Topamax - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Topamax

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 647 rub.

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Topamax is a drug with antiepileptic action.

Release form and composition

Dosage forms of Topamax release:

• capsules: hard gelatinous, white body, cap - colorless, transparent, with the inscription TOP; capsule size and dose marking (15/25/50 mg) - No. 2 / No. 1 / No. 0, "15 mg" / "25 mg" / "50 mg"; the capsules contain white or almost white granules (28 or 60 pcs. in polyethylene bottles, 1 bottle in a cardboard box);
• film-coated tablets: round, TOP marking on one side of the tablet; sheath color and dosage marking (25/100 mg) - white / yellow, "25" / "100" (7 or 10 pcs. in blisters, in a cardboard box 4 or 6 blisters).

Composition of 1 capsule:

• active substance: topiramate - 15, 25 or 50 mg;
• auxiliary components (15/25/50 mg): sugar crumbs (sucrose, starch syrup) - 45/75/150 mg; cellulose acetate - 5.423 / 9.038 / 18.076 mg; povidone - 10.4199 / 17.3665 / 34.733 mg;
• shell (15/25/50 mg): sorbitan laurate - 0.0252 / 0.0312 / 0.0397 mg; gelatin - 50.8–52.7 / 64.7–67 / 80.6–83.5 mg; titanium dioxide (E171) - 0.63 / 0.78 / 0.99 mg; sodium lauryl sulfate - 0.0252 / 0.0312 / 0.0397 mg; Opacode Black S-1-17822 / 23 black ink (solution of shellac glaze in ethanol, black iron oxide, n-butyl alcohol, isopropyl alcohol, propylene glycol, ammonium hydroxide) - 0.005–0.01 / 0.005–0.01 / 0.005– 0.01 mg; water - 9.3-11.2 / 10-12.3 / 12.5-15.4 mg.

Composition of 1 tablet:

• active substance: topiramate - 25 or 100 mg;
• auxiliary components: lactose monohydrate, pregelatinized starch, carnauba wax, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, Opadry (25/100 mg) white YS-1-7706-G / yellow YS-1-6370-G.

Indications for use

• epilepsy (children from 2 years of age and adults): monotherapy, including the treatment of newly diagnosed epilepsy; simultaneous treatment with other drugs of partial or generalized tonic-clonic seizures, as well as therapy of seizures against the background of Lennox-Gastaut syndrome;
• migraine (adults): as a prophylactic agent (use in acute attacks has not been studied).

Contraindications

Absolute:

• age up to 2 years;
• lactation period;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in which Topamax should be used with caution):

• renal / hepatic impairment;
• hypercalciuria;
• nephrourolithiasis (including past and family history indications);
• pregnancy (the safety profile for this group of patients has not been studied; since there is an increased likelihood of congenital malformations in the fetus, the appointment of Topamax is possible only in cases where the benefits exceed the possible risk if alternative treatment is impossible).

Method of administration and dosage

Topamax is taken orally, regardless of food intake.

To achieve optimal control of epileptic seizures, therapy should be started with low doses of Topamax, followed by gradual titration to the effective dose.

The capsules are recommended for patients who have difficulty swallowing tablets. Before taking the capsule, carefully open it and add the granules contained in it to any soft food (about 1 teaspoon). The resulting mixture must be swallowed immediately, without chewing (it cannot be stored). The capsules can also be swallowed whole.

Partial / generalized tonic-clonic seizures, as well as seizures associated with Lennox-Gastaut syndrome

The minimum effective adult dose when used concomitantly with other anticonvulsants is 200 mg per day. The average daily dose is 200-400 mg in 2 divided doses. In some cases, the dose may be increased to 1600 mg per day.

The selection of the dose begins with 25-50 mg per day, the dose is taken throughout the week. Then, with intervals of 7-14 days, the dose can be increased by 25-50 mg with a frequency of administration 2 times a day. When choosing a dose, one should be guided by the effectiveness of therapy. In some cases, the effect is achieved by taking Topamax 1 time per day. To achieve optimal efficacy, it is not necessary to control the plasma concentration of the drug.

When carrying out combined anticonvulsant therapy (as an additional agent) for children from 2 years of age, Topamax is usually prescribed in a daily dose of 5-9 mg / kg in 2 divided doses. Dose selection begins with 25 mg or less (based on 1–3 mg / kg per day) taken over 7 days. Then, with interruptions of 7-14 days, the dose is increased by 1-3 mg / kg, the frequency of administration is 2 times a day. When choosing a dose, one should be guided by the effectiveness of therapy. As a rule, the drug in a daily dose of up to 30 mg / kg is well tolerated.

