Qsymia 11.25/69mg Capsules
It is used to help with weight loss in certain people.
Drug Class
Weight management agent; Anorexiant; Anticonvulsant (used for weight management)
Pharmacologic Class
Sympathomimetic amine (phentermine); Sulfamate-substituted monosaccharide (topiramate)
Pregnancy Category
Category X
FDA Approved
Jul 2012
DEA Schedule
Schedule IV
Overview
What is this medicine?
Qsymia is a prescription medicine that combines two drugs, phentermine and topiramate, to help adults lose weight and keep it off. It works by helping you feel less hungry and more full, which can lead to eating less. It's used along with a reduced-calorie diet and increased physical activity.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. To minimize sleep disturbances, avoid taking this medication late in the day. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep the container tightly closed to maintain its effectiveness.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. To minimize sleep disturbances, avoid taking this medication late in the day. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep the container tightly closed to maintain its effectiveness.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a reduced-calorie diet as recommended by your healthcare provider.
- Increase your physical activity level gradually and consistently.
- Drink plenty of water to help prevent kidney stones and stay hydrated.
- Avoid alcohol, as it can increase the risk of side effects like dizziness and confusion.
- Take the capsule once daily in the morning, with or without food. Do not take it in the evening to avoid sleep problems.
- Do not crush, chew, or open the capsule; swallow it whole.
- If you miss a dose, do not take an extra dose to make up for it. Take your next dose at the regular time.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
11.25 mg phentermine / 69 mg topiramate extended-release capsule orally once daily in the morning. This is the third dose level after titration.
Dose Range:
3.75 - 15 mg
Condition-Specific Dosing:
obesity:
Initial dose: 3.75 mg phentermine / 23 mg topiramate ER once daily for 14 days. Then increase to 7.5 mg phentermine / 46 mg topiramate ER once daily. After 12 weeks on 7.5/46 mg, if <3% weight loss, increase to 11.25 mg phentermine / 69 mg topiramate ER once daily for 14 days, then to 15 mg phentermine / 92 mg topiramate ER once daily. Discontinue if <5% weight loss after 12 weeks on 15/92 mg.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in patients under 12 years of age. Limited data for adolescents 12-17 years, but not FDA approved for this age group.)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >50 mL/min)
Moderate:
Maximum dose 7.5 mg phentermine / 46 mg topiramate ER once daily (CrCl 30-50 mL/min)
Severe:
Not recommended (CrCl <30 mL/min)
Dialysis:
Not recommended
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Maximum dose 7.5 mg phentermine / 46 mg topiramate ER once daily (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Pharmacology
Mechanism of Action
Qsymia is a combination of phentermine and topiramate extended-release. Phentermine is a sympathomimetic amine that stimulates the release of norepinephrine and, to a lesser extent, dopamine from nerve terminals in the hypothalamus, leading to appetite suppression. Topiramate's exact mechanism for weight loss is not fully understood but is thought to involve multiple actions, including appetite suppression and increased satiety, possibly through enhancement of GABAergic activity, antagonism of AMPA/kainate glutamate receptors, inhibition of carbonic anhydrase, and modulation of voltage-gated sodium channels.
Pharmacokinetics
Absorption:
Bioavailability:
Phentermine: ~70-80%; Topiramate: ~81%
Tmax:
Phentermine: ~6-8 hours; Topiramate: ~2 hours
FoodEffect:
Food does not significantly affect the absorption of phentermine or topiramate from Qsymia capsules.
Distribution:
Vd:
Phentermine: ~3.7 L/kg; Topiramate: ~0.6-0.8 L/kg
ProteinBinding:
Phentermine: ~17%; Topiramate: ~9-17%
CnssPenetration:
Yes
Elimination:
HalfLife:
Phentermine: ~20 hours; Topiramate: ~21 hours
Clearance:
Phentermine: ~0.2 L/h/kg; Topiramate: ~1.2 L/h (renal clearance)
ExcretionRoute:
Phentermine: Renal (primarily unchanged); Topiramate: Renal (primarily unchanged)
Unchanged:
Phentermine: ~70-80%; Topiramate: ~70%
Pharmacodynamics
OnsetOfAction:
Weight loss typically observed within the first few weeks of treatment.
PeakEffect:
Maximum weight loss typically observed within 24-28 weeks.
DurationOfAction:
Once daily dosing provides sustained effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Abnormal or rapid heartbeat.
Confusion, difficulty focusing, or changes in behavior.
Memory problems or loss.
Speech difficulties.
Sleep disturbances.
Urination problems (inability to urinate or changes in urine output).
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone).
