$125.60
Manufacturer: Croatia
Antiepileptic drugs, other antiepileptic drugs. ATX code N03A X16.
neuropathic pain.
Algerica is indicated for the treatment of neuropathic pain of peripheral or central origin in adults.
Epilepsy.
Algerica is indicated as adjunctive treatment for partial seizures with or without secondary generalization.
Generalized anxiety disorder.
Algerica is indicated for the treatment of generalized anxiety disorder in adults.
Fibromyalgia.
Description
Algerika (pregabalin) capsules Composition
active ingredient: pregabalin;
1 capsule contains pregabalin 150 mg;
excipients: mannitol (E 421), corn starch, talc, titanium dioxide (E 171), red iron oxide (E172) (75 mg capsules), yellow iron oxide (E172) (75 mg capsules), gelatin.
Pharmacotherapeutic group
Antiepileptic drugs, other antiepileptic drugs. ATX code N03A X16.
Pharmacodynamics
The active substance of Algerika (pregabalin) capsules is pregabalin, which is an analogue of gamma-aminobutyric acid ((S) -3- (aminomethyl) -5-methylhexanoic acid).
Mechanism of action.
Pregabalin binds to an additional subunit (a2-d-protein) of voltage-gated calcium channels in the central nervous system.
Clinical efficacy and safety.
neuropathic pain.
Pregabalin has been shown to be effective in the treatment of diabetic neuropathy, postherpetic neuralgia, and spinal cord injury. The effectiveness of the drug in other types of neuropathic pain did not pass.
Pregabalin has been studied in 10 controlled clinical trials lasting up to 13 weeks with a twice daily dosing regimen and in studies up to 8 weeks with a thrice daily dosing regimen. In general, the safety and efficacy profiles for the twice and thrice daily dosing regimens were similar.
In clinical studies up to 12 weeks in which the drug was used to treat neuropathic pain, a reduction in pain of peripheral and central origin was observed after the first week and was maintained throughout the treatment period.
In controlled clinical trials of peripheral neuropathic pain, 35% of patients treated with pregabalin and 18% of patients treated with placebo experienced a 50% improvement in pain scores. Among patients who did not experience drowsiness, such an improvement was observed in 33% of patients treated with pregabalin, and in 18% of patients in the placebo group. Among patients who experienced drowsiness, the proportion of patients who responded to therapy was 48% in the pregabalin group and 16% in the placebo group.
In a controlled clinical study of neuropathic pain of central origin, 22% of patients treated with pregabalin and 7% of patients treated with placebo experienced a 50% improvement in pain score.
Epilepsy.
Additional treatment. Pregabalin was studied in 3 controlled clinical trials lasting 12 weeks with a dosing regimen twice or thrice a day. In general, the safety and efficacy profiles for the twice and thrice daily dosing regimens were similar.
A decrease in the frequency of seizures was observed already in the first week.
Children.The efficacy and safety of pregabalin as an adjuvant for epilepsy in children under 12 years of age and in adolescents has not been established. Adverse reactions observed in a pharmacokinetic and tolerability study that included patients aged 3 months to 16 years (n = 65) with partial seizures were similar to adverse reactions in adults. Results of a 12-week placebo-controlled study in 295 children aged 4 to 16 years to evaluate the efficacy and safety of pregabalin as adjunctive therapy for partial seizures and a 1-year open-label safety study in 54 children aged from 3 months to 16 years with epilepsy indicate that such adverse reactions,
In a 12-week placebo-controlled study, children were given pregabalin 2.5 mg/kg/day (maximum 150 mg/day), pregabalin 10 mg/kg/day (maximum 600 mg/day), or placebo. At least a 50% reduction in partial seizures from baseline was observed in 40.6% of patients treated with pregabalin 10 mg/kg daily (p = 0.0068 vs. placebo), 29.1 % of patients receiving pregabalin at a dose of 2.5 mg/kg/day (p = 0.2600 compared with placebo) and 22.6% of those receiving placebo.
Monotherapy (in patients with newly diagnosed disease). Pregabalin was studied in 1 controlled clinical trial lasting 56 weeks with a dosing regimen twice a day. Pregabalin was not at least as effective as lamotrigine as assessed at 6 months for the seizure-free endpoint. Pregabalin and lamotrigine were equally safe and well tolerated.
Generalized anxiety disorder.
Pregabalin was studied in 6 controlled trials lasting 4-6 weeks, one 8-week elderly study, and one long-term relapse prevention study with a double-blind relapse prevention phase lasting 6 months.
Improvement in symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) was observed as early as week 1.
In controlled clinical trials (lasting 4-8 weeks), 52% of patients treated with pregabalin and 38% of patients in the placebo group experienced an improvement of at least 50% in total HAM-A scores from baseline to end point. points.
In controlled trials, blurred vision was more common in patients treated with pregabalin than in patients treated with placebo. In most cases, this phenomenon disappeared with continued therapy. Ophthalmic examination (including visual acuity testing, formal visual field testing, and dilated pupil fundus examination) was performed in over 3,600 patients in controlled clinical trials. Among these patients, visual acuity worsened in 6.5% of patients in the pregabalin group and in 4.8% of patients in the placebo group. Visual field changes were observed in 12.4% of patients treated with pregabalin and in 11.7% of patients in the placebo group. Fundus changes were found in 1.7% of patients treated with pregabalin and 2.1% of patients in the placebo group.
