Phentermn/topiramate 7.5-46mg ER CP

Phentermine is a sympathomimetic amine that stimulates the release of norepinephrine from nerve terminals in the hypothalamus, resulting in appetite suppression. Topiramate's exact mechanism for weight loss is not fully understood but is thought to involve multiple actions, including enhancement of GABAergic activity, modulation of voltage-gated ion channels, inhibition of carbonic anhydrase, and antagonism of AMPA/kainate glutamate receptors. These actions may lead to appetite suppression, increased satiety, and altered taste perception.

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Irregular heartbeat
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when urinating
+ Frequent or urgent need to urinate
+ Fever
+ Lower abdominal pain
+ Pelvic pain
Abnormal or rapid heartbeat
Confusion, difficulty focusing, or changes in behavior
Memory problems or loss
Speech difficulties
Sleep disturbances
Urination problems, such as inability to urinate or changes in urine output
Back pain, abdominal pain, or blood in the urine, which may indicate a kidney stone
Suicidal thoughts or actions, especially in individuals with a history of such thoughts or actions. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately.
Eye problems, such as blurred vision, changes in vision, eye pain, or eye redness, which can lead to permanent vision loss if left untreated
Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause severe health problems and even death. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

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

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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
+ Certain antidepressants or Parkinson's disease medications 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 is not recommended 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 old

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 healthcare team 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.

Important Warnings and Precautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care.

Caution with Daily Activities

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. This will help prevent accidents and ensure your safety.

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 to maintain optimal health.

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 taper off the dose.

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, inform your doctor. Weight loss may increase your risk of low blood sugar, so monitor your condition closely. If you experience symptoms like dizziness, headache, fatigue, weakness, shaking, rapid heartbeat, confusion, hunger, or sweating, contact your doctor immediately.

Similarly, if you are being treated for high blood pressure, inform your doctor. Weight loss may increase your risk of low blood pressure, so be aware of symptoms like severe dizziness or fainting. If you experience these symptoms, contact your doctor right away.

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 may 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 temperatures. In rare cases, this may lead to hospitalization. If you experience a fever or decreased sweating during activities or in warm temperatures, contact your doctor immediately.

Effects on Growth and Menstrual Cycle

This medication may affect growth in children and teenagers. Regular growth checks may be necessary. Additionally, if you take birth control, your menstrual bleeding may change while taking this medication. Inform your doctor if you notice any changes.

Pregnancy and Birth Control

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

• Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation
• Hyperthyroidism
• Glaucoma
• Advanced arteriosclerosis
• Symptomatic cardiovascular disease (e.g., uncontrolled hypertension, arrhythmia, heart failure, history of stroke)

• Alcohol (increased CNS depression)
• CNS depressants (e.g., benzodiazepines, opioids, barbiturates, sedating antihistamines) - additive CNS depression
• Oral Contraceptives (Topiramate may decrease efficacy)
• Carbonic Anhydrase Inhibitors (e.g., zonisamide, acetazolamide, dichlorphenamide) - increased risk of metabolic acidosis and kidney stones
• Antiepileptic drugs (e.g., phenytoin, carbamazepine, valproic acid) - altered topiramate levels or increased risk of side effects
• Diuretics (e.g., hydrochlorothiazide) - increased risk of hypokalemia and metabolic acidosis
• Digoxin (phentermine may decrease levels)
• Insulin and/or oral hypoglycemic agents (dose adjustment may be needed due to weight loss)

• Lithium (topiramate may alter levels)
• Metformin (topiramate may increase metformin levels)
• SSRIs/SNRIs (potential for serotonin syndrome, though low risk with phentermine)
• Tricyclic antidepressants (TCAs) - potential for increased phentermine effects

• Not available

• Increased heart rate
• Elevated blood pressure
• Dizziness
• Insomnia
• Dry mouth
• Constipation
• Paresthesia (tingling/numbness)
• Cognitive impairment ('brain fog')
• Mood changes (depression, anxiety, irritability)
• Suicidal thoughts or behavior
• Eye pain
• Blurred vision
• Sudden decrease in vision
• Flank pain
• Hematuria
• Fatigue
• Muscle weakness

Contraindicated in pregnancy due to significant risk of fetal harm (oral clefts). A negative pregnancy test is required before initiation and monthly during treatment for women of childbearing potential. Part of a REMS program (Qsymia REMS).

Not recommended during breastfeeding. Both phentermine and topiramate are excreted in human milk.

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

Use with caution in elderly patients (≥65 years) due to increased likelihood of decreased renal function. Start at the lowest dose and monitor renal function, blood pressure, and heart rate closely. Max dose 7.5 mg/46 mg for moderate renal impairment.

• This medication is part of a Risk Evaluation and Mitigation Strategy (REMS) program (Qsymia REMS) due to the teratogenic risk of topiramate. Prescribers must be certified, and pharmacies must be certified to dispense.
• Patients must use effective contraception and have monthly pregnancy tests.
• Titrate dose slowly to minimize side effects and allow for adaptation.
• Discontinue gradually to reduce the risk of seizures (due to topiramate withdrawal).
• Monitor for signs of metabolic acidosis (e.g., fatigue, anorexia, hyperventilation) and kidney stones (e.g., flank pain, hematuria). Encourage adequate hydration.
• Monitor for psychiatric side effects, including depression, anxiety, and suicidal ideation.
• Advise patients about potential cognitive impairment ('brain fog') and paresthesia.
• Not for use in patients with a history of cardiovascular disease, uncontrolled hypertension, or glaucoma.
• Weight loss should be assessed at 12 weeks; if insufficient, consider dose escalation or discontinuation.

• Liraglutide (Saxenda)
• Semaglutide (Wegovy)
• Orlistat (Xenical, Alli)
• Phentermine (Adipex-P, Lomaira)
• Setmelanotide (Imcivree - for specific genetic conditions)

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, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 detailed information, including the substance taken, the amount, and the time it occurred.