topiramate (Topamax, Topamax Sprinkle, Trokendi XR, Qudexy XR) for Migraine

Migraine Headache and Tension Headache: Treatments

 

Generic Name: topiramate

Brand Names: Topamax, Topamax Sprinkle, Trokendi XR, Qudexy XR

 

Topamax

Manufacturer: Ortho-McNeill-Janssen Pharmaceuticals, Inc., a division of Johnson and Johnson Corporation

 

Overview

The generic, prescription medication topiramate has been marketed in the United States as brand-name Topamax since receiving United States Food and Drug Administration approval during 1996.  Originally developed as an anti-epileptic (anti-convulsant or anti-seizure) medication, during the past two decades, medical uses of topiramate (Topamax) have expanded to include the prevention of migraine and other headaches, acting as a mood-stabilizer in bipolar disorder, treatment of certain forms of chronic pain, and for weight loss.  In 2012, the FDA approved the prescription medication Qsymia which is a combination of topiramate (Topamax) and the appetite suppressant phentermine (Fastin, Adipex-P) for weight loss and treatment of obesity.  Most neurologist prescribe topiramate for treatment of migraine headache far more often than for the treatment of epilepsy, largely because there are so many more people suffering from migraine headaches than from seizure disorders.

When prescribed for migraine headaches and epilepsy, topiramate does not begin working immediately.  Rather, the dose of topiramate must be gradually titrated and ramped up over a period of weeks until the patient has reached doses of the medication that are typically effective.  Titrating the medication gradually helps to significantly reduce the likelihood of more common adverse reactions.  Like most preventive (prophylactic) medications for migraine, topiramate does not work immediately, and it typically takes about four weeks to six weeks for the medication to begin reducing the frequency and severity of migraine headaches.  Topiramate is not intended to be an as needed medication for migraine headache or for seizures – topiramate is not effective for treating seizures or migraine headaches once they have occurred, but rather it is prescribed to reduce the likelihood of seizures or migraines from occurring.  Topiramate should not have any long-term effects on brain chemistry and function.  Consequently, when the medication is discontinued, migraine headaches or seizures may recur.  Consult your physician before starting or stopping or adjusting the dose of topiramate.

When prescribed for the prevention of migraine headaches, the typical dose of topiramate is 50 mg twice a day.  However, the effective dose from patient to patient may vary substantially.  In my experience, rare patients may experience a reduction in headache frequency and severity in dosages as low as 12.5 mg or 25 mg taken just once a day.  Most patients will need to take topiramate for at least four to six weeks before experiencing any reduction in the frequency and severity of headaches, and most patients will need to take at least 50 mg twice a day (total daily dose of 100 mg) to experience satisfactory improvement.  Some patients do not experience satisfactory improvement until reaching doses of between 100 mg twice a day (total daily dose of 200 mg) and 200 mg twice a day (total daily dose of 400 mg), and in rare cases, patients may take up to 400 mg twice a day (total daily dose of 800 mg).  Generally, I recommend that patients increase topiramate gradually in increments of 25 mg added once during the day and increasing their dose every one or two weeks.  Patients should titrate the dose as-needed until their headaches are adequately improved, but also as tolerated.  If patients experience adverse reactions to topiramate, they should notify their treating physician.  When patients experience unacceptable side effects, I typically recommend that they decrease their dose to the previously tolerated dose, rather than completely discontinuing the medication, particularly if they have experienced successful improvement in their migraines at lower dosages.

When topiramate is prescribed for epilepsy, the dosage may vary from patient to patient.  For epileptics using topiramate as monotherapy – meaning that topiramate is the only medication prescribed for preventing seizures – the typical dose is about 200 mg taken twice a day for a total dose of 400 mg a day.  However, some patients may experience adequate control of seizures taking only 100 mg twice a day (or even less), while other patients may require dosages of up to 400 mg twice a day (total dose of 800 mg per day).  When topiramate is prescribed as adjunctive therapy for epilepsy – when it is added on top of another anti-epileptic medication – the dosages necessary to control seizures may be significantly less than would be necessary for monotherapy.

 

Indications and Usage

FDA Approved Indications

Off-Label Uses

Migraine

Neuropathic Pain

Epilepsy Monotherapy

Chronic Pain, Fibromyalgia

Epilepsy Adjunctive Therapy

Bipolar Disorder

Weight Loss and Obesity

Depression

 

Obsessive Compulsive Disorder

 

Post-Traumatic Stress Disorder

 

Borderline Personality Disorder

 

Alcohol Dependency and Addiction

 

Cocaine Addiction

 

Methamphetamine Addiction

 

FDA Approved Indications

Monotherapy in Epilepsy

Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules are FDA approved and indicated as monotherapy in children and adolescents age 10 years and older and for adults with partial onset seizures or primary generalized tonic-clonic seizures.  This means that the FDA has approved topiramate to be used as initial or first line treatment and without any other anti-epileptic medication (monotherapy).

