libro inicial para el paciente

Libro inicial del paciente

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 importanteNo 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

• 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.Hable con su profesional de atención médica

acerca de todo cambio en su dieta y rutina de ejercicios.

Dieta Su plan diario de comidas ........................... 1

Plan de dieta calórica de 1000, 1200, 1500 ...... 1

Plan de dieta calórica de 1800, 2000, 2500 ...... 2

Selecciones del plan diario de comidas ........ 3

Controlar la grasa en la dieta ....................... 13

Ejercicio ¿Cuánto es lo correcto en su caso? ............... 15

¿Cuánto ejercicio es suficiente? .................... 17

Calorías gastadas ....................................... 19

Diagrama de actividad calórica ................... 23

PrescriPtionPLUsPrograma de estiLo de vida

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SU PLAN DIARIO DE COMIDAS

❏1000 CaloríasCarbohidratos: 133 g Proteína: 56 g

Grasa: 30 g

Desayuno1 Fruta (Lista 4) 1 Almidón/pan (Lista 1) ½ Leche (Lista 5) * Alimentos libres (Lista 7)

Almuerzo

2 oz/60 g de carne (Lista 2) 1 Almidón/pan (Lista 1) 1 Fruta (Lista 4) 1 Grasa (Lista 6) 1 Verdura (Lista 3) * Alimentos libres (Lista 7)

Bocadillo de la tarde1 Fruta (Lista 4)

Cena2 oz/60 g de carne (Lista 2) 1 Almidón/pan (Lista 1) 1 Verdura (Lista 3)

* Alimentos libres (Lista 7)

Bocadillo de la noche1 Almidón/Pan (Lista 1)

1 Leche (Lista 5)

❏1200 CaloríasCarbohidratos: 154 g

Proteína: 63 g

Grasa: 36 g

Desayuno1 Fruta (Lista 4) 2 Almidón/pan (Lista 1) 1 Leche (Lista 5) * Alimentos libres (Lista 7)

Almuerzo

2 oz/60 g de carne (Lista 2) 1 Almidón/pan (Lista 1) 1 Fruta (Lista 4) 1 Grasa (Lista 6) 1 Verdura (Lista 3)



Cena2 oz/60 g de carne (Lista 2) 1 Almidón/pan (Lista 1) 1 Verdura (Lista 3) 1 Grasa (Lista 6)



1 Leche (Lista 5)


Grasa: 46 g

Desayuno1 Fruta (Lista 4) 2 Almidón/pan (Lista 1) 1 Grasa (Lista 6) 1 Leche (Lista 5) * Alimentos libres (Lista 7)

Almuerzo

2 oz/60 g de carne (Lista 2) 2 Almidón/pan (Lista 1) 1 Verdura (Lista 3) 1 Fruta (Lista 3) 1 Grasa (Lista 6)



Cena3 oz/60 g de carne (Lista 2) 2 Almidón/pan (Lista 1) 2 Verdura (Lista 3) 1 Grasa (Lista 6)


Bocadillo de la noche1 Almidón/Pan (Lista 1) 1 Leche (Lista 5)


Grasa: 56 g


Almuerzo




Cena

4 oz/60 g de carnes (Lista 2) 3 Almidón/pan (Lista 1) 2 Verdura (Lista 3) 1 Fruta (Lista 4) 2 Grasa (Lista 6)



❏2000 CaloríasCarbohidratos: 254 g Proteína: 103 g Grasa: 61 g


Almuerzo




1 Almidón/Pan (Lista 1) Cena

4 oz/60 g de carnes (Lista 2) 3 Almidón/pan (Lista 1) 2 Verdura (Lista 3) 1 Fruta (Lista 4) 2 Grasa (Lista 6)



1 Leche (Lista 5)


Grasa: 79 g


Almuerzo



Bocadillo de la tarde

1 Fruta (Lista 4)

1 Almidón/Pan (Lista 1) Cena

4 oz/60 g de carnes (Lista 2) 3 Almidón/pan (Lista 1) 2 Verdura (Lista 3) 1 Leche (Lista 5) 2 Grasa (Lista 6)



