Index of drugs

As part of a comprehensive attention deficit hyperactivity disorder (ADHD) program in children aged 6 years and older, in cases where other therapeutic approaches are not sufficiently effective. Treatment must be under the supervision of a doctor who has experience in the treatment of childhood behavioral disorders. The diagnosis should be in accordance with the DSM-IV criteria or ICD-10 guidelines and should be based on a comprehensive interview and examination. A comprehensive treatment program for patients with ADHD should consist of psychological, educational and social activities as well as pharmacotherapy. It aims to stabilize children with behavioral disorders, which may be characterized by: chronic inability to focus on longer periods, emotional instability, impulsivity, moderate to severe hyperactivity, minor neurological symptoms and abnormal EEG record. Learning ability may be disturbed or not.

1 tabl sustained release contains 18 mg or 36 mg of methylphenidate hydrochloride.

Mild stimulant o.u.n. The mechanism of therapeutic action in the attention deficit hyperactivity disorder (ADHD) is unknown. Methylphenidate is presumed to block norepinephrine and Dopamine reuptake by a presynaptic neuron and increase the release of these monoamines into the non-neuronal space. Methylphenidate is a racemic mixture consisting of levo- and dextrorotatory isomers. The dextrorotatory isomer is more pharmacologically active than the levorotatory isomer. Clinical studies have shown that the effects of Concerta were maintained for about 12 hours after taking the product once a day in the morning. After oral administration, methylphenidate is well absorbed from the gastrointestinal tract. The initial maximum concentration in the blood occurs for 1-2 h. The methylphenidate contained in the two inner shells of the preparation is gradually released over the Next few hours. Maximum blood concentrations are reached 6-8 hours after administration. Binding to the plasma proteins of the drug and its metabolites is about 15%. It is metabolized mainly through deesterification to alpha-phenylpiperidineacetic acid (PPA). T_0,5 methylphenidate is about 3.5 hours. About 90% of the dose is excreted in the urine and 1-3% - in the faeces in the form of metabolites within 48-96 hours.

Hypersensitivity to methylphenidate or to any of the excipients. Glaucoma. Phaeochromocytoma (pheochromocytoma). During the use of non-selective and irreversible monoamine oxidase (MAO) inhibitors or within 14 days of discontinuation of these drugs due to the risk of hypertensive crisis. Hyperthyroidism or thyrotoxicosis. Occurring or past severe depression, anorexia, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia or psychopathic disorders and / or borderline personality. Occurrence or past history of severe or episodic (type I) bipolar disorder (which was not well controlled). Previous cardiovascular disorders: severe hypertension, heart failure, obliterative arterial disease, ischemic heart disease, congenital haemodynamic disorders, cardiomyopathy, myocardial infarction, potentially life-threatening arrhythmias, ductopathies (disorders caused by ion channel dysfunction). Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular anomalies including vasculitis or stroke.

