Nosological classification (ICD-10)
- A48.3 Toxic shock syndrome
- A49 Bacterial infection of unspecified localization
- C71 Malignant neoplasm of the brain
- C80 Malignant neoplasm without specification of localization
- C82 Follicular [nodular] non-Hodgkin's lymphoma
- C83 Diffuse non-Hodgkin's lymphoma
- C84 Peripheral and cutaneous T-cell lymphomas
- C85 Other and unspecified types of non-Hodgkin's lymphoma
- C95 Leukemia of unspecified cell type
- C95.0 Acute leukemia of unspecified cell type
- C95.9 Leukemia, unspecified
- D59 Acquired hemolytic anemia
- D69.3 Idiopathic thrombocytopenic purpura
- D70 Agranulocytosis
- E06.1 Subacute thyroiditis
- E27.1 Primary adrenal insufficiency
- E27.2 Addison's crisis
- E27.4 Other and unspecified adrenal insufficiency
- E83.5.0* Hypercalcemia
- G00 Bacterial meningitis, not elsewhere classified
- G04 Encephalitis, myelitis and encephalomyelitis
- G93.6 Cerebral edema
- H01.0 Blepharitis
- H10.1 Acute atopic conjunctivitis
- H10.5 Blepharoconjunctivitis
- H15.0 Scleritis
- H15.1 Episcleritis
- H16.2 Keratoconjunctivitis
- H16.8 Other forms of keratitis
- H20.9 Iridocyclitis, unspecified
- H45.1 Endophthalmitis in diseases classified elsewhere
- I61 Intracerebral hemorrhage
- J40 Bronchitis, not specified as acute or chronic
- J44 Other chronic obstructive pulmonary disease
- J45 Asthma
- J46 Status asthmaticus
- J98.8.0* Bronchospasm
- L30.9 Dermatitis, unspecified
- L91.0 Keloid scar
- L92.0 Granuloma annulare
- L93.0 Discoid lupus erythematosus
- M35.9 Systemic connective tissue disorders, unspecified
- M79.0 Rheumatism, unspecified
- Q89.1 Malformations of the adrenal gland
- R57.8.0* Burn shock
- R57.9 Shock, unspecified
- S05.9 Injury to unspecified part of eye and orbit
- S06 Intracranial injury
- S09 Other and unspecified head injuries
- T78.2 Anaphylactic shock, unspecified
- T78.4 Allergy, unspecified
- T79.4 Traumatic shock
- T90.4 Consequences of injury to the eye, periorbital region
- Z100* CLASS XXII Surgical practice
- Z51.0 Radiotherapy course
- Z94.7 Presence of a transplanted cornea
Risperidone-KRKA
The most commonly observed adverse reactions (incidence >10%) were parkinsonism, sedation, headache and insomnia.
Parkinsonism and akathisia are dose-dependent adverse reactions.
Adverse reactions of risperidone in therapeutic doses are given with a distribution by frequency and organ systems. The frequency of adverse reactions was classified as follows: very often (≥ 1/10), often (from ≥ 1/100 to < 1/10), infrequently (from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/100). 10,000 to < 1/1000 cases), very rare (< 1/10,000), frequency unknown (cannot be estimated from available data).
In each group, adverse reactions are presented in order of decreasing severity.
Infectious and parasitic diseases:
often - pneumonia, bronchitis, upper respiratory tract infections, sinusitis, urinary tract infections, ear infections, influenza;
uncommon - respiratory tract infections, cystitis, eye infections, tonsillitis, onychomycosis, phlegmon, local infection, viral infections, acarodermatitis;
rarely - infection.
Blood and lymphatic system disorders:
uncommon - neutropenia, decreased leukocyte count, thrombocytopenia, anemia, decreased hematocrit, decreased eosinophil count;
rarely - agranulocytosis3.
Immune system disorders:
uncommon - hypersensitivity;
rarely - anaphylactic reaction3.
Endocrine system disorders:
often - hyperprolactinemia1;
rarely - impaired production of antidiuretic hormone, glucosuria.
Metabolic and nutritional disorders:
often - weight gain, increased appetite, decreased appetite;
uncommon - diabetes mellitus2, hyperglycemia, polydipsia, weight loss, anorexia, increased plasma cholesterol levels;
rarely - water intoxication3, hypoglycemia, hyperinsulinemia3, increased levels of triglycerides in the blood plasma;
very rarely - diabetic ketoacidosis.
