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Topamax

Topamax
Topamax is an oral drug that is used to prevent seizures of epilepsy. It is used primarily in patients who are not under the control of other antiepileptic drugs.

Brand: Topiramate

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: March 2024
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Topamax 200 mg
120 pills - 200 mg
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$411.55 $3.43 $171.85 Add to cart
90 pills - 200 mg
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$323.37 $3.59 $114.18 Add to cart
60 pills - 200 mg
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$235.21 $3.92 $56.49 Add to cart
30 pills - 200 mg
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$145.85 $4.86 No Add to cart
Topamax 100 mg
240 pills - 100 mg
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$397.93 $1.66 $241.99 Add to cart
180 pills - 100 mg
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$310.96 $1.73 $168.98 Add to cart
120 pills - 100 mg
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$235.91 $1.97 $84.05 Add to cart
90 pills - 100 mg
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$189.93 $2.11 $50.04 Add to cart
60 pills - 100 mg
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$135.95 $2.27 $24.03 Add to cart
30 pills - 100 mg $79.99 $2.67 No Add to cart
Topamax 50 mg
360 pills - 50 mg
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$427.99 $1.19 $111.41 Add to cart
240 pills - 50 mg
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$287.55 $1.20 $72.05 Add to cart
180 pills - 50 mg
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$219.91 $1.22 $49.79 Add to cart
120 pills - 50 mg
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$149.97 $1.25 $29.83 Add to cart
90 pills - 50 mg
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$119.99 $1.33 $14.86 Add to cart
60 pills - 50 mg $82.93 $1.38 $6.97 Add to cart
30 pills - 50 mg $44.95 $1.50 No Add to cart
Topamax 25 mg
360 pills - 25 mg
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$265.99 $0.74 $81.89 Add to cart
180 pills - 25 mg
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$139.99 $0.78 $33.95 Add to cart
120 pills - 25 mg $95.99 $0.80 $19.97 Add to cart
90 pills - 25 mg $75.93 $0.84 $11.04 Add to cart
60 pills - 25 mg $52.95 $0.88 $5.03 Add to cart
30 pills - 25 mg $28.99 $0.97 No Add to cart

Product description

Name

Topamax (Topiramate)

Pharmacological action

Antiepileptic drug, belongs to the class of sulfamate-substituted monosaccharides.


Topiramate blocks sodium channels and inhibits the occurrence of repetitive action potentials during prolonged depolarization of the neuronal membrane. Topiramate increases the activity of GABA (GABA) against several subtypes of GABA receptors (including GABAA-receptors) and modulates the activity of GABAA-receptors themselves, inhibits kainate/AMPK (alpha-amino-3-hydroxy-5-methylisoxazole-4-propionic acid) receptor subtype activation to glutamate, does not affect NMDA activity against NMDA-receptor subtype. These drug effects are dose-dependent at plasma concentrations of topiramate between 1 μmol and 200 μmol, with minimal activity between 1 μmol and 10 μmol.


In addition, topiramate inhibits the activity of some carboanhydrase isoenzymes. Topiramate is significantly inferior to acetazolamide, a known inhibitor of carbonic anhydrase, in terms of the severity of this pharmacological effect; therefore, this activity of topiramate is not a major component of its antiepileptic activity.


Pharmacokinetics

Absorption


After oral administration, topiramate is rapidly and effectively absorbed from the gastrointestinal tract. Bioavailability is 81%. Food intake has no clinically significant effect on the bioavailability of the drug.


Pharmacokinetics of topiramate is linear, plasma clearance remains constant and AUC in dose range from 100 mg to 400 mg increases in proportion to the dose.


After multiple oral doses of 100 mg twice daily, Cmax averages 6.76 mcg/ml.


Distribution


Binding to plasma proteins is 13-17%.


After a single oral dose of up to 1200 mg, mean Vd is 0.55-0.8 l/kg. The Vd value depends on gender. In women, the values are about 50% of those observed in men, which is associated with a higher content of adipose tissue in women.


In patients with normal renal function, it may take 4 to 8 days to reach equilibrium.


Metabolism


After ingestion, about 20% of the dose is metabolized.


Six virtually inactive metabolites have been isolated and identified from human plasma, urine and feces.


Excretion


Topiramate (70%) and its metabolites are excreted primarily by the kidneys.


After oral administration, plasma clearance of the drug is 20-30 ml/min.


After repeated administration of 50 mg and 100 mg 2 times per day, mean T1/2 was on average 21 hours.


Pharmacokinetics in special clinical cases


Renal excretion rate of topiramate depends on renal function and is independent of age.


