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Generic Topamax 25mg 20 Caps, Topiramate

Generic Topamax 25mg 20 Caps, Topiramate
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Generic Topamax 25mg 20 Caps, Topiramato

Epilepsy TOPAMAX ® is indicated as monotherapy in patients with newly diagnosed epilepsy or for conversion to monoterpia in patients with epilepsy.

TOPAMAX ® is indicated as adjunctive therapy in adults and children (over 2 years) with partial onset seizures and generalized tonic-clonic seizures.

TOPAMAX ® is also indicated in adults and children as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome.

Migraine TOPAMAX ® is indicated in adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX ® in the acute treatment of migraine headaches has not been studied.

Pharmacokinetics in Humans:

Pharmacokinetics: The tablet and capsule formulations are bioequivalent. The pharmacokinetic profile of topiramate compared with other antiepileptic drugs shows a long plasma half-life, linear pharmacokinetics, predominantly renal clearance, no significant binding to proteins and lack of clinically relevant active metabolites.

Topiramate is a potent inducer of drug metabolizing enzymes, can be administered without regard to food, and routine monitoring of plasma concentrations of topiramate is not necessary. In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events.

Topiramate is well absorbed and quickly. After oral administration of 100 mg of topiramate to healthy subjects, peak mean plasma concentration (Cmax) of 1.5 mg / ml was achieved within 2 to 3 hours (Tmax). Based on the recovery of radioactivity in the urine, the average degree of absorption of an oral dose of 100 mg of 14C-topiramate was at least 81%. There is no clinically significant effect of food on the bioavailability of topiramate. Generally 13-17% of topiramate is bound to plasma proteins. We observed a low binding capacity in place to topiramate in / on erythrocytes that is saturable plasma concentrations below 4 mg / ml. The volume of distribution varied inversely with dose. The mean apparent volume of distribution was 0.8 to 0.55 l / kg single doses in a range from 100 to 1.200 mg. Detected an effect of gender on the volume of distribution, values ​​for women about 50% of those of men. This is attributed to the higher percentage of body fat in women and is not of significant consequence.

Topiramate is not extensively metabolized (~ 20%) in healthy volunteers. TOPAMAX ® is metabolized up to 50% in patients receiving antiepileptic therapy with known inducers parelela of drug metabolizing enzymes. Six metabolites have been isolated formed from hydroxylation, hydrolysis and glucuronidation, characterized and identified from plasma, urine and feces in humans. Each metabolite is less than 3% of the total radioactivity excreted after administration of 14C-topiramate. Two metabolites, which were retained in the majority of the structure of topiramate were analyzed and found to have a small or anticonvulsant activity, had no activity.

In humans, the major route of elimination of unchanged topiramate and its metabolites is the kidney (at least 81% of the dose). Approximately 66% of a dose of 14 C-topiramate was excreted unchanged in urine within four days. After a dose of 50 and 100 mg of topiramate twice daily, the mean renal clearance was approximately 18 ml / min and 17 ml / min respectively.

There is evidence of renal tubular reabsorption of topiramate. This is supported by studies in rats where topiramate was co-administered with probenecid, and a significant increase in renal clearance of topiramate. In general, the plasma clearance is approximately 20 to 30 ml / min in humans following oral administration.

Topiramate has low inter-subject variability in plasma concentrations and, therefore, its pharmacokinetics are predictable. The pharmacokinetics of topiramate are linear with plasma clearance remaining constant and area under the curve of plasma concentration aumenfunción normal kidney may take 4 to 8 days in plasma concentrations reach steady state.

The mean Cmax after multiple oral doses of 100 mg twice daily to healthy subjects was 6.76 μ / ml. After administration of multiple doses of 50 to 100 mg of topiramate twice a day, half-life of plasma clearance was approximately 21 hours.

Concomitant administration of multiple doses of topiramate, 100 to 400 mg twice daily, with phenytoin or carbamazepine shows dose proportional increases in plasma concentrations of topiramate.

And renal plasma clearance of topiramate is decreased in patients with impaired renal function (ClCR? 60 ml / min) and plasma clearance is decreased in patients with end-stage renal disease. As a result, the expected plasma concentrations of topiramate in higher steady state for a given dose in patients with renal impairment compared with those with normal renal function. Topiramate is effectively removed from plasma by hemodialysis.

Plasma clearance of topiramate is decreased in patients with moderate to severe hepatic impairment. Plasma clearance of topiramate is unchanged in middle-aged subjects in the absence of renal disease.

