Active substanceClonazepamClonazepam
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  • Clonazepam
    pills inwards 
    Remedika Co., Ltd.     Cyprus
  • Clonazepam
    pills inwards 
  • Dosage form: & nbsppills
    Composition:

    Active substance: clonazepam 0.5 mg; 2 mg

    Excipients: povidone, microcrystalline cellulose, carboxymethyltosodium starch, pregelatinized starch, dye sunset yellow E 110 / is included in the composition of only "0.5 mg tablets", silicon dioxide colloid, magnesium stearate.
    Description:

    Tablets 0.5 mg:

    Round, flat tablets of white or almost white color, with a risk dividing the tablet into 4 parts, on the one hand and the logo of the company "Remedika Ltd" on the other hand.

    Tablets 2 mg:

    Round, flat tablets of white or almost white color, with a risk dividing the tablet into 4 parts, on the one hand and the logo of the company "Remedika Ltd" on the other hand.

    Pharmacotherapeutic group:Anticonvulsant drug
    ATX: & nbsp
  • Clonazepam
  • Pharmacodynamics:

    Antiepileptic remedy from the group of benzodiazepine derivatives. Has pronounced anticonvulsant, as well as central miorelaksiruyuschee, anxiolytic, sedative and hypnotic action.

    Increases the inhibitory effect of GABA on the transmission of nerve impulses.Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brainstem and intercalary neurons of the lateral horns of the spinal cord. Reduces the excitability of subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits postsynaptic spinal reflexes.

    Anxiolytic effect is due to the influence on the amygdala complex of the limbic system and is manifested in a decrease in emotional tension, easing anxiety, fear, anxiety.

    The sedative effect is due to the effect on the reticular formation of the brainstem and the nonspecific nuclei of the thalamus and is manifested by a decrease in neurotic symptoms (anxiety, fear).

    Anticonvulsant action is realized due to increased presynaptic inhibition. This suppresses the spread of epileptogenic activity that occurs in epileptogenic foci in the cortex, thalamus, and limbic structures, but the excited state of the focus is not removed.

    It is shown that in humans clonazepam quickly suppresses paroxysmal activity of different types, includingcomplexes "spike-wave" with absences (petit mal), slow and generalized complexes "spike-wave", "soldering" of temporal and other localization, as well as irregular "spikes" and waves.

    Changes in the generalized EEG are suppressed more than focal. In accordance with these data clonazepam has a beneficial effect in generalized and focal forms of epilepsy.

    Central miorelaksiruyuschee effect due to inhibition of the polysynaptic spinal afferent inhibitory pathways (to a lesser extent, monosynaptic). Perhaps a direct inhibition of the motor nerves and muscle functions.

    Pharmacokinetics:

    After oral administration, it is absorbed from the gastrointestinal tract by 90%. The maximum concentration in the plasma is achieved in 1-3 hours after administration. Connection with plasma proteins - 5%. Penetrates through blood-brainland placental barriers penetrate into breast milk. Clonazepam is metabolized in the liver to virtually inactive metabolites. The half-life is 20-60 hours. It is excreted as metabolites with urine (50-70%) and through the gastrointestinal tract (10-30%).About 0.5% of the dose taken is excreted by the kidneys unchanged.

    Indications:

    The first-line agent is epilepsy (adults, infants and young children): typical absences (petit mal), atypical absences (Lennox-Gastaut syndrome), cramping seizures, atonic seizures (fall syndrome or drop-attacks).

    The second-line agent is infantile spasms (West syndrome).

    The agent of the third series is tonic-clonic convulsions (grand mal), simple and complex partial seizures and secondary generalized tonic-clonic convulsions.

    Epileptic status (iv introduction).

    Somnambulism, muscle hypertonicity, insomnia (especially in patients with organic brain lesions), psychomotor agitation, alcohol withdrawal syndrome (acute agitation, tremor, threatening or acute alcohol delirium and hallucinations), panic disorders.