Renal and plasma clearance of topiramate is decreased in patients with moderate to severe renal impairment (CK ≤ 70 ml/min), resulting in increased plasma Css of topiramate compared to patients with normal renal function. The time to reach plasma Css of topiramate in patients with moderate to severe renal impairment is 10 to 15 days. Patients with moderate or severe renal impairment should use half of the recommended initial and maintenance doses.


The plasma clearance of topiramate is not altered in elderly patients without renal disease.


In patients receiving concomitant therapy with antiepileptic drugs that induce enzymes involved in drug metabolism, the metabolism of topiramate was increased by 50%.


Topiramate is effectively excreted by hemodialysis. Prolonged hemodialysis may cause blood concentrations of topiramate to fall below the amount required to maintain anticonvulsant activity. An additional dose of Topamax® may need to be administered to avoid a rapid drop in plasma concentrations of topiramate during hemodialysis. When adjusting the dose, consideration should be given to:


1) the duration of hemodialysis;


2) Clearance rate of the hemodialysis system used;


3) effective renal clearance of topiramate in a patient on dialysis.


Plasma clearance of topiramate is reduced by an average of 26% in patients with moderate to severe hepatic impairment. Therefore, topiramate should be used with caution in patients with hepatic impairment.


In children under 12 years of age the pharmacokinetic parameters of topiramate, as well as in adults receiving the drug as adjuvant therapy, are linear, and its clearance is independent of the dose, and Css in plasma increases in proportion to increasing the dose. Note that in children, topiramate clearance is increased and its T1/2 is shorter. Therefore, at the same dose per 1 kg of body weight, plasma concentrations of topiramate in children may be lower than in adults. In children, as in adults, antiepileptic drugs that induce hepatic enzymes cause a decrease in plasma concentrations of topiramate.

Contraindications to use

  • Children under the age of 2 years;
  • Hypersensitivity to the drug components.

Caution should be exercised when using with renal or hepatic insufficiency, nephrourolithiasis (including past or family history), hypercalciuria.


Administration during pregnancy and lactation

Special controlled trials in which Topamax has been used for the treatment of pregnant women have not been carried out. The data of pregnancy reports indicate a possible relation between Topamax usage during pregnancy and congenital malformations (e.g. craniofacial malformations such as "cleft lip"/"cleft palate", hypospadias and abnormalities of different body systems). These malformations have been reported both with topiramate monotherapy and with its use as part of polytherapy. Compared to the group of patients not taking antiepileptic drugs, the data of pregnancy records for Topamax monotherapy indicate the probability of low birth weight (less than 2500 g). The association of the observed phenomena with the drug administration has not been established.


In addition, pregnancy records and the results of other studies suggest that the risk of teratogenic effects may be higher with combined treatment with antiepileptic drugs than with monotherapy. Topamax use in pregnancy is justified only when the potential benefit to the mother exceeds the possible risk to the fetus.


When treating and counseling women of childbearing potential, the attending physician should weigh the balance of benefits and risks of treatment and consider alternative treatment options. If Topamax is used during pregnancy, or if the patient becomes pregnant while taking this medication, she should be warned of the potential risk to the fetus.


A limited number of observations suggest that topiramate is excreted with breast milk in women. If Topamax® must be used during lactation, discontinuation of breastfeeding should be considered.


Administration in liver impairment

Caution should be exercised when there is hepatic insufficiency. Plasma clearance is decreased in patients with moderate to severe hepatic impairment.


Administration in patients with impaired renal function

If this medicine is administered in patients with moderate or severe renal dysfunction, it should be taken into account that it may take 10-15 days to reach equilibrium condition in these patients, in contrast to 4-8 days in patients with normal renal function. Since topiramate is removed from plasma during hemodialysis, an additional dose of the drug equal to half of the daily dose should be administered in two doses (before and after the procedure) during the days of hemodialysis.


Caution should be exercised when using in case of renal insufficiency, nephrourolithiasis (including past or family history), hypercalciuria.


Administration in children

The drug is contraindicated in children under 2 years of age.

Indications of Topamax

Epilepsy:


  • As monotherapy in adults and children over 2 years of age with epilepsy (including patients with newly diagnosed epilepsy);
  • as part of complex therapy in adults and children over 2 years of age with partial or generalized tonic-clonic seizures, and for treatment of seizures against Lennox-Gastaud syndrome.

Migraine:


  • Prevention of migraine attacks in adults (the use of Topamax® for the treatment of acute migraine attacks has not been studied).


Dosing regimen

The drug is taken orally, regardless of meals.


