Medication info
Qsymia Capsule 7.5mg/46mg

Qsymia Capsule 7.5mg/46mg

Prescription medicationHard capsuleOral
Ingredient · strength
Phentermine Hydrochloride›9.34mg / 1 capsuleTopiramate›46.03mg / 1 capsule
Manufacturer / importer
Albozen Korea Co., Ltd.
Appearance
A hard capsule with opaque purple top and opaque yellow bottom containing white or almost white granules.
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 201905405 · Approved 2019.07.31

Summary

Main use
Improvement of weight management in adults with obesity or overweight with comorbidities
Who takes it
Adults
Adult dose
Take this medicine every morning, with or without food; avoid taking it in the evening because it may cause insomnia. 1) Take the initial dose of this medicine, 3.75mg/23mg, daily for 14 days. 2) After 14 days, take the recommended dose of 7.5mg/46mg for 12 weeks. 3) Assess weight loss. If taking 7.5mg/46mg does not result in a loss of at least 3% of body weight compared with the weight before the start of treatment, discontinue treatment or increase the dose. 4) If the dose is increased, take 11.25mg/69mg daily for 14 days. 5) After 14 days, take 15mg/92mg for 12 weeks. 6) Assess weight loss. If taking 15mg/92mg does not result in a loss of at least 5% of body weight compared with the weight before the start of treatment, discontinue treatment. *The 3.75mg/23mg and 11.25mg/69mg doses are for titration only. Discontinuation Because abrupt discontinuation may cause seizures, gradually discontinue the 15mg/92mg dose by taking it every other day for at least 1 week before completely stopping treatment. Patients with renal impairment Do not exceed 7.5mg/46mg once daily in patients with moderate (creatinine clearance [CrCl] of 30 or more and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment. Renal impairment is determined by calculating CrCl using the Cockcroft-Gault equation with actual body weight. Patients with hepatic impairment Do not exceed 7.5mg/46mg once daily in patients with moderate hepatic impairment (Child-Pugh score 7-9).

Ingredients

Manufacturer
Albozen Korea Co., Ltd.

Efficacy & effects

Improvement of weight management in adults with obesity or overweight with comorbidities

View approved original text

This medication is used as an adjunct to a low-calorie diet and increased physical activity in adult patients with an initial body mass index (BMI) of 30 or more, or in patients with a BMI of 27 or more with weight-related comorbid conditions such as hypertension, type 2 diabetes, or dyslipidemia. Additionally, this medication should be taken alone and not in combination with other appetite suppressants. It aids in weight control, improving healthy weight management.

How to take

Adult dose

Take this medicine every morning, with or without food; avoid taking it in the evening because it may cause insomnia. 1) Take the initial dose of this medicine, 3.75mg/23mg, daily for 14 days. 2) After 14 days, take the recommended dose of 7.5mg/46mg for 12 weeks. 3) Assess weight loss. If taking 7.5mg/46mg does not result in a loss of at least 3% of body weight compared with the weight before the start of treatment, discontinue treatment or increase the dose. 4) If the dose is increased, take 11.25mg/69mg daily for 14 days. 5) After 14 days, take 15mg/92mg for 12 weeks. 6) Assess weight loss. If taking 15mg/92mg does not result in a loss of at least 5% of body weight compared with the weight before the start of treatment, discontinue treatment. *The 3.75mg/23mg and 11.25mg/69mg doses are for titration only. Discontinuation Because abrupt discontinuation may cause seizures, gradually discontinue the 15mg/92mg dose by taking it every other day for at least 1 week before completely stopping treatment. Patients with renal impairment Do not exceed 7.5mg/46mg once daily in patients with moderate (creatinine clearance [CrCl] of 30 or more and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment. Renal impairment is determined by calculating CrCl using the Cockcroft-Gault equation with actual body weight. Patients with hepatic impairment Do not exceed 7.5mg/46mg once daily in patients with moderate hepatic impairment (Child-Pugh score 7-9).

Precautions

This medication should not be used in conjunction with other appetite suppressants. Safety and efficacy are not established for concomitant use with other weight loss drugs, and thus concurrent administration is not recommended. During pregnancy, this medication may harm the fetus, so it should not be taken. Particularly in early pregnancy, there may be an increased risk of cleft lip and palate in the fetus. If this medication is taken during pregnancy or if pregnancy is confirmed while taking this medication, it should be discontinued immediately, and women of childbearing potential should have regular pregnancy tests before and during treatment and use effective contraception. Topiramate, an ingredient in this medication, can cause serious skin reactions. If symptoms such as rash, blisters, or ulcers appear, the medication should be stopped immediately, and a doctor should be consulted. Pregnant women, patients with glaucoma, hyperthyroidism, those taking certain medications, children under 18, and those with cardiovascular diseases should not take this medication. Patients with kidney or liver dysfunction should use this medication cautiously, and caution is also advised if there are allergic reactions to certain pigment components. This medication can cause a variety of side effects, including altered perception, dizziness, altered taste, insomnia, constipation, dry mouth, headache, altered oral perception, attention disorders, depression, anxiety, nausea, diarrhea, indigestion, gastroesophageal reflux disease, systemic fatigue, irritability, thirst, chest discomfort, blurred vision, eye pain, dry eyes, palpitations, rash, hair loss, hypokalemia, decreased appetite, dysmenorrhea, upper respiratory infections, nasopharyngitis, sinusitis, bronchitis, influenza, and urinary infections. These symptoms mainly occur within the first 12 weeks of treatment but may arise during treatment as well. Moreover, heart rate may increase, so patients with a history of heart disease or cerebrovascular disease should exercise particular caution. If any abnormal symptoms occur while taking this medication, consult a doctor immediately, and it is important to comply with the prescribed dosage and administration.

Side effects

  • Abnormal perception
  • dizziness
  • abnormal taste
  • insomnia
  • constipation
  • dry mouth
  • headache
  • sensory loss
  • attention deficit
  • depression
Show 57 more
  • anxiety
  • nausea
  • diarrhea
  • indigestion
  • gastroesophageal reflux disease
  • oral perception abnormality
  • fatigue
  • hypersensitivity
  • thirst
  • chest discomfort
  • blurred vision
  • eye pain
  • dry eyes
  • palpitations
  • rash
  • hair loss
  • hypokalemia
  • decreased appetite
  • dysmenorrhea
  • upper respiratory tract infection
  • nasopharyngitis
  • sinusitis
  • bronchitis
  • influenza
  • urinary tract infection
  • gastroenteritis
  • back pain
  • limb pain
  • muscle cramps
  • musculoskeletal pain
  • neck pain
  • cough
  • nasal congestion
  • throat pain
  • nasal congestion
  • post-procedural pain
  • suicidal thoughts
  • suicidal behavior
  • acute angle-closure glaucoma
  • increased intraocular pressure
  • hives
  • increased blood pressure
  • ischemic event
  • relief
  • psychosis
  • tremor
  • change in libido
  • erectile dysfunction
  • vesicular skin reaction
  • pemphigus
  • pancreatitis
  • liver failure
  • hepatitis
  • hyperammonemia
  • hypothermia
  • maculopathy
  • increased heart rate

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air or moisture. The appropriate storage temperature is between 1 degree and 30 degrees Celsius, and it should be kept away from overly hot or cold places.

Appearance and packaging

Appearance

A hard capsule with opaque purple top and opaque yellow bottom containing white or almost white granules.

Package unit

28 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.