PHENTERMINE HYDROCHLORIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

PD-Rx Pharmaceuticals, Inc.

INN (nemzetközi neve):

PHENTERMINE HYDROCHLORIDE

Összetétel:

PHENTERMINE HYDROCHLORIDE 37.5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Phentermine hydrochloride, USP 37.5 mg is indicated as 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/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. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] 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 Use in Specific Populations ( 8.1) ] - Nursing [see Use in Specific Populations ( 8.3) ] - Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines 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. 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. 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. 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. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment [ see Clinical Pharmacology ( 12.3) ]. Use caution when administering phentermine hydrochloride to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ), limit the dosage of phentermine hydrochloride to 15 mg daily [see Dosage and Administration ( 2.2)]. Phentermine hydrochloride has not been studied in patients with eGFR less than 15 mL/min/1.73 m 2 , including end-stage renal disease requiring dialysis; avoid use in these populations. 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 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. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Termék összefoglaló:

Available in tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg Phentermine base). Phentermine hydrochloride tablets, USP 37.5 mg (equivalent to 30 mg phentermine base), are supplied as blue and white mottled oval tablets debossed “K” left to bisect “25” on one side and plain on the other side. Bottles of 7, NDC 55289-701-07 Bottles of 14, NDC 55289-701-14 Bottles of 15, NDC 55289-701-15 Bottles of 21, NDC 55289-701-21 Bottles of 28, NDC 55289-701-28 Bottles of 30, NDC 55289-701-30 Bottles of 32, NDC 55289-701-32 Bottles of 42, NDC 55289-701-42 Bottles of 45, NDC 55289-701-45 Bottles of 56, NDC 55289-701-56 Bottles of 60, NDC 55289-701-60 Bottles of 90, NDC 55289-701-90 Bottles of 120, NDC 55289-701-98 Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP/NF, with a child-resistant closure (as required). Keep out of the reach of children

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENTERMINE
HYDROCHLORIDE TABLETS, USP 37.5 MG SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG.
PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG (PHENTERMINE
HYDROCHLORIDE, USP) CIV 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/m
, or greater than or equal to 27 kg/m
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, 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 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
m
) ( 2.2)
DOSAGE FORMS AND STRENGTHS
Capsules containing 37.5 mg phentermine hydrochloride. ( 3)
Tablets containing 37.5 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 hype