Pregabalin-Richter - Instructions For Use, Price, Reviews, Capsules 75 Mg

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

Pregabalin-Richter

Pregabalin-Richter: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Pregabalin-Richter

ATX code: N03AX16

Active ingredient: pregabalin (pregabalin)

Producer: Gedeon Richter JSC (Hungary), Gedeon Richter-RUS CJSC (Russia)

Description and photo update: 2018-21-11

Prices in pharmacies: from 282 rubles.

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Pregabalin-Richter is an antiepileptic agent with analgesic and anticonvulsant action.

Release form and composition

Pregabalin-Richter is produced in the form of capsules - hard, gelatinous, Coni-Snap, the contents are almost white or white crystalline powder:

• 25 mg: size no. 4, body and cap are yellow;
• 50 mg: size No. 3, body - yellow, lid - light brown;
• 75 mg: size # 4, body and lid are pale brown;
• 100 mg: size No. 3, body - yellow, lid - brown;
• 150 mg: size 2, brown body and lid;
• 200 mg: size # 1, body - yellow, cap - dark brown;
• 300 mg: size no. 0, body and cap are dark brown.

Capsules are packaged in 14 pcs. in blisters, in a cardboard box - 1 or 4 blisters.

Composition for 1 capsule:

• active substance: pregabalin - 25, 50, 75, 100, 150, 200 or 300 mg;
• auxiliary components: corn starch, lactose monohydrate, talc; additionally for 25 and 50 mg - pregelatinized corn starch;
• capsule body: gelatin; 25, 50, 75, 100, 150 and 200 mg - titanium dioxide; 25, 50, 100 and 200 mg - dyes quinoline yellow and sunset yellow; 75, 150 and 300 mg - dyes of iron oxide red and iron oxide black; 75 and 150 mg - iron oxide yellow oxide;
• capsule cap: gelatin; 25, 50, 75, 100 and 150 mg - titanium dioxide; 25 mg - dyes quinoline yellow and sunset yellow; 50, 75, 100, 150, 200 and 300 mg - dyes of iron oxide red and iron oxide black; 50, 75, 100, 150 - iron oxide yellow dye.

Pharmacological properties

Pharmacodynamics

Pregabalin, the active substance Pregabalin-Richter, is an analogue of γ-aminobutyric acid [(S) -3- (aminomethyl) -5-methylhexanoic acid]. By binding to an additional subunit (α ₂ -delta protein) of voltage-gated calcium channels in the central nervous system (CNS), pregabalin irreversibly replaces [3H] -gabapentin. Presumably, such a relationship may contribute to the manifestation of the anticonvulsant and analgesic effect of the substance.

Pregabalin is effective in patients with postherpetic neuralgia and diabetic neuropathy. It was found that against the background of taking the substance 2 times a day for no more than 13 weeks and 3 times a day for no more than 8 weeks, the threat of the development of undesirable effects was identical. When using the drug for a course of up to 13 weeks, a decrease in pain syndrome was noted during the first week, and the effect persisted throughout the entire period of therapy.

A 50% decrease in pain index was recorded in 35% of patients taking pregabalin and 18% of those taking placebo. In the group of patients receiving pregabalin who did not experience sleepiness, a 50% decrease in pain index was noted in 33%, and in the group receiving placebo - in 18%. Drowsiness was reported in 48% of patients taking pregabalin and 16% of those taking placebo.

A significant reduction in pain was observed with the treatment of fibromyalgia with pregabalin at a daily dose of 300–600 mg. The efficacy of doses of 450 and 600 mg per day was similar, but the daily dose of 600 mg was generally worse tolerated. Also, against the background of the use of the substance, a decrease in the severity of sleep disorders and an improvement in the functional activity of patients were observed. Taking the drug in the treatment of fibromyalgia in a daily dose of 600 mg caused a more pronounced improvement in sleep, when compared with a daily dose of 300-450 mg.

Against the background of the treatment of epilepsy when pregabalin was taken 2 or 3 times a day for a course of 12 weeks, its efficacy and the threat of adverse reactions with these dosage regimens were identical. A decrease in the frequency of seizures was recorded already during the first week of using Pregabalin-Richter.

