Topamax

DRUG DESCRIPTION

Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX® (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX® (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food.

Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-?-D-fructopyranose sulfamate and has the following structural formula:

TOPAMAX
  (topiramate) Structural Formula Illustration

TOPAMAX® (topiramate) Tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, purified water, carnauba wax, hypromellose, titanium dioxide, polyethylene glycol, synthetic iron oxide (25, 50, 100, and 200 mg tablets) and polysorbate 80.

TOPAMAX® (topiramate capsules) Sprinkle Capsules contain topiramate coated beads in a hard gelatin capsule. The inactive ingredients are: sugar spheres (sucrose and starch), povidone, cellulose acetate, gelatin, sorbitan monolaurate, sodium lauryl sulfate, titanium dioxide, and black pharmaceutical ink.

What are the possible side effects of topiramate (Topamax, Topamax Sprinkle)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Stop taking topiramate and call your doctor at once if you have any of these serious side...

Read All Potential Side Effects and See Pictures of Topamax »

What are the precautions when taking topiramate (Topamax)?

Before taking topiramate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain eye problem (narrow angle glaucoma), kidney problems (such as kidney stones), liver problems, mental/mood problems (such as depression, thoughts of suicide), lung/breathing problems, a certain metabolic imbalance (metabolic acidosis), long-term diarrhea, a diet high in fat and low in carbohydrates (ketogenic diet), brittle bones (osteoporosis).

This drug may make you dizzy or drowsy or impair your judgment....

Read All Potential Precautions of Topamax »


Topamax Consumer (continued)

SIDE EFFECTS: Tiredness, drowsiness, dizziness, loss of coordination, tingling of the hands/feet, loss of appetite, bad taste in your mouth, diarrhea, and weight loss may occur. Mental problems such as confusion, slowed thinking, trouble concentrating or paying attention, nervousness, memory problems, or speech/language problems may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: signs of kidney stones (such as severe back/side/abdominal/groin pain, fever, chills, painful/frequent urination, bloody/pink urine).

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor right away if any of these rare but serious side effects occur: rapid breathing, fast/slow/irregular heartbeat, bone pain, broken bones, loss of consciousness.

Rarely, topiramate may cause a very serious eye problem, generally within 1 month of starting treatment. If untreated, this eye problem can lead to permanent blindness. Therefore, get medical help right away if any of these side effects occur: sudden vision changes (such as decreased vision, blurred vision), eye pain/redness.

This medication can rarely cause a serious metabolic problem (high amount of ammonia in the blood), especially if you are also taking valproic acid. Tell your doctor right away if you experience sudden/unexplained tiredness, vomiting, or mental changes (such as decreased alertness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking topiramate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain eye problem (narrow angle glaucoma), kidney problems (such as kidney stones), liver problems, mental/mood problems (such as depression, thoughts of suicide), lung/breathing problems, a certain metabolic imbalance (metabolic acidosis), long-term diarrhea, a diet high in fat and low in carbohydrates (ketogenic diet), brittle bones (osteoporosis).

This drug may make you dizzy or drowsy or impair your judgment. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Topiramate can infrequently cause decreased sweating, which could raise your body temperature to unsafe levels (hyperthermia). The risk of this serious side effect is greater in hot weather and/or during vigorous exercise, especially in children. Drink plenty of fluids and dress lightly in hot weather or when exercising. Check carefully for signs of decreased sweating. If this occurs, immediately stop exercising and seek cooler shelter. Get medical help right away if you develop a fever, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor (see also Drug Interactions section). If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. If you are taking this drug to treat seizures, note that untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, so do not stop taking this medication unless directed by your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Topamax Patient Information Including Side Effects

Brand Names: Topamax, Topamax Sprinkle

Generic Name: topiramate (Pronunciation: toe PYRE a mate)

  • What is topiramate (Topamax)?
  • What are the possible side effects of topiramate (Topamax)?
  • What is the most important information I should know about topiramate (Topamax)?
  • What should I discuss with my healthcare provider before taking topiramate (Topamax)?
  • How should I take topiramate (Topamax)?
  • What happens if I miss a dose (Topamax)?
  • What happens if I overdose (Topamax)?
  • What should I avoid while taking topiramate (Topamax)?
  • What other drugs will affect topiramate (Topamax)?
  • Where can I get more information?

What is topiramate (Topamax)?

Topiramate is a seizure medication, also called an anticonvulsant.

Topiramate is used alone or in combination with other medications to prevent seizures in adults and children who are at least 2 years old.

Topiramate is also used to prevent migraine headaches. Topiramate will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.

Topiramate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of topiramate (Topamax)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Stop taking topiramate and call your doctor at once if you have any of these serious side effects:

  • sudden vision loss, pain around or behind your eyes;
  • dry mouth, increased thirst, confusion, drowsiness, decreased sweating, increased body temperature, and hot, dry skin,
  • nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions); or
  • severe pain in your side or lower back, painful or difficult urination.

Less serious side effects may include:

  • slowed thinking, memory problems, trouble concentrating;
  • problems with speech or balance;
  • numbness or tingling;
  • sleep problems (insomnia);
  • tired feeling;
  • headache, dizziness; or
  • loss of appetite, weight loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about topiramate (Topamax)?

Seek emergency medical attention if you have a sudden change in vision and pain around or behind the eyes. These may be early signs of a serious side effect of topiramate.

Do not stop taking topiramate without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking topiramate suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking topiramate.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Carry an ID card or wear a medical alert bracelet stating that you are taking topiramate, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Topiramate can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol. It can increase some of the side effects of topiramate, and can also increase the risk of a seizure.

Ketogenic or "ketosis" diets that are high in protein and low in carbohydrates can increase the risk of kidney stones. Avoid the use of such diets while you are taking topiramate.

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