NDC 61919-557 Phentermine Hydrochloride

Phentermine Hydrochloride

NDC Product Code 61919-557

NDC Code: 61919-557

Proprietary Name: Phentermine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phentermine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
ORANGE (C48331)
GRAY (C48324)
Shape: CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
LANNETT;1742
Score: 1

NDC Code Structure

  • 61919 - Direct_rx
    • 61919-557 - Phentermine Hydrochloride

NDC 61919-557-30

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Product Information

Phentermine Hydrochloride with NDC 61919-557 is a a human prescription drug product labeled by Direct_rx. The generic name of Phentermine Hydrochloride is phentermine hydrochloride. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Direct_rx

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule IV (CIV) Substances What is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States.

Phentermine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENTERMINE HYDROCHLORIDE 15 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SHELLAC (UNII: 46N107B71O)
  • METHYL ALCOHOL (UNII: Y4S76JWI15)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • GELATIN (UNII: 2G86QN327L)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Appetite Suppression - [PE] (Physiologic Effect)
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
  • Sympathomimetic Amine Anorectic - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct_rx
Labeler Code: 61919
FDA Application Number: ANDA087022 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-09-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Phentermine Hydrochloride Product Label Images

Phentermine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications & Usage

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/m2Height (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.

Dosage & Administration

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.

Dosage Forms & Strengths

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.

Contraindications

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

Warnings And Precautions

5.1 Coadministration with Other Drug Products for Weight LossPhentermine 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 HypertensionPrimary 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 DiseaseSerious 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 ToleranceWhen 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 TasksPhentermine 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 DependencePhentermine 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 AlcoholConcomitant use of alcohol with phentermine may result in an adverse drug reaction.5.8 Use in Patients with HypertensionUse 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 MellitusA reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Adverse Reactions

5.1 Coadministration with Other Drug Products for Weight LossPhentermine 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 HypertensionPrimary 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 DiseaseSerious 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 ToleranceWhen 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 TasksPhentermine 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 DependencePhentermine 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 AlcoholConcomitant use of alcohol with phentermine may result in an adverse drug reaction.5.8 Use in Patients with HypertensionUse 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 MellitusA reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Drug Interactions

7.1 Monoamine Oxidase InhibitorsUse 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 AlcoholConcomitant use of alcohol with phentermine may result in an adverse drug reaction.7.3 Insulin and Oral Hypoglycemic MedicationsRequirements may be altered [see Warnings and Precautions (5.9)].7.4 Adrenergic Neuron Blocking DrugsPhentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Use In Specific Populations

8.1 PregnancyTeratogenic EffectsPregnancy 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 MothersIt 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 UseSafety 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 UseIn 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 ImpairmentPhentermine 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)].

Drug Abuse And Dependence

9.1 Controlled SubstancePhentermine is a Schedule IV controlled substance.9.2 AbusePhentermine 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 DependenceAbuse 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.

Overdosage

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.10.1 Acute OverdosageManifestations 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 IntoxicationManifestations 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).

Description

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. 185.7Phentermine 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.

Clinical Pharmacology

12.1 Mechanism of ActionPhentermine 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 PharmacodynamicsTypical 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 PharmacokineticsFollowing 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.

Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityStudies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

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.

How Supplied

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.

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 (5.1)].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 aboutthe 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
CIB70554BRev. 05/2016

* Please review the disclaimer below.

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