    Contraindications:Inhibition of the respiratory center, severe COPD (progression of the degree of respiratory failure), acute respiratory failure, myasthenia gravis, coma, shock, angle-closure glaucoma (acute attack or predisposition), acute alcohol intoxication with impaired vital functions,acute poisoning with narcotic analgesics and hypnotics, severe depression (suicidal tendencies may occur), pregnancy, lactation period, hypersensitivity to clonazepam.
    Carefully:

    With extreme caution apply in patients with ataxia, severe liver disease, severe chronic respiratory failure, especially in the acute deterioration phase, with episodes of nocturnal apnea.

    With caution apply in elderly patients, tk. they can be slowed withdrawal of clonazepam and reduced tolerance, especially in the presence of cardiopulmonary insufficiency.

    Pregnancy and lactation:

    The drug should not be used in pregnant women, unless the potential benefit to the mother does not exceed the possible risk to the fetus (arrhythmia, hypothermia, lowering blood pressure, respiratory depression).

    Use immediately before delivery or during labor can cause muscle weakness in newborns.
    Dosing and Administration:

    Inside. The dose and duration of therapy is determined by the doctor. Treatment should be started with low doses,increasing them gradually to obtain the optimal therapeutic effect.

    Adults: initial dose not more than 1,5 mg / day divided into three doses.

    The dose can be gradually increased by 0.5 mg every 3 days. The maintenance dose is set individually for each patient, admission). The maximum daily dose is 20 mg -1.5 mg / day for 2-3 reception. The maintenance daily dose is 3-6 mg. The maximum daily dose for children is 0.2 mg / kg of body weight / day.

    Children with 3 before 10 years: 0.01-0.03 mg / kg / daytoand for 2-3 reception.

    Patients of advanced age (over 65 years): a dose reduction is recommended. The initial dose should not exceed 0.5 mg / day. Pacentnersclients from plank bedthetiontheKidney function may be necessary to reduce the dose of the drug.

    Side effects:

    From the side of the central nervous system: at the beginning of treatment - severe inhibition, fatigue, drowsiness, lethargy, dizziness, numbness, headaches; rarely - confusion, ataxia. When used in high doses, especially with prolonged treatment - violations of articulation, diplopia, nystagmus; paradoxical reactions (incl.acute excitation conditions); anterograde amnesia. Rarely - hyperergic reactions, muscle weakness - depression. With prolonged treatment of some forms of epilepsy, an increase in the frequency of seizures is possible.

    From the digestive system: rarely dry mouth, nausea, diarrhea, heartburn, nausea, vomiting, decreased appetite, constipation or diarrhea, impaired liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice. Infants and young children may have increased salivation.

    From the cardiovascular system: reduction of blood pressure, tachycardia.

    From the endocrine system: change in libido, dysmenorrhea, reversible premature sexual development in children (incomplete premature puberty).

    From the respiratory system: with intravenous administration, respiratory depression may be possible, especially when treated with other drugs that cause respiratory depression; in infants and young children, bronchial hypersecretion is possible.

    On the part of the hematopoiesis system: leukopenia, neutropenia, agranulocytosis, anemia, thrombocytopenia.

    From the urinary system: urinary incontinence, urinary retention, renal dysfunction.

    Allergic reactions: urticaria, skin rash, itching, extremely rarely - anaphylactic shock.

    Dermatological reactions: transient alopecia, changes in pigmentation.

    Influence on the fetus: teratogenicity (especially I trimester), oppression CNA, violation of respiration and suppression of the sucking reflex in newborns whose mothers used the drug.

    Other: addictive, drug dependence (both physical and mental - the risk of dependence increases with increasing dose and duration of treatment, a predisposition is observed especially in patients with alcoholism or other kinds of dependencies in the anamnesis); a decrease in blood pressure; rarely - weight loss, tachycardia, transient alopecia, changes in pigmentation.