In the treatment of generalized anxiety disorder, a decrease in symptoms was noted in the first week of the course. After 8 weeks, a 50% improvement in symptoms on the Hamilton Anxiety Scale (HAM-A) was observed in 52% of patients taking pregabalin and 38% of those taking placebo.

Pharmacokinetics

The pharmacokinetic parameters of the active substance in an equilibrium state when taken by healthy volunteers, patients with epilepsy receiving antiepileptic therapy, and patients with chronic pain were similar.

Following oral administration on an empty stomach, pregabalin is rapidly absorbed. With a single, as well as repeated use, the maximum concentration of the substance (Cmax) in the blood plasma is reached after one hour. Oral bioavailability is at least 90% and does not depend on the dose. The steady-state concentration of pregabalin in the blood (Css) is observed after 24–48 hours. In the case of simultaneous intake with food, Cmax of the drug decreases by about 25-30%, while the time to reach this indicator increases to about 2.5 hours. When using Pregabalin-Richter with meals, no clinically significant change in the degree of absorption was found.

The apparent volume of distribution (Vd) of the drug after oral administration is approximately 0.56 l / kg. The active substance does not bind to blood plasma proteins and practically does not undergo metabolic transformation. After ingestion of unchanged labeled pregabalin, about 98% of the radioactive label was detected in the urine. No signs of racemization of the S-enantiomer of pregabalin into the R-enantiomer were noted.

The agent is excreted mainly in the urine unchanged, the half-life (T½) is 6.3 hours. Renal and plasma clearance of pregabalin is directly proportional to creatinine clearance (CC).

The pharmacokinetics of the drug when used in the range of recommended daily doses is linear, interindividual pharmacokinetic variability is low - less than 20%. With repeated use, the pharmacokinetic parameters of pregabalin can be predicted based on the corresponding single dose rates. As a result, there is no need for regular monitoring of the plasma concentration of the substance in the blood.

Indications for use

• generalized anxiety disorder;
• neuropathic pain;
• epilepsy (as an additional treatment in patients with partial convulsive seizures, including those accompanied by secondary generalization);
• fibromyalgia.

Contraindications

Absolute:

• age up to 17 years inclusive;
• rare hereditary pathologies of digestion, including glucose-galactose malabsorption, lactase deficiency, galactose intolerance;
• hypersensitivity to any of the constituents of the drug.

According to the instructions, Pregabalin-Richter should be used with caution in the presence of the following diseases / conditions: heart failure; impaired renal function; a history of drug dependence (such patients require close medical supervision during drug treatment).

Instructions for use Pregabalin-Richter: method and dosage

Pregabalin-Richter is taken orally, regardless of food intake, in a daily dose of 150–600 mg, divided into 2 or 3 doses.

Recommended dosage regimen:

• epilepsy, neuropathic pain: the initial dose is 150 mg per day, taking into account the therapeutic response and tolerability, 7 days after the start of the course (for the relief of neuropathic pain - 3-7 days), the daily dose may be increased to 300 mg, and after another 7 days, if necessary, up to a maximum allowable dose of 600 mg per day;
• generalized anxiety disorder, fibromyalgia: initial dose - 150 mg per day (with fibromyalgia - Pregabalin-Richter 75 mg 2 times a day), depending on the patient's individual response to therapy and drug tolerance, after 7 days (with fibromyalgia - 3-7 days), you can increase the daily dose to 300 mg, and in the absence of the desired effect - to 450 mg; if necessary, after another 7 days, a maximum daily dose of 600 mg can be prescribed.

If it is necessary to stop treatment with pregabalin, it is recommended to do so gradually over a period of at least 7 days.

If another dose of Pregabalin-Richter is missed, the next dose should be taken as soon as possible, but a double dose of pregabalin should not be used. In the future, the drug is recommended to be taken according to the usual scheme.

