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LYRICA . 150 mg. 56 capsules View full size

LYRICA . 150 mg. 56 capsules

Neuropathic pain
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
epilepsy
Lyrica is indicated as add-on therapy in adults with partial seizures with or bezvtorichna generalization.
GAD
Lyrica is indicated for the treatment of generalized anxiety disorder (GAD) in adults.

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59.00 €

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LYRICA . 150 mg. 56 capsules

 LYRICA caps. 150 mg, Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults

SUMMARY OF PRODUCT

LYRICA 150 mg hard capsules

 

QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each capsule contains 25 mg of Pregabalin (pregabalin). Lyrica capsules also contain lactose monohydrate.

 

PHARMACEUTICAL FORM

 

Hard kapsulaByala, marked "Pfizer" on the cap and "PGN 25" on the body with chernomastilo.

 

CLINICAL DATA

 

 Therapeutic indications

 

Neuropathic pain

 

Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.

 

Epilepsy

 

Lyrica is indicated as add-on therapy in adults with partial seizures with or bezvtorichna generalization.

 

GAD

 

Lyrica is indicated for the treatment of generalized anxiety disorder (GAD) in adults.

  

 Posology and method of administration

 

The dose range is 150 to 600 mg per day, divided into two or three priema.Lyrica can be taken with or without food.

  

Neuropathic pain

 

Pregabalin treatment can be started at a dose of 150 mg per day. Depending otindividualniya patient response and tolerability dosing may badeuvelichena to 300 mg per day after an interval of 3 to 7 days, if necessary maksimalnadoza to 600 mg per day after an additional 7-day interval.

 

Epilepsy

 

Pregabalin treatment can be started at a dose of 150 mg per day. Depending otindividualniya patient response and tolerability dosing may badeuvelichena to 300 mg per day after one week. The maximum dose of 600 mg per day can badedostignata after one additional week. GAD

 

The dose range is 150 to 600 mg per day, divided into two or three priema.Neobhodimostta treatment should be reassessed redovno.Lechenieto with pregabalin can start with a dose of 150 mg per day. Depending otindividualniya patient response and tolerability dosing may badeuvelichena to 300 mg per day after one week. After an additional week dozirovkatamozhe be increased to 450 mg per day. The maximum dose of 600 mg per day can badedostignata after one additional treatment sedmitsa.Prekratyavane pregabalinV accordance with current clinical practice, if treatment with pregabalin should badeprekrateno recommended this be done gradually over a minimum of 1 sedmitsanezavisimo of reading (see . 4.8). Use in patients with hepatic impairment

 

In patients with hepatic impairment is not required dosage (see tochka5.2).

 

Use in children and adolescents

 

Lyrica is not recommended for use in children under 12 years of age and adolescents (12 - 17godishna age) due to insufficient data on safety and efficacy (see tochka5.3). Application for the elderly (over 65 years) in patients with elderly may be necessary to reduce the dose of pregabalinporadi reduced renal function (see "Patients with impaired renal function").

  

 Contraindications

 

Hypersensitivity to the active substance or to any of the excipients.

  

 Special warnings and precautions for use

 

In accordance with current clinical practice, some patients with diabetes who naddavatna weight during treatment with pregabalin, it is necessary to adjust hypoglycaemic lechenie.Ot postmarketing experience, there have been reports of hypersensitivity reactions, angioedema vklyuchitelnosluchai. If you experience symptoms of angioedema such as swollen face, okoloustata or upper respiratory tract, pregabalin should be withdrawn nezabavno.Lechenieto with pregabalin was associated with dizziness and somnolence, which could dauvelichat occurrence of accidental injury (fall) in elderly. There ipost-marketing reports of loss of consciousness, confusion and mental uvrezhdane.Sledovatelno, patients should be advised to exercise caution dokatone be familiar with the potential effects of treatment.

