Topiramate (Oral Route)

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Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of topiramate for the treatment of seizures in children younger than 2 years of age (when used alone or together with other medicines). Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of topiramate for the prevention of migraine headaches in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of topiramate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of topiramate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving topiramate.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Citalopram
• Ketorolac
• Metformin
• Naproxen

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Carbamazepine
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fosphenytoin
• Ginkgo
• Hydrochlorothiazide
• Levonorgestrel
• Medroxyprogesterone Acetate
• Mestranol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Phenobarbital
• Phenytoin
• Pioglitazone
• Posaconazole
• Valproic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (e.g., osteomalacia, osteoporosis, rickets) or
• Depression, history of or
• Eye or vision problems (e.g., glaucoma) or
• Mental illness, history of or
• Metabolic acidosis (too much acid in the blood), history of—Use with caution. May make these conditions worse.

• Congenital metabolism disorders (born with a disease that affects metabolism)—Use with caution. May increase risk for more serious side effects.

• Diarrhea or
• Ketogenic diet (high-fat, low-protein, low-carbohydrate diet) or
• Kidney problems or
• Lung disease or other breathing problems or
• Status epilepticus (e.g., a state of epilepsy where you have many seizures in a row and do not gain consciousness) or
• Surgery—These problems may make a condition called metabolic acidosis occur or make it worse.

• Kidney disease or
• Liver disease—Use with caution. Higher blood levels of topiramate may result and increase the chance of side effects.

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