Side effects

• nervous system: very often - drowsiness, dizziness; often - imbalance / coordination, memory impairment, impaired attention, tremor, paresthesia, dysarthria, ataxia, lethargy, sedation, amnesia; infrequently - a burning sensation on the skin and mucous membranes, loss of taste, myoclonic seizures, speech impairment, nystagmus, hypesthesia, cognitive disorders, psychomotor agitation, dyskinesia, hyporeflexia, hyperesthesia, intentional tremor, postural dizziness, fainting, stupor; rarely - dysgraphia, parosmia, hypokinesia; with an unknown frequency - cognitive impairment, headache, seizures, loss of consciousness;
• mental disorders: often - irritability, insomnia, disorientation, confusion, euphoria, decreased libido; infrequently - anxiety, agitation, depressed mood, apathy, mood lability, difficulty in finding words, depression, unusual dreams, increased insomnia, hallucinations, depersonalization, panic attacks, increased libido, anorgasmia; rarely - high spirits, disinhibition;
• cardiovascular system: infrequently - skin hyperemia, hot flashes, cold extremities, increase / decrease in blood pressure (BP), atrioventricular block (AV block) of the 1st degree, tachycardia; rarely - sinus bradycardia, sinus arrhythmia, sinus tachycardia; with an unknown frequency - chronic heart failure (CHF), prolongation of the QT interval;
• digestive system: often - constipation, flatulence, dry mouth, bloating, vomiting; infrequently - increased salivation, hypesthesia of the oral mucosa, gastroesophageal reflux; rarely - dysphagia, ascites, pancreatitis; with an unknown frequency - diarrhea, nausea, swelling of the tongue;
• respiratory system, organs of the chest and mediastinum: infrequently - dryness of the nasal mucosa, cough, shortness of breath; rarely - a feeling of tightness in the throat, bleeding from the nose, nasal congestion, snoring, rhinitis; with an unknown frequency - pulmonary edema;
• reproductive system and mammary glands: often - erectile dysfunction; infrequently - sexual dysfunction, delayed ejaculation; rarely - discharge from the mammary glands, pain in the mammary glands, enlargement of the mammary glands in volume, amenorrhea, dysmenorrhea; with an unknown frequency - gynecomastia;
• organ of hearing and labyrinth: often - vertigo; infrequently - hyperacusis;
• organ of vision: often - diplopia, blurred vision; infrequently - increased lacrimation, puffiness of the eyes, dry / painful eyes, asthenopia, decreased visual acuity or narrowing; rarely - eye irritation, flickering sparks in front of the eyes, mydriasis, increased brightness of visual perception, loss of peripheral vision, impaired perception of visual depth, strabismus, oscillopsia (subjective sensation of vibration / movement of the objects in question); with an unknown frequency - keratitis, loss of vision;
• kidneys and urinary tract: infrequently - urinary incontinence, dysuria; rarely - renal failure, oliguria; with an unknown frequency - urinary retention;
• metabolism and nutritional disorders: often - increased appetite; infrequently - hypoglycemia, anorexia;
• musculoskeletal system: infrequently - back and / or limb pain, joint swelling, muscle spasms, muscle twitching / stiffness, arthralgia, myalgia; rarely - neck pain, spasm of the cervical muscles, rhabdomyolysis;
• immune system: with an unknown frequency - hypersensitivity, allergic reactions, angioedema;
• blood and lymphatic system: rarely - neutropenia;
• skin and subcutaneous fat: infrequently - papular rash, sweating; rarely - cold sweat, urticaria; with an unknown frequency - itching, facial edema, Stevens-Johnson syndrome;
• infections and invasions: infrequently - nasopharyngitis;
• laboratory indicators: infrequently - an increase in the activity of creatine phosphokinase (CPK), aspartate aminotransferase (AST), alanine aminotransferase (ALT), a decrease in the number of platelets; rarely - a decrease in the level of potassium, the number of leukocytes in the blood, an increase in the concentration of glucose and creatinine;
• others: often - a feeling of drunkenness, fatigue, gait disturbance, edema (including peripheral), weight gain; infrequently - thirst, chills, chest tightness, falls, pain, asthenia, pathological sensations, generalized edema; rarely - weight loss, hyperthermia.

The aforementioned adverse reactions can also be due to the underlying disease and / or concomitant treatment.