1 Fruta (Lista 4)

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1. Almidones y panesUna porción de cada alimento en esta lista contiene aproximadamente 15 g de carbohidratos, 3 g de proteína, mínima grasa y 80 calorías. Para elegir una porción similar de almidón o pan que no esté en la lista, siga estas reglas generales:

Cereal, grano, pasta .................................................................. ½ taza Producto de pan ........................................................................ 1 oz/30 g

Panes Porciones Bagel (tamaño deli) .................................................................... ¼ (1 oz/30 g) Panecillo (hamburguesa, hot dog) ................................................. ½ (1 oz/30 g) English muffin ............................................................................ ½ Pita (6"/15 cm de ancho) ........................................................... ½ Tortilla, harina o maíz (6"/15 cm de ancho) ................................... 1 Trigo integral, centeno, blanco, pumpernickel, pasas (sin glasear) ....... 1 rebanada (1 oz/30 g)

Cereales/Granos/Pasta Cereal de salvado, concentrado como Bran Buds®, All-Bran® .................................................................. 1/3 taza Cereal de salvado, hojuelas ........................................................ ½ taza Cereal cocinado, sémola de maíz, trigo bulgor ............................... ½ taza Macarrones, fideos, spaghetti (cocinados) ...................................... 1/3 taza Cereal inflado ........................................................................... 1 ½ tazas Cereal sin azúcar listo para comer ................................................ ¾ taza Arroz, blanco o integral .............................................................. 1/3 taza Trigo triturado ............................................................................ ½ taza Germen de trigo ........................................................................ 3 cucharadas

Galletas saladas/Bocadillos Graham cracker (cuadrado de 2 ½"/6 cm) .................................... 3 Matzo ...................................................................................... ¾ oz/21 g Tostada Melba .......................................................................... 4 rebanadas Mini galletas para sopa .............................................................. 20 Palomitas de maíz/popcorn, reventado, sin grasa añadida .............. 3 tazas Pretzels .................................................................................... ¾ oz/21 g Galleta de arroz (4"/10 cm de ancho) ......................................... 2 Galleta de centeno (2" x 3 ½"/5 x 9 cm) ...................................... 4 Galletas Saltines ........................................................................ 6

seLecciones deL PLan diario de comidas

Verduras almidonadas Frijoles, asados .......................................................................... 1/3 taza Maíz ....................................................................................... ½ taza o mazorca de 6"/15 cm Lentejas, frijoles o guisantes (secos), como kidney, blancos, partidos, carita ........................................... ½ taza Habas (congeladas) ................................................................... 2 oz/60 g Guisantes, verdes (enlatados o congelados) .................................... ½ taza Papas, asadas .......................................................................... 1 pequeña (3 oz/85 g) Papas, puré .............................................................................. ½ taza Calabaza de invierno (bellota, butternut) ........................................ 1 taza Batata, sola .............................................................................. 1/3 taza

Alimentos con almidón preparados usando grasa (Cuenta como 1 intercambio de almidón/pan y 1 intercambio de grasa)

Galleta dulce (2 ½"/6 cm de ancho) ............................................ 1 Fideos Chow mein ..................................................................... ½ taza Pan de maíz (cubo de 2"/5 cm) ................................................... 1 (2 oz/60 g) Galleta salada, tipo redondo con mantequilla ................................. 6 Papas fritas (2-3½"/ 5-7 cm de largo) .......................................... 1 taza (2 oz/60 g) Muffin (cupcake pequeño, solo) .................................................... 1 Chips de bocadillo, sin grasa o al horno ........................................ 15-20 (¾ oz/21 g) Relleno, mezcla preparada para pavo relleno ................................. 1/3 taza Tortilla para taco (6"/15 cm de ancho) .......................................... 2

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2. Carnes y sustitutos de carneUna porción de cada alimento en esta lista contiene unos 7 g de proteína. Las carnes magras y los sustitutos de carne tienen unas 55 calorías por ración; otros productos cárneos tienen 78 a 100 calorías por ración. Para seguir una dieta baja en colesterol y grasa saturada, elija carnes magras, pescado y otros productos que aparecen con letra negrita. Las porciones se pesan después de cocinar y habiendo sacado la piel, los huesos y la grasa.