Pediatric pharmacokinetics up to 12 years: The pharmacokinetics of topiramate in children as in adults receiving adjuvant therapy is linear with clearance independent of dose and steady-state plasma concentrations increasing in proportion to dose. Children, however, have a higher clearance and an elimination half-life shorter. Consequently, plasma concentrations of topiramate for the same dose mg / kg may be lower in children compared with adults. As in adults, hepatic enzyme-induced AEDs diminuyen plasma concentrations at steady state.

CONTRAINDICATIONS: Hypersensitivity to any component of the formula.

PRECAUTIONS: In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TOPAMAX ® should be withdrawn gradually to minimize the potential for seizures or increase the frequency of the attack. In clinical studies, daily doses were reduced weekly intervals of 50-100 mg in adults with epilepsy and 25-50 mg in adults receiving Topamax ® at doses above 100 mg / day in migraine prophylaxis. In clinical studies in children, TOPAMAX ® was withdrawn gradually over an interval of 2-8 weeks.

In situations where rapid withdrawal of TOPAMAX ® is medically required, appropriate monitoring is recommended.

The main route of elimination of unchanged topiramate and its metabolites is the kidney. Renal elimination is dependent on renal function and is independent of age. Patients with moderate or severe renal impairment may require 10 to 15 days to reach plasma concentrations at steady state, compared with 4 to 8 days in patients with normal renal function.

Like all patients, the degree program should be guided by clinical outcome (eg, crisis management, avoiding side effects) with the knowledge that patients with known renal impairment may require more time to reach the state equilibrium at each dose.

It is very important proper hydration while taking topiramate. Hydration may reduce the risk of nephrolithiasis. Proper hydration before and during activities such as exercise or exposure to high temperatures may reduce the risk of adverse events related to heat.

Mood disorders / depression: An increased incidence of mood disorders and depression during treatment with topiramate.

Attempted suicide: In double-blind phases of clinical trials with topiramate in approved indications and research, suicide attempts occurred at a rate of 0.003 (13 events / patient year 3.999) with topiramate against 0 (0 events / 1.430 patient years) placebo. Suicide was reported in a patient receiving topiramate in a study of bipolar disorder.

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

Risk factors for nephrolithiasis include prior stone formation, family history of nephrolithiasis and hypercalciuria. None of these risks can really predict stone formation during topiramate treatment, addition, patients taking other medications associated with nephrolithiasis may increase the risk.

Hepatic function impairment: In patients with hepatic impairment, topiramate should be administered with caution as the clearance of topiramate may be decreased.

Acute myopia and secondary angle closure glaucoma: a syndrome has been reported consisting of acute myopia with secondary angle closure glaucoma in patients receiving TOPAMAX ®. Symptoms include acute onset of decreased visual acuity and / or eye pain. Ophthalmologic findings can include myopia, anterior chamber surface, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not have. 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 therapy with TOPAMAX ®. In contrast to primary narrow angle glaucoma, which is rare in people under 40 years, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients and adults. Treatment includes discontinuation of TOPAMAX ® 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. [Elevated intraocular pressure of any etiology, if left untreated, can cause serious sequelae including permanent vision loss].

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

Chronic metabolic acidosis in pediatric patients can reduce growth rates. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated in pediatric or adult populations.

Depending on underlying conditions, topiramate therapy is recommended appropriate evaluation including serum bicarbonate. If metabolic acidosis develops and persists, consideration should be taken to reduce the dose or discontinuing topiramate (using dose reduction).

Nutritional Supplementation: We may consider a dietary supplement or increased food intake if the patient is losing weight while taking this medicine.

Use in Pregnancy and Lactation: In preclinical studies, topiramate has been shown to have teratogenic effects in the species studied (mice, rats and rabbits). In rats, topiramate crosses the plancentaria.

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

Topiramate is excreted in the milk of lactating rats. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into breast milk. Because many drugs are excreted in human milk, take the decision to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

In postmarketing experience, there have been cases of hypospadias in male infants exposed in utero to topiramate, with or without other anticonvulsants, but has not established a causal relationship with topiramate. Do not use during pregnancy and lactation.

ADVERSE REACTIONS: The most common adverse events in clinical trials were mild to moderate severity and dose related.

These adverse events related to the dose typically began in the titration phase and often persisted into the maintenance phase but infrequently began in the maintenance phase. A rapid rate of titration and higher initial doses were associated with higher incidences of adverse events resulting in discontinuation.

