Clinical and pharmacological group: & nbsp

Antiepileptic agents

Included in the formulation
  • Algerika
    capsules inwards 
  • Lyrics®
    capsules inwards 
    Pfizer Inc.     USA
  • Prabegin®
    capsules inwards 
  • Pregabalin
    capsules inwards 
    GEROPHARM, LLC     Russia
  • Pregabalin
    capsules inwards 
  • Pregabalin Zentiva
    capsules inwards 
    Zentiva c.s.     Czech Republic
  • Pregabalin Canon
    capsules inwards 
  • Pregabalin-native
    capsules inwards 
    NATIVA, LLC     Russia
  • Pregabalin-Richter
    capsules inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Pregabalin-SZ
    capsules inwards 
    NORTH STAR, CJSC     Russia
  • Prigabilon
    capsules inwards 
  • Replica
    capsules inwards 
    ARS, LLC     Russia
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    N.03.A.X.16   Pregabalin

    Pharmacodynamics:

    The drug is alkylated analog GABA, is associated with α2-γ-subunit of potential-dependent calcium channels in the central nervous system, as a result, there is a decrease in calcium transport to neuronal cells in response to the action potential. The use of pregabalin leads to a decrease in the release of neurotransmitter pain (including glutamate, norepinephrine and substance P) into the synaptic gap when neurons are excited. Due to such changes, the pulse is selectively suppressed by the action of pregabalin. It should be noted that pregabalinum suppresses the excitability of the network of neurons only in pathological conditions. Has anticonvulsant, analgesic and anxiolytic effect.

    Pharmacokinetics:

    After ingestion on an empty stomach, the drug is rapidly absorbed from the gastrointestinal tract. Maximum concentration in plasma is achieved in 1 h as in a single or repeated admission. Bioavailability of pregabalin when ingested is ≥ 90% and does not depend on the dose. It does not bind to plasma proteins, is slightly biotransformed in the liver. The half-life is 6.3 hours, the kidneys excrete 98% unchanged, 0.9% in the form of metabolites.

    Indications:
    • Fibromyalgia in adults
    • Neuropathic pain in adults
    • Epilepsy: as an additional therapy in adults with partial seizures, accompanied or not accompanied by secondary generalization.
    • Generalized anxiety condition

    V.F40-F48.F41.1   Generalized anxiety disorder

    VI.G40-G47.G40   Epilepsy

    VI.G40-G47.G40.1   Localized (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

    VI.G40-G47.G40.2   Localized (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

    VI.G60-G64.G62.9   Polyneuropathy, unspecified

    XIII.M70-M79.M79.1   Myalgia

    XVIII.R50-R69.R52.2   Another constant pain

    Contraindications:
    • Hypersensitivity
    • Age before 17 years
    • Breast-feeding
    • Intolerance to galactose, lactase insufficiency, impaired absorption of glucose / galactose (for dosage forms containing lactose)
    Carefully:
    • Diabetes
    • Kidney Diseases
    • Heart failure
    • Drug dependence in history
    • Encephalopathy in history
    • Simultaneous use with lorazepam, ethanol, oxycodone
    • Patients of advanced age (over 65 years)
    • Pregnancy
    Pregnancy and lactation:

    Category FDA - FROM. When pregnancy is taken with caution, with breastfeeding the drug is contraindicated.

    Dosing and Administration:

    Orally, regardless of meals 150-600 mg in 2-3 divided doses. Capsules are recommended to be swallowed whole, without chewing or grinding, with plenty of water.

    Neuropathic pain. The initial dose is 150 mg in daydivided into 2 or 3 receptions. Depending on the individual response to treatment and individual patient tolerance, after 3-7 days the dose may be increased to 300 mg in dayand, if necessary, after 7 days, the dose can be increased to 600 mg in sukit. The maximum daily dose is 600 mg.

    Additional therapy of epilepsy with partial seizures (accompanied or not accompanied by secondary generalization). The initial dose is 150 mg in daydivided into 2 or 3 receptions. Depending on the individual response to treatment and individual patient tolerance, after 7 days the dose may be increased to 300 mg in dayand, if necessary, after 7 days, the dose can be increased to 600 mg in day. The maximum daily dose is 600 mg.

    Generalized anxiety disorders. The initial dose is 150 mg in day, divided into 2 or 3 reception. Depending on the individual response to treatment and individual patient tolerance, after 7 days the dose may be increased to 300 mg in day. In the absence of positive dynamics after 7 days, the dose is increased to 450 mg in day, if necessary, after 7 days - up to 600 mg in day. The maximum daily dose is 600 mg.