The capsules should be opened carefully, mix their contents with a small amount (about 1 teaspoon) of some soft food. This mixture should be swallowed immediately, without chewing. Do not keep the drug mixed with food until the next dose. Topamax® capsules may be swallowed whole.


To achieve optimal control of epileptic seizures in adults and children, it is recommended to start treatment with a low dose followed by titration to an effective dose.


The capsules are intended for patients who have difficulty swallowing tablets (e.g., in children and elderly patients).


Partial or generalized tonic-clonic seizures, as well as seizures on the background of Lennox-Gastaud syndrome


Combination anticonvulsant therapy in adults. Minimum effective dose is 200 mg/day. Usually the total daily dose is 200 mg to 400 mg and is taken in 2 doses. Some patients may need to increase the daily dose to a maximum of 1600 mg. It is recommended to start treatment with a low dose followed by gradual adjustment to an effective dose. The dose is started with 25-50 mg taken at night for 1 week. Thereafter, the dose may be increased by 25-50 mg at 1-2 week intervals and taken in 2 doses. When selecting a dose it is necessary to be guided by the clinical effect. In some patients, the effect can be achieved by taking the drug once a day. It is not necessary to monitor the plasma concentration of Topamax to achieve the optimal effect of treatment.


These dose recommendations are applicable to all adult patients, including elderly patients, in the absence of renal disease.


Combination anticonvulsant therapy in children over 2 years of age. Recommended total daily dose of Topamax® as an additional therapy is from 5 to 9 mg/kg and should be taken in 2 intakes. The dose should be started at 25 mg (or less, based on an initial dose of 1 to 3 mg/kg/day) at night for 1 week. Subsequently, the dose may be increased at 1- to 2-week intervals by 1 to 3 mg/kg and taken in 2 doses. Dose selection should be guided by clinical effect. Daily dose up to 30 mg/kg is usually well tolerated.


Epilepsy (including newly diagnosed)


When withdrawing concomitant anticonvulsants for topiramate monotherapy, the possible effect of this step on seizure frequency must be considered. When it is not necessary to abruptly withdraw concomitant anticonvulsants for safety reasons, it is recommended to reduce their doses gradually, reducing the dose of concomitant antiepileptic drugs by 1/3 every 2 weeks.


When drugs that are inducers of microsomal liver enzymes are withdrawn, blood concentrations of topiramate will increase. In such situations, if clinically indicated, the dose of Topamax can be reduced.


In monotherapy in adults, Topamax is given at a dose of 25 mg at bedtime for 1 week. Then the dose is increased at 1-2 week intervals by 25 mg or 50 mg in 2 doses. If a patient cannot tolerate this dose escalation regimen, the intervals between dose escalations may be increased or the dose may be raised more gently. Dose selection should be guided by clinical effect. The starting dose for monotherapy with topiramate in adults is 100 mg/day, and the maximum daily dose should not exceed 500 mg. Some patients with refractory forms of epilepsy tolerate topiramate monotherapy in doses up to 1000 mg/day. These dosing recommendations apply to all adults, including elderly patients without kidney disease.


In monotherapy in children over 2 years of age, Topamax is administered in a dose of 0.5-1 mg/kg body weight before bedtime in the first week of treatment. Then the dose is increased at 1-2 week intervals by 0.5-1 mg/kg/day in 2 doses. If the child cannot tolerate this mode of dose increase, the dose may be increased more gently or the intervals between dose increases may be increased. The size of the dose and the rate of dose increase depend on the clinical effect. The recommended dose range for monotherapy with topiramate in children over 2 years of age is 100-400 mg/day. Children with newly diagnosed partial seizures may be prescribed up to 500 mg/day.

Migraine


For prevention of migraine attacks, the recommended daily dose of topiramate is 100 mg in 2 doses. At the beginning of treatment, 25 mg is prescribed before bedtime for 1 week. Then the dose is increased by 25 mg/day at 1 week intervals. If such therapy regimen is intolerable, the dose is increased by a smaller amount or at longer intervals. The dose is adjusted depending on the clinical effect. In some cases, positive results are achieved with a daily dose of 50 mg of topiramate. In clinical trials, patients received different doses of topiramate, but not more than 200 mg/day.


Special patient groups


Patients with moderate to severe renal impairment may need a reduced dose. Half the recommended initial and maintenance dose is recommended.


Hemodialysis: since topiramate is removed from plasma during hemodialysis, an additional dose of Topamax should be given on the days of hemodialysis equal to approximately half the daily dose. The additional dose should be divided into two doses taken at the beginning and after the completion of hemodialysis. The additional dose may vary depending on the characteristics of the equipment used for hemodialysis.


Topiramate should be used with caution in patients with hepatic impairment.