Adverse events from clinical trials of adjunctive therapy in epilepsy: Since TOPAMAX ® has been most frequently co-administered with other antiepileptic agents, it is not possible to determine which agents, if any, are associated with adverse events.

Adults: In double-blind clinical studies, aglunos of which included a rapid titration period, adverse events occurred at a frequency greater than or equal to 5% and with a higher incidence in adult patients treated with topiramate than in the placebo group and included drowsiness, dizziness, nervousness, ataxia, fatigue, speech disorders related to speech problems, psychomotor slowness, abnormal vision, difficulty with memory NOS *, confusion, paresthesia, diplopia, anorexia, nystagmus, nausea, decreased weight, language problems, difficulty with concentration / attention, depression, abdominal pain, fatigue and changes in mood.

Adverse events considered potentially less common but medically relevant included: abnormal taste, agitation, cognitive problems NOS *, emotional lability, poor coordination, abnormal gait, apathy, psychosis / psychotic symptoms, behavioral / aggressive reactions, leucopenia and nephrolithiasis. Have also been isolated reports of thromboembolic events, however, no causal relationship was established with the medicine.

Children: In double-blind studies, adverse events occurred at a frequency equal to or greater than 5% and a higher incidence in the group of pediatric patients treated with topiramate than in the placebo group and included drowsiness, anorexia, fatigue, nervousness , personality changes, difficulty with concentration / attention, aggressive reactions, weight loss, abnormal gait, mood problems, ataxia, increased salivation, nausea, difficulty with memory NOS *, hyperkinesia, dizziness, slurred speech and paresthesia. Adverse events occurred less frequently but were considered potentially medically relevant included: emotional lability, agitation, apathy, cognitive problems NOS *, psychomotor slowness, confusion, hallucinations, depression, and leukopenia.

Monotherapy trials in epilepsy: Quantitatively, all types of adverse events observed in monotherapy studies were similar to those observed during the studies as adjunctive therapy. With the exception of paresthesia and fatigue, these adverse events were reported at rates similar or lower incidence in monotherapy trials.

Adults: In double-blind clinical trials, clinically relevant adverse events that occurred with an incidence greater than or equal to 10% in adult patients treated with topiramate included: paresthesia, headache, fatigue, dizziness, drowsiness, weight loss, nausea and anorexia.

Children: In double-blind clinical trials, clinically relevant adverse events that occurred with an incidence greater than or equal to 10% in pediatric patients treated with topiramate included: headache, fatigue, drowsiness, and anorexia.

Clinical studies in migraine: double-blind clinical studies, clinically relevant adverse events occurred at a frequency of 5% or greater and were observed with a higher incidence in patients treated with topiramate in placebo-treated patients and included fatigue, paresthesia, dizziness, hypesthesia, slurred speech, nausea, diarrhea, dyspepsia, dry mouth, weight loss, anorexia, drowsiness, difficulty with memory NOS *, difficulty with concentration / attention, insomnia, anxiety, mood, depression , taste perversion, abnormal vision.

Patients treated with topiramate experienced mean percent changes in body weight were dose dependent.

This change was not observed in the placebo group. Mean changes were observed in 0.0, -2.3%, -3.2% and -3.8% for placebo and topiramate groups of 50, 100 and 200, respectively.


It is recommended that therapy be initiated at low doses followed by titration to achieve an effective dose.

TOPAMAX ® is available in tablet and capsule formulation TOPAMAX ® SPRINKLE.

It is recommended not break tablets. TOPAMAX ® SPRINKLE formulation is recommended for patients who can not take the tablets, for example, children and elderly.

TOPAMAX ® (topiramate) SPRINKLE capsules can be swallowed whole or may be administered carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food.

This mixture of drug / food should be eaten immediately and not chewed. It should not be stored for future use.

It is not necessary to monitor topiramate plasma concentrations to optimize TOPAMAX ® therapy. On rare occasions, the addition of TOPAMAX ® to phenytoin may require adjustment of the dose of phenytoin to achieve optimal clinical outcome. May require dose adjustment of TOPAMAX ® to the addition or withdrawal of phenytoin and carbamazepine to TOPAMAX ® Adjuvant.

TOPAMAX ® may be taken without food.

Adjunctive therapy for epilepsy:

Adults should initiate therapy with 25-50 mg at night for a week. It has been reported using lower initial doses, but have not been systematically studied. Subsequently, at intervals of one or two weeks, the dosage should be increased by 25-50 [a 100] mg / day, taken in 2 divided doses. The dose titration should be guided by clinical assessment. Some patients may achieve efficacy with a single daily dose.

