Diario de comidas y actividad física -...

Diario de comidas y actividad

física

1

NOMBRE

DIRECCIÓN

CIUDAD ESTADO

PESO ACTUAL FECHA

PESO DESEADO FECHA DESEADA

Su médico le ha entregado este cuaderno para que lo utilice a fin de anotar su reducción de peso así como hacer seguimiento de su consumo diario de comida y actividades.

Le ayudará a ver como va progresando su reducción de

peso y le dará sugerencias sobre dieta y ejercicio.

Importante: Todo programa de dieta o reducción de peso debe llevarse a cabo bajo la supervisión de un médico. Su médico puede ayudarle a reducir calorías conforme a

las necesidades individuales de su cuerpo.

Su diario perSonal de comidaS y actividad fíSica

1

2 3

Hable con su médico antes de empezar cualquier dieta y programa de ejercicios.

Para mantener el éxito, aquí tiene 10 consejos importantes:

1. Las pequeñas cosas son a menudo causantes del fracaso. Dos tazas de café, cada una con dos cubos de azúcar y dos cucharadas de crema, suman 292 calorías. Dos tazas con endulzante sin calorías y crema no láctea aportan solo 22 calorías, una diferencia de más de diez veces. Esté alerta a las trampas que tengan alto contenido de calorías y que puede evitar fácilmente.

2. Con cada década después de cumplir 30 años, los requisitos calóricos bajan en aproximadamente un diez por ciento. Si a los 40 come exactamente igual que si tuviera 20, no se sorprenda de los rollos. A menos que tenga un nivel de actividad excepcional, tendrá que reducir su consumo al ir avanzando en edad solo para mantenerse igual.

3. Siempre hay una batalla entre los alimentos cremosos y los crujientes. Todas las cosas cremosas deliciosas — mantequilla, crema, mayonesa, aceite de ensalada, helado, salsas, mousses — tienen múltiples calorías que suman cientos, mientras las cosas crujientes — apio, rábanos, pepinos, lechuga, pepinillos en vinagre al eneldo — tienen pocas calorías.

4. Si la persona importante en su vida está luchando por controlar su peso, puede ayudarle no solo sustituyendo una manzana por la tarta con abundante helado, sino también explicándole el motivo. Muchas personas, incluso quienes tienen un alto nivel de educación, simplemente no entienden los fundamentos sobre la comida. “Solo me comí una hamburguesa de almuerzo” pueden comentar, olvidando mencionar que también consumieron una pila de papas fritas, varios anillos de cebolla frita y un pan de hamburguesa grande lleno de ketchup – es decir más de 1,000 calorías en total.

10 SugerenciaS para

ayudarle a mantener

el éxito5. Cuidado con los platos de fruta que llaman dietéticos en muchos restaurantes. Las bolas de melón cantaloupe solo tienen unas 30 calorías y los segmentos de toronja otras 30, pero la mitad de pera en conserva puede tener 78, el durazno en conserva 90, la gelatina de fruta 80, el requesón 50 y el aderezo, que probablemente pone usted generosamente encima sintiéndose muy virtuoso, por lo menos tiene 80. Esto suma 438 calorías. Por supuesto que la fruta es buena para usted, pero no se engañe pensando que ha comido unas pocas calorías.

6. A medida que desaparece la grasa corporal, a menudo el cuerpo retiene agua; especialmente en mujeres de mediana edad o mayores. La acumulación de agua explica por qué usted puede ser fiel a su dieta y ver que no se refleja que baje de peso en la balanza. Una buena manera de reducir la retención de agua es reducir el consumo de sal y aumentar su actividad física. No tome diuréticos, a menos que se lo ordene específicamente su médico.

7. No ayune más de dos o tres días sin supervisión médica estricta. Una abstención de 24 o 48 horas de los alimentos sólidos (tomando agua, jugo u otros líquidos de pocas calorías) puede dejarlo dichoso y triunfante, pesando varias libras menos — por unos días. Pero el ayuno a largo plazo sin suplementos de proteína y vigilancia cuidadosa de las funciones vitales puede destruir músculos y tejido de los órganos vitales.

8. Cuando se trata de subir o bajar de peso, su cuerpo no distingue entre 400 calorías en una salchicha de cerdo y las mismas en un trozo de pastel de chocolate. Sin embargo, las calorías que evite siempre deben ser las más superfluas — aquellas que contienen menos proteína, vitaminas y minerales. Cincuenta calorías son bien invertidas en un vaso de jugo de naranja, pero mal invertidas en una bebida gaseosa azucarada.