Patients taking this medication may be at a higher risk of suicidal thoughts or actions, especially if they have a history of such thoughts or behaviors. If you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. Contact your doctor immediately if you experience new eye symptoms such as blurred vision, changes in vision, eye pain, or eye redness.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing serious health problems or even death. Seek medical help immediately if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following possible side effects:
Headache.
Diarrhea or constipation.
Dry mouth.
Numbness or tingling.
Dizziness, tiredness, or weakness.
Changes in taste.
Upset stomach.
Common cold symptoms.
Nose or throat irritation.
Back pain.
* Joint pain.
If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Abnormal or rapid heartbeat.
Confusion, difficulty focusing, or changes in behavior.
Memory problems or loss.
Speech difficulties.
Sleep disturbances.
Urination problems (inability to urinate or changes in urine output).
Back pain, abdominal pain, or blood in the urine (may indicate a kidney stone).
Patients taking this medication may be at a higher risk of suicidal thoughts or actions, especially if they have a history of such thoughts or behaviors. If you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
This medication may cause severe eye problems, potentially leading to permanent vision loss if left untreated. Contact your doctor immediately if you experience new eye symptoms such as blurred vision, changes in vision, eye pain, or eye redness.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing serious health problems or even death. Seek medical help immediately if you experience symptoms such as red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following possible side effects:
Headache.
Diarrhea or constipation.
Dry mouth.
Numbness or tingling.
Dizziness, tiredness, or weakness.
Changes in taste.
Upset stomach.
Common cold symptoms.
Nose or throat irritation.
Back pain.
* Joint pain.
If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden decrease in vision or eye pain (could be acute angle-closure glaucoma, seek immediate medical attention)
- Tingling or numbness in hands or feet (paresthesia)
- Difficulty concentrating, memory problems, or word-finding difficulties ('brain fog')
- Mood changes, depression, anxiety, or thoughts of self-harm (report immediately)
- Increased heart rate or blood pressure
- Chest pain or shortness of breath
- Signs of kidney stones (severe pain in your side or back, blood in urine)
- Signs of metabolic acidosis (tiredness, loss of appetite, irregular heartbeat)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Overactive thyroid disease
+ Depression or a history of suicidal thoughts
+ Kidney disease
+ Liver disease
Medications you are currently taking, particularly:
+ Acetazolamide, dichlorphenamide, methazolamide, or zonisamide
+ Certain drugs for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure
+ Linezolid or methylene blue
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy
Breast-feeding, as you should not breast-feed while taking this medication
The patient's age, especially if they are under 12 years old, as this medication is not approved for use in children younger than 12 years of age
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is crucial to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Overactive thyroid disease
+ Depression or a history of suicidal thoughts
+ Kidney disease
+ Liver disease
Medications you are currently taking, particularly:
+ Acetazolamide, dichlorphenamide, methazolamide, or zonisamide
+ Certain drugs for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure
+ Linezolid or methylene blue
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy
Breast-feeding, as you should not breast-feed while taking this medication
The patient's age, especially if they are under 12 years old, as this medication is not approved for use in children younger than 12 years of age
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Monitoring and Follow-up
Regularly check your blood work, blood pressure, and heart rate as instructed by your doctor. Additionally, follow the diet and exercise plan recommended by your doctor.
Stopping the Medication
Do not abruptly stop taking this medication without consulting your doctor, as this may increase the risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually discontinue it.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, discuss the potential risks with your doctor.
Special Considerations for Diabetes and High Blood Pressure
If you have diabetes and take medications to lower your blood sugar, be aware that weight loss may increase the risk of low blood sugar. Monitor your blood sugar levels closely and contact your doctor immediately if you experience symptoms such as dizziness, headache, fatigue, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Similarly, if you are being treated for high blood pressure, weight loss may increase the risk of low blood pressure. Seek medical attention immediately if you experience severe dizziness or fainting.
Metabolic Acidosis
This medication may cause a condition called metabolic acidosis, which can be more likely in children, individuals with kidney problems, breathing difficulties, or diarrhea. The risk may also be higher if you take certain medications, undergo surgery, or follow a ketogenic diet. Over time, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Heat-Related Risks
Be cautious in hot weather and during physical activity, as this medication can cause decreased sweating and increased body temperature, potentially leading to hospitalization. Contact your doctor immediately if you experience fever or decreased sweating during activities or in warm temperatures.
Effects on Growth and Development
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and you should discuss any concerns with your doctor.
Birth Control and Menstrual Changes
If you use birth control, you may experience changes in your menstrual bleeding pattern while taking this medication. Inform your doctor if you notice any changes.
