LOMAIRA- phentermine hydrochloride tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)

Prieinama:

KVK-TECH, INC.

INN (Tarptautinis Pavadinimas):

PHENTERMINE HYDROCHLORIDE

Sudėtis:

PHENTERMINE HYDROCHLORIDE 8 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

LOMAIRA™ tablets 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 in patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 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/m 2 The limited usefulness of agents of this class, including phentermine (see Clinical Pharmacology ), should be measured against possible risk factors inherent in their use such as those described below. • 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 Precautions ) • Nursing (see Precautions ) • Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines Phentermine is a Schedule IV controlled substance. 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. 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.

Produkto santrauka:

LOMAIRA™ is available as follows: LOMAIRA™ 8 mg is supplied as white butterfly shaped tablets with blue speckles, debossed “K1” on one side and bisected on the other side. Bottles of 30, NDC 10702-001-03 Bottles of 60, NDC 10702-001-06 Bottles of 90, NDC 10702-001-09 Bottles of 250, NDC 10702-001-25 Bottles of 500, NDC 10702-001-50 Bottles of 1000, NDC 10702-001-10 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. Manufactured by: KVK-Tech, Inc. 110 Terry Drive Newtown, PA 18940 Item ID# 006178/09 Manufacturer’s Code: 10702 12/23

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LOMAIRA- PHENTERMINE HYDROCHLORIDE TABLET
KVK-TECH, INC.
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LOMAIRA™ (PHENTERMINE HYDROCHLORIDE USP) TABLETS, CIV
DESCRIPTION
Phentermine hydrochloride is a sympathomimetic amine anorectic. Its
chemical name is
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.
LOMAIRA™ tablet is available as an oral tablet containing 8 mg of
phentermine
hydrochloride (equivalent to 6.4 mg of phentermine base). Each
LOMAIRA™ tablet also
contains the following inactive ingredients: Corn Starch, Magnesium
Stearate, NF,
Microcrystalline Cellulose 102, NF, Stearic Acid, NF, FD&C Blue #1 and
Sucrose.
CLINICAL PHARMACOLOGY
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.
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.
PHARMACOKINETICS
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
62%-85%. Exposure increases can be expected in patients with renal
impairment. Use
caution when administering phentermine to patients with renal
impairment