Carne de res/vacuno Los cortes magros de carne de res como el tipo USDA Good/Choice paleta, lomo o espaldilla, filete, carne ahumada ........................................ 1 oz/30 g Todos los otros cortes .................................................................. 1 oz/30 g

Queso Requesón o ricotta ...................................................................... ¼ taza Dieta (menos de 55 calorías por oz/30 g) ..................................... 1 oz/30 g Parmesano, rallado .................................................................... 2 cucharadas Otros quesos (salvo queso crema) ................................................. 1 oz/30 g

Huevos Sustituto de huevo (menos de 55 calorías por ¼ taza) ............................................... ¼ taza Clara de huevo ......................................................................... 2 Huevo, entero ........................................................................... 1

Pescados, crustáceos y mariscos Todo pescado fresco o congelado ................................................ 1 oz/30 g Almejas, cangrejo, langosta, camarones, veneras ............................ 1 oz/30 g Arenque, ahumado .................................................................... 1 oz/30 g Ostras ...................................................................................... 6 medianas Sardinas (enlatadas) ................................................................... 2 medianas Atún (envasado en agua) ............................................................. 1 oz/30 g Salmón (enlatado) ...................................................................... 1 oz/30 g

Varios Hot dog (10 por libra/454 g)* ................................................... 1 Cordero (todos los cortes) ............................................................ 1 oz/30 g Hígado, corazón, riñones, mollejas ............................................... 1 oz/30 g Embutidos o cecinas–95% magros; todos los otros ........................... 1 oz/30 g Mantequilla de cacahuetes* ........................................................ 1 cucharada Salchichones, como polacos, italianos, ahumados* ......................... 1 oz/30 g *Cuenta como 1 oz/30 g de proteína y 1 de grasa.

Cerdo Cortes magros, como jamón canadiense; jamón fresco, enlatado, curado, hervido; filete ................................................... 1 oz/30 g Otros cortes .............................................................................. 1 oz/30 g

Ave Pollo, pavo, gallinita (sin piel) ....................................................... 1 oz/30 g

Ternera Chuletas y asados magros ........................................................... 1 oz/30 g Cortes delgados ........................................................................ 1 oz/30 g

3. VerdurasUna porción de cada verdura en esta lista contiene aproximadamente 5 g de carbohidratos, 2 g de proteína y 25 calorías. Si no se indica ningún tamaño de porción, deben usarse las siguientes medidas:

Verduras cocidas o jugo .............................................................. ½ taza Verduras crudas ......................................................................... 1 taza

Revise los alimentos libres (Lista 7) y almidones/panes (Lista 1) para verduras no indicadas en las listas.

Espárragos Frijoles (verdes, habichuelas, italianos) Brotes de frijoles Betarragas Brócoli Repollitos de Bruselas Col (cocinada) Zanahoria Coliflor Apio

Pepino Berenjena Verdura (Col crespa, hojas de mostaza, etc.) Hongos (cocinados) Ocra o quimbombo Cebolla Guisantes en su vaina (arvejas chinas) Pimientos (verdes) Rábanos

Chucrut Espinaca (cocinada) Calabaza de verano (cuello chueco) Tomate (1 grande) Jugo de tomate o de verduras Nabo Castañas de agua Calabacines (cocinados)

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4. FrutasUna porción de cada fruta en esta lista contiene aproximadamente 15 g de carbohidratos y 60 calorías. Para elegir una porción similar de una fruta que no esté en la lista, siga estas reglas generales:

Fruta fresca, enlatada o congelada, sin azúcar añadida .................. ½ taza Fruta seca ................................................................................. ¼ taza

Fruta seca Manzana, 4 oz/115 g .............................................................. 1 pequeña Albaricoque .............................................................................. 3 Dátil (mediano) ........................................................................ 2 Higo (pequeño) ....................................................................... 2 Ciruela seca (mediana) ............................................................... 3 Pasas ....................................................................................... 2 cucharadas

