PHENTERMINE HYDROCHLORIDE - phentermine hydrochloride capsule
Dispensing Solutions, Inc.
PHENTERMINE HCI 15MG USP CAPSULES PHENTERMINE HCI 30MG USP CAPSULES
Phentermine hydrochloride USP has the chemical name of α, α-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.
(KVK TECH INC. manufacture)
Phentermine hydrochloride, an anorectic agent for oral administration, is available as: a) powder-filled
capsules containing 15 mg of phentermine hydrochloride(equivalent to 12mg of phentermine) or 30 mg
phentermine hydrochloride ( equivalent to 24mg phentermine) and inactive ingredients:
Corn starch, gelatin, magnesium stearate, lactose monohydrate. In addition, the 15mg capsules contain D
and C Yellow #10, FD and C Blue #1, FD and C Red #3, FD and C Red #40, titanium dioxide and the
30mg capsules contain D and C Yellow #10, FD and C RED #3, titanium dioxide
b) bead-filled capsules containing 30mg phentermine hydrochloride (equivalent to 24mg phentermine)
and inactive ingredients:
Corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD and C Blue
#1-Brilliant blue FCF aluminum lake, D and C Red # 28 and gelatin.
(LANNETT COMPANY, INC. manufacture)
Phentermine hydrochloride, an anorectic agent for oral administration, is available as: powder-filled
capsules containing 30 mg of phentermine hydrochloride (equivalent to 24 mg of phentermine base) and
inactive ingredients: corn starch, magnesium stearate, lactose anhydrous.
In addition, the natural/blue capsules contain gelatin, D and C Red # 28, and FD and C Blue # 1; the
yellow/yellow capsules contain gelatin, D and C Yellow # 10, FD and C Red # 3, and titanium dioxide;
the black/black capsules contain gelatin, FD and C Yellow # 6, FD and C Blue # 1, and FD and C Red #
40. The imprinting ink for the natural/blue capsules and yellow/yellow capsules contains the following
ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A
alcohol, FD and C Blue # 2 Aluminum Lake, FD and C Red # 40 Aluminum Lake, FD and C Blue # 1
Aluminum Lake, and D and C Yellow # 10 Aluminum Lake. The imprinting ink for the black/black
capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone.
(MUTUAL Phamaceutical manufacture)
Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule
containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each
capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate,
gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting
ink contains FD and C Blue #2, FD and C Red #40, FD and C Blue #1 and D and C Yellow #10 Lake.
Phentermine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the
prototype drugs of this class used in obesity, the amphetamines. 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 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, for example.
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
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 week 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' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be
considered clinically limited.
INDICATIONS AND USAGE
Phentermine hydrochloride is 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/m , or ≥ 27 kg/m 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 × 0.0254 = meters.
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.
Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism,
known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive
crises may result).
Phentermine hydrochloride 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, 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; 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 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. 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.
Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the
recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should
Phentermine hydrochloride 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
Usage with Alcohol
Concomitant use of alcohol with phentermine hydrochloride may result in an adverse drug interaction.
Caution is to be exercised in prescribing phentermine hydrochloride for patients with even mild
Insulin requirements in diabetes mellitus may be altered in association with the use of phentermine
hydrochloride and the concomitant dietary regimen.
Phentermine hydrochloride may decrease the hypotensive effect of guanethidine.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the
possibility of overdosage.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed with phentermine hydrochloride to determine the potential for
carcinogenesis, mutagenesis or impairment of fertility.
Teratogenic EffectsPregnancy Category C
Animal reproduction studies have not been conducted with phentermine hydrochloride. It is also not
known whether phentermine hydrochloride can cause fetal harm when administered to a pregnant woman
or can affect reproductive capacity. Phentermine hydrochloride should be given to a pregnant woman
only if clearly needed.
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.
Safety and effectiveness in pediatric patients have not been established.
Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see
WARNINGS), palpitation, tachycardia, elevation of blood pressure.
Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria,
tremor, headache; rarely psychotic episodes at recommended doses.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal
Endocrine: Impotence, changes in libido.
DRUG ABUSE AND DEPENDENCE
Phentermine hydrochloride is related chemically and pharmacologically to the amphetamines.
Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of
phentermine hydrochloride should be kept in mind when evaluating the desirability of including a drug
as part of a weight reduction program. 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 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.
Manifestations of acute overdosage with phentermine include restlessness, tremor, hyperreflexia, rapid
respiration, confusion, assaultiveness, hallucinations, 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.
Fatal poisoning usually terminates in convulsions and coma.
Management of acute phentermine 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 has been suggested for possible acute, severe hypertension, if this complicates
DOSAGE AND ADMINISTRATION
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is 15 to 30 mg at approximately 2 hours after breakfast for appetite control. Late
evening medication should be avoided because of the possibility of resulting insomnia.
Administration of one capsule (30 mg) daily has been found to be adequate in depression of the appetite
for 12 to 14 hours.
Phentermine is not recommended for use in patients sixteen (16) years of age and under.
Phentermine hydrochloride capsules are supplied as:
KVK-Tech Inc. (manufacture)
30 mg capsules, blue cap, natural body with black imprint "K28" on both the cap and body, filled with
white and blue colored beads.
Phentermine 30mg capsules (blue/clear) are available as follows:
NDC 66336-0185-07 Bottle of 7
NDC 66336-0185-14 Bottle of 14
NDC 66336-0185-21 Bottle of 21
NDC 66336-0185-28 Bottle of 28
NDC 66336-0185-30 Bottle of 30
NDC 66336-0185-42 Bottle of 42
Storage and Dispensing
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature]
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
PRINCIPAL DISPLAY PANEL
phentermine hydrochloride capsule
Product T ype
Ite m Code (Source )
NDC:6 6 336 -
18 5(NDC:10 70 2-0 28 )
Route of Administration
DEA Sche dule
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
PHENTERMINE HYDRO CHLO RIDE (UNII: 0 K2I50 5OTV) (PHENTERMINE -
Stre ng th
STARCH, CO RN (UNII: O8 232NY3SJ)
GELATIN (UNII: 2G8 6 QN327L)
LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
Dispensing Solutions, Inc.
FD&C RED NO . 3 (UNII: PN2ZH5LOQY)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
blue (blue cap, natural bo dy)
no sco re
S hap e
S iz e
Marketing Start Date
Marketing End Date
NDC:6 6 336 -18 5-0 7
7 in 1 BOTTLE
NDC:6 6 336 -18 5-14
14 in 1 BOTTLE
NDC:6 6 336 -18 5-21
21 in 1 BOTTLE
NDC:6 6 336 -18 5-28
28 in 1 BOTTLE
NDC:6 6 336 -18 5-30
30 in 1 BOTTLE
NDC:6 6 336 -18 5-42
42 in 1 BOTTLE
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 40 8 75
0 6 /0 1/19 9 8
Dispensing Solutions, Inc. (066070785)
PSS World Medical, Inc. (101822682)
Ad d re s s
Busine ss Ope rations
Dispensing So lutio ns, Inc.
0 6 6 0 70 78 5