4 5

Para calcular sus necesidades individuales más precisamente, estime 15 calorías por cada libra (34/kg) de peso corporal si tiene un estilo de vida moderadamente activo. Esto significa que si usted pesa 120 libras (54 kg), requiere 1,800 calorías al día; si pesa 150 libras (68 kg), necesita 2,250 calorías. Si lleva una vida sedentaria, sus necesidades calóricas serán algo menores. Si es extremadamente activo, necesitará consumir más calorías para mantener su peso actual.

contenido calórico de ciertoS alimentoS

9. Aunque se sabe mucho sobre la relación entre calorías y peso corporal, ni los investigadores más diligentes pueden aún explicar por qué algunas personas parecen romper las reglas. Todos hemos conocido gente delgadísima que consume gran cantidad de leche malteada, martinis y cafés irlandeses llenos de crema batida encima, además de cenas de siete platos, y nunca suben un gramo. También hemos conocido al eterno gordito que sube dos libras solo por leer unas recetas (o al menos eso es lo que dice). Aunque las teorías sobre “glándulas” tienen poca credibilidad entre las autoridades médicas actuales, ciertas personas efectivamente parecen tener un metabolismo inusual que requiere gran cantidad de comida para efectuar el trabajo de una jornada normal. En vez de envidiar a los que comen mucho, piense en ellos como máquinas ineficientes — lástima que tienen que acumular tanto combustible costoso del supermercado.

10. Cuando elimine los pasteles, tartas, crema batida, bistecs y asados llenos de grasa, fruta enlatada en jarabe espeso y comida chatarra de todo tipo de su lista de compras, su presupuesto de comida rinde mucho más en términos de valor nutritivo. Además al reducir la carne y el pescado de alto costo a unas raciones modestas de 100 o 200 calorías, encontrará que un asado, un molde de carne molida o un filete de pescado rinde dos veces más raciones que antes. En otras palabras, realmente vale la pena reducir calorías.

4 5

6 7

PRESENTE DÍA 30

Fecha

Busto superior

Bajo el busto

Parte superior de los brazos

Cintura

Caderas

Muslos

Pantorrillas

Total

Cambio (+/-)

medidaS

8 9

En casaFECHA PESO REDUCCIÓN

Total:

Cita con el médico:

Comentarios:

mi regiStro de reducción de peSo


Total:


Comentarios:

10 11

diario de comidaS y ejercicio

DÍA 1 DÍA 2

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo

Consumo de agua – vasos de 8 oz (237 mL)


Ejercicio/actividad Ejercicio/actividad


Total:


Comentarios:

mi regiStro de reducción de peSo

12 13

DÍA 5 DÍA 6

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 3 DÍA 4

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





14 15

DÍA 9 DÍA 10

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 7 DÍA 8

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





16 17

DÍA 13 DÍA 14

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 11 DÍA 12

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





18 19

DÍA 17 DÍA 18

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 15 DÍA 16

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





20 21

DÍA 21 DÍA 22

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 19 DÍA 20

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





22 23

DÍA 25 DÍA 26

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 23 DÍA 24

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





24 25

DÍA 29 DÍA 30

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo




DÍA 27 DÍA 28

Desayuno Desayuno

Bocadillo Bocadillo

Almuerzo Almuerzo

Bocadillo Bocadillo

Cena Cena

Bocadillo Bocadillo





26 27

Calabaza, • De verano, hervida ............................................... 3 tazas • De invierno, al horno ............................................. 1 taza

Cangrejo, al vapor ............................................. 3 oz (85 g)

Carne de res, molida-asada, 83 % magra ...............1 oz/28 g

Cebollas (crudas) ............................................... 2 medianas

Cerezas, frescas ....................................................... 1 taza

Cerveza, light ...............................................12 oz (355 mL)

Chucrut ............................................................... 2 tazas

Chuleta de cerdo, asada ..................................... 1 oz (28 g) • Filete, asado .............................................. 1½ oz (57 g)

Chuleta de cordero, magra ............................... 1½ oz (57 g)

Ciruelas, enlatadas o frescas .............................................. 2

Ciruelas secas • Secas o frescas ............................................................ 5

Col, cocida ............................................................ 2 tazas

Coliflor, cocida ........................................................ 2 tazas