Jugos de fruta Jugo de manzana o sidra ............................................................ ½ taza Jugo cóctel de arándanos rojos..................................................... 1/3 taza Jugo de uva .............................................................................. 1/3 taza Jugo de ciruelas ......................................................................... 1/3 taza Otro, como naranja, piña, etc. ..................................................... ½ taza

Fruta Manzana, fresca (2"/5 cm de ancho), 4 oz/60 g .......................... 1 Puré de manzana, sin azúcar añadida ........................................... ½ taza Albaricoque, fresco (mediano) ...................................................... 4 Banana (9"/23 cm de largo) ....................................................... ½ Moras o arándanos, sin cocer ...................................................... ¾ taza Melón cantaloupe o honeydew .................................................... 1 taza Cerezas frescas, 3 oz/85 g ........................................................ 12 Higo fresco (2"/5 cm de ancho) ................................................... 2

Cóctel de frutas, enlatado............................................................ ½ taza Toronja (mediana) ...................................................................... ½ Segmentos de toronja ................................................................. ¾ taza Uvas (pequeñas) ....................................................................... 15 Kiwi (grande) ............................................................................ 1 Mandarinas .............................................................................. ¾ taza Nectarines (2 ½"/6 cm de ancho) ................................................ 1 Naranja (2 ½"/6 cm de ancho) ................................................... 1 Papaya (½”/1.5 cm de ancho) .................................................... 1 taza, cortada en cubos Melocotón (mediano), 4 oz/115 g............................................... 1 entero (¾ taza) Pera ........................................................................................ ½ grande/ 1 pequeña Caqui (nativo, mediano) .............................................................. 2 Piña, fresca ............................................................................... ¾ taza Piña, enlatada ........................................................................... ½ taza Ciruela, fresca (2"/5 cm de ancho) ............................................... 2 Frambuesas, frescas ................................................................... 1 taza Fresas, frescas (enteras) ............................................................... 1 ¼ tazas Tangerina (2 ½"/ 6 cm de ancho) ................................................ 2 Sandía ..................................................................................... 1 ¼ taza

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5. Leche y productos lácteosUna porción de leche o de cada producto lácteo en esta lista contiene aproximadamente 12 g de carbohidratos y 8 g de proteína.Estos alimentos también contienen de 1 a 8 g de grasa y 90 a 150 calorías por ración, dependiendo de su contenido de grasa láctea. Elija alimentos de los grupos de leche descremada y bajo contenido graso con la mayor frecuencia posible, porque contienen menos grasa láctea que los productos de leche entera.

Leche descremada y con muy bajo contenido graso Leche descremada, ½ % o 1 % .................................................... 1 taza Leche de manteca, bajo contenido graso ....................................... 1 taza Leche evaporada descremada ...................................................... 4 oz. líq. (118 mL) Leche en polvo descremada ......................................................... 1/3 taza en polvo Yogur descremado, natural .......................................................... 6 oz/170 g

Leche con bajo contenido graso Cuenta como 1 intercambio de leche y 1 intercambio de grasa de leche 2 % leche 2 % ................................................................................. 1 taza Yogur parcialmente descremado, natural (con sólidos lácteos descremados sin grasa) .................................... 6 oz/170 g

Leche entera Cuenta como 1 intercambio de leche y 2 intercambios de grasa Leche entera ....................................................................1 taza Leche entera evaporada ....................................................½ taza Yogur de leche entera, natural ............................................8 oz/230 g

6. GrasasUna porción de cada alimento en esta lista contiene aproximadamente 5 g de grasa y 45 calorías. Elija grasas insaturadas en vez de grasas saturadas con la mayor frecuencia posible.