 

In controlled studies, a higher proportion of patients treated with pregabalin for sasaobshtili blurred vision, compared with patients treated with placebo, which in most cases eotzvuchalo during prolonged application. In clinical trials, which were conducted ophthalmic examinations, reducing the frequency of zritelnataostrota and changes in the visual field is greater in patients treated with pregabalin than patients treated with placebo, the incidence of fundoskopskite change is greater in patients treated with placebo (see section 5.1). reported from postmarketing experience also report adverse reactions to the sight, most of which relate to transient blurred vision or other changes vzritelnata sharpness. Discontinuation of pregabalin may result in resolution or IMPROVMENT these visual simptomi.Saobshtavat Cases of renal failure, and discontinuation of pregabalin ubeditelnopokazva reversibility of this adverse reaktsiya.Sashtestvuvat insufficient data to stop concomitant antiepileptichnilekarstva after achieving seizure control with Pregabalin as add-on therapy assignments to pass the pregabalin monotherapy. Observed withdrawal symptoms in some patients after discontinuation of short-term treatment with pregabalin idalgosrochno. The following events have been mentioned: insomnia, headache, nausea, diarrhea, flu syndrome, nervousness, depression, pain, sweating, and dizziness. Patsientitetryabva be informed at the start of treatment.

 

There are no data on the incidence and severity of withdrawal symptoms depending otprodalzhitelnostta use and dosage of pregabalin in the treatment termination nadalgosrochno pregabalin.

 

There have been post-marketing reports of congestive heart failure in nyakoipatsienti receiving pregabalin. These occurred mainly in patients aged vstarcheska cardiovascular impairment during treatment of neuropathy spregabalin. Pregabalin should be used with caution in these пациенти.Преустанавяването of pregabalin may lead to resolution of reaktsiyata.Patsienti with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this treatment lekarstvo.Pri central neuropathic pain due to spinal cord injury is bilauvelichena incidence of adverse events in general, adverse events of CNS iosobeno sleepiness. This can be attributed to the additive effect due to sapatstvashtotolechenie (eg anti-spasticity agents) needed for this condition. This should be imapredvid when pregabalin is prescribed for this condition.

  

 Interaction with other medicinal products and other forms of interaction

 

Since pregabalin is predominantly excreted unchanged in the urine metabolized seprenebrezhimo least in humans (<2% of the dose was recovered in urine as nametaboliti), does not inhibit drug metabolism in vitro and is not associated with plazmenitebeltatsi, it is unlikely to cause or contribute to фармакокинетичнивзаимодействия.

 

Accordingly, in vivo studies are not clinically significant фармакокинетичнивзаимодействия between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, or ethanol oskikodon. Population farmakokinetichenanaliz indicated that oral antidiabetic agents, diuretics, insulin, phenobarbital, tiagabine and topiramate no clinically relevant effect on the clearance of pregabalin.Ednovremennoto administration of pregabalin oral contraceptives and sredstvanoretisteron and / or ethinyl estradiol pharmacokinetics statsionarnosastoyanie in any of these veshtestva.Pregabalin can enhance the effects of ethanol and lorazepam. In controlled klinichniprouchvaniya multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol produced no clinically important effects on respiration. In post-marketing experience respiratory failure and coma in patients taking pregabalin and other CNS depressant drug. Pregabalin is probably aditivnodeystvie on violations of cognitive and motor function caused otoksikodon.Ne have been no specific studies of pharmacodynamic interactions pridobrovoltsi elderly. Interaction studies have only been performed privazrastni.

 

 Pregnancy and lactation

 

There are no adequate data from the use of pregabalin in bremenni.Prouchvaniyata in animals have shown reproductive toxicity (see section 5.3) Potentsialniyatrisk in humans is unknown. Lyrica should not be used during pregnancy, unless it is not necessary (if the benefit to the mother clearly outweighs the potential risk to the fetus). Prizheni of childbearing age should be administered effectively kontratseptsiya.Ne known if pregabalin is excreted in human milk, however, it seustanovyava in the milk of rats. Therefore, during treatment with pregabalinne recommended breastfeeding.