Crema, espesa .................................................1 cucharada • Agria .........................................................3 cucharadas

Dátiles ............................................................................ 4

Donas (tipo bizcocho) ...................................................... ½

Embutidos, jamón (bajo contenido graso) ............ 1½ oz (57 g)

Espárragos, crudos ............................................28 unidades • congelados ..................................................20 unidades

Espinaca, cocida ..................................................... 2 tazas

Frambuesas ........................................................... 1½ taza

Fresas, frescas, sin azúcar .................................... 20 grandes

Frijoles, asados ........................................................ 1/3 taza • Habas, hervidas sin sal ......................................... ½ taza • Habichuelas verdes, cocidas, alubias o judías ........... 2 tazas

Galleta con chispas de chocolate, mediana ............ 2 galletas

Galleta, muffins, panecillo ....................(2.25”/25 cm de diá.)

Nota: Las porciones son promedio o medianas a menos que se especifique lo contrario. Aceite, vegetal............................................... 2 cucharaditas

Aderezo de ensalada • French .........................................................1 cucharada • Queso azul ..................................................1 cucharada

Aguacate ................................................................ ¼ fruta

Albaricoques, frescos ........................................................ 5

Alcachofa ................................................................ 1 taza

Almejas, crudas ................................................ 3 oz (85 g)

Apio (crudo) .......................................................... 16 tallos

Arándanos ............................................................... 1 taza

Arroz, hervido, blanco o integral ................................. 1/3 taza

Atún enlatado (en agua) ................................... 2½ oz (71 g)

Avena, cocida ......................................................... ½ taza

Azúcar, granulada .......................................... 6 cucharaditas

Banana, pequeña ............................................................ 1

Barras dulces (tamaño “fun size”) • Butterfinger .........................................................2 barras • Milky Way ..........................................................1 barra • Snickers ..............................................................1 barra

Batata .................................................................... ½ taza

Bebida gaseosa, carbonatada ........................... 6 oz (170 g)

Bebidas alcohólicas • Whisky, gin, aguardiente, 40 grados ............1½ oz (44 mL) • Vino .......................................................3½ oz (104 mL)

Berros, picados ...................................................... 25 tazas

Betarragas, rebanadas, cocidas .................................. 1 taza

Brócoli, cocido ........................................................ 2 tazas

Brownie, sin glaseado, sin grasa,cuadrado de 2” (5 cm) ........ 1

Cacahuetes, tostados ...................................................... 16 • Mantequilla de cacahuetes ............................2 cucharadas

porcioneS de aproxima-damente 100 caloríaS

28 29

Naranja, fresca .....................................................1 grande • Jugo ........................................................... 6 oz (170 g)

Nueces ...............................................................7 mitades

Ostras, medianas ............................................................ 6

Pan, blanco o integral .........................................1 rebanada

Panqueques, solos, 4” (10 cm) de ancho ............................. 2

Papa, blanca • Hervida o asada............................................ 3 oz (85 g) • Puré ................................................................... 1/3 taza • Fritas, congeladas ............................................. 10 trozos • Ensalada ............................................................ ¼ taza

Pasas .............................................................3 cucharadas

Pastel, Angelfood ..................................................... 1 trozo

Pepinillos en vinagre, al eneldo (pequeños) .................8 enteros

Pepinos (crudos) ................................................... 2 grandes

Pera, fresca ........................................................ 1 mediana • Enlatada ............................................................. ½ taza

Pescado - lenguado, bacalao, espada • Asado u horneado ......................................... 2 oz (57 g) • Varitas empanizadas, fritas .....................................1 varita

Pimientos, verdes .............................................................. 5

Piña (cruda) .............................................................. 1 taza • Enlatada ............................................................. ½ taza

Pollo/pavo ....................................................... 2 oz (57 g)

Queso, americano, normal .................................. 1 oz (28 g) • Azul ............................................................. 1 oz (28 g) • Crema, normal ............................................2 cucharadas • Feta ............................................................. 1 oz (28 g)

Rábanos (crudos) .......................................................... 100

Repollitos de Bruselas ............................................. 1½ tazas

Rice Krispies ............................................................ ¾ taza

Salame, tipo seco .............................................2 rebanadas

Salchicha, cerdo, fresca, cocinada ........................2 unidades

Galletas saladas, de queso o para sopa ............................ 20 • Saltines ...................................................................... 6

