Recommended Topic Related To:

Qsymia

"Jan. 9, 2013 -- The best diet plan for overall health may not cost a thing.

A new ranking of diets by U.S. News & World Report gives top honors for best overall diet to the DASH (Dietary Approaches to Stop Hypertension) diet.

"...

Qsymia

Indications
Dosage
How Supplied

INDICATIONS

Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of

Limitations of Use

The effect of Qsymia on cardiovascular morbidity and mortality has not been established.

The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations have not been established.

DOSAGE AND ADMINISTRATION

General Dosing And Administration

Determine the patient's BMI. BMI is calculated by dividing weight (in kilograms) by height (in meters) squared. A BMI conversion chart (Table 1) based on height [inches (in) or centimeters (cm)] and weight [pounds (lb) or kilograms (kg)] is provided below.

Table 1: BMI Conversion Chart

Weight (lb) 125 130 135 140 145 150 155 160 165 170 175 180 185 190 195 200 205 210 215 220 225
(kg) 56. 8 59. 1 61. 4 63. 6 65. 9 68. 2 70. 5 72. 7 75. 0 77. 3 79. 5 81. 8 84. 1 86. 4 88. 6 90. 9 93. 2 95. 5 97. 7 100. 0 102. 3
Height                                          
(in) (cm)                                          
58 147. 3 26 27 28 29 30 31 32 34 35 36 37 38 39 40 41 42 43 44 45 46 47
59 149. 9 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 43 44 45 46
60 152. 4 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44
61 154. 9 24 25 26 27 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43
62 157. 5 23 24 25 26 27 27 28 29 30 31 32 33 34 35 36 37 38 38 39 40 41
63 160. 0 22 23 24 25 26 27 28 28 29 30 31 32 33 34 35 36 36 37 38 39 40
64 162. 6 22 22 23 24 25 26 27 28 28 29 30 31 32 33 34 34 35 36 37 38 39
65 165. 1 21 22 23 23 24 25 26 27 28 28 29 30 31 32 33 33 34 35 36 37 38
66 167. 6 20 21 22 23 23 24 25 26 27 27 28 29 30 31 32 32 33 34 35 36 36
67 170. 2 20 20 21 22 23 24 24 25 26 27 27 28 29 30 31 31 32 33 34 35 35
68 172. 7 19 20 21 21 22 23 24 24 25 26 27 27 28 29 30 30 31 32 33 34 34
69 175. 3 18 19 20 21 21 22 23 24 24 25 26 27 27 28 29 30 30 31 32 33 33
70 177. 8 18 19 19 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 32 32
71 180. 3 17 18 19 20 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31 31
72 182. 9 17 18 18 19 20 20 21 22 22 23 24 24 25 26 27 27 28 29 29 30 31
73 185. 4 17 17 18 19 19 20 20 21 22 22 23 24 24 25 26 26 27 28 28 29 30
74 188. 0 16 17 17 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28 29
75 190. 5 16 16 17 18 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28
76 193. 0 15 16 16 17 18 18 19 20 20 21 21 22 23 23 24 24 25 26 26 27 27

In adults with an initial BMI of 30 kg/m² or greater or 27 kg/m² or greater when accompanied by weight-related co-morbidities such as hypertension, type 2 diabetes mellitus, or dyslipidemia prescribe Qsymia as follows:

  • Take Qsymia once daily in the morning with or without food. Avoid dosing with Qsymia in the evening due to the possibility of insomnia.
  • Start treatment with Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg extended-release) daily for 14 days; after 14 days increase to the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release) once daily.
  • Evaluate weight loss after 12 weeks of treatment with Qsymia 7.5 mg/46 mg.
    If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg, discontinue Qsymia or escalate the dose, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.
    To escalate the dose: Increase to Qsymia 11.25 mg/69 mg (phentermine 11.25 mg/topiramate 69 mg extended-release) daily for 14 days; followed by dosing Qsymia 15 mg/92 mg (phentermine 15 mg/topiramate 92 mg extended-release) once daily.
  • Evaluate weight loss following dose escalation to Qsymia 15 mg/92 mg after an additional 12 weeks of treatment.
    If a patient has not lost at least 5% of baseline body weight on Qsymia 15 mg/92 mg, discontinue Qsymia as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
  • Qsymia 3.75 mg/23 mg and Qsymia 11.25 mg/69 mg are for titration purposes only.
Discontinuing Qsymia
  • Discontinue Qsymia 15 mg/92 mg gradually by taking a dose every other day for at least 1 week prior to stopping treatment altogether, due to the possibility of precipitating a seizure [see WARNINGS AND PRECAUTIONS].

Dosing In Patients With Renal Impairment

In patients with moderate (creatinine clearance [CrCl] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment dosing should not exceed Qsymia 7.5 mg/46 mg once daily. Renal impairment is determined by calculating CrCl using the Cockcroft-Gault equation with actual body weight [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Dosing In Patients With Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh score 7 -9), dosing should not exceed Qsymia 7.5 mg/46 mg once daily [see WARNINGS AND PRECAUTIONSand CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Qsymia capsules are formulated in the following four strength combinations (phentermine mg/topiramate mg extended-release):

  • 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
  • 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
  • 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
  • 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]

Storage And Handling

Qsymia is available as phentermine hydrochloride (expressed as the weight of the free base)/topiramate extended-release gelatin capsules in the following strengths and colors:

  • 3.75 mg/23 mg [Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23]
  • 7.5 mg/46 mg [Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46]
  • 11.25 mg/69 mg [Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69]
  • 15 mg/92 mg [Yellow cap imprinted with VIVUS, White body imprinted with 15/92]

The capsules are supplied as follows:

Strength   NDC Code
Unit of Use Bottle (14 capsules) 3.75 mg/23 mg capsules 62541-201-14
Pharmacy Bottle (30 capsules) 3.75 mg/23 mg capsules 62541-201-30
Unit of Use Bottle (30 capsules) 7.5 mg/46 mg capsules 62541-202-30
Unit of Use Bottle (30 capsules) 15 mg/92 mg capsules 62541-204-30
Pharmacy Bottle (30 capsules) 11.25 mg/69 mg capsules 62541-203-30
Starter Pack - Blister Configuration 3.75 mg/23 mg and 62541-210-28
(28 Capsules) 7.5 mg/46 mg capsules  
Dose Escalation Pack - Blister 11.25 mg/69 mg and 62541-220-28
Configuration (28 Capsules) 15 mg/92 mg capsules

Store at controlled room temperature, 15°C to 25°C (59°F to 77°F). Keep container tightly closed and protect from moisture.

VIVUS, Inc 351 East Evelyn Avenue Mountain View, CA 94041 USA. Issued: 09/2014

Last reviewed on RxList: 10/9/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.