Medication info
Qsymia Capsule 11.25mg/69mg

Qsymia Capsule 11.25mg/69mg

Prescription medicationHard capsuleOral
Ingredient · strength
Phentermine Hydrochloride›14mg / 1 capsuleTopiramate›68.85mg / 1 capsule
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
Opaque yellow hard capsule containing white or almost white granules
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 201905408 · Approved 2019.07.31

Summary

Main use
Treatment of overweight in adults with obesity and weight-related 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
Alvogen Korea Co., Ltd.

Efficacy & effects

Treatment of overweight in adults with obesity and weight-related comorbidities

View approved original text

This medication is used in adult patients with an initial body mass index (BMI) of 30 kg/m² or higher, or in cases where there are weight-related comorbidities such as hypertension, type 2 diabetes, or dyslipidemia and a BMI of 27 kg/m² or higher. This medication is used as an adjunct to a low-calorie diet and increased physical activity for chronic weight management and is important to be used alone without the combination of other appetite suppressants. It is a medication that helps with weight loss and improvement of healthy lifestyle habits.

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 combination with other appetite suppressants, as safety and efficacy have not been established for concurrent use. Taking this medication during pregnancy may harm the fetus, so if pregnancy occurs, it must be stopped immediately. Women of childbearing age should confirm pregnancy before starting treatment and undergo monthly pregnancy tests during treatment, using effective contraception. One of the ingredients in this medication, topiramate, can cause severe skin reactions, so if any abnormal skin symptoms occur, use should be discontinued immediately. Pregnant women, patients with glaucoma, hyperthyroidism, those on specific medications, patients with drug allergy history, children under 18 years of age, and those with cardiovascular diseases should not take this medication. Patients with impaired kidney or liver function, and those with a known allergy history to certain dyes in the medication should use it with caution. This medication may cause neurological symptoms, such as sensory disturbances, dizziness, taste abnormalities, insomnia, constipation, dry mouth, among others, and some patients may experience psychiatric symptoms, such as depression, anxiety, or cognitive impairment. Regular monitoring is necessary, as bicarbonate, potassium, and creatinine levels may change in blood tests. There is also a possibility of developing kidney stones, so if symptoms occur, consultation with a healthcare professional is needed. Additionally, this medication may increase heart rate, so patients with heart conditions or sensitivity to changes in heart rate should use caution. If any adverse reactions occur, medication should be discontinued or healthcare professionals should be consulted depending on the severity of the symptoms.

Side effects

  • Abnormal sensations
  • dizziness
  • altered taste
  • insomnia
  • constipation
  • dry mouth
  • headache
  • sensory loss
  • attention disorders
  • depression
Show 57 more
  • anxiety
  • nausea
  • diarrhea
  • dyspepsia
  • gastroesophageal reflux disease
  • oral perceptual abnormalities
  • 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
  • pharyngeal pain
  • nasal congestion
  • post-procedural pain
  • suicidal thoughts
  • suicidal behavior
  • acute angle-closure glaucoma
  • increased intraocular pressure
  • urticaria
  • elevated blood pressure
  • ischemic events
  • euphoria
  • psychosis
  • tremors
  • changes in libido
  • erectile dysfunction
  • vesicular skin reactions
  • pemphigus
  • pancreatitis
  • hepatic 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 air and moisture, and it is safe to store it at room temperature between 1 degrees and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

Opaque yellow hard capsule 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.