Overdose

Overdose symptoms most frequently observed during post-marketing use of pregabalin were anxiety, agitation, depression, drowsiness, confusion, and mood disorders. Against the background of an overdose (up to 15 mg), no unexpected undesirable effects were recorded.

In this condition, it is recommended to carry out gastric lavage, maintenance therapy and, if necessary, hemodialysis.

special instructions

Pregabalin-Richter, like other antiepileptic drugs, can aggravate the risk of suicidal thoughts and tendencies. Therefore, during the period of treatment, it is required to carefully monitor the condition of patients in order to timely identify the possible development / worsening of depression, the occurrence of suicidal thoughts or behavior.

Patients with diabetes mellitus due to an increase in body weight during therapy may require a change in the dosage of hypoglycemic drugs.

If signs of angioedema appear (edema of the upper respiratory tract or perioral edema, facial edema), the use of pregabalin should be stopped immediately.

Taking Pregabalin-Richter can cause drowsiness and dizziness, increasing the incidence of unintentional injury (falls) in elderly patients. With the post-marketing use of pregabalin, cases of confusion, impaired cognitive functions, and loss of consciousness have been reported. Therefore, patients need to be careful until they can assess the risk of adverse drug effects.

There are insufficient data on the possibility of discontinuation of concomitant antiepileptic drugs after seizure suppression with pregabalin and the feasibility of switching to pregabalin monotherapy. There have been recorded episodes of seizures, including status epilepticus and minor seizures during the period of taking pregabalin or immediately after completion of treatment.

There is also information about renal failure developing as a result of therapy with Pregabalin-Richter. Sometimes after discontinuation of the drug, kidney function was restored.

With the development of side effects in the form of visual impairments (including blurred vision) against the background of treatment, refusal to further use the drug can help relieve these symptoms.

After the cancellation of long-term / short-term administration of pregabalin, the following adverse reactions were noted: headache, anxiety, insomnia, depression, nausea, diarrhea, sweating, flu-like syndrome, convulsions. There is no information on the severity and frequency of withdrawal symptoms depending on the dose of Pregabalin-Richter and the duration of therapy.

In the process of post-marketing use of pregabalin, CHF was noted in some patients. This complication occurred mainly in elderly people with impaired cardiac function who were taking pregabalin for neuropathy. Therefore, in this category of patients, it is necessary to use the drug with extreme caution. After refusal to take Pregabalin-Richter, the manifestations of such violations may no longer be observed.

During the treatment of central neuropathic pain caused by spinal cord injury, an increase in the incidence of drowsiness was noted. This may be due to the additive effect due to the combination of pregabalin with other drugs (including antispastic drugs). When treating central neuropathic pain with a drug, this fact should be taken into account.

Cases of dependence development have been recorded when using pregabalin.

The appearance of encephalopathy was noted, in most cases in patients with concomitant diseases that contribute to its occurrence.

Influence on the ability to drive vehicles and complex mechanisms

Pregabalin-Richter can cause the development of drowsiness and dizziness, thereby negatively affecting the speed of the patient's psychomotor reactions and the ability to concentrate. Therefore, during the period of its administration, it is necessary to refrain from driving vehicles and managing any complex equipment until an individual response to therapy is established.

Application during pregnancy and lactation

There is insufficient data on the use of the drug during pregnancy. During animal studies, signs of reproductive toxicity of the drug were revealed. During pregnancy, Pregabalin-Richter is allowed to be used only if the expected benefit for the woman significantly exceeds the possible threat to the health of the fetus.

There is no data on the penetration of the active substance into breast milk in women, but it has been established that it is excreted in animal milk. As a result, during the period of therapy, breastfeeding is recommended to be abandoned.

Women of reproductive age need to use reliable methods of contraception while taking Pregabalin-Richter.

Pediatric use

The efficacy and safety of using pregabalin in patients under 17 years of age (inclusive) have not been established, and therefore, the use of Pregabalin-Richter is contraindicated in childhood and adolescence.