 

 Effects on ability to drive and use machines

 

Lyrica may have minor or moderate influence on the ability to drive and use of machinery. Lyrica may cause dizziness and somnolence and therefore may povliyaesposobnostta to drive or operate machinery. Patients are advised not to drive, non-working complex machinery or engage in other potentially hazardous activities until serazbere whether treatment affects their ability to perform these activities. 

Pregabalin clinical program involved over 9000 patients izpolzvalipregabalin, over 5000 of whom participated in a double-blind placebo-kontroliraniprouchvaniya. The most frequently reported adverse events were dizziness and sanlivost.Nezhelanite reactions were generally mild to moderate in intensity. The withdrawal rate due to adverse events nalechenieto all controlled studies was 13% patients who achieved remission receiving pregabalin and 7% for patients receiving placebo. Most chestitenezhelani events leading to discontinuation in the groups treated with pregabalin are bilizamayanost and drowsiness.

 

In the table below are listed by class and frequency (very common (> 1/10), common (> 1/100, <1/10), uncommon (> 1/1000, <1/100) and rare (<1 / 1000)) all adverse reactions that occurred with an incidence greater than placebo in more than one patient. In vsyakogrupirane frequency undesirable effects are presented in order otnoshenieserioznostta.

 

These side effects could be related to underlying disease and / ilisapatstvashto treatment.

 

In the treatment of central neuropathic pain due to spinal cord injury is bilauvelichena incidence of adverse events in general, adverse events of CNS iosobeno sleepiness (see section 4.4).

 

Additional reactions reported from post-marketing experience are included as "Sneizvestna rate" in Italic below. Body System

 

Adverse reactions

 

Immune System

 

Not known

 

Hypersensitivity, angioedema, allergic reaction

 

Blood and lymphatic system

 

Rare

 

Neutropenia 

Metabolism and nutrition 

Common 

Uncommon 

Rare 

Increased appetite 

Anorexia 

Hypoglycemia 

Psychiatric Disorders 

Common 

Euphoric mood, confusion, irritability, decreased libido 

Uncommon

 

Hallucinations, panic attacks, anxiety, agitation, depression, depressed mood, changes vnastroenieto, depersonalization, increased insomnia, difficulty finding words, patologichnisanishta, increased libido, anorgasmia, apathy

 

Rare 

Intemperance, elation 

Nervous System 

Very common 

Dizziness, drowsiness

Common

Ataxia, incoordination, tremors, dysarthria, memory impairment, impaired attention, paraesthesia

 

Uncommon

 

Syncope, stupor, myoclonus, increased psychomotor activity ageusia, dyskinesia, orthostatic dizziness, intentsionen tremor, nystagmus, cognitive disorder, speech disorder, hyporeflexia, hypoesthesia, amnesia, hyperaesthesia, burning

 

Rare 

Hypokinesia, parosmia, dysgraphia 

Not known 

Loss of consciousness, mental impairment, headache 

Eye Disorders 

Common 

Blurred vision diplopiyaNechesti

Visual disturbance, eye swelling, visual field defect, decreased visual acuity, eye pain, asthenopia, dry eyes, increased lakrimatsiyaRedkiS unknown chestotaZaguba peripheral vision ostsilopsiya, narushenozritelno perception of depth, photopsia, vochite irritation, mydriasis, strabismus, increased brightness наобразитеКератитНарушения Ear and лабиринтаЧестиРедкиСветовъртежХиперакузисСърдечни нарушенияНечестиРедкиТахикардияАтриовентрикуларен block first degree, sinus tachycardia, sinus bradycardia, heart aritmiyaS unknown chestotaZastoyna nedostatachnostSadovi нарушенияНечестиРедкиЗачервяване, hot valniHipotoniya, hypertension, cold extremities Respiratory, thoracic and mediastinal disorders

 

Uncommon 

Rare 

Dyspnea, nasal dryness 

Epistaxis, throat tightness, nasopharyngitis, cough, nasal congestion, rhinitis, snoring 