Pregnancy and Birth Defects
A pregnancy test will be conducted before starting and during treatment with this medication to ensure you are not pregnant. The risk of birth defects is higher if this medication is taken during pregnancy, and the baby may be smaller at birth. Although the long-term effects are unknown, it is essential to use birth control while taking this medication. If you become pregnant, contact your doctor immediately.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Monitoring and Follow-up
Regularly check your blood work, blood pressure, and heart rate as instructed by your doctor. Additionally, follow the diet and exercise plan recommended by your doctor.
Stopping the Medication
Do not abruptly stop taking this medication without consulting your doctor, as this may increase the risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually discontinue it.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, discuss the potential risks with your doctor.
Special Considerations for Diabetes and High Blood Pressure
If you have diabetes and take medications to lower your blood sugar, be aware that weight loss may increase the risk of low blood sugar. Monitor your blood sugar levels closely and contact your doctor immediately if you experience symptoms such as dizziness, headache, fatigue, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating.
Similarly, if you are being treated for high blood pressure, weight loss may increase the risk of low blood pressure. Seek medical attention immediately if you experience severe dizziness or fainting.
Metabolic Acidosis
This medication may cause a condition called metabolic acidosis, which can be more likely in children, individuals with kidney problems, breathing difficulties, or diarrhea. The risk may also be higher if you take certain medications, undergo surgery, or follow a ketogenic diet. Over time, metabolic acidosis can lead to kidney stones, bone problems, or growth issues in children.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Heat-Related Risks
Be cautious in hot weather and during physical activity, as this medication can cause decreased sweating and increased body temperature, potentially leading to hospitalization. Contact your doctor immediately if you experience fever or decreased sweating during activities or in warm temperatures.
Effects on Growth and Development
In some cases, this medication may affect growth in children and adolescents. Regular growth checks may be necessary, and you should discuss any concerns with your doctor.
Birth Control and Menstrual Changes
If you use birth control, you may experience changes in your menstrual bleeding pattern while taking this medication. Inform your doctor if you notice any changes.
Pregnancy and Birth Defects
A pregnancy test will be conducted before starting and during treatment with this medication to ensure you are not pregnant. The risk of birth defects is higher if this medication is taken during pregnancy, and the baby may be smaller at birth. Although the long-term effects are unknown, it is essential to use birth control while taking this medication. If you become pregnant, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Phentermine overdose: Restlessness, tremor, hyperreflexia, rapid breathing, confusion, assaultiveness, hallucinations, panic states, high fever, rhabdomyolysis, arrhythmias, hypertension or hypotension, circulatory collapse, seizures, coma.
- Topiramate overdose: Convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, depression, metabolic acidosis.
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222). Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment. Hemodialysis is effective for topiramate removal.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
- Hyperthyroidism
- Glaucoma
- Pregnancy
Major Interactions
- Central Nervous System (CNS) Depressants (e.g., alcohol, benzodiazepines, barbiturates) - increased risk of CNS depression
- Carbonic Anhydrase Inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide) - increased risk of metabolic acidosis and kidney stone formation
- Oral Contraceptives - topiramate may decrease efficacy of estrogen-containing contraceptives
- Metformin - increased risk of metabolic acidosis (rare, but possible with topiramate)
- Valproic Acid - increased risk of hyperammonemia with or without encephalopathy when used with topiramate
- Other Sympathomimetic Amines (e.g., other anorexiants, decongestants) - increased risk of cardiovascular effects
Moderate Interactions
- Antidiabetic Agents (e.g., insulin, sulfonylureas) - potential for altered glycemic control, requiring dose adjustment
- Digoxin - phentermine may decrease digoxin levels
- Lithium - topiramate may decrease lithium levels
- Hydrochlorothiazide - may increase topiramate levels
- Phenytoin/Carbamazepine - may decrease topiramate levels
Minor Interactions
- Not specifically listed as minor, but general caution with drugs affecting renal function or electrolyte balance.
Monitoring
Baseline Monitoring
Pregnancy Test
Rationale: Qsymia is contraindicated in pregnancy due to teratogenic risk (oral clefts) with topiramate.
Timing: Prior to initiation in females of reproductive potential.
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Phentermine can increase BP and HR.
Timing: Prior to initiation.
Serum Electrolytes (especially Bicarbonate)
Rationale: Topiramate can cause metabolic acidosis.
Timing: Prior to initiation.
Renal Function (CrCl)
Rationale: Dose adjustment required for renal impairment; drug is renally excreted.
Timing: Prior to initiation.
