Topiramat AL Migräne Overdose

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What happens if I overdose Topiramat AL Migräne?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Topiramat AL Migräne extended-release capsules:

Store Topiramat AL Migräne extended-release capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Do not store in the bathroom. Keep Topiramat AL Migräne extended-release capsules out of the reach of children and away from pets.

Overdose of Topiramat AL Migräne in details

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Overdoses of Topiramat AL Migräne resulted in signs and symptoms which included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after polydrug overdoses involving Topiramat AL Migräne.

Topiramat AL Migräne overdose has resulted in severe metabolic acidosis.

A patient who ingested a dose between 96 g and 110 g of Topiramat AL Migräne was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.

Similar signs, symptoms, and clinical consequences are expected to occur with overdosage of Topiramat AL Migräne Extended-Release Capsules. Therefore, in acute overdose with Topiramat AL Migräne Extended-Release Capsules, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb Topiramat AL Migräne in vitro. Treatment should be appropriately supportive. Hemodialysis is an effective means of removing Topiramat AL Migräne from the body.

What should I avoid while taking Topiramat AL Migräne?

Do not drink alcohol. Dangerous side effects or increased seizures can occur when alcohol is combined with Topiramat AL Migräne.

Avoid becoming overheated or dehydrated in hot weather. Topiramat AL Migräne can decrease sweating and increase body temperature, leading to life-threatening dehydration (especially in children). This effect can be worse if you also use: cold or allergy medicine, bladder or urinary medicine, a bronchodilator, medicine for Parkinson's disease, or medicine to treat stomach ulcers or irritable bowel syndrome.

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

Topiramat AL Migräne may cause blurred vision or impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places.

Topiramat AL Migräne warnings

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Acute Myopia and Secondary Angle Closure Glaucoma

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving Topiramat AL Migräne. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating Topiramat AL Migräne therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with Topiramat AL Migräne has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of Topiramat AL Migräne Extended-Release Capsules as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of Topiramat AL Migräne Extended-Release Capsules, may be helpful.

Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

Visual Field Defects

Visual field defects have been reported in patients receiving Topiramat AL Migräne independent of elevated intraocular pressure. In clinical trials, most of these events were reversible after Topiramat AL Migräne discontinuation. If visual problems occur at any time during Topiramat AL Migräne treatment, consideration should be given to discontinuing the drug.

Oligohydrosis and Hyperthermia

Oligohydrosis (decreased sweating), resulting in hospitalization in some cases, has been reported in association with Topiramat AL Migräne use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures.

The majority of the reports have been in pediatric patients. Patients, especially pediatric patients, treated with Topiramat AL Migräne Extended-Release Capsules should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Topiramat AL Migräne Extended-Release Capsules are prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

Metabolic Acidosis

Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with Topiramat AL Migräne treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of Topiramat AL Migräne on carbonic anhydrase. Such electrolyte imbalance has been observed with the use of Topiramat AL Migräne in placebo-controlled clinical trials and in the post-marketing period. Generally, Topiramat AL Migräne-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet or specific drugs) may be additive to the bicarbonate lowering effects of Topiramat AL Migräne.

Adults

In adults, the incidence of persistent treatment-emergent decreases in serum bicarbonate (levels of less than 20 mEq/L at two consecutive visits or at the final visit) in controlled clinical trials for adjunctive treatment of epilepsy was 32% for 400 mg per day, and 1% for placebo. Metabolic acidosis has been observed at doses as low as 50 mg per day. The incidence of persistent treatment-emergent decreases in serum bicarbonate in adults in a controlled clinical trial for monotherapy was 15% for 50 mg per day and 25% for 400 mg per day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value less than 17 mEq/L and greater than 5 mEq/L decrease from pretreatment) in the adjunctive therapy trials was 3% for 400 mg per day, and 0% for placebo and in the monotherapy trial was 1% for 50 mg per day and 7% for 400 mg per day. Serum bicarbonate levels have not been systematically evaluated at daily doses greater than 400 mg per day.