Gastrointestinal Disorders 

Common 

Vomiting, dry mouth, constipation, flatulen 

Uncommon

Bloating, gastroesophageal reflux, increased salivation, hypoaesthesia ustnatakuhina

 

Rare

 

Ascites, pancreatitis, dysphagia, nausea 

Not known

Swollen tongue, diarrhea, nausea 

Skin and subcutaneous tissue disorders

 

NechestiRedki 

Papular rash, sweating 

Urticaria, cold sweat

Not known

Syndrome Stevens Johnson, Itching

Disorders of the musculoskeletal system and connective tissue 

Uncommon 

Muscle twitching, joint swelling, muscle cramps, myalgia, arthralgia, back pain, pain in extremity, muscle stiffness 

RedkiRabdomioliza, cervical spasm, neck pain 

Renal and urinary patishtNechesti

Rare 

Urinary incontinence, dysuria

Renal failure, oliguria

 

Not known

Urinary retention

Reproductive system and breast disorders

Commo 

Erectile Dysfunction

Uncommon

Delayed ejaculation, sexual dysfunction

 

Rare

 

Amenorrhea, breast discharge, breast pain, dysmenorrhea, breast hypertrophy 

General disorders and administration site conditions

Common

Abnormal gait, feeling of intoxication, fatigue, peripheral edema, edema

Uncommon

 

Fall, chest tightness, asthenia, thirst

Rare 

Anasarca, pyrexia, chills, increased pai 

Not known

Swelling of the face

Researc 

ChestiUvelichavane weight

Uncommon

Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, decreased platelet count

 

RedkiPovishenie blood sugar, decrease in potassium levels, decreased white blood cell count, increased blood creatinine, weight loss

 

Some patients have experienced withdrawal symptoms after stopping treatment with short idalgosrochno pregabalin. The following events have been mentioned: insomnia, headache, nausea, diarrhea, flu syndrome, nervousness, depression, pain, sweating, and dizziness. Patsientitetryabva be informed at the start of lechenieto.Lipsvat data on the incidence and severity of withdrawal symptoms depending otprodalzhitelnostta use and dosage of pregabalin termination of dalgosrochnolechenie with pregabalin.

 

 Overdose

 

In overdoses up to 15 g no unexpected adverse reaktsii.Nay frequently reported adverse reactions from post-marketing experience observed in the pregabalin overdose included somnolence, confusional state, agitation and bezpokoystvo.Lechenieto overdose of pregabalin has include general supportive measures ieventualno hemodialysis if necessary (see section 4.2 Table 1). Pharmacological SVOYSTVA5.1 Pharmacodynamic свойстваФармакотерапевтична group: antiepileptics, ATC code: N03AH16Aktivnoto substance Pregabalin is an analogue of gamma-aminobutyric acid ((S) -3 - (aminomethyl)-5-metilheksanoeva acid). Mechanism of deystviePregabalin is associated with an auxiliary subunit (α 2-δ protein) of voltage-zavisimitekaltsievi channels in the central nervous system, potently displacing [3 H]-gabapentin.Klinichen experience

 

Neuropathic pain

 

Efficacy has been shown in studies in diabetic neuropathy, post-herpetic neuralgia igrabnachnomozachna trauma. Effectiveness have not been studied in other models nevropatichnabolka.

 

Pregabalin has been studied in 10 controlled clinical trials up to 13 weeks with twice daily (BID) and up to eight weeks with three times daily (TID). Overall, the safety and effectiveness of dosing regimens BID and TID were shodni.V clinical studies up to 12 weeks for both peripheral and zatsentralna neuropathic pain, reduction in pain was seen by parvatasedmitsa and was maintained throughout the treatment period.

 

In controlled clinical studies in peripheral neuropathic pain 35% of patients treated with pregabalin and 18% of placebo patients had an improvement of 50% natochkoviya score for pain assessment. Among patients without takovapodobrenie drowsiness was observed in 33% of patients treated with pregabalin and 18% of placebo patsientitena. In patients with somnolence the responder rates were 48% in the spregabalin and 16% in the placebo group.