 

Adjunctive Therapy in Epilepsy

Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules are FDA approved and indicated as adjunctive therapy for adults and for pediatric patients age 2 years to 16 years with partial onset seizures or primary generalized tonic-clonic seizures and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.  This means that the FDA has approved topiramate to be used as add-on therapy to another FDA approved anti-epileptic medication (adjunctive therapy) for patients who have failed to respond to monotherapy with the original anti-epileptic medication.

 

Migraine Headaches

Topamax (topiramate) Tablets and Topamax (topiramate capsules) Sprinkle Capsules are FDA approved and indicated for adults for prophylaxis of migraine headache.  This means that topiramate is used as a preventive medication for migraine headaches to make the headaches less frequent, less severe, and of shorter duration.  Topiramate is not intended to be used as an abortive medication to treat an acute migraine attack.

 

Weight Loss and Obesity

The United States FDA approved Qsymia (phentermine and topiramate extended-release) to be prescribed in addition to a reduced-calorie diet and regular exercise for weight loss and chronic management of obesity.  Qsymia (phentermine and topiramate extended-release) is approved for usage in adults who are obese with a body mass index (BMI) of 30 or greater or for adults who are overweight with a body mass index (BMI) of 27 or greater who have at least one weight-related complication such as type 2 diabetes mellitus, high cholesterol (dyslipidemia, hyperlipidemia), or high blood pressure (hypertension).

 

Side Effects and Adverse Reactions

As a member of the carbonic anhydrase inhibitor anticonvulsant drug class of medications, the most common side effects of topiramate may include intermittent numbness and tingling (paresthesias), altered sense of taste (dysosmia), memory loss, and weight loss.  These mild adverse reactions are not typically serious, and they tend to be temporary, intermittent, and dose-dependent.  For most patients these may diminish over or resolve over a period of days, and they are more likely to occur with higher doses of the medication.  If these side effects continue, consult with your physician about lowering your dose of topiramate or possibly discontinuing the medication altogether.  These adverse symptoms should always resolve with lowering or discontinuing the medication, and they should never be permanent.  To help reduce the likelihood of these more common adverse reactions, make sure to drug plenty of water each day, and take topiramate on a regimented schedule at the same times each day.

While serious side effects from topiramate are uncommon, patients using topiramate should be aware that approximately one out of every one hundred patients taking topiramate (about 1 percent) will develop kidney stones (nephrolithiasis).  Most patients who develop kidney stones do not experience serious or life-threatening complications from the kidney stones.  In fact, some patients with epilepsy have decided – in consultation with their neurologist – to continue treatment with topiramate for prevention of seizures even after they have experienced nephrolithiasis.  Patients with a history of kidneys stones (nephrolithiasis) should consult with their neurologist prior to beginning treatment with topiramate to determine whether or not other medications may be safer and more effective for treating their diagnosis.  A history of nephrolithiasis should be considered a relative-contraindication rather than an absolute contraindication.  As a neurologist who has prescribed topiramate since 1996, I have encountered a handful of patients who have developed kidney stones, and none of them have experienced any type of serious complication.  I have been surprised that many of these patients forgot that topiramate can cause kidney stones even though I make a specific effort to mention this to every patient before starting therapy with topiramate.  Often other physicians, even urologists who specialize in treating kidney stones, are not aware that topiramate can cause kidney stones.

Topiramate can rarely cause acute angle closure glaucoma.  If you have a history of glaucoma, you should consult with your neurologist and ophthalmologist before taking topiramate.

Topiramate is a pregnancy category D medication, meaning that there is evidence that there is risk to the fetuses of women taking topiramate.  For some women – particularly those with potentially life-threatening epilepsy – the potential benefits of treatment with topiramate may outweigh the risks to the unborn baby.  Do not start or stop taking topiramate during pregnancy without first consulting with your doctor.  Most neurologists instruct women of child-bearing age who are prescribed topiramate to take the vitamin folic acid in conjunction with topiramate and to use adequate, reliable birth control.  Topiramate can make hormonal contraceptive medications such as birth control pills less effective, particularly when prescribed at doses equal to or greater than 100 milligrams twice a day.  Women of child-bearing age who are sexually active are encouraged to use a barrier method of birth control (such as a condom or diaphragm with spermicidal gel) even along with the hormonal contraceptive to prevent pregnancy.  Tell your doctor immediately if you become pregnant during treatment with topiramate.

Topiramate can pass into breast milk and consequently may harm a nursing baby.  Before taking topiramate, tell your physician if you are breast-feeding a baby.

 

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