Epilepsy, including newly diagnosed

Before prescribing monotherapy with Topamax, it is necessary to take into account the possible effect of the withdrawal of concomitant anticonvulsants on the frequency of seizures. If there is no need to abruptly cancel the concomitant anticonvulsant drug, it is recommended to reduce the dose gradually, every 14 days by 1/3.

With the abolition of drugs that are inducers of liver enzymes, the concentration of the active substance of Topamax in the blood will increase. In the presence of clinical indications in these situations, the dose of the drug can be reduced.

Adults at the beginning of monotherapy are usually prescribed for 7 days at 25 mg at bedtime. After that, with an interval of 7-14 days, the dose is increased by 25 or 50 mg and the patient is transferred to Topamax 2 times a day. With poor tolerance, the daily dose can be increased more slowly based on the clinical effect.

The adult initial daily dose for monotherapy is 100 mg, and the maximum is 500 mg. Some patients with refractory epilepsy are prescribed monotherapy at a dose of 1000 mg per day. These recommendations also apply to elderly patients without kidney disease.

For children from 2 years of age, in the first week of monotherapy, Topamax is prescribed 0.5–1 mg / kg at bedtime. The daily dose with an interval of 7-14 days is gradually increased by 0.5-1 mg / kg (should be divided into 2 doses). With poor tolerance, a slower dose increase is possible. The recommended dose range is 100 to 400 mg per day. Children with newly diagnosed partial seizures may be given 500 mg daily.

Migraine

In case of migraine, for prophylactic purposes, 100 mg of Topamax is usually prescribed in 2 doses. The initial dose for 7 days is 25 mg before bedtime, then with an interval of 7-14 days the dose is increased by 25 mg per day. With poor tolerance, the daily dose can be increased more slowly based on the clinical effect. In some cases, the clinical effect is achieved with 50 mg of Topamax per day. The efficacy and safety of taking more than 200 mg of the drug per day has not been studied.

In moderate / severe renal impairment, dose reduction may be necessary, it is recommended to take half the recommended initial and maintenance doses. On the days of hemodialysis, an additional dose of Topamax is required, equal to approximately 1/2 of the daily dose. It should be divided into 2 parts, which should be taken at the beginning and after the end of the hemodialysis procedure. The size of the additional dose may vary depending on the characteristics of the equipment used in the hemodialysis.

Side effects

Most often during therapy, the development of the following side effects is observed: depression, anorexia, decreased appetite, slow thinking, impaired free speech, insomnia, impaired concentration / coordination of movements, dizziness, drowsiness, paresthesia, tremor, blurred vision, lethargy, dysarthria, hypesthesia, dysgeusia, memory impairment, nystagmus, diplopia, nausea, diarrhea, fatigue, weight loss, irritability.

Other probable violations (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):