Pediatric Patients (2 years to 16 years of age)

The incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adjunctive treatment of Lennox-Gastaut syndrome or refractory partial onset seizures in patients age 2 years to 16 years was 67% for Topiramat AL Migräne (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value less than 17 mEq/L and greater than 5 mEq/L decrease from pretreatment) in these trials was 11% for Topiramat AL Migräne and 0% for placebo. Cases of moderately severe metabolic acidosis have been reported in patients as young as 5 months old, especially at daily doses above 5 mg/kg/day.

In pediatric patients (6 years to 15 years of age), the incidence of persistent treatment-emergent decreases in serum bicarbonate in the epilepsy controlled clinical trial for monotherapy performed with Topiramat AL Migräne was 9% for 50 mg per day and 25% for 400 mg per day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value less than 17 mEq/L and greater than 5 mEq/L decrease from pretreatment) in this trial was 1% for 50 mg per day and 6% for 400 mg per day.

Pediatric Patients (under 2 years of age)

Although Topiramat AL Migräne Extended-Release Capsules are not approved for use in patients less than 2 years of age with partial onset seizures, a study of Topiramat AL Migräne as adjunctive use in patients under 2 years of age revealed that Topiramat AL Migräne produced a metabolic acidosis that is notably greater in magnitude than that observed in controlled trials in older children and adults. The mean treatment difference (25 mg/kg/day Topiramat AL Migräne-placebo) was -5.9 mEq/L for bicarbonate. The incidence of metabolic acidosis (defined by a serum bicarbonate less than 20 mEq/L) was 0% for placebo, 30% for 5 mg/kg/day, 50% for 15 mg/kg/day, and 45% for 25 mg/kg/day.

Manifestations of Metabolic Acidosis

Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of Topiramat AL Migräne on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Long-term, open-label treatment of infants/toddlers, with intractable partial epilepsy, for up to 1 year, showed reductions from baseline in Z SCORES for length, weight, and head circumference compared to age and sex-matched normative data, although these patients are likely to have different growth rates than normal infants. Reductions in Z SCORES for length and weight were correlated to the degree of acidosis. Topiramat AL Migräne treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate from possible transfer of Topiramat AL Migräne to the fetus.

Risk Mitigation Strategies

Measurement of baseline and periodic serum bicarbonate during Topiramat AL Migräne treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Topiramat AL Migräne (using dose tapering). If the decision is made to continue patients on Topiramat AL Migräne in the face of persistent acidosis, alkali treatment should be considered.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED, including Topiramat AL Migräne Extended-Release Capsules, for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Topiramat AL Migräne Extended-Release Capsules or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, behavior or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Cognitive/Neuropsychiatric Adverse Reactions

Adverse reactions most often associated with the use of Topiramat AL Migräne, and therefore expected to be associated with the use of Topiramat AL Migräne Extended-Release Capsules were related to the central nervous system and were observed in the epilepsy population. In adults, the most frequent of these can be classified into three general categories: 1) Cognitive-related dysfunction (e.g. confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech or language problems, particularly word-finding difficulties), 2) Psychiatric/behavioral disturbances (e.g. depression or mood problems), and 3) Somnolence or fatigue.

Adult Patients

Cognitive Related Dysfunction

The majority of cognitive-related adverse reactions were mild to moderate in severity, and they frequently occurred in isolation. Rapid titration rate and higher initial dose were associated with higher incidences of these reactions. Many of these reactions contributed to withdrawal from treatment.

In the adjunctive epilepsy controlled trials conducted with Topiramat AL Migräne (using rapid titration such as 100 mg per day to 200mg per day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 42% for 200mg per day, 41% for 400mg per day, 52% for 600mg per day, 56% for 800 and 1,000 mg per day, and 14% for placebo. These dose-related adverse reactions began with a similar frequency in the titration or in the maintenance phase, although in some patients the events began during titration and persisted into the maintenance phase. Some patients who experienced one or more cognitive-related adverse reactions in the titration phase had a dose-related recurrence of these reactions in the maintenance phase.