With impaired renal function

Since pregabalin is mainly excreted by the kidneys in the presence of functional impairments, the dosage of Pregabalin-Richter should be reduced. For patients in this risk group, the dose must be selected individually depending on the CC value, which is calculated using the following formula:

CC (ml / min) = (140 - age in years) × body weight in kg / 72 × serum creatinine (mg / dl). The resulting value for women must be multiplied by a factor of 0.85.

Recommended daily doses (initial and maximum) and frequency of administration per day, depending on the CC value (ml / min):

• more than 60 - initial daily dose - 150 mg, maximum - 600 mg, in 2-3 doses;
• from 30 to 60 - initial daily dose - Pregabalin-Richter 75 mg, maximum - 300 mg, in 2-3 doses;
• from 15 to 30 - initial daily dose - 25-50 mg, maximum - 150 mg, in 1-2 doses;
• less than 15 - the initial daily dose is 25 mg, the maximum is 75 mg, in 1 dose.

An additional single dose after each 4-hour hemodialysis session is: initial - 25 mg, maximum - 100 mg.

For violations of liver function

Due to the fact that pregabalin does not undergo significant metabolic transformation and is excreted mostly by the kidneys unchanged, functional disorders of the liver should not significantly affect its concentration in blood plasma. Patients with liver pathology do not need to adjust the Pregabalin-Richter dose.

Use in the elderly

Patients over 65 years of age may need to reduce the dose of Pregabalin-Richter due to deterioration in renal function.

Drug interactions

• drugs that suppress the central nervous system: the development of respiratory failure and coma is possible;
• lorazepam, ethanol: the effects of these drugs are enhanced;
• oxycodone: possible aggravation of the impairment of motor and cognitive functions caused by the drug;
• oxycodone, lorazepam, ethanol: there is no clinically significant effect on the respiratory system with repeated oral administration of pregabalin;
• opioid analgesics (agents that cause constipation): the threat of intestinal obstruction, paralytic ileus, constipation is aggravated;
• oral contraceptives containing ethinyl estradiol and / or norethisterone: their equilibrium pharmacokinetics are not affected by pregabalin;
• lorazepam, gabapentin, lamotrigine, oxycodone, ethanol, carbamazepine, phenytoin, valproic acid: no clinically significant pharmacokinetic interaction was found;
• topiramate, tiagabine, phenobarbital, oral hypoglycemic agents, insulin, diuretics: pregabalin clearance does not change significantly.

Analogs

The analogues of Pregabalin-Richter are: Pregabalin, Lyrica, Pregabalin Zentiva, Prabegin, Algerika, Pregabalin Canon, Pregabio, Prigabilon, Pregabalin-SZ, Replica.

Terms and conditions of storage

Store out of the reach of children, at a temperature not exceeding 30 ° C.

Shelf life: capsules 25, 50, 75, 150 and 300 mg - 3 years; capsules 100 and 200 mg - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Pregabalin-Richter

Reviews about Pregabalin-Richter are ambiguous. Many patients taking the drug describe it as an effective remedy for epilepsy, anxiety disorders, relieving neurological symptoms in polyneuropathy.

However, there are many reviews expressing the dissatisfaction of patients with the lack of effect during treatment, the development of a large number of side effects (drowsiness, headache, nausea, shortness of breath, decreased blood pressure, edema of the face and neck). Many patients attribute the high cost of capsules to the disadvantages.

Price for Pregabalin-Richter in pharmacies

The price for Pregabalin-Richter can be approximately:

• dosage 75 mg: 14 capsules per pack - 470 rubles, 56 capsules - 1600 rubles;
• dosage 150 mg: 56 capsules per package - 1900-2300 rubles;
• dosage of 300 mg: 56 capsules per package - 3600 rubles.

Pregabalin-Richter: prices in online pharmacies

Drug name Price Pharmacy

Pregabalin-Richter 150 mg capsules 14 pcs. 282 r Buy

Pregabalin-Richter 300 mg capsules 14 pcs. 795 RUB Buy

Pregabalin-Richter 150 mg capsules 56 pcs. 818 RUB Buy

Pregabalin-Richter 300 mg capsules 56 pcs. RUB 3154 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

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