LYRICA. 100 mg. 21 capsules

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LYRICA. 100 mg. 21 capsules
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neuropathic pain
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
epilepsy
Lyrica is indicated as adjunctive therapy in adults with partial seizures with or bezvtorichna generalization.
GAD.

LYRICA. 100 mg. 21 capsules

 
 
Indications
neuropathic pain
Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
epilepsy
Lyrica is indicated as adjunctive therapy in adults with partial seizures with or bezvtorichna generalization.
GAD
Lyrica is indicated for the treatment of generalized anxiety disorder (GAD ) in adults.
 
2 . Dosage 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, the dose can badeuvelichena to 300 mg per day, after an interval of 3 to 7 days , and if necessary to maksimalnadoza than 600 mg per day after additional 7-day interval .
epilepsy
Pregabalin treatment can be started at a dose of 150 mg per day . Depending otindividualniya patient response and tolerability, the dose can badeuvelichena to 300 mg per day after 1 week. The maximum dose of 600 mg per day can badedostignata after an 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 pregabalin may begin with a dose of 150 mg per day . Depending otindividualniya patient response and tolerability, the dose can badeuvelichena to 300 mg per day after 1 week. After an additional week dozirovkatamozhe be increased to 450 mg per day . The maximum dose of 600 mg per day can badedostignata after an additional sedmitsa.Prekratyavane treatment pregabalinV accordance with current clinical practice , if pregabalin should badeprekrateno recommended this should 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 adjustment (see tochka5.2 ) .
 Use in children and adolescents
Lyrica is not recommended for use in children under 12 years of age and older (12 - 17godishna age) due to insufficient data on safety and efficacy (see section 5.3 ) . Use in 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 " ) .
3 . Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4 . Special warnings and precautions for use
In accordance with current clinical practice, some patients with diabetes who naddavatna weight on pregabalin treatment may need 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 stopped nezabavno.Lechenieto Pregabalin has been 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 sasaobshtili blurred vision, compared with patients treated with placebo , which eotzvuchalo in most cases with continued dosing . In clinical studies where ophthalmologic testing was conducted , the rate of reduction of zritelnataostrota and visual field changes was greater in patients treated with pregabalin than patients treated with placebo , the incidence of fundoscopic changes was greater in patients treated with placebo (see section 5.1). from post-marketing experience are also reported side effects in terms of vision, 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 on the withdrawal of concomitant antiepileptichnilekarstva after achieving seizure control with pregabalin in the add , set to monotherapy on pregabalin. Observed withdrawal symptoms in some patients after discontinuation of short idalgosrochno treatment with pregabalin. The following events have been mentioned: insomnia , headache , nausea, diarrhea, flu syndrome, nervousness , depression , pain, sweating and dizziness. Patsientitetryabva be informed of this at the start of treatment.
There are no data on the incidence and severity of withdrawal symptoms depending otprodalzhitelnostta of use and dosage of pregabalin in termination nadalgosrochno treatment with pregabalin.
There have been post -marketing reports of congestive heart failure in nyakoipatsienti receiving pregabalin . These occurred primarily in patients vstarcheska age with cardiovascular damage during treatment of neuropathy spregabalin . Pregabalin should be used with caution in these ????????.????????????????? of pregabalin may resolve the 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 bilauvelichena frequency of adverse events in general , adverse events of CNS iosobeno sleepiness. This can be attributed to an additive effect due to sapatstvashtotolechenie (e.g., anti- spasticity agents ) needed for this state . This should be imapredvid when prescribing pregabalin in this condition.
 
5 . Interaction with other medicinal products and other forms of interaction
Since pregabalin is predominantly excreted unchanged in the urine seprenebrezhimo metabolism in humans (<2% of the dose was recovered in the urine in the form nametaboliti ) , does not inhibit drug metabolism in vitro and is not associated with plazmenitebeltatsi , it is unlikely to cause or contribute to the ?????????????????????????????? .
Accordingly, in in vivo studies no clinically significant pharmacokinetic interactions between pregabalin and phenytoin , carbamazepine, valproic acid , lamotrigine, gabapentin, lorazepam, or ethanol oskikodon . Farmakokinetichenanaliz population indicated that oral antidiabetics, diuretics , insulin, phenobarbital , tiagabine and topiramate had no clinically significant effect on pregabalin clearance . Co-administration of pregabalin and oral contraceptives norethisterone and / or ethinyl estradiol did not affect the steady-state pharmacokinetics of either of these substances. Pregabalin may potentiate the effects of ethanol and lorazepam . In controlled klinichniprouchvaniya multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration . In post - marketing experience respiratory failure and coma in patients taking pregabalin and other CNS depressant drug . Pregabalin appears to be aditivnodeystvie the impairment of cognitive and gross motor function caused otoksikodon . No specific pharmacodynamic interaction studies pridobrovoltsi elderly . Interaction studies have only been performed privazrastni .
6 . 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 the is not necessary (if the benefit to the mother clearly outweighs the potential risk to the fetus) . Prizheni childbearing age should be given effective kontratseptsiya.Ne known if pregabalin is excreted in human milk , however, it seustanovyava in the milk of rats . Therefore , during the treatment with pregabalin recommended lactation .
 
7 . 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 can povliyaesposobnostta to drive or operate machinery. Patients are advised not to drive, being down complex machinery or engage in other potentially hazardous activities until serazbere whether treatment affects their ability to perform these activities.
 