In clinical trials of adjunctive therapy, 200 mg were effective being the lowest dose studied. Therefore, it is considered the minimum effective dose. The usual dose is 200-400 mg daily in two divided doses. Patients have received single doses as high as 1.600 mg / day. TOPAMAX ® as the plasma is removed by dialysis, should be given an additional dose of TOPAMAX ® equals approximately half the daily dose hemodialysis days. The supplemental dose should be administered in divided doses at baseline and completion of the hemodialysis procedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used.

These dosing recommendations apply to all adults including seniors, in the absence of underlying renal disease.

Children over 2 years: The recommended total dose of TOPAMAX ® (topiramate) as adjunctive therapy is approximately 5 to 9 mg / kg / day in 2 divided doses. Titration should begin with 25 mg (or less, based on the range of 1 to 3 mg / kg / day) every night during the first week. Then the dose will be increased in intervals of 1 to 2 weeks with increases of 1 to 3 mg / kg / day (given in 2 divided doses), to achieve optimal clinical response. The increased dosing should be guided by the clinical effects. We have studied dose to 30 mg / kg / day and were generally well tolerated.

Epilepsy Monotherapy in general: When removing other antiepileptic drugs (AEDs) concomitant to achieve monotherapy with topiramate should be considerations for the effects this may have in controlling the crisis. Unless of safety issues require a concomitant abrupt withdrawal of the MFA, it is recommended to phase out at a rate of about one third of the dose of concomitant MAE every 2 weeks. When removed enzyme-inducing drugs, topiramate levels are increased. It may require lowering the dose of TOPAMAX ® if clinically indicated.

Adults: The title should begin with a dose of 25 mg every night for a week after the dose may be increased at intervals of 1-2 weeks with increases of 25 or 50 mg / day in 2 divided doses. If the patient is unwilling to tolerate the titration regimen, you can use smaller increments or longer intervals. Increasing the dose and titration should be guided by clinical effects.

The ideal initial dose recommended for topiramate monotherapy in adults is 100 mg / day and the maximum recommended daily dose is 500 mg. Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1.000 mg / day. These recommended rates apply to all adults, including elderly patients with no history of renal disease.

Children: Treatment for children 2 and older, start with 0.5 to 1 mg / kg at night during the first week.

After the dose may be increased at intervals of 1 or 2 weeks with increases of 0.5 to 1 mg / kg / day, given in 2 divided doses. If the child is unwilling to tolerate the titration regimen, smaller increments may be used or long-gos intervals. It should guide the dose and dose titration by clinical evaluation.

The recommended dose range for topiramate monotherapy start in children 2 years or more is 3 to 6 mg / kg / day. Children in recently diagnosed partial onset seizures at doses up to 500 mg / day.

Migraine: The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg / day given in two divided doses. Titration should begin at 25 mg / kg at night for a week. After the dose may be increased by 25 mg / day given at intervals of 1 week. If the patient is unwilling to tolerate the titration regimen can be used longer intervals between dose adjustments, given in 2 divided doses. If the child is unwilling to tolerate the titration regimen, you can use smaller increments or longer intervals.

Some patients may experience benefit at a total daily dose of 50 mg / day.

Patients received a total daily dose of 200 mg / day. The dose and titration should be guided by clinical outcome.


Signs and Symptoms: There are no reports of topiramate overdose. Signs and symptoms included convulsions, dizziness, slurred speech, blurred vision, diplopia, mental impairment, 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 multiple drug overdoses involving topiramate.

Topiramate overdose can lead to severe metabolic acidosis (see Warnings).

A patient who ingested a dose calculated between 96 and 110 g topiramate was admitted to hospital with coma for 20-24 hours followed by full recovery after 3 to 4 days.

Treatment: In acute topiramate overdose, if the ingestion is recent, proceed immediately to an empty stomach by lavage or by induction of emesis. The activated carbon to adsorb topiramate has been shown in vitro.

Treatment should be adequate support. Hemodialysis has proved an effective means of removing topiramate from the body. The patient should be well hydrated.

Drug Name: Topamax
Brand comparison: Topamax
Active ingredient: Topiramate
Presentation: Tablets
Concentration: 100 mg
Response time: No
Laboratory Janssen, S. A. de CV
Box of 20 Pills
Manufactured in: Mexico

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