 

In a controlled clinical trial in central neuropathic pain, 22% of patients treated with pregabalin and 7% of placebo patients had an improvement of 50% tochkoviyarezultat assessment of pain. EpilepsiyaPregabalin was studied in three controlled trials lasting 12 sedmitsipri twice (BID) or three times (TID) daily. Overall, the safety iefektivnostta dosing regimens BID and TID were shodni.Namalenie in seizure frequency was observed until the end of the first week.

 

GAD

 

Pregabalin has been studied in six clinical trials lasting 4-6 weeks, a study of elderly patients for 8 weeks and ednodalgosrochno study of relapse prevention double-blind phase of the prevention retsidivas duration of 6 months.

 

Relief of symptoms of GAD as measured by the Hamilton scale for assessing natrevozhnostta (HAM-A), was observed by the end of the first sedmitsa.V controlled clinical trials (4-8 weeks duration) 52% of patients treated with pregabalin and 38 % of placebo patients had at least 50% improvement in obshtiyarezultat NAM-A from baseline to endpoint.

 

In controlled studies, a higher proportion of patients treated with pregabalin for sasaobshtili blurred vision than patients treated with placebo, which in most cases eotzvuchalo during prolonged application. There were oftalmologichniizsledvaniya (including research on visual acuity testing standard and extended field nazritelnoto fundoskopski review) in more than 3,600 patients in controlled clinical trials ramkitena. In these patients, visual acuity was reduced pri6, 5% of patients treated with pregabalin and 4.8% of patients treated with platsebo.Promeni visual field were detected in 12.4% of patients treated with pregabalin and 11.7% otlekuvanite placebo patients. Fundoskopski changes were observed in 1.7% otlekuvanite with pregabalin and 2.1% of placebo-treated patients.

 

 Pharmacokinetic properties

 

Steady-state pharmacokinetics of pregabalin are similar in healthy volunteers and patients with epilepsy receiving antiepileptic drugs, and patients with chronic pain.

 

Absorption:

 

Pregabalin is rapidly absorbed under fasting conditions, with peak plasma concentrations occurring within one hour after administration of a single dose as well namnogokratni doses. Oral bioavailability of pregabalin is expected to be ≥ 90% of the dose and enezavisima. After repeated administration, steady state is reached within 48 hours 24do. The rate of pregabalin absorption is decreased when given with food, resulting doponizhenie of C max by about 25-30% and a delay of t max to approximately 2.5 hours. Napregabalin food intake, however, no significant effect on the extent of absorption napregabalin.

 

Distribution:

 

Preclinical studies have shown that pregabalin crosses the blood-brain barrier mice, rats and monkeys. It has been shown that pregabalin crosses the placenta priplahove and is found in the milk of lactating rats. In humans napregabalin volume of distribution following oral administration is approximately 0,56 l / kg. Pregabalin is not bound splazmenite proteins.

 

Metabolism:

 

Pregabalin metabolism in humans is negligible. After administration of radiolabelled pregabalin dozaradioaktivno approximately 98% of the radioactivity vurinata was unchanged pregabalin. N-methylated derivative of pregabalin osnovniyatmetabolit of pregabalin found in urine, accounted for 0.9% of the dose. In predklinichniprouchvaniya no evidence of racemization of the S-enantiomer of pregabalin to negoviyaR-enantiomer.

 

Elimination

 

Pregabalin is eliminated from the systemic circulation primarily by renal excretion vnepromenen kind. The mean half-life of pregabalin is 6.3 hours. The plasma clearance of pregabalin ibabrechniyat are directly proportional to creatinine clearance (see section 5.2 Renal impairment).

 

In patients with reduced renal function or undergoing hemodialysis is necessary nadozata (see section 4.2, Table 1).