Mental disorders:
very often - insomnia4;
often - sleep disturbances, agitation, depression, anxiety;
infrequently - mania, confusion, decreased libido, nervousness, nightmares;
rarely - catatonia, somnambulism, eating disorder (sleep-related), flattening of affect, anorgasmia.
Nervous system disorders:
very often - sedation, drowsiness, parkinsonism4, headache;
often - akathisia4, dystonia4, dizziness, dyskinesia4, tremor;
uncommon - tardive dyskinesia, cerebral ischemia, lack of response to stimulation, loss of consciousness, decreased level of consciousness, convulsions, syncope, psychomotor hyperactivity, imbalance, impaired coordination, postural dizziness, impaired attention, dysarthria, dysgeusia, hypoesthesia, paresthesia;
rarely - neuroleptic malignant syndrome (NMS), cerebrovascular disorders, diabetic coma, head tremor.
Visual disorders:
often - blurred vision, conjunctivitis;
infrequently - photophobia, dry eyes, increased lacrimation, eye hyperemia;
rarely - glaucoma, involuntary rotation of the eyeballs, impaired eye movements, formation of crusts on the edge of the eyelid, intraoperative floppy iris syndrome (IFIS)3.
Hearing and labyrinth disorders:
uncommon - tinnitus, vertigo, ear pain.
Cardiac disorders:
often - tachycardia;
uncommon - atrial fibrillation, atrioventricular block, conduction disturbance, prolongation of the electrocardiographic QT interval on the electrocardiogram (ECG), bradycardia, deviations in electrocardiographic parameters, palpitations;
rarely - sinus arrhythmia.
Vascular disorders:
often - arterial hypertension;
uncommon - arterial hypotension, orthostatic hypotension, hot flashes;
rarely - pulmonary embolism, deep vein thrombosis.
Disorders of the respiratory system, chest and mediastinal organs:
often - shortness of breath, pain in the larynx and pharynx, cough, nosebleeds, nasal congestion;
uncommon - aspiration pneumonia, pulmonary congestion, respiratory distress, wheezing, wheezing, airway congestion, dysphonia, respiratory system disorder;
rarely - sleep apnea syndrome, hyperventilation.
Digestive system disorders:
often - abdominal pain, stomach discomfort, vomiting, diarrhea, constipation, nausea, dyspepsia, dry oral mucosa, toothache;
uncommon - fecal incontinence, fecaloma, gastroenteritis, dysphagia, flatulence;
rarely - pancreatitis, intestinal obstruction, swelling of the tongue, intestinal obstruction, cheilitis;
very rarely - ileus.
Disorders of the liver and biliary tract:
infrequently - increased transaminase activity, increased gamma-glutamyl transferase activity, increased activity of liver enzymes in the blood plasma;
rarely - jaundice.
Disorders of the skin and subcutaneous tissues:
often - skin rash, erythema;
uncommon - urticaria, itching, alopecia, hyperkeratosis, eczema, dry skin, skin discoloration, acne, seborrheic dermatitis, skin inflammation, disruption of the integrity of the skin;
rarely - toxicoderma, dandruff;
very rarely - Quincke's edema.
Musculoskeletal and connective tissue disorders:
often - muscle spasms, skeletal muscle soreness, back pain, arthralgia;
uncommon - increased creatine phosphokinase activity in the blood plasma, forced body position, joint stiffness, joint swelling, muscle weakness, neck pain; rarely - rhabdomyolysis.
Renal and urinary tract disorders:
often - enuresis;
uncommon - pollakiuria, urinary retention, dysuria.
Pregnancy, postpartum and neonatal conditions:
rarely - cogwheel syndrome, bradykinesia, hypokinesia, mask-like face, muscle tension, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait and impaired glabellar reflex, parkinsonian tremor at rest), akathisia
(akathisia, restlessness, hyperkinesia and restless legs syndrome), tremor,
dyskinesia
(dyskinesia, muscle cramps, choreoathetosis, athetosis and myoclonus), dystonia.
Dystonia
includes dystonia, muscle hypertension, torticollis, involuntary muscle contractions, muscle contracture, blepharospasm, movements of the eyeballs, tongue paralysis, spasm of the facial muscles, laryngospasm, myotonia, opisthotonus, spasm of the oropharynx, bending of the body towards greater muscle contraction, spasm of the tongue muscles and trismus.