Treatment with methylphenidate is not indicated in all children with ADHD. Patients undergoing long-term treatment (ie over 12 months) must be monitored for: cardiovascular status, development, height, weight, appetite, emergencede novo or worsening of pre-existing mental disorders (motor and vocal tics, aggressive and hostile behavior, excitement, anxiety, depression, psychosis, mania, delusions, irritability, lack of spontaneity, withdrawal and excessive perseveration). The decision to use the medicine must be based on a detailed assessment of the severity and chronicity of the child's symptoms, taking into account their age.For patients who are considering therapy with stimulants, an accurate medical history should be obtained (with the assessment of family history and sudden deaths and ventricular arrhythmias) and physical tests (with measurement of blood pressure and heart rate) should be performed to assess the presence of the disease heart and refer to further cardiac examinations, especially if the initial assessment indicates a history of heart disease. Patients who experience heart palpitations, exertional chest pain, unexplained fainting, shortness of breath or other symptoms that may suggest heart disease should be immediately evaluated for cardiology. Caution is advised when treating patients whose health is threatened by increased blood pressure or heart rate. The condition of the cardiovascular system should be carefully monitored. Blood pressure values ​​and heart rate should be recorded on the percentile grid after each dose modification and at least once every 6 months. The use of the drug is contraindicated in some previously diagnosed cardiovascular disorders, unless otherwise advised by a specialist in pediatric cardiology. There have been cases of sudden death associated with the use of stimulating drugs o.u.n. in the standard dose in children; some children have had heart irregularities or serious heart problems. Although some heart disease may spontaneously increase the risk of sudden death, stimulants are not recommended in children and adolescents with known heart anomalies, cardiomyopathy, severe cardiac arrhythmias or other serious cardiac conditions as they may increase their sensitivity to sympathomimetic effects of the drug stimulating. Abnormal use of central nervous system stimulants may be associated with sudden death or other serious, undesirable symptoms of the cardiovascular system. In patients with cardiovascular disease and concomitant blood pressure-lowering medicinal products, neurological examination should be performed for signs or symptoms every time after starting treatment with methylphenidate. In patients who develop new neurological symptoms (such as severe headaches, numbness, weakness, paralysis, and poor coordination, vision and speech, language skills, memory), the diagnosis of cerebrovascular inflammation should be considered. Early diagnosis based on a high suspicion rate may allow immediate withdrawal of methylphenidate and early treatment. The drug is contraindicated in people with partial paresis. In the case of new psychiatric symptoms or exacerbation of pre-existing psychiatric disorders, methylphenidate should be used only if the benefits outweigh the potential risk to the patient. The appearance or deterioration of mental disorders should be monitored during each dose adjustment, followed every 6 months and during each follow-up visit; it may be advisable to stop treatment. The use of methylphenidate in patients with psychosis may exacerbate the symptoms of behavioral and thinking disorders. Psychotic symptoms and symptoms of mania have been reported in patients without a history of mania, if such symptoms occur during treatment, discontinuation of treatment should be considered. If signs of aggression or hostile behavior appear or worsen, please assess whether dosage adjustment will be necessary. In patients who develop suicidal ideation or behavior, treatment of the underlying mental health problem should be considered, discontinuation of methylphenidate therapy should also be considered. The use of methylphenidate is associated with the emergence of new or exacerbating the occurring motor and verbal tics. The deterioration of the patient's condition in the course of Tourette's syndrome was also reported. The patient should be monitored for the onset or worsening of tics. Monitoring should be carried out every time the dose is changed, followed by at least every 6 months or during each follow-up visit. Before using the medicine, make sure that you do not have anxiety, agitation, or tension. Patients who experience them must be monitored regularly for signs of worsening during treatment, during each dose adjustment, and then at least every 6 months or during each follow-up visit.Particularly caution should be exercised in patients with ADHD who have concurrent bipolar affective disorder, due to the possibility of a mixed / manic episode; these patients should be closely monitored (monitoring should occur during each dose adjustment and then at least every 6 months and during each follow-up visit). Physical development should be monitored during the treatment: height, weight and appetite and record results at least every 6 months in the development card. In patients in whom psychological development or weight gain do not meet expectations, discontinuation of treatment should be considered. Use with caution in patients with epilepsy. If seizures occur more frequently or occur for the first time, the medicine should be discontinued. Methylphenidate should be used with caution in patients with a known alcohol or drug addiction due to potential abuse, sham use or inappropriate use of methylphenidate. Chronic abuse can lead to pronounced tolerance and mental addiction, accompanied by varying degrees of behavioral disorders; psychotic episodes may appear, especially for parenteral abuse. In the case of withdrawal, careful supervision is required, because discontinuation of the drug may reveal depression as well as chronic hyper-reactivity; in people abusing the product, discontinuation of treatment may cause severe depression. The preparation should not be used in the prevention or treatment of normal fatigue. In the event of leukopenia, thrombocytopenia, anemia or other abnormalities including those indicative of severe renal and hepatic impairment, discontinuation of the drug should be considered. The preparation should not be administered to patients with pre-existing severe constrictions of the gastrointestinal tract (pathological or iatrogenic) or patients with dysphagia or significant difficulty swallowing tablets. The efficacy and safety of the preparation in elderly patients and in children up to the age of 6 have not been established - the preparation should not be used in these age groups. In patients who develop symptoms even after entering adulthood and who have clearly benefited from treatment, it may be appropriate to continue treatment in adulthood. However, it is inappropriate to start pre-treatment therapy in adults. In adults, it is necessary to assess the need for further treatment regularly, once a year. The preparation contains lactose and therefore should not be used in patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation is not recommended for use during pregnancy (there have been spontaneous reports of cardiac respiratory toxicity in neonates, in particular fetal tachycardia and respiratory distress syndrome), unless clinical judgment indicates that discontinuation of therapy would be more of a threat to pregnancy. Methylphenidate is excreted in human milk. One unspecified loss of weight was reported in an infant during the exposure period. A decision should be made whether to discontinue breast-feeding or discontinue methylphenidate, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Very often: insomnia, nervousness, headache. Common: nasopharyngeal inflammation, upper respiratory tract infection, sinusitis, anorexia, decreased appetite, moderate reduction in weight gain and growth during long-term use in children, anorexia, emotional lability, aggression, agitation, anxiety, depression, irritability, unusual behavior, mood swings, tics, insomnia, depressive mood, depression, decreased libido, tension, bruxism, panic attacks, dizziness, dyskinesias, psychomotor hyperactivity, drowsiness, paresthesia, tension-type headache, accommodation disorders, arrhythmias, tachycardia, palpitations, hypertension, cough, mouth and throat pain, epigastric pain, diarrhea, nausea, abdominal discomfort, vomiting, dry mouth, indigestion, alopecia, pruritus, rash, urticaria muscle contraction, muscle strain, pain joints, erectile dysfunction, fever, fatigue, irritability, asthenia, alteration arterial blood pressure and heart rate, increased ALT.Uncommon: hypersensitivity reactions such as angioneurotic edema, anaphylactic reactions, swollen ears, bullous reactions, flaky skin, urticaria, pruritus, rash and skin blemishes, psychiatric disorders, auditory hallucinations, visual and sensory disturbances, anger, suicidal thoughts, mood changes , nervousness, crying, deterioration of already existing tics in Tourette's syndrome, excessive alertness, sleep disorders, sedation, tremors, lethargy, blurred vision, dry eyeball, chest pain, hot flushes, shortness of breath, constipation, increased liver enzymes , angioneurotic edema, bladder reactions, peeling of the epidermis, muscle pain, heart murmurs, increased liver enzymes. Rare: confusion, mania, libido disorders, confusion, difficulties in accommodation, blurred vision, double vision; angina pectoris; excessive sweating, macular rash, erythema; gynecomastia. Very rare: suicide attempts (including suicide), abnormal thinking, apathy, repetition of behavior, excessive concentration; convulsions, choreoathetotic movements, reversible ischemic neurological disorders, neuroleptic malignant syndrome (NMS); cardiac arrest, myocardial infarction; inflammation and / or closure of the cerebral arteries, freezing of distal parts of the body, Raynaud's symptoms; impaired liver function, including hepatic coma; erythema multiforme, exfoliative dermatitis, constant drug eruption; muscle cramps; sudden cardiac death; increased alkaline phosphatase in the blood, increased bilirubin, decreased platelet counts, and abnormal white blood cell counts. Unknown frequency: delusions, thinking disorders, addiction, cases of abuse and addiction were more often described with immediate-release forms of the drug; cerebrovascular disorders (including vasculitis, cerebral haemorrhage, cerebral arteritis, cerebral vascular obstruction); grand mal seizures, migraine; pupil dilation; supraventricular tachycardia, bradycardia, additional ventricular spasms, extra spasms; chest discomfort, very high fever.