8 . Undesirable effects
Pregabalin clinical program involved over 9000 patients who izpolzvalipregabalin , over 5,000 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 incidence of discontinuation due to adverse reactions nalechenieto all controlled studies was 13% of patients who achieved remission receiving pregabalin and 7% for patients receiving placebo. Most chestitenezhelani events leading to discontinuation in the group treated with pregabalin 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 and in more than one patient . In vsyakogrupirane frequency undesirable effects are presented in order otnoshenieserioznostta .
These side effects could be associated with the underlying disease and / ilisapatstvashto treatment.
In the treatment of central neuropathic pain due to spinal cord injury bilauvelichena frequency 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 frequency" in Italic below. Body System
Undesirable effects
Immune system disorders
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: incontinence, elevated mood
Nervous System Disorders
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 , intention 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 , diplopia
Uncommon: visual impairment , eye swelling , visual field defect , decreased visual acuity , eye pain , asthenopia , dry eye , lacrimation increased
Rare Unknown: loss of peripheral vision , ostsilopsiya , narushenozritelno depth perception , photopsia, vochite irritation , mydriasis , strabismus , increased brightness of images Keratin Ear and labyrinth
cardiac disorders
Tachycardia , atrioventricular block first degree , sinus tachycardia, sinus bradycardia, sinus arrhythmia , congestive heart failure
vascular disorders
Flushing, hot valniHipotoniya , hypertension, cold extremities
Respiratory, thoracic and mediastinal disorders
Dyspnea, nasal dryness , epistaxis , throat tightness , nasopharyngitis, cough , nasal congestion , rhinitis , snoring
Gastrointestinal Disorders
Vomiting , dry mouth , constipation , flatulence
Bloating, gastroesophageal reflux , increased salivation, hypoaesthesia ustnatakuhina
Ascites, pancreatitis , dysphagia, nausea
Swollen tongue, diarrhea , nausea
Skin and subcutaneous tissue disorders
Papular rash , sweating
Urticaria, cold sweat
Unknown: 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 limb , muscle stiffness
Rare: Rhabdomyolysis , cervical spasm , neck pain
Renal and urinary disorders
 
Urinary incontinence , dysuria
Renal failure , oliguria , Urinary retention
Reproductive system and breast disorders
Common: 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 drunk , fatigue , peripheral edema, edema
Uncommon: Fall , chest tightness , asthenia , thirst
Rare: Anasarca , pyrexia , chills , increased pain
Unknown: Swelling of the face
research
Common: Weight increase
Uncommon : increased creatinine phosphokinase , increased alanine aminotransferase , aspartate aminotransferase increased , decreased platelet count
Rare: increases in blood sugar, decrease in blood potassium , reduction in the number of leukocytes , increased blood creatinine , weight loss
In some patients, symptoms of withdrawal after stopping short idalgosrochno pregabalin treatment . The following events have been mentioned: insomnia , headache , nausea, diarrhea, flu syndrome, nervousness , depression , pain, sweating and dizziness. Patsientitetryabva be informed of this at the start of lechenieto.Lipsvat data on the incidence and severity of withdrawal symptoms depending otprodalzhitelnostta of use and dosage of pregabalin in termination of dalgosrochnolechenie pregabalin .
 
 9. overdose
In overdoses up to 15 g no reported unexpected adverse reaktsii.Nay frequently reported adverse reactions from post- marketing experience observed of pregabalin overdose included somnolence , confusional state , agitation and bezpokoystvo.Lechenieto of pregabalin overdose should include general supportive measures ieventualno hemodialysis if necessary ( see section 4.2 Table 1). Pharmacological SVOYSTVA5.1 Pharmacodynamic ??????????????????????????? group: antiepileptics, ATC code: N03AH16Aktivnoto substance Pregabalin is an analogue of gamma-aminobutyric acid ((S) -3 - ( aminomethyl) -5- methylhexanoic acid). Mechanism deystviePregabalin binds to an auxiliary subunit (? 2 -? 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 of nevropatichnabolka .
Pregabalin has been studied in 10 controlled clinical trials up to 13 weeks with twice-daily dosing (BID) and up to 8 weeks with three times daily (TID) dosing . 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, a reduction in pain was seen by parvatasedmitsa and was maintained throughout the treatment period.
In controlled clinical trials in peripheral neuropathic pain 35% of patients treated with pregabalin and 18% of patients on placebo had a 50% improvement natochkoviya score for pain assessment . Among patients not experiencing somnolence takovapodobrenie 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 patients on placebo had a 50% improvement of tochkoviyarezultat assessment of pain. EpilepsiyaPregabalin has been studied in 3 controlled clinical studies of 12 sedmitsipri twice ( BID) or three times ( TID ) daily intake. Overall, the safety iefektivnostta dosing regimens BID and TID were shodni.Namalenie of seizure frequency was observed by the end of the first week .
GAD
Pregabalin has been studied in 6 controlled clinical trials lasting 4-6 weeks , a study in elderly patients with a duration of 8 weeks ednodalgosrochno study for prevention of recurrence of double-blind phase of prevention retsidivas duration of 6 months.
Relief of symptoms of GAD as measured by the Hamilton scale assessment 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 patients on placebo had at least a 50% improvement in obshtiyarezultat HAM-A from baseline to endpoint.
In controlled studies, a higher proportion of patients treated with pregabalin sasaobshtili blurred vision than did patients treated with placebo , which eotzvuchalo in most cases with continued dosing . Studies were oftalmologichniizsledvaniya (including testing of visual acuity testing nazritelnoto field testing and dilated funduscopic examination ) in more than 3600 patients WITHIN controlled clinical trials. 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. Funduscopic changes were observed in 1.7% otlekuvanite pregabalin and 2.1% of placebo-treated patients.
 
 
10 . PHARMACEUTICAL PARTICULARS
List of excipients
Capsule contents:
lactose monohydrate
cornstarch
talc
Capsule :
gelatin
Titanium dioxide (E171)
sodium lauryl sulfate
Silica colloidal anhydrous
purified water
 
 
 
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