Galletas, sola/avena con pasas ............................... 1 galleta

Guisantes, frescos o enlatados .................................... ½ taza • Secos, partidos ............................................2 cucharadas • Sopa ................................................................. ½ taza

Helado, dieta (50 % menos grasa) .............................. ½ taza

Hígado, picado, solo .......................................... 1 oz (28g)

Huevo, crudo o hervido ..................................................... 1 • Solo claras .................................................................. 5 • Solo yemas ................................................................. 1

Jamón, fresco, magro ....................................... 1½ oz (57 g)

Langosta, fresca ................................................. 3 oz (85 g)

Leche, descremada.................................................... 1 taza • Entera ................................................................ ½ taza • Reducida al 2 % .................................................. ½ taza

Lechuga (cruda, pequeña) ......................................3 cabezas

Lentejas, secas ......................................................... 1/3 taza

Macarrones, cocidos ................................................ ½ taza

Maíz (crudo) ...................................................... 1 mazorca • Enlatado (en crema) .............................................. ½ taza • Desgranado ........................................................ ½ taza • Hojuelas .............................................................. 1 taza

Mantequilla ........................................2 cuadrados pequeños

Manzana, pequeña .......................................................... 1

Mayonesa, normal ......................................... 2 cucharaditas

Melocotones, frescos ...................................... 1½ medianos • Enlatados............................................................ ½ taza

Melón cantaloupe, pequeño .................................... 1½ taza

Mermeladas, jaleas ..........................................6 cucharadas

Miel, arce o jarabe de maíz ............................1½ cucharada

Moras, frescas .......................................................... 1 taza

Mortadela, res o cerdo .................................... 1½ oz (43 g)

30 31

Salmón • Fresco o enlatado .............................................. 1½ taza • Ahumado ...................................................... 3 oz (85 g)

Salsa de arándanos rojos, endulzada ....................1 rebanada

Sandía ................................................ 1 rebanada pequeña

Sopa, caldo de pollo ................................................ 5 tazas • Fideos con pollo ................................................... 1 taza • Verduras .............................................................. 1 taza

Spaghetti, cocidos .................................................... ½ taza

Tangerinas ........................................................ 2 medianas

Ternera, chuleta magra ..................................... 1½ oz (57 g) • Corte delgado ................................................ 1 oz (28g)

Tocino .............................................................2 rebanadas

Tomates, frescos (medianos) ............................................... 6 • Jugo ................................................................... 2 tazas • Salsa .................................................................. 1 taza

Toronja ........................................................................ 1½ • Jugo, enlatado, sin azúcar ...................................... 1 taza

Trigo inflado ............................................................ 2 tazas

Uva ...................................................................... 20 uvas

Veneras, al vapor ............................................... 3 oz (85 g)

Waffles, congelados, solos ................................................ 1

Yogur, natural (bajo contenido graso) ........................... ¾ taza

Zanahorias (crudas) ..............................3 medianas, 1 grande

Esta lista de alimentos es una pauta. Consulte con su médico para obtener consejo sobre tratamientos.

31

32 33

eStilo de vida Saludable

Datos básicos Son importantes los factores como nutrición, ejercicio y un

cambio de hábitos de comida para la reducción de peso, pero no se puede mejorar sin la actitud y el comportamiento adecuados.

Usted controla sus pensamientos. Su peso y hábitos de comida no. Piense positivamente:

• No peso demasiado para hacer ejercicio • Puedo controlar lo que como • No estoy “condenado” al sobrepeso • Puedo bajar de peso

Cinco pasos para un estilo de vida saludable1. Ejercicio: quema calorías, aumenta el tono muscular, aporta un comportamiento alternativo en vez de comer, mejora la autoestima y la sensación de logro.

2. Nutrición: fomenta entender los grupos de alimentos, el control de porciones, contar calorías, contenido de grasa y dieta sensata; facilita la reducción y el control del peso, mejorando a la vez la salud general.

3. Modificación del comportamiento: sirve para identificar y cambiar hábitos problemáticos, actitudes y tendencias de estilo de vida.

4. Autovigilancia: al anotar el consumo de comida, peso, medidas, ejercicio; ayuda a promover la reducción y el control del peso, además de cambios positivos del comportamiento.

5. Red de apoyo: apoyo de la familia, los amigos, los profesionales de salud; implica a otros en su programa y alienta la reducción y el mantenimiento del peso con éxito.