Thyroid Function Tests
Rationale: Contraindicated in hyperthyroidism.
Timing: Prior to initiation.
Eye Exam (for glaucoma)
Rationale: Contraindicated in glaucoma; topiramate can cause acute myopia and secondary angle-closure glaucoma.
Timing: Prior to initiation.
Mental Health Screening (history of depression, suicidal ideation)
Rationale: Topiramate can increase risk of suicidal thoughts or behavior.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: Maintain within acceptable limits.
Action Threshold: Discontinue if sustained clinically significant increase in BP or HR.
Serum Bicarbonate
Frequency: Periodically during treatment.
Target: Maintain within normal range.
Action Threshold: If persistent decrease below normal range, consider dose reduction or discontinuation.
Weight Loss
Frequency: After 12 weeks on 7.5/46 mg, and after 12 weeks on 15/92 mg.
Target: >3% weight loss at 12 weeks on 7.5/46 mg; >5% weight loss at 12 weeks on 15/92 mg.
Action Threshold: Discontinue if target weight loss not achieved.
Pregnancy Test
Frequency: Monthly in females of reproductive potential.
Target: Negative.
Action Threshold: Discontinue immediately if pregnancy occurs.
Renal Function
Frequency: Periodically, especially in patients with pre-existing renal impairment or risk factors.
Target: Stable CrCl.
Action Threshold: Adjust dose or discontinue if renal function declines.
Electrolytes (Potassium, Calcium)
Frequency: Periodically, especially if risk factors for kidney stones or metabolic acidosis.
Target: Normal range.
Action Threshold: Address abnormalities.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Palpitations
- Dizziness
- Vision changes (e.g., sudden decrease in vision, eye pain)
- Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
- Mood changes (e.g., depression, anxiety, agitation)
- Suicidal thoughts or behavior
- Tingling/numbness in extremities (paresthesia)
- Kidney stone symptoms (e.g., flank pain, hematuria)
- Signs of metabolic acidosis (e.g., fatigue, anorexia, cardiac arrhythmias)
Special Patient Groups
Pregnancy
CONTRAINDICATED. Qsymia can cause fetal harm, including oral clefts (cleft lip and/or cleft palate). Females of reproductive potential must have a negative pregnancy test before starting treatment and monthly thereafter, and use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Highest risk of oral clefts (cleft lip and/or cleft palate) if exposed during the first trimester.
Second Trimester:
Potential for other adverse developmental outcomes, though data are less clear than for first trimester.
Third Trimester:
Potential for adverse effects on the neonate, including metabolic acidosis.
Lactation
Not recommended. Both phentermine and topiramate are excreted into human milk. Potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, drowsiness, metabolic acidosis).
Infant Risk:
Risk level L3 (Moderate Concern) for both components. Weigh potential benefits of breastfeeding against potential risks to the infant and the mother's clinical need.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in adolescents (12-17 years) is not FDA-approved, though some studies have been conducted. Potential for growth retardation and cognitive effects with topiramate.
Geriatric Use
Use with caution. Start at the lowest dose and titrate slowly due to potential for decreased renal function and increased sensitivity to adverse effects. Monitor renal function closely. Dose adjustment may be necessary for renal impairment.
Clinical Information
Clinical Pearls
- Qsymia is part of a REMS program due to the teratogenic risk of topiramate. Ensure all female patients of reproductive potential are enrolled and understand the risks and contraception requirements.
- Emphasize the importance of lifestyle modification (diet and exercise) as Qsymia is an adjunct, not a standalone treatment.
- Monitor for cardiovascular side effects (BP, HR) and metabolic acidosis (bicarbonate levels) regularly.
- Counsel patients on potential cognitive side effects ('brain fog') and vision changes, advising immediate medical attention for sudden vision loss or eye pain.
- Titration is crucial to minimize side effects and optimize tolerability. Do not abruptly discontinue, especially higher doses of topiramate, to avoid potential for seizures.
- Consider discontinuing if significant weight loss (e.g., 3% at 12 weeks on 7.5/46mg or 5% at 12 weeks on 15/92mg) is not achieved, as continued use may not be beneficial.
Alternative Therapies
- Liraglutide (Saxenda)
- Semaglutide (Wegovy)
- Tirzepatide (Zepbound)
- Orlistat (Xenical, Alli)
- Phentermine (Adipex-P, Lomaira)
- Setmelanotide (Imcivree - for specific genetic conditions)
Cost & Coverage
Average Cost:
$200 - $300+ per 30 capsules
Insurance Coverage:
Tier 3 or higher (Non-preferred brand). Coverage varies widely by insurance plan, often requiring prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.