Grasas monoinsaturadas Almendras, tostadas secas ........................................................... 6 enteras Aguacate (mediano) ................................................................... 1 oz/30 g Margarina, dieta ....................................................................... 1 cucharada Aceite (oliva, cacahuetes, colza) ................................................... 1 cucharadita Nueces o pecanas ..................................................................... 2 enteras

Grasas poliinsaturadas Margarina, dieta ....................................................................... 1 cucharada Mayonesa (normal) .................................................................... 2 cucharaditas Mayonesa (menos grasa/dieta) .................................................... 1 cucharada Aceite (maíz, semilla de algodón, soja, alazor, girasol) ..................... 1 cucharadita Aderezo de ensalada, tipo mayonesa (menos grasa) ....................... 2 cucharadas Aderezo de ensalada, otras variedades ......................................... 1 cucharada Semillas de girasol ..................................................................... 1 cucharada

Grasas saturadas Tocino ...................................................................................... 1 rebanada Mantequilla .............................................................................. 1 cucharadita Coco, rallado grueso .................................................................. 2 cucharadas Sustituto de crema no láctea para el café, líquido ............................ 2 cucharadas Sustituto de crema no láctea para el café, en polvo .......................... 4 cucharaditas Crema, mitad leche y mitad crema ................................................ 2 cucharadas Crema (entera, para batir) ........................................................... ¾ cucharada Queso crema ............................................................................ 1 cucharada

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Extractos saborizantes (vainilla, almendra, mantequilla, etc.) Ajo natural o en polvo Hierbas, frescas o secas Limón o especias con jugo de limón Cebolla en polvo

Paprika Pimienta Pimiento rojo Salsa de soja Especias Salsa Worcestershire

7. Alimentos libresCada alimento o bebida libre en esta lista contiene menos de 20 calorías por porción. Puede comer todo lo que quiera de los alimentos libres que no tienen tamaño de porción indicado; puede comer dos o tres porciones al día de los alimentos libres que tienen porciones indicadas. Asegurese de siempre repartir las porciones a lo largo del día.

Bebidas Caldo claro o bouillon, sin grasa, bajo contenido de sodio Cacao en polvo, sin azúcar para hornear (1 cucharada) Café o té Bebidas gaseosas, sin calorías, incluidas las bebidas carbonatadas

Condimentos Sustituto de crema no láctea para el café, líquido (1 cucharada) Sustituto de crema no láctea para el café, en polvo (2 cucharaditas) Pepinillos en vinagre al eneldo, sin azúcar Rábano picante Salsa picante Ketchup (1 cucharada) Mostaza Aderezo de ensalada, bajas calorías, incluso tipo mayonesa (1 cucharada) Salsa mexicana (¼ taza) Salsa para tacos (1 cucharada) Vinagre

Sustitutos edulcorantes Gelatina, sin azúcar Mermeladas o jalea, sin azúcar (2 cucharaditas) Sustituto de crema batida (2 cucharadas)

Especias para sazonar Se pueden usar como se desee. Si sigue una dieta con bajo contenido de sodio, siempre lea las etiquetas y elija especias que no contengan ni sodio ni sal.

Fruta Arándanos rojos o ruibarbo, sin azúcar (½ taza)

Verduras (crudas, sin exceder 1 taza) Col Apio Pepino Cebolla verde o cebollino Chiles o ajíes picantes Hongos Rábanos Vegetales verdes para ensalada (según lo desee) • Lechuga • Romana • Espinaca (cruda) Calabacines

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DATOS NUTRICIONALES DE LAS GRASAS UTILIZADAS COMÚNMENTE (tamaño de ración = 1 cucharada)

Aceites vegetales y manteca vegetal

Ácidos grasos poliinsaturados

Ácidos grasos monoinsaturados

Ácidos grasos saturados

Aceite de colza 3.5 g 8.4 g 1 g

Aceite de alazor 10.1 g 2 g 0.8 g

Aceite de girasol 3.9 g 7.8 g 1.2 g

Aceite de maíz 7.4 g 3.7 g 1.7 g

Aceite de oliva 1.4 g 9.8 g 1.8 g

Aceite de sésamo/ajonjolí 5.7 g 5.4 g 1.9 g

Aceite de soja 7.8 g 3.1 g 2.1 g

Aceite de caca-huetes 4.3 g 6.2 g 2.3 g

Aceite de semilla de algodón 7.1 g 2.4 g 3.5 g

Aceite de salvado de arroz 4.8 g 5.3 g 2.7 g

Manteca de cerdo 1.4 g 5.8 g 5.0 g

Aceite de palma 1.3 g 5.0 g 6.7 g

Mantequilla 0.4 g 3 g 7 g

Margarina en barras 3.4 g 5.4 g 2.1 g

Margarina batida en tazón 3.8 g 5.2 g 2 g

Manteca vegetal para el hogar 3.6 g 5.3 g 3.2 g

Aceite de coco 0.2 g 0.8 g 11.8 g

controLar La grasa en La dieta

Datos básicos Las autoridades de salud

recomiendan disminuir el contenido total de grasa en la dieta al 30%: 7-10% saturada,10% poliinsaturada y 10-15% monoinsaturada.