• central nervous system: very often - paresthesia, drowsiness, dizziness; often - cognitive disorders, impaired concentration / memory, amnesia, tremor, nystagmus, hypesthesia, dysgeusia, impaired thinking, psychomotor disorders, convulsions, impaired coordination of movements / sense of balance, lethargy, dysarthria, sedation, intentional tremor; infrequently - tonic-clonic seizures of the "grand mal" type, depressed consciousness, impaired visual field, complex partial seizures, psychomotor hyperactivity, speech impairment, fainting, sensory impairment, hypersomnia, salivation, aphasia, repetitive speech, hypokinesia, loss of sensitivity, dyskinesia, postural dizziness, poor sleep quality, burning sensation, parosmia, cerebral syndrome, dysesthesia, hypogeusia, dystonia, stupor, aura, ageusia, clumsiness, dysphasia,dysgraphia, peripheral neuropathy, light-headedness, disturbance of the circadian rhythm of sleep, feeling of creep; rarely - essential tremor, akinesia, apraxia, hyperesthesia, anosmia, lack of reactions to stimuli, hyposmia;
• immune system: often - hypersensitivity; with an unknown frequency - conjunctival edema, allergic edema;
• metabolism and nutrition: often - anorexia, decreased appetite; infrequently - polydipsia, metabolic acidosis, increased appetite, hypokalemia; rarely - hyperchloremic acidosis;
• invasions and infections: very often - nasopharyngitis;
• blood and lymphatic system: often - anemia; infrequently - thrombocytopenia, lymphadenopathy, leukopenia, eosinophilia; rarely, neutropenia;
• psyche: very often - depression; often - disorientation, insomnia, slow thinking, impaired free speech, anxiety, confusion, aggressive reactions, behavioral / mood disorders, emotional lability, agitation, anger, depressed mood; infrequently - suicidal thoughts, sleep disturbances, suicidal attempts, psychotic disorders, hallucinations, auditory hallucinations, visual hallucinations, pathological thinking, decreased libido, apathy, difficulty speaking, affective lability, loss of libido, lethargy, panic reactions, anxiety, restlessness, crying, euphoric mood, paranoia, perseveration of thinking, flattening of emotions, panic attacks, tearfulness, impaired reading / falling asleep skills, early awakening in the morning, intrasomical disorder, absent-mindedness, high spirits;rarely - hypomania, mania, a sense of hopelessness, panic disorder;
• digestive system: very often - nausea, diarrhea; often - constipation, vomiting, epigastric / abdominal pain, dyspepsia, dry mouth, abdominal / stomach discomfort, sensitivity disorders in the oral cavity, gastritis; infrequently - flatulence, pancreatitis, gastroesophageal reflux, bloating, pain in the lower abdomen, decreased sensitivity in the mouth, bleeding gums, sensitivity in the abdomen, epigastric discomfort, glossodynia, oral pain, bad breath, hypersalivation;
• organ of vision: often - diplopia, blurred / impaired vision; infrequently - decreased visual acuity, photophobia, increased lacrimation, mydriasis, photopsia, scotoma, myopia, dry eyes, strange sensations in the eyes, blepharospasm, presbyopia; rarely - one-sided blindness, transient blindness, glaucoma, impaired accommodation, impaired visual spatial perception, atrial scotoma, eyelid edema, night blindness, amblyopia; with an unknown frequency - angle-closure glaucoma, impaired eye mobility, maculopathy;
• hepatobiliary system: rarely - liver failure, hepatitis;
• musculoskeletal system: often - muscle weakness, arthralgia, myalgia, muscle spasms, muscle cramps, musculoskeletal pain in the chest; infrequently - muscle fatigue, joint swelling, side pain, muscle stiffness; rarely - discomfort in the limbs;
• organ of hearing and balance: often - vertigo, ringing / pain in the ears; infrequently - deafness, discomfort in the ear, sensorineural / one-sided deafness, hearing impairment;
• cardiovascular system: infrequently - sinus bradycardia, bradycardia, palpitations, orthostatic hypotension, hypotension, hot flushes, hot flashes; rarely - Raynaud's phenomenon;
• respiratory system: often - shortness of breath, nasal congestion, epistaxis, cough, rhinorrhea; infrequently - shortness of breath on exertion, dysphonia, hypersecretion in the paranasal sinuses;
• skin and subcutaneous tissue: often - rash, alopecia, itching; infrequently - anhidrosis, erythema, urticaria, generalized itching, allergic dermatitis, impaired sensitivity in the face area, macular rash, skin pigmentation disorders, facial swelling; infrequently - Stevens-Johnson syndrome, erythema polymorphism, changes in skin odor, paraorbital edema, localized urticaria; with an unknown frequency - toxic epidermal necrolysis;
• kidneys and urinary tract: often - pollakiuria, nephrolithiasis, dysuria; infrequently - pain in the kidney area, exacerbation of urolithiasis, hematuria, stress urinary incontinence, urinary incontinence, renal colic, frequent urge to urinate; rarely - renal tubular acidosis, exacerbation of urolithiasis;
• genitals and mammary gland: infrequently - sexual / erectile dysfunction;
• social functioning: infrequently - learning disabilities;
• laboratory indicators: very often - weight loss; often - weight gain; infrequently - an abnormal result of the tandem gait test, crystalluria, increased activity of liver enzymes in the blood serum, leukopenia; rarely - a decrease in the content of hydrocarbons in the blood;
• general disorders: very often - fatigue; often - irritability, fever, asthenia, feeling unwell, gait disturbances, anxiety; infrequently - thirst, hyperthermia, flu-like syndrome, feeling of intoxication, slowness, cold extremities; rarely - calcification, facial edema.

Disorders that are recorded in children 2 or more times more often than in adults: suicidal thoughts, increased / decreased appetite, feeling unwell, hypokalemia, hyperchloremic acidosis, behavioral disorders, apathy, aggressive reactions, falling asleep, impaired concentration / gait, lethargy, poor sleep quality, disturbed circadian rhythm of sleep, increased lacrimation, sinus bradycardia.