Treatment should always be carried out under the supervision of a specialist dealing with behavioral disorders in children and / or adolescents.
Orally. Children (over 6 years) and adolescents.Patients not previously using methylphenidate: 18 mg once a day. The dose should then be carefully adjusted, increasing it by 18 mg at approximately weekly intervals. The maximum daily dose is 54 mg. Clinical experience with the preparation in these patients is limited. The use of the preparation may not be indicated in all children with ADHD. In patients previously treated with methylphenidate, a lower dose of this drug in short-acting preparations may be sufficiently effective.Patients currently taking methylphenidate: with a previous dosage of 5 mg 3 times a day - 18 mg Concerts once a day; at a dosage of 10 mg 3 times a day - 36 mg Concerts once a day; at a dosage of 15 mg 3 times a day - 54 mg Concerts once a day. If no improvement is observed for a period of 1 month of application at the appropriate dose, the drug should be discontinued. The safety and efficacy of long-term use of methylphenidate has not been systematically evaluated in controlled clinical trials. A doctor who decides to administer the preparation for a long time (over 12 months) should periodically verify the long-term suitability of the drug in individual cases, attempting to stop treatment to determine the functioning of the patient without pharmacotherapy. It is recommended that the preparation be discontinued at least once a year (preferably during the summer holidays) to assess the condition of the child. The improvement may persist both during periodic and permanent discontinuation of the drug. Treatment with methylphenidate should not be indefinite, usually treatment can be discontinued during or after puberty. In cases where paradoxical worsening of symptoms occurs or side effects occur, the dose should be reduced and if necessary, the drug should be discontinued.
Serve in the morning, regardless of meals. The tablets should be swallowed whole and taken with a small amount of liquid. The preparation may not be chewed, divided or crushed.