Phentermin/topiramate 15-92mg ER CP

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 modulation of neurotransmitters (GABA potentiation, glutamate antagonism) and carbonic anhydrase inhibition.

Urgent Side Effects: Seek Medical Attention Immediately

While 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 help 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, 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 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).
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

Most medications can cause side effects, but many people experience none or only mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:

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 conditions and circumstances 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
+ Recent use (within the last 14 days) of certain drugs for depression or Parkinson's disease, including 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 is contraindicated during pregnancy
Breast-feeding, as you should not breast-feed while taking this medication
The patient's age, particularly if the patient is a child under 12 years old, as this medication is not approved for use in this age group

This list is not exhaustive, and it is essential to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.

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 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 the 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 the 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, 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.

Allergic Reactions
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 temperatures, which may lead to 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
This medication may affect growth in children and teenagers, and 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 experience any changes.

Pregnancy and Birth Control
A pregnancy test will be conducted to confirm that you are not pregnant before starting this medication and during treatment. The risk of birth defects is higher if this medication is taken during pregnancy, and the baby may be smaller at birth. It is unknown whether this leads to long-term problems. If you may become pregnant, you must use birth control while taking this medication. 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)
• Other sympathomimetic amines (e.g., other appetite suppressants, decongestants)

• CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive CNS depression
• Oral contraceptives - topiramate may decrease efficacy of estrogen-containing contraceptives
• Carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, methazolamide) - increased risk of metabolic acidosis and kidney stones
• Diuretics (e.g., hydrochlorothiazide) - increased risk of hypokalemia and metabolic acidosis
• Antidiabetic agents (e.g., insulin, sulfonylureas) - potential for hypoglycemia due to weight loss; dose adjustment may be needed
• Digoxin - topiramate may decrease digoxin levels
• Lithium - topiramate may alter lithium levels
• Valproic acid - concurrent use with topiramate may cause hyperammonemia with or without encephalopathy

• Antihypertensive agents - phentermine may counteract effects of antihypertensives
• Antidepressants (e.g., SSRIs, SNRIs, TCAs) - caution due to potential for serotonin syndrome or altered phentermine metabolism
• St. John's Wort - may reduce efficacy of oral contraceptives

• Not specifically identified as minor, but general caution with other CNS active drugs.

• Chest pain
• Shortness of breath
• Palpitations
• Dizziness
• Fainting spells
• Changes in vision (eye pain, blurred vision)
• Severe back or flank pain (kidney stones)
• Numbness or tingling in extremities (paresthesia)
• Difficulty concentrating or memory problems
• Mood changes (depression, anxiety, irritability)
• Suicidal thoughts or behavior
• Unexplained fatigue or weakness
• Rapid breathing

CONTRAINDICATED in pregnancy (Pregnancy Category X). Weight loss during pregnancy offers no benefit and may cause fetal harm. Topiramate is associated with an increased risk of oral clefts (cleft lip and/or palate) in infants exposed during the first trimester.

Not recommended during breastfeeding. 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, diarrhea).

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

Use with caution in elderly patients (≥65 years of age) due to increased likelihood of decreased renal function and potential for increased sensitivity to adverse effects. Start at the lower end of the dosing range and monitor closely for adverse reactions, especially cardiovascular and cognitive effects.

• This medication is a combination product and should not be used with other sympathomimetic agents or other carbonic anhydrase inhibitors.
• Patients must be screened for pregnancy before starting treatment and monthly thereafter. Effective contraception is mandatory for females of reproductive potential.
• Tapering the dose is crucial upon discontinuation to minimize the risk of seizures, especially in patients with a history of seizures or those on higher doses.
• Monitor for signs of metabolic acidosis (e.g., fatigue, rapid breathing, anorexia) and kidney stones (e.g., acute flank pain, hematuria). Adequate hydration is important.
• Patients should be advised about potential cognitive side effects ('topiramate fog') and paresthesia.
• Cardiovascular monitoring (BP, HR) is essential due to the phentermine component. Discontinue if sustained increases occur.
• This medication is an adjunct to, not a substitute for, lifestyle modification (diet and exercise).

• Liraglutide (Saxenda, Wegovy)
• 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's essential to contact your doctor for further guidance. To ensure your safety, 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 it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. Be prepared to provide detailed information about the incident, including the medication taken, the amount, and the time it occurred.