Topamax (Topiramate) is medication effective in epilepsy seizures treatment and prevention. This drug can be applied as monotherapy and combined with other anti-epileptic drugs.
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Table of Contents
- Indications
- Dosage and Instruction for Use
- Overdose
- Contraindications
- Side Effects
- Drug Interactions
- Special Recommendations
- Storage
Product Info
Indications
Epilepsy
As a monotherapy: initial therapy in patients older than 2 years with partial or primary genitalized tonic-clonic seizures.
As part of complex therapy: in adults and children older than 2 years with partial or generalized tonic-clonic seizures, as well as for the treatment of seizures on the background of Lennox-Gastaut syndrome.
Migraine
Prevention of migraine attacks in adults. The use of Topamax for the treatment of acute migraine attacks has not been studied.
Dosage and Instruction for Use
monotherapy for adults, including elderly patients with normal kidney function, at the beginning of treatment: the dose – 25 mg 1 time/day before going to bed. The course duration is 1 week. Then the dose is increased in the interval between 1-2 weeks by 25-50 mg/day divided in 2 doses. If the treatment regimen is intolerant, the dose is increased by a smaller amount or at longer intervals. The initial dose is 100 mg/day, the maximum daily dose is 500 mg. In some cases, in the refractory form of epilepsy, patients tolerate monotherapy with Topamax at doses up to 1 g/day.
monotherapy for children over 2 years in the first week of treatment: the dose of 0.5-1 mg/kg of body weight before going to bed. Then the dose is increased in the intervals between 1-2 weeks by 0.5-1 mg/kg/day divided into 2 doses. If this pattern is ineffective, the dose can be increased by a smaller amount or at longer intervals. The magnitude of the dose and the rate of its increase are determined by the clinical effectiveness of the therapy. The recommended range of doses for monotherapy with topiramate in children over 2 years is 3-6 mg/kg/day. With newly diagnosed partial seizures, the dose may be up to 500 mg/day.
combination therapy with other anticonvulsants in adults, including elderly patients with normal renal function: the minimum dose is 200 mg/day. The recommended daily dose is 200-400 mg. The frequency of reception is 2 times/day. Selection of the dose begins with 25-50 mg 1 time/day before going to bed, the drug is taken within 1 week. Next, you should increase the dose by 25-50 mg in the interval between 1 or 2 weeks before selecting the effective dose. The reception frequency is 2 times/day.
combination therapy with other anticonvulsants in children older than 2 years: the recommended daily dose is 5 to 9 mg/kg. The reception frequency is 2 times/day. The adjustment of the dose begins from 25 mg/day during a week before going to bed.
With the withdrawal of concomitant anticonvulsants for the purpose of monotherapy with topiramate, it is necessary to take into account the possible influence of this step on the frequency of seizures. In those cases where there is no need to abruptly cancel the concomitant anticonvulsant for safety reasons, it is recommended that their doses be gradually reduced, reducing the dose of the concomitant antiepileptic drug by one third every 2 weeks.
Overdose
Symptoms: convulsions, insomnia, speech and vision dysfunctions, diplopia, memory disorders, movement coordination disorders, lethargy, arterial hypotension, abdominal pain, dizziness, agitation and depression. In most cases, the side effects manifestations were not severe, but there were deaths after an overdose using a mixture of several medicines.
Treatment: with an acute overdose it is mandatory to immediately lavage the stomach or induce vomiting. If necessary, symptomatic therapy should be carried out. An effective way to remove topiramate from the body is hemodialysis. Patients are advised to adequately increase the amount of fluid consumed.
Contraindications
- children under 2 years old;
- hypersensitivity to the components of the drug.
With caution it should be used in case of renal or hepatic insufficiency, nephrourolythiasis (including in the past or in a family history), with hypercalciuria.
Side Effects
- central nervous system and peripheral nervous system: very often – drowsiness, dizziness, paresthesia, in children – apathy, attention impairment; discoordination, nystagmus, lethargy, memory impairment, impaired concentration, tremor, amnesia, abnormal gait, hypesis, impaired thinking, speech disorder, dysarthria, cognitive disorders, mental impairment, psychomotor disorders, sedation; sometimes loss of taste sensitivity, akinesia, loss of smell, aphasia, burning sensation, cerebellar syndrome, complex partial seizures, convulsions, postural dizziness, increased salivation, dysesthesia, dysgraphia, dyskinesia, dysphasia , a sensation of “goosebumps” in the body, tonic-clonic seizures of the type grand mal, hyperesthesia, hypogeousia, hypokinesia, hyposmia, peripheral neuropathy, parosmia, pre-stupor states, syncope, lack of response to stimuli in children – psychomotor hyperactivity.
