Medication info
Qsymia Capsule 3.75mg/23mg

Qsymia Capsule 3.75mg/23mg

Prescription medicationHard capsuleOral
Ingredient · strength
Phentermine Hydrochloride›4.67mg / 1 capsuleTopiramate›23mg / 1 capsule
Manufacturer / importer
Albozen Korea Co., Ltd.
Appearance
An opaque purple hard capsule upper and an opaque white lower section containing white or nearly white granules
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 201905406 · Approved 2019.07.31

Summary

Main use
Improvement of obesity and overweight with weight-related comorbidities in adults
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 obesity and overweight with weight-related comorbidities in adults

View approved original text

This medication is used as a treatment to aid a reduced-calorie diet and increased physical activity for adult patients with a body mass index (BMI) of 30 or higher, or BMI of 27 or higher with weight-related comorbidities such as hypertension, type 2 diabetes, or dyslipidemia. It should only be used alone and not in conjunction with other appetite suppressants to be effective and safe. It helps in weight management and chronic weight control.

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 may not be safe if used with other appetite suppressants, so it must be taken alone. During pregnancy, the ingredients of this medication may be harmful to the fetus, and use during pregnancy should be avoided. Women planning for pregnancy should confirm their pregnancy status before taking this medication. This medication can cause severe skin reactions; therefore, if skin rashes or blisters develop, stop taking it immediately and consult a doctor. Some patients, such as pregnant women, patients with glaucoma, hyperthyroidism, or those on certain medications, may be at risk when taking this medication, so consult with a doctor before use. Patients with kidney or liver function issues, or those with allergies to certain pigments should use this medication with caution. This medication may cause dizziness, altered taste, insomnia, constipation, dry mouth, and other side effects, so consult a doctor if symptoms are severe. Mood changes or sleep disorders may occur, and if symptoms of depression or anxiety arise, inform medical staff immediately. Electrolyte imbalance or changes in kidney function may appear in blood tests, so regular testing is necessary. This medication may increase heart rate, hence patients with a history of heart disease should be especially cautious, and consult medical staff in case of significant changes in heart rate.

Side effects

  • Dizziness
  • vertigo
  • taste disturbances
  • insomnia
  • constipation
  • dry mouth
  • headache
  • sensory loss
  • attention deficit
  • depression
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  • anxiety
  • nausea
  • diarrhea
  • dyspepsia
  • gastroesophageal reflux disease
  • oral sensory disturbances
  • fatigue
  • irritability
  • 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 spasms
  • musculoskeletal pain
  • neck pain
  • cough
  • congestion
  • throat pain
  • nasal congestion
  • post-procedural pain
  • suicidal thoughts
  • suicidal behavior
  • acute closed-angle glaucoma
  • elevated intraocular pressure
  • hives
  • elevated blood pressure
  • ischemic events
  • well-being
  • psychosis
  • tremors
  • changes in libido
  • erectile dysfunction
  • vesicular skin reactions
  • pemphigus
  • pancreatitis
  • liver dysfunction
  • hepatitis
  • hyperammonemia
  • hypothermia
  • maculopathy

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage helps preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

An opaque purple hard capsule upper and an opaque white lower section containing white or nearly 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.

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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.