ADIPEX-P® (phentermine hydrochloride USP) CIV se usa por un corto periodo (algunas semanas), como parte de un plan de tratamiento de reducción de peso que incluye ejercicio, cambios en el comportamiento y una dieta hipocalórica para personas obesas con un índice de masa corporal mayor de o igual a 30 kg/m2, o un índice de masa corporal mayor de o igual a 27 kg/m2 y otros factores de riesgo (por ej., hipertensión controlada, diabetes, colesterol elevado).

INFORMACIÓN DE SEGURIDAD IMPORTANTE

No tome ADIPEX-P si:

• Tiene historial clínico de enfermedad cardíaca (por ej., enfermedad de las arterias coronarias, accidente cerebrovascular, arritmias, insuficiencia cardíaca congestiva, deficiencia cardíaca, hipertensión descontrolada)

• Toma ciertos medicamentos llamados inhibidores de monoamina oxidasa (MAOI) o ha tomado MAOI en los últimos 14 días

32 33

• Tiene problemas de tiroides (hipertiroidismo)

• Tiene glaucoma (mayor presión en los ojos)

• Ha sufrido estados de agitación o tiene antecedentes de abuso de drogas

• Está embarazada o amamantando

• Tiene alergia a las aminas simpatomiméticas como fentermina o cualquiera de los ingredientes

Uso con otros medicamentos para adelgazar. No se recomienda tomar ADIPEX-P con otros fármacos para adelgazar.

Hipertensión pulmonar primaria. En los pacientes que toman fentermina y productos similares a la fentermina se ha reportado una enfermedad rara pero a menudo mortal de los pulmones. Dígale a su médico si le falta el aliento, tiene dolor de pecho o del corazón, o si sufre desmayos o hinchazón en la parte inferior de la pierna. Póngase en contacto con su médico inmediatamente si sufre alguna disminución en la cantidad de ejercicio que normalmente puede tolerar.

Enfermedad de las válvulas cardíacas. Se ha reportado enfermedad valvular o problemas graves con las válvulas del corazón en pacientes que toman fentermina u otros productos similares a la fentermina para adelgazar. No se puede descartar la posibilidad de una asociación.

Tolerancia. Existe el potencial de desarrollar tolerancia, donde es posible que la misma dosis no funcione tan bien como al principio. Si ocurre esto, no debe aumentarse la dosis recomendada, sino que debe discontinuarse el medicamento.

Afección motora. ADIPEX-P puede afectar su capacidad para operar maquinaria o conducir un vehículo motorizado.

Riesgo de abuso y dependencia. Mantenga ADIPEX-P en un lugar seguro para evitar robos, sobredosis accidentales, uso indebido o abuso.

Uso con alcohol. No use ADIPEX-P con alcohol porque puede causar una reacción perjudicial del medicamento.

Pacientes con hipertensión. ADIPEX-P puede causar un aumento de la presión sanguínea. Informe a su médico si tiene o ha tenido antecedentes de alta presión sanguínea.

Pacientes diabéticos. Puede ser necesario disminuir la dosis de insulina u otros medicamentos hipoglicémicos orales. Hable con su médico si está tomando medicamentos para la diabetes.

Pacientes con afección renal. Evite el uso si tiene una afección renal o se somete a diálisis.

Infórmele a su doctor acerca de todas sus afecciones médicas y sobre todos los medicamentos que esté tomando, incluso tratamientos de venta libre o botánicos.

Algunos efectos secundarios de ADIPEX-P incluyen hipertensión pulmonar, enfermedad cardíaca, palpitaciones, ritmo cardíaco acelerado o mayor presión sanguínea, insomnio, inquietud, boca seca, diarrea, estreñimiento y cambios en la libido. Dígale a su proveedor de atención médica si tiene algún efecto secundario que le moleste o que persista.

Estos no son todos los efectos secundarios posibles de ADIPEX-P. Para saber más detalles, pregúntele a su proveedor de atención médica o farmacéutico.

Lo alentamos a informar a la FDA sobre efectos secundarios negativos de medicamentos recetados. Visite www.fda.gov/medwatch o llame al 1-800-FDA-1088.

Consulte la información completa de prescripción adjunta.