In the monotherapy epilepsy controlled trial conducted with Topiramat AL Migräne, the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for Topiramat AL Migräne 50mg per day and 26% for 400mg per day.

Psychiatric/Behavioral Disturbances

Psychiatric/behavioral disturbances (depression or mood) were dose-related for the epilepsy population treated with Topiramat AL Migräne.

Somnolence/Fatigue

Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of Topiramat AL Migräne for adjunctive epilepsy. For the adjunctive epilepsy population, the incidence of somnolence did not differ substantially between 200 mg per day and 1,000 mg per day, but the incidence of fatigue was dose-related and increased at dosages above 400 mg per day. For the monotherapy epilepsy population in the 50 mg per day and 400 mg per day groups, the incidence of somnolence was dose-related (9% for the 50 mg per day group and 15% for the 400 mg per day group) and the incidence of fatigue was comparable in both treatment groups (14% each). For other uses not approved for Topiramat AL Migräne Extended-Release Capsules, somnolence and fatigue were more common in the titration phase.

Additional nonspecific CNS events commonly observed with Topiramat AL Migräne in the adjunctive epilepsy population include dizziness or ataxia.

Pediatric Patients

In double-blind adjunctive therapy and monotherapy epilepsy clinical studies conducted with Topiramat AL Migräne, the incidences of cognitive/neuropsychiatric adverse reactions in pediatric patients were generally lower than observed in adults. These reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems and language problems. The most frequently reported neuropsychiatric reactions in pediatric patients during adjunctive therapy double-blind studies were somnolence and fatigue. The most frequently reported neuropsychiatric reactions in pediatric patients in the 50 mg per day and 400 mg per day groups during the monotherapy double-blind study were headache, dizziness, anorexia, and somnolence.

No patients discontinued treatment due to any adverse events in the adjunctive epilepsy double-blind trials. In the monotherapy epilepsy double-blind trial conducted with immediate-release Topiramat AL Migräne product, 1 pediatric patient (2%) in the 50 mg per day group and 7 pediatric patients (12%) in the 400 mg per day group discontinued treatment due to any adverse events. The most common adverse reaction associated with discontinuation of therapy was difficulty with concentration/attention; all occurred in the 400 mg per day group.

Fetal Toxicity

Topiramat AL Migräne can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to Topiramat AL Migräne in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received Topiramat AL Migräne at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.

Consider the benefits and risks of Topiramat AL Migräne when administering the drug in women of childbearing potential, particularly when Topiramat AL Migräne is considered for a condition not usually associated with permanent injury or death. Topiramat AL Migräne should be used during pregnancy only if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.

Withdrawal of Antiepileptic Drugs

In patients with or without a history of seizures or epilepsy, antiepileptic drugs including Topiramat AL Migräne Extended-Release Capsules, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In situations where rapid withdrawal of Topiramat AL Migräne Extended-Release Capsules is medically required, appropriate monitoring is recommended.

Hyperammonemia and Encephalopathy

Hyperammonemia/Encephalopathy Without Concomitant Valproic Acid (VPA)

Topiramat AL Migräne treatment has produced hyperammonemia (in some instances dose-related) in clinical investigational programs in very young pediatric patients (1 month to 24 months) who were treated with adjunctive Topiramat AL Migräne for partial onset epilepsy (8% for placebo, 10% for 5 mg/kg/day, 0% for 15 mg/kg/day, 9% for 25 mg/kg/day). Topiramat AL Migräne Extended-Release Capsules are not approved as adjunctive treatment of partial onset seizures in pediatric patients less than 2 years old. In some patients, ammonia was markedly increased (greater than 50% above upper limit of normal). The hyperammonemia associated with Topiramat AL Migräne treatment occurred with and without encephalopathy in placebo-controlled trials, and in an open-label, extension trial. Dose-related hyperammonemia was also observed in the extension trial in pediatric patients up to 2 years old. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting.