    With a sharp decrease in dose or discontinuation of reception - the syndrome "canceling" (tremor, increased sweating, agitation, irritability, nervousness, sleep disturbances, expressed anxiety, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, myalgia, depression, nausea, vomiting, tachycardia, seizures and epileptic seizures, which may be a manifestation of the underlying disease; in severe cases, derealization, hyperacusis, paresthesia, photophobia, hyperesthesia, hallucinations can develop).Manifestations of the "withdrawal" syndrome are usually observed with a sharp cessation of treatment. Therefore, if it is necessary to stop treatment, the dose of the drug should be reduced gradually under the supervision of a doctor. With prolonged use, it is possible to develop drug dependence and weaken the effect of the drug as a result of the development of tolerance.

    Overdose:

    Symptoms: drowsiness, confusion, paradoxical agitation, decreased reflexes, dysarthria, ataxia, nystagmus, tremor, bradycardia, dyspnea or shortness of breath, severe weakness, decreased blood pressure, depression of cardiac and respiratory activity, coma.

    Treatment: gastric lavage, reception of activated charcoal. Symptomatic therapy (maintenance of breathing and blood pressure). Hemodialysis is ineffective. The benzodiazepine antagonist flumazenil is not indicated in epileptic patients who received treatment with benzodiazepines. In such patients, antagonistic action with respect to benzodiazepineMr.Am can provoke epileptic seizures.

    Interaction:

    The mutual enhancement of the effects of antipsychotic LC (neuroleptics), tricyclic antidepressants, other antiepileptic and hypnotics LC, general anesthetics, narcotic analgesics, drugs reducing blood pressure of central blood, muscle relaxants and ethanol. Alcohol consumption during treatment with clonazepam, chromiume provoke paradoxical reactions: psychomotor agitation, aggressive behavior or a state of pathological intoxication.

    Pathological intoxication does not depend on the type and amount of alcohol consumed.

    Reduces the effectiveness of levodopa in patients with Parkinsonism.

    It is possible to increase zidovudine toxicity when combined.

    When used simultaneously with valproic acid, it can lead to the development of epileptic status of small seizures.

    Inhibitors of microsomal oxidation, extending T1 /2, increase the risk of toxic effects.

    Inducers of microsomal liver enzymes (barbiturates, phenytoin or carbamazepine) accelerate the metabolism of clonazepam, without affecting its binding to proteins (clonazepam does not induce enzymes involved in its metabolism), reduce the effectiveness of the drug.

    The narcotic analgesics intensify euphoria, leading to an increase in psychological dependence.

    Hypotensive drugs can increase the severity of blood pressure lowering.

    Against the background of simultaneous administration of clozapine, an increase in respiratory depression is possible.

    With the simultaneous use of phenytoin or primidone, an increase in the concentration of these drugs in the blood serum. Cimetidine lengthens the action.

    Myelotoxicitykie LS increase the manifestation of hematotoxicity of the drug.

    Smoking of tobacco can lead to a weakening of clonazepam.

    Special instructions:

    During prolonged therapy with clonazepam, periodic laboratory monitoring of blood and functional liver samples is recommended. During treatment with clonazepam and within 3 days after its completion, you should not drink alcohol.

    Effect on the ability to drive transp. cf. and fur:During the drug intake it is necessary to refrain from driving vehicles and performing work that requires the speed of psychomotor reactions.
    Form release / dosage:

    Tablets 0.5 mg, 2 mg.

    Packaging:By 10 tablets in a blister (PBX/ Al). For 3 blisters together with instructions for use are placed in a cardboard box.
    Storage conditions:

    The drug belongs to the list of strong BACC substances.

    In withthehomeland, behindwSeekernanom from the placese, or temporatoure not atsshe 25 °FROM.

    Keep out of the reach of children!

    Shelf life:5 years.
    Terms of leave from pharmacies:On prescription
    Registration number:П N012884 / 01-2001
    Date of registration:25.06.2008
    Expiration Date:Unlimited
    The owner of the registration certificate: Remedika Co., Ltd. Remedika Co., Ltd. Cyprus
    Manufacturer: & nbsp
    Representation: & nbspTRB Kemedika International SA TRB Kemedika International SA Argentina
    Information update date: & nbsp29.01.2018
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