34 35

NOMBRE HA LOGRADO SU META DE REDUCCIÓN DE PESO

REDUCCIÓN DE PESO FECHA

FIRMA DEL MÉDICO

©2017 Teva Pharmaceuticals USA, Inc. ADIPEX-P® es una marca registrada de Teva Pharmaceuticals USA, Inc.ADI-40070 Mayo 2017

www.adipex.com

FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION 2.1 Exogenous Obesity 2.2 Dosage in Patients With Renal Impairment3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 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 Mellitus6 ADVERSE REACTIONS7 DRUG INTERACTIONS 7.1 Monoamine Oxidase Inhibitors 7.2 Alcohol 7.3 Insulin and Oral Hypoglycemic Medications 7.4 Adrenergic Neuron Blocking Drugs8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 9.3 Dependence10 OVERDOSAGE 10.1 Acute Overdosage 10.2 Chronic Intoxication11 DESCRIPTION12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of

Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not listed.

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ADIPEX-P® safely and effectively. See full prescribing information for ADIPEX-P®.ADIPEX-P® (phentermine hydrochloride USP) for oral use CIVInitial U.S. Approval: 1959

INDICATIONS AND USAGEADIPEX-P® is a sympathomimetic amine anorectic indi-cated as a short-term adjunct (a few weeks) in a regi-men 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, hyper-lipidemia). (1)The limited usefulness of agents of this class, including ADIPEX-P®, 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)• ADIPEX-P® 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 37.5 mg phentermine hydrochlo-ride. (3)

• Tablets containing 37.5 mg phentermine hydrochlo-ride. (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. ADIPEX-P® 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, ADIPEX-P® should be discontinued. The recommended dose should not be exceeded. (5.4)

• ADIPEX-P® 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 REACTIONSAdverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. (6)

To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS• Monoamine oxidase inhibitors: Risk of hypertensive

crisis. (4, 7.1)• Alcohol: Consider potential interaction (7.2)• Insulin and oral hypoglycemics: Requirements may

be altered. (7.3)• Adrenergic neuron blocking drugs: Hypotensive effect

may be decreased by ADIPEX-P®. (7.4)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: 03/2017

FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEADIPEX-P® 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 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 (feet, inches)Weight(pounds)

5’0” 5’3” 5’6” 5’9” 6’0” 6’3”

140 27 25 23 21 19 18150 29 27 24 22 20 19160 31 28 26 24 22 20170 33 30 28 25 23 21180 35 32 29 27 25 23190 37 34 31 28 26 24200 39 36 32 30 27 25210 41 37 34 31 29 26220 43 39 36 33 30 28230 45 41 37 34 31 29240 47 43 39 36 33 30250 49 44 40 37 34 31The limited usefulness of agents of this class, including ADIPEX-P®, [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 AND ADMINISTRATION2.1 Exogenous ObesityDosage should be individualized to obtain an adequate response with the lowest effective dose.The usual adult dose is one capsule (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast for appetite control.The usual adult dose is one tablet (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.ADIPEX-P® is not recommended for use in pediatric patients less than or equal to 16 years of age.Late evening medication should be avoided because of the possibility of resulting insomnia.2.2 Dosage in Patients With Renal ImpairmentThe recommended maximum dosage of ADIPEX-P® is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2). Avoid use of ADIPEX-P® in patients with eGFR less than 15 mL/min/1.73 m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].3 DOSAGE FORMS AND STRENGTHSCapsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).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 sym-

