Qsymia 7.5-46mg Capsules

Qsymia is a combination of phentermine and topiramate extended-release. Phentermine is a sympathomimetic amine that stimulates the release of norepinephrine and dopamine from nerve terminals, and inhibits their reuptake, leading to appetite suppression and increased energy expenditure. Topiramate's exact mechanism for weight loss is not fully understood but is thought to involve multiple actions including potentiation of GABA activity, antagonism of AMPA/kainate glutamate receptors, and inhibition of carbonic anhydrase, which may contribute to satiety and reduced food intake.

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 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 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. If you notice new eye symptoms like blurred vision, changes in vision, eye pain, or eye redness, contact your doctor immediately.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing severe health problems or even death. Seek medical help immediately if you experience symptoms 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 may cause side effects in some people. Many individuals may not experience any side effects or only mild ones. 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 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 old

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor first.

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 suddenly stop taking this medication without consulting your doctor, as this may increase your 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 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, consult 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.
Similarly, if you are being treated for high blood pressure, inform your doctor, as weight loss may increase your risk of low blood pressure. Seek medical attention right away if you experience severe dizziness or fainting.

Risk of Metabolic Acidosis
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.

Allergy Warning
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 high body temperature, which may require hospitalization. Seek medical attention immediately if you experience a fever or decreased sweating during activities or in warm temperatures.

Effects on Growth and Menstrual Cycle
In some cases, this medication may affect growth in children and teenagers, and they may require regular growth checks. Additionally, if you take birth control, your menstrual bleeding may change while taking this medication. Inform your doctor if you experience any changes.

Pregnancy and Birth Control
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 to prevent pregnancy. If you become pregnant, inform your doctor immediately.

• Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of hypertensive crisis)
• Patients with glaucoma
• Patients with hyperthyroidism
• Patients with unstable heart disease or advanced arteriosclerosis
• Patients with a history of drug abuse
• Pregnancy

• Central Nervous System (CNS) Depressants (e.g., alcohol, benzodiazepines, barbiturates): Increased risk of CNS depression.
• Other Sympathomimetic Amines (e.g., other appetite suppressants, decongestants): Increased risk of cardiovascular and CNS adverse effects.
• Carbonic Anhydrase Inhibitors (e.g., acetazolamide, zonisamide): Increased risk of metabolic acidosis and kidney stones.
• Oral Contraceptives: Topiramate may decrease the efficacy of estrogen-containing oral contraceptives, leading to breakthrough bleeding and potential for unintended pregnancy.
• Antidiabetic Agents (e.g., insulin, sulfonylureas): Weight loss may improve glycemic control, requiring dose adjustments of antidiabetic medications.
• Non-potassium-sparing diuretics (e.g., hydrochlorothiazide): May exacerbate hypokalemia and metabolic acidosis.

• Digoxin: Topiramate may decrease digoxin levels.
• Lithium: Topiramate may alter lithium levels.
• Valproic Acid: Concomitant use with topiramate has been associated with hyperammonemia with or without encephalopathy.

• Not many specific minor interactions are consistently cited; general caution with other CNS-active drugs.

• Symptoms of metabolic acidosis (e.g., fatigue, anorexia, rapid breathing, cardiac arrhythmias)
• Symptoms of kidney stones (e.g., flank pain, hematuria, dysuria)
• Symptoms of acute myopia and secondary angle-closure glaucoma (e.g., sudden decreased vision, eye pain, redness)
• Psychiatric symptoms (e.g., depression, anxiety, insomnia, suicidal ideation)
• Cardiovascular symptoms (e.g., palpitations, chest pain, shortness of breath, dizziness, syncope)
• Cognitive impairment (e.g., difficulty concentrating, memory problems, word-finding difficulties)
• Numbness or tingling in extremities (paresthesia)

Qsymia is contraindicated in pregnancy (Pregnancy Category X). It can cause fetal harm, specifically oral clefts (cleft lip and/or cleft palate), when administered during the first trimester. Females of reproductive potential must have a negative pregnancy test before starting treatment and use effective contraception during therapy.

Not recommended during breastfeeding. Both phentermine and topiramate are excreted into human milk. Potential for serious adverse reactions in breastfed infants, including irritability, poor feeding, sedation, and metabolic acidosis.

Safety and efficacy have not been established in pediatric patients (under 18 years of age). Not approved for use in this population.

Use with caution in elderly patients (≥65 years of age) due to a greater likelihood of decreased renal function and increased sensitivity to adverse effects (e.g., cardiovascular, CNS). Start at the lower end of the dosing range and monitor renal function.

• Qsymia is part of a Risk Evaluation and Mitigation Strategy (REMS) program due to the teratogenic risk (oral clefts) associated with topiramate. Prescribers must be certified and pharmacies must be certified to dispense Qsymia.
• Gradual titration of the dose is crucial to minimize side effects, especially those related to topiramate (e.g., paresthesia, cognitive impairment, mood changes).
• Discontinuation of Qsymia should be gradual to avoid potential withdrawal symptoms (e.g., seizures in patients with a history of seizures, or increased frequency of seizures in those without, from topiramate).
• Patients should be advised to stay well-hydrated to reduce the risk of kidney stone formation.
• Monitor for signs of metabolic acidosis, especially in patients with predisposing conditions (e.g., renal disease, severe respiratory disorders, diarrhea, ketogenic diet).
• Counsel patients on the importance of effective contraception throughout treatment due to the severe teratogenic risk.

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

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, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. 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.