Disminuir el consumo de grasa total se traduce en elegir alimentos con menos contenido graso y cocinar con métodos magros.

Sustituya grasas poli o monoinsaturadas en vez de grasas saturadas siempre que sea posible.

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

¿Cuánto es lo correcto en su caso?Datos básicos El ejercicio forma parte de la reducción de peso; en combinación con una dieta sensata,

ayuda a quemar más grasas y menos tejido magro del cuerpo.

El ejercicio regular mantiene el índice metabólico alto hasta por 30 minutos después de que termine; por eso es especialmente importante para mantener el peso.

Las distintas formas de ejercicio queman calorías a distinta intensidad; cualquiera sea el tipo de ejercicio que seleccione, lo importante es seguir moviéndose y hacer ejercicio regularmente.

Sustituya grasas poli o monoinsaturadas en vez de grasas saturadas siempre que sea posible.

Precalentamiento y enfriamiento Siempre incorpore 5–10 minutos de ejercicio de bajo nivel antes y

después de la sesión de ejercicios, como: • Caminar • Marchar sin avanzar • Trotar lentamente

Luego siga con estiramientos suaves y lentos. Sostenga cada estiramiento de 10 a 20 segundos.

El precalentamiento prepara sus músculos para el ejercicio y sirve para prevenir dolores y lesiones.

El enfriamiento ayuda a prevenir dolores y promueve la circulación de sangre al corazón para que usted no se sienta mareado ni aturdido.

ejercicio

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¿Cuánto ejercicio es suficiente?1. Calcule su máxima capacidad de pulsaciones. Haga esto restando su edad de 220.

Luego multiplique esa cifra por 70 % para determinar las pulsaciones para un nivel moderado de actividad.

POR EJEMPLO, SI TIENE 40 AÑOS:

220 - 40 = 180 180 x 0.70 = 126Las pulsaciones deseadas

para el ejercicio moderado son = 126

2. Sepa cómo contar sus pulsaciones reales:

• Póngase dos dedos a un costado del cuello, justo debajo del hueso de la mandíbula, donde pueda sentir las pulsaciones de la arteria carótida.

• Cuente las pulsaciones que siente durante 10 segundos, luego multiplique por 6 para obtener sus pulsaciones por minuto.

3. Siga haciendo ejercicio regularmente y póngase un reto usted mismo para mejorar su estado físico junto con sus pulsaciones deseadas a partir de este punto.

IMPORTANTE: Antes de empezar un programa de ejercicios, consulte con su médico, especialmente si tiene más de 35 años o no ha hecho ejercicio regularmente.

Ejercicio requerido para quemar un número determinado de calorías (basado en una persona que pesa 150 libras/68 kg):

Caminar–5.0 calorías por minuto (297 calorías por hora).

Nadar–10.0 calorías por minuto (603 calorías por hora).

Andar en bicicleta–7.4 calorías por minuto (441 calorías por hora).

Correr–11.2 calorías por minuto (675 calorías por hora).