    Fibromyalgia. The initial dose is 150 mg in day, divided into 2 or 3 reception. Depending on the individual response to treatment and individual patient tolerance after 7 days, the dose may be increased to 300 mg in day. In the absence of positive dynamics after 7 days, the dose is increased to 450 mg in day, and if necessary, after 7 days - up to 600 mg in day. The maximum daily dose is 600 mg.

    The cessation of treatment should occur gradually within a week. For elderly patients, as well as patients with kidney disease, a dose adjustment is required.

    Side effects:

    From the side nervous system and sense organs: drowsiness, ataxia, incoordination, tremor, paresthesia, balance disorder, amnesia, lethargy, hypoesthesia, disturbance of speech, weakened reflexes, psychomotor agitation, hypersensitivity, burning sensation on the mucous membranes and skin, stupor, hypokinesia, dysgraphia, dizziness, diplopia, hyperacusis,decreased visual acuity, dry eyes, increased lacrimation, eye irritation, oscilloscopy, loss of peripheral vision, increased brightness of visual perception, dizziness, impaired attention, memory impairment, dysarthria, sedation, cognitive disorders, nystagmus, myoclonic spasms, dyskinesia, postural dizziness, loss of taste sensations, intentional tremor, fainting, parosmia, headache, blurred vision, narrowing of the fields of vision, pain in the eyes, asthenopia, puffiness of eyes, flashing of sparks before eyes, mydriasis, impaired perception of depth of vision, strabismus, keratitis.

    From the side mentality: confusion, irritability, disorientation, anorgasmia, depression, mood lability, difficulty in word selection, unusual dreams, panic attacks, increased insomnia, high spirits, euphoria, decreased libido, insomnia, depersonalization, anxiety, agitation, Depressed mood, hallucinations, increased libido, apathy, disinhibition.

    From the side metabolism: weight gain, hypoglycemia, increased appetite, anorexia, weight loss.

    From the side respiratory system: cough, nasopharyngitis, nosebleeds, snoring, pulmonary edema, dyspnea, dryness of the nasal mucosa, nasal congestion, rhinitis, a feeling of tightness in the throat.

    From the side of cardio-vascular system: tachycardia, hot flashes, cold extremities, sinus tachycardia, sinus bradycardia, lengthening of the interval QT, atrioventricular blockade I degree, lowering blood pressure, increasing blood pressure, sinus arrhythmia, chronic heart failure.

    From the side musculoskeletal system: swelling of the joints, muscle spasms, arthralgia, pain in the extremities, spasm of the neck muscles, rhabdomyolysis, muscle twitching, myalgia, back pain, stiffness in the muscles, pain in the neck.

    From the side gastrointestinal tract: constipation, flatulence, increased salivation, hypoesthesia of the oral cavity mucosa, dysphagia, tongue edema, diarrhea, dry mouth, vomiting, bloating, gastroesophageal reflux, ascites, pancreatitis, nausea.

    From the side skin integument: hyperemia of the skin, papular rash, itchy skin, sweating, cold sweat, Stevens-Johnson syndrome.

    From the side reproductive system: delay of ejaculation, amenorrhea, discharge from the mammary glands, enlargement of mammary glands in volume, erectile dysfunction, sexual dysfunction, pain in the mammary glands, dysmenorrhea.

    From the side urinary system: incontinence, renal insufficiency, dysuria, oliguria.

    From the side hematopoiesis system: neutropenia.

    From the side laboratory indicators: a decrease in the number of platelets, a decrease in the level of potassium in the blood, increased activity of ALT, AST, creatine phosphokinase, increase in glucose and creatinine in the blood, decrease in the number of leukocytes in the blood.

    Other: peripheral edema, gait disturbance, falls, chest tightness, chills, hyperthermia, fatigue, feelings of intoxication, asthenia, thirst, generalized edema, pain.

    Overdose:

    Symptoms: drowsiness, confusion, depression, agitation and anxiety, in rare cases - coma.

    Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy, hemodialysis should be used if necessary.

    Interaction:

    Respiratory failure and coma, while the use of pregabalin with other drugs depressing the central nervous system.

    Also reported was the negative effect of pregabalin on the gastrointestinal tract (including the development of intestinal obstruction, paralytic ileus, constipation) with concomitant use with drugs that cause constipation (such as non-narcotic analgesics).

    Special instructions:

    The drug should be discontinued in case of symptoms of angioedema.

    The drug increases the risk of suicidal behavior.

    Dependence on the drug may develop.

    Impact on the ability to drive vehicles and manage mechanisms.

    It is not recommended to drive vehicles and perform other potentially dangerous jobs that require concentration of attention when taking the drug.

    Instructions
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