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

phentermine and topiramate 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.

Do not use if you are pregnant or if you become pregnant. phentermine and topiramate may increase the risk of a birth defect called cleft lip and palate in a newborn.

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

Topiramate may cause vision problems that can be permanent if not treated quickly. Call your doctor right away if you have a sudden decrease in vision.

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.

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

Take phentermine and topiramate each morning, with or without food.

Drink plenty of water each day to prevent dehydration or kidney stones while you are taking phentermine and topiramate.

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.

Do not stop using phentermine and topiramate suddenly or you could have a seizure (convulsions). Follow your doctor's instructions about tapering your dose.

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

Store at room temperature away from moisture and heat.

Phentermine may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Usual Adult Dose for Weight Loss:

All doses expressed as phentermine/topiramate XR:

Initial dose: 3.75 mg/23 mg orally once a day for 14 days, then 7.5 mg/46 mg orally once a day
-After 12 weeks of dosing at 7.5 mg/46 mg once a day; evaluate weight loss and if weight loss is less than 3% of baseline weight, discontinue therapy or escalate dose:

Dose escalation: 11.25 mg/69 mg orally once a day for 14 days, then 15 mg/92 mg orally once a day
-After 12 weeks of dosing at 15 mg/92 mg once a day; evaluate weight loss and if weight loss is less than 5% of baseline weight, discontinue therapy

Maintenance dose: 7.5 mg/46 mg OR 15 mg/92 mg orally once a day
-Doses of 3.75 mg/23 mg and 11.25 mg/69 mg are for titration purposes only

Comments:
-Dosing should be in the morning (with or without food) to avoid the possibility of insomnia.
-Doses should be titrated and weight loss evaluated as described above; if percent weight loss is not achieved by stated timeline it is unlikely that patients will achieve and sustain clinically meaningful weight loss and therefore discontinuation is recommended.
-Discontinuation from dose of 15 mg/92 mg once a day should be gradual; decrease to every other day for at least 1 week prior to stopping treatment.

Uses: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients:
-With an initial body mass index (BMI) of 30 kg/m2 or greater (obese)
-With an initial BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

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.

You should not use this medicine if you are allergic to phentermine or topiramate, or if you have:

• glaucoma;

• overactive thyroid; or

• if you are pregnant or may become pregnant.

You may need to have a negative pregnancy test before starting this treatment. Do not use phentermine and topiramate if you are pregnant. Stop taking this medicine and call your doctor right away if you 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.

You should not breastfeed while using this medicine.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phentermine and topiramate can be fatal.

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.

Do not take other weight-loss products without your doctor's advice.

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 phentermine and topiramate.

Drinking alcohol with this medicine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid becoming overheated or dehydrated in hot weather. This medicine can decrease sweating and increase body temperature, leading to life-threatening dehydration.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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.

Phentermine and topiramate may cause serious side effects. Call your doctor at once if you have:

• 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 of phentermine and topiramate 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.

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.

Using this medicine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

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.