 

Linearity / non-linearity:

 

Pregabalin pharmacokinetics are linear within the dose range preporachitelniyadneven. The variability in the pharmacokinetics of pregabalin mezhduindividite is low (<20%). Multiple-dose pharmacokinetics can badepredskazana from single-dose data. Therefore, it is not necessary rutinnomonitorirane plasma concentrations of pregabalin.

 

Pharmacokinetics in special patient groups:

 

Sex

 

Clinical studies indicate that gender had no clinically significant effect varhuplazmenite concentrations of pregabalin.

 

Renal impairment

 

Pregabalin clearance is proportional to creatinine clearance. Besides tovapregabalin is effectively removed from plasma by hemodialysis (after 4 chasovohemodializno treatment plasma concentrations of pregabalin decreased by priblizitelno50%). Because renal elimination is the major route of elimination in patients snarushena renal function is necessary to reduce the dosage and after hemodialysis eneobhodim supplementation (see section 4.2 Table 1).

 

Hepatic Impairment

 

There have been no specific pharmacokinetic studies in patients with narushenachernodrobna function. Since pregabalin does not undergo significant metabolism and is ekskretirapredimno unchanged in the urine, impaired liver function should not dapromenya significant plasma concentrations of pregabalin. 

Elderly (over 65 years)

 

There is a tendency to reduce the clearance of pregabalin with increasing vazrastta.Tova reduction in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age. In patients with age obuslovenonarushenie renal function may require a reduction in dose of pregabalin (see section 4.2 Table 1).

 

 Preclinical safety data

 

In conventional safety pharmacology studies in animals pregabalin epokazal well tolerated at doses clinically relevant application. In studies zatoksichnost repeated dose studies in rats and monkeys were nablyudavaniefekti CNS, including hypoactivity, hyperactivity and ataxia. Sledprodalzhitelna exposure to pregabalin at exposures ≥ 5 times the midst of the human exposure at the maximum recommended clinical dose nablyudavapovishena incidence of retinal atrophy commonly observed in albino rats vnaprednala age.

 

Pregabalin was not teratogenic in mice, rats or rabbits. Fetal toxicity plahovei rabbits occurred at exposures sufficiently above people. Vprenatalni / postnatal toxicity studies, pregabalin has led to the emergence of toksichniefekti on offspring development in rats at exposures> 2 times the recommended otmaksimalnata exposure.

 

Pregabalin is not genotoxic based on results from a series of in vitro and in vivo prouchvaniya.Pri rats and mice were conducted biennial surveys zakartsinogennost pregabalin. In rats, no tumors were observed at exposures up to 24 times the average golemiot human exposure at the maximum recommended clinical dose of 600 mg / den.Pri mice an increased incidence of tumors at exposures similar middle exposure, but higher exposures was observed povishenachestota of haemangiosarcomas. Nongenotoxic mechanism pregabalinobrazuvane induced tumors in mice include changes in platelets and cell proliferation naendotelni. These platelet changes were observed in rats or prihora based on short-term and limited long-term data. Lipsvatdokazatelstva to suggest risk in humans. 

In young rats the types of toxicity do not differ qualitatively from those observed in rats Prizren. Young rats, however, are more sensitive. At therapeutic exposures Sabina established clinical manifestations of CNS hyperactivity and gnashing of teeth izvestnipromeni growth (transient suppression of weight gain). Effects on narazgonvane cycles were observed at exposures in excess of 5 times that of hora.Redutsiran response to a sudden acoustic stimulus was observed in young rats 1-2 sedmitsisled exposure> 2 times greater than human therapeutic exposure. Nine sedmitsisled exposure, this effect was not observed.

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LYRICA . 150 mg. 56 capsules

LYRICA . 150 mg. 56 capsules

Neuropathic pain
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
epilepsy
Lyrica is indicated as add-on therapy in adults with partial seizures with or bezvtorichna generalization.
GAD
Lyrica is indicated for the treatment of generalized anxiety disorder (GAD) in adults.

Write your review