PHENTERMINE HYDROCHLORIDE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)
09-07-2019

Ingredientes activos:

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

Disponible desde:

Direct_Rx

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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/m2 Height (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

Resumen del producto:

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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

                                PHENTERMINE HYDROCHLORIDE- PHENTERMINE HYDROCHLORIDE CAPSULE
DIRECT_RX
----------
PHENTERMINE HYDROCHLORIDE
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/m2
Height (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.
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.
Phentermine hydrochloride capsules USP, 15 mg (equivalent to 12 mg
phentermine base): powder-filled
capsules, gray/orange; imprinted 
                                
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