Qsymia 3.75-23mg Capsules

Qsymia is a combination of phentermine and topiramate extended-release. Phentermine is a sympathomimetic amine that stimulates the release of norepinephrine 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, increased satiety, and altered taste perception. It may also affect energy metabolism and fat storage. Topiramate's mechanisms include potentiation of GABA activity, antagonism of AMPA/kainate glutamate receptors, inhibition of carbonic anhydrase, and blockade of voltage-gated sodium channels.

Urgent Side Effects: Seek Medical Help Right Away

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

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 when 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).
Suicidal thoughts or actions: if you experience new or worsening symptoms such as depression, nervousness, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately.
Eye problems: if you notice new or changes in vision, eye pain, or eye redness, seek medical attention right away, as untreated eye problems can lead to permanent vision loss.
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis): seek medical help immediately if you experience 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

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

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.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
Medications you are currently taking, particularly:
+ Acetazolamide, dichlorphenamide, methazolamide, or zonisamide
+ Recent use (within the last 14 days) of certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to 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 old

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure it is safe to take this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor first.

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 that you receive proper care and avoid any potential interactions.

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 advised by your doctor.

Follow the diet and exercise plan recommended by your doctor to maintain a healthy lifestyle. 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 substances that may impair your actions, or taking prescription or over-the-counter medications that may interact with this drug, consult your doctor. If you have diabetes and are taking medications to lower your blood sugar, discuss this with your doctor, as weight loss may increase your risk of low blood sugar. Be aware of the signs 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.

If you are being treated for high blood pressure, inform your doctor, as weight loss may increase your risk of low blood pressure. Monitor yourself for signs of low blood pressure, such as severe dizziness or fainting, and seek medical attention right away if you experience any of these symptoms.

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, as it may cause decreased sweating and increased body temperature, which can lead to hospitalization. Be careful in hot weather and during physical activity, and seek medical attention immediately if you experience a fever or decreased sweating.

In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

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

A pregnancy test will be conducted before starting this medication and during treatment to ensure that 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 it is unclear whether this leads to long-term problems, it is essential to use birth control while taking this medication to prevent pregnancy. If you become pregnant, inform your doctor immediately.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis (within 14 days)
• Glaucoma (narrow angle)
• Hyperthyroidism
• Unstable heart disease (e.g., unstable angina, recent MI)
• Advanced arteriosclerosis
• Pregnancy

• Central Nervous System (CNS) depressants (e.g., alcohol, benzodiazepines, barbiturates) - increased CNS depression
• Oral Contraceptives - decreased efficacy of oral contraceptives (due to topiramate)
• Carbonic Anhydrase Inhibitors (e.g., zonisamide, acetazolamide) - increased risk of metabolic acidosis and kidney stones
• Non-potassium-sparing diuretics (e.g., hydrochlorothiazide) - increased risk of hypokalemia and metabolic acidosis
• Antidiabetic agents (e.g., insulin, sulfonylureas) - potential for hypoglycemia (dose adjustment may be needed)
• Digoxin - decreased digoxin levels (due to phentermine)
• Lithium - decreased lithium levels (due to topiramate)
• Valproic Acid - increased risk of hyperammonemia with or without encephalopathy (due to topiramate)

• Antihypertensive agents - potential for increased blood pressure (phentermine) or decreased blood pressure (topiramate), monitor BP
• Antidepressants (e.g., SSRIs, SNRIs, TCAs) - potential for serotonin syndrome (rare, with phentermine)
• Migraine medications (e.g., triptans) - potential for serotonin syndrome (rare, with phentermine)
• Other sympathomimetic agents - additive effects, increased risk of cardiovascular events
• CNS stimulants - additive effects, increased risk of cardiovascular events
• Phenytoin - altered phenytoin levels (due to topiramate)

• Not specifically categorized as minor, but general caution with drugs affecting electrolyte balance or CNS.

• Vision changes (e.g., blurred vision, eye pain, redness)
• Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
• Mood changes (e.g., depression, anxiety, agitation, suicidal thoughts)
• Paresthesia (tingling/numbness)
• Kidney stone symptoms (e.g., flank pain, hematuria)
• Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing)
• Symptoms of hypokalemia (e.g., muscle weakness, cramps, palpitations)
• Symptoms of hyperammonemia (e.g., lethargy, vomiting, confusion)

Contraindicated in pregnancy (Category X). Can cause fetal harm, including increased risk of major congenital malformations (e.g., orofacial clefts) and being small for gestational age. Females of reproductive potential must have a negative pregnancy test before starting treatment and monthly thereafter, and use effective contraception.

Contraindicated. Both phentermine and topiramate are excreted in human milk. Potential for serious adverse reactions in the breastfed infant (e.g., irritability, poor feeding, drowsiness, metabolic acidosis, diarrhea).

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 for Qsymia, though topiramate monotherapy is approved for certain seizure disorders in this age group. The risks associated with phentermine and topiramate (e.g., cardiovascular effects, cognitive impairment, metabolic acidosis, kidney stones, growth retardation) must be carefully considered.

Use with caution in elderly patients (≥65 years) due to the greater frequency of decreased renal function, concomitant disease, and other drug therapy. Start at the lowest dose and titrate slowly. Monitor renal function, blood pressure, and heart rate closely. Avoid in severe renal impairment.

• Qsymia is an adjunct to a reduced-calorie diet and increased physical activity; it is not a standalone weight loss solution.
• Strict adherence to the titration schedule is crucial to minimize side effects and assess tolerability.
• Discontinue treatment gradually to avoid potential withdrawal symptoms (e.g., seizures if on topiramate for epilepsy, though less likely with weight loss doses).
• Patients should be advised to report any new or worsening mood changes, suicidal thoughts, or vision problems immediately.
• Adequate hydration is important to reduce the risk of kidney stones.
• Monitor for signs of metabolic acidosis, especially in patients with predisposing conditions or on other carbonic anhydrase inhibitors.
• Counsel patients on the importance of effective contraception due to the severe teratogenic risk.

• Liraglutide (Saxenda, Wegovy)
• Semaglutide (Wegovy)
• Orlistat (Xenical, Alli)
• Phentermine (Adipex-P, Lomaira - monotherapy)
• Bupropion/Naltrexone (Contrave)
• Setmelanotide (Imcivree - for specific genetic conditions)
• Bariatric surgery (for severe obesity)
• Lifestyle modification (diet and exercise)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.