19 20

CALORÍAS GASTADAS

Comida Calorías Minutos de actividad*

CAMINAR NADAR ANDAR EN BICICLETA CORRER

Manzana, grande 110 30 9 17 13

Tocino, 2 tiras 92 25 8 14 10

Banana, pequeña 90 25 7 14 10

Cerveza, 1 vaso 86 24 7 13 10

Pastel, 2 capas, 1/8 260 72 21 39 30

Bebida carbonatada, 8 oz/230 g 97 27 8 15 11

Zanahoria, cruda, grande 30 8 2 5 3

Cereal, seco, 1 taza 100 28 8 15 11

Pollo, frito, 3 oz/85 g 218 60 18 33 25

Galleta dulce, avena 81 22 7 12 9

Huevo, frito 90 25 7 14 10

Jamón (3 oz/85 g) 125 34 10 19 14

Helado, 1 bola 151 42 12 23 17

Batido de leche malteada (mediano) 506 139 42 77 58

Leche, entera, 8 oz/230 g 147 41 12 22 17

Leche, descremada, 8 oz/1 taza 91 25 7 14 10

Jugo de naranja, 8 oz. 112 31 9 17 13

Panqueque, sin mantequilla ni miel 120 33 10 18 14

Melocotón, mediano 38 10 3 6 4

Tarta, manzana, 1/6 277 76 23 42 32

Pizza, queso, 1/8 272 75 22 41 31

Chuleta de cerdo, lomo 197 54 16 30 22

Sándwich Club 510 141 42 77 58

Hamburguesa 250 69 21 38 28

Camarones, fritos 73 20 6 11 8

Spaghetti, 1 taza 224 62 19 34 25

Bistec, entrecot (4 oz/115 g) 200 55 17 30 23

Pastel de fresas, 1 rebanada 218 60 18 33 25

*Basado en una mujer de 35 años, 5.74 pies/1.75 m de estatura, que pesa 144 libras/65 kg

21 22

Cómo puede serle útil el ejercicio El ejercicio quema calorías.

El ejercicio aeróbico quema grasas.

El ejercicio puede aumentar la masa muscular.

El ejercicio moderado ayuda a controlar el apetito.

El ejercicio ayuda a combatir el estrés y a contrarrestar la depresión, factores desencadenantes comunes de comer en exceso.

El ejercicio y su salud El ejercicio regular:

• Ayuda a reducir la alta presión sanguínea

• Ayuda a controlar la diabetes

• Ayuda a controlar los niveles de colesterol

• Fortalece el corazón y los huesos

• Ayuda a reducir los altos niveles de lípidos en la sangre

• Le ayuda a dormir mejor

RECOMENDACIONES DE EJERCICIO PARA CONTROLAR EL PESO

Frecuencia Cinco veces por semana

Tiempo 30–60 minutos de actividad aeróbica por sesión

TipoLa actividad aeróbica continua como caminar, pedalear en una bicicleta estacionaria, nadar, remar, practicar el esquí de fondo o trotar

23 24

Diagrama de actividad calórica*PESO CORPORAL (LIBRAS)

125 150 175 200

ACTIVIDAD (15 MINUTOS) CALORÍAS QUEMADAS

Bajar escaleras 29 34 40 46

Subir escaleras 100 119 139 159

Caminar – 2 mph/3229 m/h 21 26 30 34

Caminar – 4 mph/6437m/h 57 68 80 91

Andar en bicicleta – 5.5 mph/8851 m/h 43 51 60 68

TRABAJO DE CASA (15 MINUTOS) CALORÍAS QUEMADAS

Barrer/pasar la aspiradora 36 43 50 57

Hacer las camas 14 17 20 23

Lavar las ventanas 29 34 40 46

Desempolvar 21 26 30 34

Preparar una comida 21 26 30 34

Jardinería ligera 43 51 60 68

Cortar el césped (con máquina) 64 77 89 102

Pintar la casa (adentro) 29 34 40 46

RECREACIÓN (15 MINUTOS) CALORÍAS QUEMADAS

Badminton 50 60 70 80

Boliche 29 34 40 46

Canotaje–4 mph/6437m/h 86 102 119 137

Baile (moderado) 50 60 70 80

Golf (con carro) 36 43 50 57

Ping-Pong 43 51 60 68

Nadar (espalda) 86 102 119 137

Nadar (crawl, 50 yardas/minuto/46 metro/minuto, moderado)

100 119 139 159

*Determinar cuántas calorías quema no es una ciencia exacta. Estas cifras deben usarse solo como estimaciones.

©2017 Teva Pharmaceuticals USA, Inc.

ADIPEX-P® es una marca registrada de Teva Pharmaceuticals USA, Inc.

ADI-40068 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

libro inicial para el paciente

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