Hyperammonemia with and without encephalopathy has also been observed in post-marketing reports in patients who were taking Topiramat AL Migräne without concomitant valproic acid (VPA).

Hyperammonemia/Encephalopathy With Concomitant Valproic Acid (VPA)

Concomitant administration of Topiramat AL Migräne and valproic acid (VPA) has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either drug alone based upon post-marketing reports. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting. In most cases, symptoms and signs abated with discontinuation of either drug. This adverse reaction is not due to a pharmacokinetic interaction.

Although Topiramat AL Migräne Extended-Release Capsules are not indicated for use in infants/toddlers (1 month to 24 months), Topiramat AL Migräne with concomitant VPA clearly produced a dose-related increase in the incidence of treatment-emergent hyperammonemia (above the upper limit of normal, 0% for placebo, 12% for 5 mg/kg/day, 7% for 15 mg/kg/day, 17% for 25 mg/kg/day) in an investigational program using Topiramat AL Migräne. Markedly increased, dose-related hyperammonemia (0% for placebo and 5 mg/kg/day, 7% for 15 mg/kg/day, and 8% for 25 mg/kg/day) also occurred in these infants/toddlers. Dose-related hyperammonemia was similarly observed in a long-term, extension trial utilizing Topiramat AL Migräne in these very young, pediatric patients.

Hyperammonemia with and without encephalopathy has also been observed in post-marketing reports in patients taking Topiramat AL Migräne with valproic acid (VPA).

The hyperammonemia associated with Topiramat AL Migräne treatment appears to be more common when used concomitantly with VPA.

Monitoring for Hyperammonemia

Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, Topiramat AL Migräne or Topiramat AL Migräne Extended-Release Capsules treatment or an interaction of concomitant Topiramat AL Migräne-based product and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons.

In patients who develop unexplained lethargy, vomiting, or changes in mental status associated with any Topiramat AL Migräne treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.

Kidney Stones

A total of 32/2086 (1.5%) of adults exposed to Topiramat AL Migräne during its adjunctive epilepsy therapy development reported the occurrence of kidney stones, an incidence about 2 to 4 times greater than expected in a similar, untreated population. In the double-blind monotherapy epilepsy study, a total of 4/319 (1.3%) of adults exposed to Topiramat AL Migräne reported the occurrence of kidney stones. As in the general population, the incidence of stone formation among Topiramat AL Migräne-treated patients was higher in men. Kidney stones have also been reported in pediatric patients. During long-term (up to 1 year) Topiramat AL Migräne treatment in an open-label extension study of 284 pediatric patients 1 month to 24 months old with epilepsy, 7% developed kidney or bladder stones that were diagnosed clinically or by sonogram. Topiramat AL Migräne Extended-Release Capsules are not approved for pediatric patients less than 2 years old.

Topiramat AL Migräne Extended-Release Capsules would be expected to have the same effect as Topiramat AL Migräne on the formation of kidney stones. An explanation for the association of Topiramat AL Migräne and kidney stones may lay in the fact that Topiramat AL Migräne is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH. The concomitant use of Topiramat AL Migräne Extended-Release Capsules with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.

Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Hydration is recommended to reduce new stone formation.

Hypothermia with Concomitant Valproic Acid Use

Hypothermia, defined as an unintentional drop in body core temperature to less than 35ºC (95ºF) has been reported in association with Topiramat AL Migräne use with concomitant valproic acid (VPA) both in the presence and in the absence of hyperammonemia. This adverse reaction in patients using concomitant Topiramat AL Migräne and valproate can occur after starting Topiramat AL Migräne treatment or after increasing the daily dose of Topiramat AL Migräne. Consideration should be given to stopping Topiramat AL Migräne or valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems. Clinical management and assessment should include examination of blood ammonia levels.