Adverse reactions that are observed only in children: impaired learning ability, eosinophilia, vomiting, vertigo, pyrexia, hyperthermia, psychomotor hyperactivity.

special instructions

To reduce the likelihood of an increase in the frequency of seizures, Topamax should be canceled gradually: adults - by 50-100 mg at weekly intervals in the treatment of epilepsy and by 25-50 mg when taken to prevent migraine; children - for 2-8 weeks. If a faster withdrawal of the drug is required, it is necessary to monitor the patient's condition.

With moderate / severe impairment of renal function, it may take 10-15 days to achieve stable plasma concentrations of Topamax, in patients with normal renal function - 4-8 days.

During therapy, there may be an increase in the incidence of mood disorders and depression, as well as the risk of suicidal thoughts / behavior (it is necessary to monitor the patient's condition).

During the period of use of Topamax in some patients, especially if there is a predisposition to nephrolithiasis, the risk of kidney stones and the appearance of related symptoms - renal colic, pain in the kidney / side, may increase. To reduce the likelihood of developing this disorder, an adequate increase in the volume of fluid consumed is shown. Risk factors include hypercalciuria, history of nephrolithiasis (including family history), concomitant drug therapy that contribute to nephrolithiasis.

In patients with renal insufficiency (with creatinine clearance <70 ml / min) and impaired hepatic function, the administration of the drug requires caution.

Topamax therapy can lead to the development of a syndrome including acute myopia with concomitant secondary angle-closure glaucoma. The main symptoms are eye pain and / or an acute decrease in visual acuity. When conducting an ophthalmological examination, myopia, flattening of the anterior chamber of the eye, hyperemia of the eyeball, increased intraocular pressure can be detected. Mydriasis may occur with fluid secretion, leading to anterior displacement of the iris and lens with the development of secondary angle-closure glaucoma. As a rule, symptoms appear 1 month after the start of therapy. When a syndrome appears, including myopia associated with angle-closure glaucoma, Topamax is canceled. Before prescribing the drug to patients with a history of eye diseases, it is necessary to correlate the expected benefit with the possible risk.

During the period of therapy, metabolic acidosis may develop, which is not associated with anion deficiency (for example, a decrease in the plasma concentration of hydrocarbons in the absence of respiratory alkalosis). As a rule, such cases are observed at the beginning of the drug intake, although this violation can manifest itself at any stage of the drug use. Certain diseases or therapies that predispose to the development of acidosis (for example, severe respiratory diseases, surgery, ketogenic diet, kidney disease, diarrhea, status epilepticus, therapy with certain drugs) may be additional factors that enhance the hydrocarbonate-reducing effect Topamax. In children, chronic metabolic acidosis can lead to stunted growth. In cases of the onset of symptoms of metabolic acidosis, it is recommended to control the serum concentration of hydrocarbons. With the development of a violation, a dose reduction or discontinuation of therapy is indicated.

With a loss of body weight during treatment with Topamax, it is necessary to consider the advisability of enhanced nutrition.

During the period of treatment, it is possible to develop such adverse reactions as visual impairment, dizziness, drowsiness, which can be dangerous for patients driving vehicles, especially during the period until the patient's reaction to the drug is studied.

Drug interactions

The combined use of Topamax with certain drugs / substances can lead to the following effects:

• carbamazepine, phenytoin: a decrease in the plasma concentration of Topamax (a dose adjustment may be required);
• digoxin: a decrease in its plasma concentration (it is necessary to monitor this indicator);
• drugs that depress the central nervous system: the interaction has not been studied, and therefore the combination is not recommended;
• St. John's wort: a decrease in the plasma concentration of Topamax in the blood, and, as a result, its effectiveness;
• oral contraceptives: an increase in the likelihood of a decrease in their effectiveness (changes in the timing and nature of menstrual bleeding should be reported to the doctor);
• valproic acid: increased likelihood of developing hyperammonemia with / without encephalopathy;
• lithium: a change in its concentration in the blood (it is required to control this indicator);
• metformin, pioglitazone, glibenclamide: monitoring of the patient's condition is necessary in order to assess the course of diabetes mellitus;
• drugs that predispose to nephrolithiasis: an increase in the likelihood of kidney stones (combinations are recommended to be avoided)
• amitriptyline, haloperidol, propranolol, diltiazem, flunarizine: potential for interaction.

Analogs

Topamax analogs are: Topsaver, Toreal, Maxitopyr, Epitop, Topiromax, Topalepsin, Topiramat, Topiramat-Teva, Torapimat

Terms and conditions of storage

Store in a place protected from moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life:

• capsules - 2 years;
• tablets - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Topamax: prices in online pharmacies

Drug name Price Pharmacy

Topamax 25 mg capsules 60 pcs. 647 r Buy

Topamax 50 mg capsule 60 pcs. 995 RUB Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!