Fibromyalgia.
The efficacy of pregabalin has been established in one 14-week, double-blind, placebo-controlled, multicentre study (F1) and in one 6-week randomized withdrawal study (F2). These studies enrolled patients diagnosed with fibromyalgia based on the American College of Rheumatology criteria (history of widespread pain for 3 months and pain present at 11 or more of 18 specific tender points). Studies have demonstrated a reduction in pain on a visual analog scale. Improvement was further demonstrated in the overall patient score and in the fibromyalgia impact questionnaire.
Children. A 15-week placebo-controlled study was conducted in 107 children aged 12-17 years with fibromyalgia who used pregabalin at a dose of 75-450 mg per day. Based on the primary efficacy endpoint (change in overall pain intensity from baseline to week 15; calculated using an 11-point rating scale), there was a numerically greater improvement in the condition of patients treated with pregabalin compared with patients treated with placebo, but this improvement did not reach statistical significance. The most common adverse reactions observed in clinical studies were dizziness, nausea, headache, weight gain and fatigue. The overall safety profile in adolescents was similar to that in adults with fibromyalgia.
Indications
neuropathic pain.
Algerika (pregabalin) capsules are indicated for the treatment of neuropathic pain of peripheral or central origin in adults.
Epilepsy.
Algerika (pregabalin) capsules are indicated as adjunctive treatment for partial seizures with or without secondary generalization.
Generalized anxiety disorder.
Algerika (pregabalin) capsules are indicated for the treatment of generalized anxiety disorder in adults.
Fibromyalgia.
Contraindications
Hypersensitivity to the active substance or any of the excipients.
Dosage and administration
Algerika (pregabalin) capsules are prescribed in a dose of 150 to 600 mg per day, divided into 2 or 3 doses. Pregabalin can be taken with or without food. The drug is intended exclusively for oral use.
neuropathic pain
The starting dose of pregabalin is 150 mg per day. Depending on the individual response of the patient and the tolerability of the drug, the dose may be increased after 3-7 days to 300 mg per day and, if necessary, increased to a maximum dose of 600 mg per day after 7 days.
fibromyalgia
Usually the dose for most patients is 300-450 mg per day, divided into 2 doses. For some patients, a dose of 600 mg per day may be required. The drug should be started at a dose of 75 mg 2 times a day (150 mg / day), which can be increased depending on the effectiveness and tolerability, up to 150 mg 2 times a day (300 mg / day) for one week. For patients for whom doses of 300 mg / day are not effective enough, the dose can be increased to 225 mg 2 times a day (450 mg / day). If necessary, the dose can be increased after a week to a maximum of 600 mg / day.
Epilepsy
The starting dose of pregabalin is 150 mg per day. Depending on the individual response of the patient and the tolerability of the drug, the dose can be increased to 300 mg per day after 1 week. After a week, the dose can be increased to a maximum of 600 mg per day.
Generalized Anxiety Disorders
The daily dose varies from 150 to 600 mg, divided into 2 or 3 doses. The need for pregabalin treatment should be reviewed regularly.
Treatment with pregabalin can be initiated at a dose of 150 mg daily. Depending on the individual response and tolerability of the drug, the dose can be increased to 300 mg per day after the first week of treatment. During the next week of treatment, the dose may be increased to 450 mg per day. After a week, the dose can be increased to a maximum of 600 mg per day.
Cancellation of pregabalin
According to current clinical practice, if pregabalin should be discontinued, it is recommended to gradually stop taking the drug for at least 1 week, regardless of the indication.
Patients with impaired renal function
Pregabalin is eliminated from the systemic circulation unchanged, predominantly by the kidneys. Since pregabalin clearance is directly proportional to creatinine clearance, dose reduction for patients with impaired renal function should be carried out individually, according to the creatinine clearance rate (CLcr), as indicated in the table below and determined by the formula.
Pregabalin is effectively removed from plasma by hemodialysis (50% of the drug over 4 hours). For patients undergoing hemodialysis, the daily dose of pregabalin should be adjusted according to renal function. In addition to the daily dose, immediately after each 4-hour dialysis session, an additional dose of the drug should be used (see Table).
| Creatinine clearance (CLcr) (ml/min) | Total dose of pregabalin per day * | Dosing schedule | |
| Initial dose (mg per day) | Maximum dose (mg per day) | ||
| ≥60 | 150 | 600 | 2 or 3 times a day |
| ≥30 − <60 | 75 | 300 | 2 or 3 times a day |
| ≥15 – <30 | 25-50 | 150 | 1 or 2 times a day |
| <15 | 25 | 75 | 1 time per day |
| Additional dose after hemodialysis (mg) | |||
| 25 | 100 | Single dose + | |
* The total daily dose (mg/day) should be divided by the number of doses to get the number of milligrams per dose.
+ An additional dose is a one-time additional dose.
Patients with impaired liver function
There is no need for dose adjustment for patients with impaired liver function.
Use in elderly patients (over 65 years of age)
For elderly patients, it may be necessary to reduce the dose of Algerika (pregabalin) capsules due to decreased renal function.
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