Paresthesia

Paresthesia (usually tingling of the extremities), an effect associated with the use of other carbonic anhydrase inhibitors, appears to be a common effect of Topiramat AL Migräne. Paresthesia was more frequently reported in the monotherapy epilepsy trials conducted with immediate-release Topiramat AL Migräne than in the adjunctive therapy epilepsy trials conducted with the same product. In the majority of instances, paresthesia did not lead to treatment discontinuation.

Interaction with Other CNS Depressants

Topiramat AL Migräne is a CNS depressant. Concomitant administration of Topiramat AL Migräne with other CNS depressant drugs or alcohol can result in significant CNS depression. Patients should be watched carefully when Topiramat AL Migräne Extended-Release Capsules are co-administered with other CNS depressant drugs.

What should I discuss with my healthcare provider before taking Topiramat AL Migräne?

You should not use Topiramat AL Migräne if you are allergic to it.

To make sure you can safely take Topiramat AL Migräne, tell your doctor if you have any of these other conditions:

You may have thoughts about suicide while taking Topiramat AL Migräne. Tell your doctor if you have new or worsening symptoms of depression, anxiety, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits.

FDA pregnancy category D. Taking Topiramat AL Migräne during pregnancy may increase the risk of cleft lip and/or cleft palate in the newborn. Do not start taking Topiramat AL Migräne without telling your doctor if you are pregnant or planning to become pregnant. Use effective birth control while you are taking Topiramat AL Migräne.

Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking Topiramat AL Migräne. Follow your doctor's instructions about taking Topiramat AL Migräne while you are pregnant.

Although Topiramat AL Migräne may harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking Topiramat AL Migräne, do not stop taking the medicine without your doctor's advice.

Topiramat AL Migräne can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Topiramat AL Migräne. If you are not planning a pregnancy while taking Topiramat AL Migräne, use effective birth control, and tell your doctor if you become pregnant during treatment.

Topiramat AL Migräne can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Topiramat AL Migräne precautions

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In patients with or without a history of seizures or epilepsy, antiepileptic drugs including Topiramat AL Migräne, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In clinical trials, daily dosages were decreased in weekly intervals by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving Topiramat AL Migräne at doses up to 100 mg/day for migraine prophylaxis. In clinical trials of children, Topiramat AL Migräne was gradually withdrawn over a 2- to 8-week period. In situations where rapid withdrawal of Topiramat AL Migräne is medically required, appropriate monitoring is recommended.

The major route of elimination of unchanged Topiramat AL Migräne and its metabolites is via the kidney. Renal elimination is dependent on renal function and is independent of age. Patients with moderate or severe renal impairment may take 10-15 days to reach steady-state plasma concentrations as compared to 4-8 days in patients with normal renal function.

As with all patients, the titration schedule should be guided by clinical outcome (ie, seizure control, avoidance of side effects) with the knowledge that subjects with known renal impairment may require a longer time to reach steady-state at each dose.

Adequate hydration while using Topiramat AL Migräne is very important. Hydration can reduce the risk of nephrolithiasis. Proper hydration prior to and during activities eg, exercise or exposure to warm temperature may reduce the risk of heat-related adverse events.

Mood Disturbances/Depression: An increased incidence of mood disturbances and depression has been observed during Topiramat AL Migräne treatment.

Suicide Attempt: In the double-blind phases of clinical trials with Topiramat AL Migräne in approved and investigational indications, suicide attempts occurred at a rate of 0.003 (13 events/3999 patient years) on Topiramat AL Migräne versus 0 (0 event/1430 patient years) on placebo. One completed suicide was reported in a bipolar disorder trial in a patient on Topiramat AL Migräne.

Nephrolithiasis: Some patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms eg, renal colic, renal pain or flank pain.

Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria. None of these risk factors can reliably predict stone formation during Topiramat AL Migräne treatment. In addition, patients taking other medication associated with nephrolithiasis may be at increased risk.

Decreased Hepatic Function: In hepatically-impaired patients, Topiramat AL Migräne should be administered with caution as the clearance of Topiramat AL Migräne may be decreased.