- mental disorders: often – delayed thinking, confusion, depression, insomnia, aggressive reactions, agitation, disorientation, emotional lability, erectile dysfunction, in children – behavioral change; sometimes anorgasmia, sexual dysfunction, crying, disturbance of sexual arousal, dysphhemia, early waking up in the morning, euphoric mood, auditory and visual hallucinations, hypomanic conditions, decreased libido, mania, panic, paranoid states, perseveration of thinking, violation of reading skills, restlessness , sleep disorders, suicidal ideation or attempts, tearfulness; very rarely – a feeling of despair.
- digestive system: very often – a decrease in appetite, anorexia; often – nausea, diarrhea; sometimes – abdominal pain, constipation, dry mouth, impaired sensation in the mouth, increased appetite, gastritis, gastroesophageal reflux, bad breath, flatulence, pain in the oral cavety, thirst, dyspeptic symptoms (discomfort in stomach, discomfort in the epigastric region, heaviness in the stomach), in children – vomiting.
- musculoskeletal system: often – myalgia, muscle spasms, muscular pains in the thorax, arthralgia; sometimes – back pain, stiffness of the muscles; very rarely – swelling of the joints, discomfort in the extremities.
- cardiovascular system: sometimes – bradycardia, rapid heartbeat, flushes of blood, orthostatic hypotension, the phenomenon of Raynaud.
- organ of vision: often – diplopia, visual impairment, dry eyes; sometimes – a violation of accommodation, amblyopia, blepharospasm, transient blindness, unilateral blindness, increased lacrimation, mydriasis, night blindness, photopsy, presbyopia, scotoma (including ciliary), decreased visual acuity; very rarely – glaucoma, involuntary movements of the eyeballs, eyelid edema, myopia, conjunctival edema, maculopathy.
- organ of hearing: often – pain in the ears, ringing in the ears, children – vertigo; sometimes – deafness, discomfort in the ears, hearing impairment.
- respiratory system: often – shortness of breath, nosebleeding; sometimes – hoarseness, dyspnea with exercise, nasal congestion, hypersecretion in the paranasal sinuses, in children – rhinorrhea; very rarely – nasopharyngitis.
- dermatological reactions: often – rash, alopecia, itching, a decrease in the sensitivity of the face; Sometimes – no sweating, allergic dermatitis, redness of the skin, skin pigmentation disorder, facial edema, unpleasant skin odor, urticaria; very rarely – erythema multiforme, paraorbital edema, Stevens-Johnson syndrome, toxic epidermal necrolysis.
- urinary system: often – nephrolithiasis, dysuria, pollakiuria; sometimes – exacerbation of urolithiasis, hematuria, urinary incontinence, frequent urge to urinate, renal colic, pain in the kidney area; very rarely – renal tubular acidosis.
- hemopoietic system: often – anemia; sometimes – leukopenia, lymphadenopathy, thrombocytopenia, in children – eosinophilia; very rarely – neutropenia.
- other: very often – fatigue, irritability, weight loss; often – asthenia, anxiety, in children – fever; infrequently – edema of the face, allergic reactions, hyperchloremic acidosis, polydipsia, cold extremities, fatigue, weakness, calcification; very rarely – generalized edema, flu-like diseases, allergic edema, weight gain.
Drug Interactions
- The use of Topamax decreases the effectiveness of oral estrogen-containing contraceptives.
- Reduces the digoxin AUC by 12%.
- It is not recommended simultaneous with ethanol or other drugs that depress the central nervous system.
- At simultaneous admission with carbamazepine AUC carbamazepine remains unchanged or slightly changes (less than 10%), whereas the AUP of Topamax is reduced by 40%.
- When co-administered, the AUC of phenytoin remains unchanged or increases by 25%, while the Topamax AUC is reduced by 48%; it may be necessary to correct the dosage regimen of the latter.
- With the simultaneous application of Topamax with valproic acid, valproic acid AUC is reduced by 11%, Topamax by 14%.
- Inhibitors of carbonic anhydrase (acetazolamide) increase the risk of formation of renal calculi.
Special Recommendations
Special controlled trials in which Topamax was used to treat pregnant women have not been conducted. Pregnancy records indicate a possible association between its use during pregnancy and congenital malformations. These developmental anomalies were documented both with monotherapy with this epilepsy drug and with its use in a combined therapy. In addition, pregnancy records and other studies indicate that the risk of developing teratogenic effects in combination therapy with antiepileptic drugs may be higher than with monotherapy. Its use in pregnancy is justified only if the potential benefit of therapy for the mother exceeds the possible risk to the fetus.
Storage
Store in a dry place inaccessible to children at a temperature not exceeding + 25 °С. The shelf life is 2 years.