4WP)

PHENTERMINE

HYDROCHLORIDE

15 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SHELLAC (UNII: 46 N10 7B71O)

METHYL ALCO HO L (UNII: Y4S76 JWI15)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN (UNII: 2G8 6 QN327L)

BUTYL ALCO HO L (UNII: 8 PJ6 1P6 TS3)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Product Characteristics

Color

o range, gray

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

LANNETT;1742

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -557-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 9 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 8 70 22

0 7/0 9 /20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Dire ct_Rx

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -557)

Revised: 7/2019

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