phentermine and topiramate

What is the most important information I should know about phentermine and topiramate?

Phentermine and topiramate can increase your resting heart rate. Tell your doctor if you have fast or pounding heartbeats while you are resting.

Some people have thoughts about suicide while taking topiramate. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What is phentermine and topiramate?

Phentermine and topiramate is a combination medicine used together with diet and exercise to treat obesity in people 12 years and older.

This medicine is sometimes used to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure. Phentermine and topiramate will not treat these underlying conditions. Keep using any other medicines your doctor has prescribed.

Phentermine and topiramate may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking phentermine and topiramate?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

• glaucoma;
• overactive thyroid; or
• if you are pregnant or may become pregnant.

Topiramate may increase the risk of cleft lip and palate in a newborn. This birth defect occurs early in pregnancy, and can develop even before you know you are pregnant. Weight loss during pregnancy also can harm an unborn baby, even if you are overweight. Use effective birth control to prevent pregnancy while you are using phentermine and topiramate.

Taking this medicine together with birth control pills may cause breakthrough bleeding (spotting). However, this is unlikely to make your birth control pills less effective in preventing pregnancy. If you have spotting or irregular bleeding, keep taking your birth control pills and talk with your doctor.

Tell your doctor if you have ever had:

• heart problems, high blood pressure;
• a heart attack or stroke;
• diabetes (weight loss may cause low blood sugar);
• metabolic acidosis (too much acid in your blood);
• soft or brittle bones (osteomalacia, osteopenia, osteoporosis);
• kidney disease, kidney stones, or dialysis;
• liver disease;
• mood problems, depression, or suicidal thoughts or actions;
• an allergy to aspirin or yellow dye (tartrazine);
• a seizure; or
• chronic diarrhea.

Topiramate can increase the level of acid in your blood (metabolic acidosis). This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. You may need blood tests to make sure you do not have metabolic acidosis.

Some people have thoughts about suicide while taking topiramate. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

How should I take phentermine and topiramate?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine each morning, with or without food.

Your doctor may change your dose or tell you to stop taking this medicine if you have not lost a certain amount of weight during the first 12 weeks. Follow your doctor's dosing instructions very carefully. You must also follow a low-calorie diet.

Phentermine and topiramate can increase your resting heart rate. Your doctor will need to check your heart function.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include confusion, hallucinations, panic, personality changes, tremors, a restless feeling followed by severe tiredness, nausea, vomiting, diarrhea, stomach cramps, irregular heartbeat, rapid breathing, seizure, or coma.

What should I avoid while taking phentermine and topiramate?

Ketogenic or "ketosis" diets that are high in fat and low in carbohydrates can increase the risk of metabolic acidosis. Avoid the use of such diets while you are taking this medicine.

What are the possible side effects of phentermine and topiramate?

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

• unusual changes in mood or behavior;
• confusion, trouble concentrating, problems with speech or memory;
• fast or pounding heartbeats while you are resting;
• a seizure;
• signs of a kidney stone --severe pain in your side or lower back, painful or difficult urination; or
• signs of too much acid in your blood --loss of appetite, tiredness, thinking problems, irregular heartbeats.

Common side effects may include:

• joint pain, ankle sprain;
• flu-like symptoms;
• dizziness;
• constipation;
• numbness or tingly feeling;
• sleep problems (insomnia);
• dry mouth, changes in your sense of taste; or
• mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, thoughts about hurting yourself.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect phentermine and topiramate?

Phentermine and topiramate can cause irregular vaginal bleeding while you are taking birth control pills. This should not make the pills less effective in preventing pregnancy.

Tell your doctor about all your other medicines, especially:

• acetazolamide;
• methazolamide;
• zonisamide;
• valproic acid or divalproex sodium (Depakene or Depakote)
• birth control pills;
• a diuretic or "water pill"; or
• insulin or oral diabetes medicine.

This list is not complete. Other drugs may affect phentermine and topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about phentermine and topiramate.