Acute Myopia and Secondary Angle Closure Glaucoma: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving Topiramat AL Migräne. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating Topiramat AL Migräne therapy. In contrast to primary narrow angle glaucoma, which is rare <40 years, secondary angle closure glaucoma associated with Topiramat AL Migräne has been reported in pediatric patients as well as adults. Treatment includes discontinuation of Topiramat AL Migräne, as rapidly as possible in the judgment of the treating physician and appropriate measures to reduce intraocular pressure. These measures generally result in a decrease in intraocular pressure.

Oligohydrosis and Hyperthermia: Oligohydrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with Topiramat AL Migräne use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of these cases were reported after exposure to elevated environmental temperature. The majority of the reports have been in children. Patients, especially pediatric patients treated with Topiramat AL Migräne should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Topiramat AL Migräne is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

Metabolic Acidosis: Hyperchloremic, non-anion gap, metabolic acidosis (ie, decreased serum bicarbonate below the normal reference range in the absence of respiratory alkalosis) is associated with Topiramat AL Migräne treatment. This decrease in serum bicarbonate is due to the inhibitory effect of Topiramat AL Migräne on renal carbonic anhydrase. Generally, the decrease in bicarbonate occurs early in the treatment although it can occur at any time during treatment. These decreases are usually mild to moderate (average decrease of 4 mmol/L at doses of ≥100 mg/day in adults and at approximately 6 mg/kg/day in pediatric patients. Rarely, patients have experienced decreases to values <10 mmol/L. Conditions or therapies that predispose to acidosis (eg, renal diseases, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic, diet or certain drugs) may be additive to the bicarbonate lowering effects of Topiramat AL Migräne.

Chronic metabolic acidosis in pediatric patients can reduce growth rate. The effect of Topiramat AL Migräne on growth and bone-related sequelae has not been systematically investigated in the pediatric or adult populations.

Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with Topiramat AL Migräne therapy. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Topiramat AL Migräne (use dose tapering).

Nutritional Supplementation: A dietary supplement or increased food intake may be considered if the patient is losing weight while on this medication.

Effects on the Ability to Drive or Operate Machinery: As with all antiepileptic drugs, Topiramat AL Migräne acts on the CNS and may produce drowsiness, dizziness or other related symptoms. It may cause visual disturbances and/or blurred vision. These adverse events could potentially be dangerous in patients driving a vehicle or operating machinery, particularly until such time as the individual patient's experience with Topiramat AL Migräne is established.

Use in pregnancy & lactation: As with other antiepileptic drugs, Topiramat AL Migräne was teratogenic in mice, rats and rabbits. In rats, Topiramat AL Migräne crosses the placental barrier.

There are no studies using Topiramat AL Migräne in pregnant women. However, Topiramat AL Migräne should be used during pregnancy only if the potential benefit outweighs the potential risk.

Topiramat AL Migräne is excreted in the milk of lactating rats. The excretion of Topiramat AL Migräne in human milk has not been evaluated in controlled studies. Limited observations in patients suggests an extensive excretion of Topiramat AL Migräne into breast milk. Since many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

In post-marketing experience, cases of hypospadias have been reported in male infants exposed in utero to Topiramat AL Migräne, with or without other anticonvulsants; however, a causal relationship with Topiramat AL Migräne has not been established.

Use in children: Safety and effectiveness in patients <2 years have not been established. Topiramat AL Migräne is associated with metabolic acidosis. Chronic untreated metabolic acidosis in pediatric patients may cause osteomalacia (rickets) and may reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of Topiramat AL Migräne on growth and bone-related sequelae has not been systematically investigated.

What happens if I miss a dose of Topiramat AL Migräne?

If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss two or more doses.



References

  1. DailyMed. "TOPIRAMATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DrugBank. "topiramate". http://www.drugbank.ca/drugs/DB00273 (accessed September 17, 2018).
  3. MeSH. "Neuroprotective Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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