pathomimetic amines

5 WARNINGS AND PRECAUTIONS5.1 Coadministration With Other Drug Products for Weight LossADIPEX-P® is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with ADIPEX-P® and any other drug products for weight loss including prescribed drugs, over-the-counter prepara-tions, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxe-tine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of ADIPEX-P® and these drug products is not recommended.5.2 Primary Pulmonary HypertensionPrimary 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 ADIPEX-P® 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, 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, and patients should be evaluated for the possible presence of pulmonary hypertension.5.3 Valvular Heart DiseaseSerious regurgitant cardiac valvular disease, primar-ily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fen-fluramine 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 ADIPEX-P® 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 ToleranceWhen 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 TasksADIPEX-P® 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 DependenceADIPEX-P® is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and to other related stimulant drugs that have been extensively abused. The possibility of abuse of ADIPEX-P® 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 AlcoholConcomitant use of alcohol with ADIPEX-P® may result in an adverse drug reaction.5.8 Use in Patients With HypertensionUse caution in prescribing ADIPEX-P® 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 MellitusA reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.6 ADVERSE REACTIONSThe 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:CardiovascularPrimary pulmonary hypertension and/or regurgitant car-diac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.Central Nervous SystemOverstimulation, restlessness, dizziness, insomnia, eupho-ria, dysphoria, tremor, headache, psychosis.GastrointestinalDryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.AllergicUrticaria.EndocrineImpotence, changes in libido.7 DRUG INTERACTIONS7.1 Monoamine Oxidase InhibitorsUse of ADIPEX-P® is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.7.2 AlcoholConcomitant use of alcohol with ADIPEX-P® may result in an adverse drug reaction.7.3 Insulin and Oral Hypoglycemic MedicationsRequirements may be altered [see Warnings and Precautions (5.9)].7.4 Adrenergic Neuron Blocking DrugsADIPEX-P® may decrease the hypotensive effect of adrenergic neuron blocking drugs.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category XADIPEX-P® 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 dl 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 MothersIt is not known if ADIPEX-P® 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 UseSafety 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 recom-mended.8.5 Geriatric UseIn 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 ImpairmentBased 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 ADIPEX-P® to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), limit the dosage of ADIPEX-P® to 15 mg daily [see Dosage and Administration (2.2)]. ADIPEX-P® has not been studied in patients with eGFR less than 15 mL/min/1.73 m2, including end-stage renal disease requiring dialysis; avoid use in these populations.9 DRUG ABUSE AND DEPENDENCE9.1 Controlled SubstancePhentermine is a Schedule IV controlled substance.9.2 AbusePhentermine is related chemically and pharmacologi-cally 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 DependenceAbuse 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.10 OVERDOSAGEThe least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.10.1 Acute OverdosageManifestations of acute overdosage include restless-ness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of phar-macologically 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 hemo-dialysis 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 IntoxicationManifestations 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 DESCRIPTIONPhentermine hydrochloride USP is a sympathomimetic amine anorectic. It has the chemical name of a,a,-Dimethylphenethylamine hydrochloride. The structural formula is as follows:

NH2CH2C

CH3

CH3

• HCl

C10H15N•HCl M.W. 185.7Phentermine hydrochloride is a white, odorless, hygro-scopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.ADIPEX-P®, an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).ADIPEX-P® Capsules contain the inactive ingredients Black Iron Oxide, Corn Starch, D&C Red #33, FD&C

Blue #1, Gelatin, Lactose Monohydrate, Magnesium Stea-rate, Propylene Glycol, Shellac, and Titanium Dioxide.ADIPEX-P® Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Micro- crystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1.12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionADIPEX-P® is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dl 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 PharmacodynamicsTypical 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 PharmacokineticsFollowing the administration of phentermine, phentermine reaches peak concentrations (Cmax) after 3.0 to 4.4 hours.Drug InteractionsIn 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 phenter-mine. However in the presence of topiramate, phenter-mine Cmax and AUC increase 13% and 42%, respectively.Specific PopulationsRenal ImpairmentCumulative 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 TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityStudies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.14 CLINICAL STUDIESNo clinical studies have been conducted with ADIPEX-P®.In relatively short-term clinical trials, adult obese sub-jects 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 HANDLINGAvailable in tablets and capsules containing 37.5 mg phen-termine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, speckled, scored tablet is debossed with “ADIPEX-P” and “9”-“9”. The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with “ADIPEX-P” - “37.5” on the cap and two stripes on the body using dark blue ink.

Tablets are packaged in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).Capsules are packaged in bottles of 100 (NDC 57844-019-01).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 THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.17 PATIENT COUNSELING INFORMATIONPatients must be informed that ADIPEX-P® 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 [see Indications and Usage (1) and Warnings and Precautions (5)].Patients must be instructed on how much ADIPEX-P®

to take, and when and how to take it [see Dosage and Administration (2)].Advise pregnant women and nursing mothers not to use ADIPEX-P® [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) and Drug 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 ADIPEX-P® in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away ADIPEX-P® may harm others and is against the law.All trademarks are the property of their respective owners.Manufactured In Croatia By:Pliva Hrvatska d.o.o.Zagreb, CroatiaManufactured For:Teva Select Brands, Horsham, PA 19044Division of Teva Pharmaceuticals USA, Inc.Rev. Z 3/2017

ADI-40062

Diario de comidas y actividad física -...

Documents

Transcript of Diario de comidas y actividad física -...