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NDC 13107-0106-01 Phentermine 30 mg/1 Details
Phentermine 30 mg/1
Phentermine is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurolife Pharma, LLC. The primary component is PHENTERMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet. Phentermine is in a class of medications called anorectics. It works by decreasing appetite.
Related Packages: 13107-0106-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phentermine
Product Information
| NDC | 13107-0106 |
|---|---|
| Product ID | 13107-106_53dd7857-41fb-4da1-88f7-5c68a509bfb0 |
| Associated GPIs | 61200070100115 |
| GCN Sequence Number | 005154 |
| GCN Sequence Number Description | phentermine HCl CAPSULE 30 MG ORAL |
| HIC3 | J8A |
| HIC3 Description | ANTI-OBESITY - ANOREXIC AGENTS |
| GCN | 20692 |
| HICL Sequence Number | 002111 |
| HICL Sequence Number Description | PHENTERMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Phentermine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Phentermine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/1 |
| Substance Name | PHENTERMINE HYDROCHLORIDE |
| Labeler Name | Aurolife Pharma, LLC |
| Pharmaceutical Class | Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA204318 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 13107-0106-01 (13107010601)
| NDC Package Code | 13107-106-01 |
|---|---|
| Billing NDC | 13107010601 |
| Package | 100 CAPSULE in 1 BOTTLE (13107-106-01) |
| Marketing Start Date | 2017-03-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.10891 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | PHENTERMINE 30 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 737eef3b-9a6b-4ab3-a25c-49d84d2a0197 Details
HIGHLIGHTS OF PRESCRIBING INFORMATION
PHENTERMINE hydrochloride capsules, for oral use
Initial U.S. Approval: 1959
INDICATIONS AND USAGE
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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 greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including Phentermine Hydrochloride Capsules USP, should be measured against possible risk factors inherent in their use. (1)
DOSAGE AND ADMINISTRATION
- Dosage should be individualized to obtain an adequate response with the lowest effective dose. (2.1)
- Late evening administration should be avoided (risk of insomnia). (2.1)
- Phentermine hydrochloride Capsules can be taken with or without food. (2.1)
- Limit the dosage to 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) (2.2)
DOSAGE FORMS AND STRENGTHS
- Capsules containing 15 mg or 30 mg phentermine Hydrochloride (3)
CONTRAINDICATIONS
- History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) (4)
- During or within 14 days following the administration of monoamine oxidase inhibitors (4)
- Hyperthyroidism (4)
- Glaucoma (4)
- Agitated states. (4)
- History of drug abuse (4)
- Pregnancy (4, 8.1)
- Nursing (4, 8.3)
- Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines (4)
WARNINGS AND PRECAUTIONS
- Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). (5.1)
- Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. (5.2)
- Rare cases of serious regurgitant cardiac valvular disease have been reported. (5.3)
- Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued. The recommended dose should not be exceeded. (5.4)
- Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. (5.5)
- Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. (5.6)
- Concomitant alcohol use may result in an adverse drug reaction. (5.7)
- Use caution in patients with even mild hypertension (risk of increase in blood pressure). (5.8)
- A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. (5.9)
ADVERSE REACTIONS
Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
- Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. (4, 8.3)
- Pediatric use: Safety and effectiveness not established. (8.4)
- Geriatric use: Due to substantial renal excretion, use with caution. (8.5)
- Renal Impairment: Avoid use in patients with eGFR less than 15 mL/min/m2 or end-stage renal disease requiring dialysis) (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 1/2019
Table Of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
2.1 Exogenous Obesity
2.2 Dosage in Patients with Renal Impairment
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Coadministration with Other Drug Products for Weight Loss
5.2 Primary Pulmonary Hypertension
5.3 Valvular Heart Disease
5.4 Development of Tolerance, Discontinuation in Case of Tolerance
5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks
5.6 Risk of Abuse and Dependence
5.7 Usage with Alcohol
5.8 Use in Patients with Hypertension
5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus
5.10 Risk of Allergic Reactions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase Inhibitors
7.2 Alcohol
7.3 Insulin and Oral Hypoglycemic Medications
7.4 Adrenergic Neuron Blocking Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
10.1 Acute Overdosage
10.2 Chronic Intoxication
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
- *
- Sections or subsections omitted from the full prescribing information are not listed.
1 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 greater than or equal to 30 kg/m2, or greater than or equal to 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 (fe
et, 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.
