Qsymia 15-92mg Capsules

Phentermine is a sympathomimetic amine that stimulates the release of norepinephrine and 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 potentiation of GABA activity, antagonism of AMPA/kainate glutamate receptors, inhibition of carbonic anhydrase, and voltage-gated sodium channel blockade.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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, difficulty 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, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, nausea, 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 pass urine 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 actions. If you experience new or worsening symptoms like depression, anxiety, 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 like 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 notice signs like 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

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Headache.
Diarrhea or constipation.
Dry mouth.
Numbness or tingling.
Dizziness, fatigue, or weakness.
Changes in taste.
Nausea or stomach upset.
Common cold symptoms.
Nose or throat irritation.
Back pain.
* Joint pain.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

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
Concurrent use of specific medications, such as:
+ Acetazolamide, dichlorphenamide, methazolamide, or zonisamide
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including 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 is contraindicated during pregnancy
Breast-feeding, as you should not breast-feed while taking this medication
The patient's age, as this medication is not approved for children under 12 years of age

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications
Natural products
Vitamins
Health problems

This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require alertness. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor.

Follow the diet and exercise plan recommended by your doctor to maximize the benefits of this medication. Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of seizures. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it.

Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor.

If you have diabetes and are taking medications to lower your blood sugar, consult your doctor about the potential risks of low blood sugar due to weight loss. Be aware of the symptoms of low blood sugar, such as dizziness, headache, fatigue, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating, and seek medical attention immediately if you experience any of these symptoms.

Similarly, if you are being treated for high blood pressure, discuss the potential risks of low blood pressure with your doctor, as weight loss may increase this risk. Seek medical attention immediately if you experience severe dizziness or fainting.

This medication may cause a condition called metabolic acidosis, which can be more likely in children, people 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.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.

Be cautious when taking this medication, especially in hot weather or during physical activity, as it may cause decreased sweating and increased body temperature. In some cases, this has led to hospitalization. Seek medical attention immediately if you experience a fever or decreased sweating during activities or in warm temperatures.

This medication may affect growth in children and adolescents, and regular growth checks may be necessary. Discuss any concerns with your doctor.

If you are taking birth control, you may experience changes in your menstrual bleeding pattern while taking this medication. Inform your doctor if you notice any changes.

Before starting this medication, a pregnancy test will be performed to confirm that you are not pregnant. While taking this medication, you will need to use birth control to prevent pregnancy, as the risk of birth defects is higher if the medication is taken during pregnancy. The baby may also be smaller at birth, and it is unclear whether this may lead to long-term problems. If you become pregnant, inform your doctor immediately.

• Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)

• CNS Depressants (e.g., alcohol, benzodiazepines, barbiturates) - increased risk of CNS depression
• Oral Contraceptives - topiramate may decrease efficacy of estrogen-containing contraceptives (use alternative or additional birth control)
• Carbonic Anhydrase Inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide) - increased risk of metabolic acidosis and kidney stone formation
• Non-potassium-sparing Diuretics (e.g., hydrochlorothiazide) - increased risk of hypokalemia and metabolic acidosis
• Other Sympathomimetic Amines - increased risk of cardiovascular effects

• Digoxin - topiramate may decrease digoxin levels
• Metformin - topiramate may increase metformin levels
• Lithium - topiramate may decrease lithium levels
• Valproic Acid - concurrent use with topiramate may cause hyperammonemia with or without encephalopathy

• Not specifically listed as minor, but general caution with other drugs affecting renal function or acid-base balance.

• Changes in mood or behavior (e.g., depression, anxiety, agitation)
• Suicidal thoughts or actions
• Difficulty concentrating or memory problems
• Numbness or tingling in extremities (paresthesia)
• Fatigue or weakness
• Rapid or irregular heartbeat
• Increased blood pressure
• Kidney stone symptoms (e.g., severe flank pain, blood in urine)
• Acute vision changes (e.g., blurred vision, eye pain)
• Signs of metabolic acidosis (e.g., hyperventilation, fatigue, anorexia)

Contraindicated in pregnancy due to significant risk of fetal harm (Category X). Females of reproductive potential must have a negative pregnancy test before starting and monthly thereafter, and use effective contraception.

Both phentermine and topiramate are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., irritability, poor feeding, sedation, metabolic acidosis), breastfeeding is not recommended during Qsymia treatment.

Safety and effectiveness have not been established in pediatric patients. Not approved for use in individuals under 18 years of age.

Use with caution in elderly patients (≥65 years of age) due to a greater likelihood of decreased renal function. Start at the lowest dose and titrate slowly. Monitor renal function and for adverse effects more closely.

• Qsymia is an extended-release formulation and should be taken once daily in the morning, with or without food. Avoid taking it in the evening to prevent insomnia.
• Patients should be advised on the importance of consistent contraception due to the teratogenic risk of topiramate.
• Emphasize the need for adequate hydration to minimize the risk of kidney stone formation.
• Monitor for psychiatric side effects, including depression and suicidal ideation, especially at the beginning of treatment or during dose escalation.
• Gradual discontinuation is recommended to avoid potential withdrawal symptoms (e.g., seizures) from topiramate, especially at higher doses.
• Regular monitoring of blood pressure and heart rate is crucial, as phentermine can cause cardiovascular effects.

• Liraglutide (Saxenda)
• Semaglutide (Wegovy)
• Naltrexone/Bupropion (Contrave)
• Orlistat (Xenical, Alli)
• Phentermine (Adipex-P, Lomaira - monotherapy)
• Bariatric surgery (for eligible patients)

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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.