2 DOSAGE & ADMINISTRATION
2.1 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 patient’s≤16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
With dry hands, gently remove the Phentermine Hydrochloride Capsule from the bottle. Immediately place the Phentermine Hydrochloride Capsule on top of the tongue where it will dissolve, then swallow with or without water.
2.2 Dosage in Patients with Renal Impairment
The recommended maximum dosage of Phentermine Hydrochloride Capsule is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Avoid use of Phentermine Hydrochloride Capsule in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6)andClinical Pharmacology (12.3)]
3 DOSAGE FORMS & STRENGTHS
Capsules containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base respectively)
15 mg Capsules: white to off-white powder filled in Size ‘3’ gray opaque/yellow opaque capsules, imprinted with “U47” on cap and body in black ink.
30 mg Capsules: white to off-white powder filled in Size ‘3’ yellow opaque/yellow opaque capsules, imprinted with “U48” on cap and body in black ink.
4 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
5 WARNINGS AND PRECAUTIONS
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, syncopeor lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment shouldbe 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 d/l-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.
5.10 Risk of Allergic Reactions
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
6 ADVERSE REACTIONS
The following adverse reactions are described, or described in greater detail, in other sections:
- Primary pulmonary hypertension [see Warnings and Precautions (5.2)]
- Valvular heart disease [see Warnings and Precautions (5.3)]
- Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]
- Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence (9.3)]
The following adverse reactions to phentermine have been identified:
Cardiovascular
- Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.
Central Nervous System
- Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.
Gastrointestinal
- Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
Allergic
- Urticaria.
Endocrine
- Impotence, changes in libido.
7 DRUG INTERACTIONS
Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.
7.1 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.
7.3 Insulin and Oral Hypoglycemic Medications
Requirements may be altered [see Warnings and Precautions (5.9)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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 d/l-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
Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [seeClinical Pharmacology (12.3)].
Use caution when administering Phentermine to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2), limit the dosage of Phentermine to 15 mg daily [see Dosage and Administration (2.2)]. Phentermine has not been studied in patients with eGFR less than 15 mL/min/1.73m2, including end-stage renal disease requiring dialysis; avoid use in these populations.
9 DRUG ABUSE AND DEPENDENCE
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.
10 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) .
11 DESCRIPTION
Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is a,a,-dimethylphenethylamine hydrochloride. The structural formula is as follows:
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 capsule USP is available as an oral capsule containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base)
Powder-filledcapsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: lactose monohydrate, magnesium stearate, iron oxide black, Shellac Glaze, N-Butyl alcohol, Isopropyl alcohol, propylene Glycol and Ammonium Hydroxide.
In addition, the 15 mg capsules contain gelatin, titanium dioxide, D&C yellow # 10, FD&C yellow # 6, FD&C red # 40, FD&C blue # 1 and FD&C yellow # 5; the 30 mg capsules contain gelatin, titanium dioxide, iron oxide yellow and iron oxide red.
12 CLINICAL PHARMACOLOGY
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 d/l-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 actions 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.
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.
Specific Populations
Renal Impairment
Cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions was 62% to 85%.
Systemic exposure of phentermine may increase up to 91%, 45%, and 22% in patients with severe, moderate, and mild renal impairment, respectively [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].
13 NONCLINICAL TOXICOLOGY
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 30 NDC 13107-105-30
Bottles of 100 NDC 13107-105-01
Phentermine Hydrochloride Capsules USP, 30 mg are white to off-white powder filled in Size ‘3’ yellow opaque/yellow opaque capsules, imprinted with “U48” on cap and body in black ink.
Bottles of 30 NDC 13107-106-30
Bottles of 100 NDC 13107-106-01
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 [seeIndications 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)andDrug 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
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL –Phentermine Hydrochloride Capsules, USP 15 mg - 100 Capsules Label Text
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – Phentermine Hydrochloride Capsules, USP 30 mg - 100 Capsules Label Text
INGREDIENTS AND APPEARANCE
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| Labeler - Aurolife Pharma, LLC (829084461) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
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| Aurolife Pharma, LLC | 829084461 | MANUFACTURE(13107-105, 13107-106) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurolife Pharma LLC | 078296263 | RELABEL(13107-105, 13107-106) , REPACK(13107-105, 13107-106) , LABEL(13107-105, 13107-106) , PACK(13107-105, 13107-106) | |