It should be noted that the list includes a wider range of symptoms that are not necessarily of extrapyramidal origin. Insomnia includes
initial insomnia and intrasomnia disorder.
Seizures
include grand mal seizures.
Menstrual irregularities
include irregular menstruation and oligomenorrhea.
Edema
includes anasarca, peripheral edema, and mild edema.
Undesirable effects noted with the use of dosage forms of paliperidone
Paliperidone is an active metabolite of risperidone, so the adverse reaction profiles of risperidone and paliperidone are relevant to each other. In addition to the above-mentioned adverse reactions with paliperidone, the following adverse reactions have been reported and may also occur with risperidone.
Vascular disorders:
postural orthostatic tachycardia syndrome.
Class effects
As with other antipsychotic drugs, very rare cases of QT prolongation have been observed during the post-marketing observation period. Other classes of cardiovascular effects observed with antipsychotic drugs that prolong the QT interval include ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest, and torsade de pointes (TdP).
Venous thromboembolism
Cases of venous thromboembolism, including pulmonary embolism and cases of deep vein thrombosis, have been observed with the use of antipsychotic drugs (frequency unknown).
Weight gain
A number of placebo-controlled studies of 6 to 8 weeks compared the proportion of patients with schizophrenia treated with risperidone or placebo who experienced a weight gain of 7% or more, and found a statistically significant increase in the incidence of excess weight gain in the group patients receiving risperidone (18%) compared with patients receiving placebo (9%). In a series of 3-week placebo-controlled studies in adults with acute mania, the incidence of weight gain of 7% or more at endpoint was comparable between the risperidone (2.5%) and placebo groups ( 2.4%), and slightly higher in the group receiving the active control drug (3.5%).
In children and adolescents with conduct and other behavioral disorders in long-term clinical studies, body weight increased by an average of 7.3 kg after 12 months of therapy. The expected increase in body weight in children with normal development between the ages of 5 and 12 years is 3-5 kg per year, in the period from 12 to 16 years - 3-5 kg per year for girls and about 5 kg per year for boys.
Special patient groups
Elderly patients with dementia
Transient ischemic attacks and stroke were observed in clinical trials with an incidence of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following adverse effects have been reported in elderly patients with dementia at an incidence of >5% and at a frequency at least twice that of other patient populations: urinary tract infections, peripheral edema, lethargy, and cough.
Children
The following side effects were reported in children (5 to 17 years of age) with an incidence >5% and an incidence at least 2 times higher than in other patient populations during clinical trials: drowsiness/sedation, fatigue, headache, increased loss of appetite, vomiting, upper respiratory tract infections, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhea, enuresis.
Directions for use and doses
IV, slow stream or drip (in acute and emergency conditions); i/m; local (into the pathological formation) administration is also possible.
The dosage regimen is individual and depends on the indications, the patient’s condition and his response to therapy.
To prepare a solution for intravenous drip infusion, you should use an isotonic sodium chloride solution or a 5% dextrose solution.
In the acute period for various diseases and at the beginning of therapy, Dexamethasone is used in higher doses. During the day, you can administer from 4 to 20 mg of Dexamethasone 3-4 times.
Doses of the drug for children (i.m.)
When carrying out replacement therapy (for adrenal insufficiency) - 0.0233 mg/kg or 0.67 mg/m2, divided into 3 doses, every 3rd day or 0.00776–0.01165 mg/kg or 0.233–0.335 mg/m2 daily. For other indications, the recommended dose is 0.02776 to 0.16665 mg/kg or 0.833 to 5 mg/m2 every 12 to 24 hours.
When the effect is achieved, the dose is reduced to maintenance or until treatment is stopped. The duration of parenteral use is usually 3-4 days, then switch to maintenance therapy with Dexamethasone tablets.
Long-term use of high doses of the drug requires a gradual dose reduction in order to prevent the development of acute adrenal insufficiency.
Awards
In 2010, for the achieved labor success, high professionalism and great contribution to the socio-economic development of the Moscow region, the team of KRKA-RUS LLC received diplomas of gratitude signed by the Governor of the Moscow Region.
In 2016, at the Government House of the Moscow Region, Governor of the Moscow Region Vorobiev A.Yu. presented the sign of St. Sergei of Radonezh[1] to director Peter Zupan for his active participation in the development of foreign economic and investment cooperation in the Istra district of the Moscow Region. The award received indicates that the KRKA company, together with the Moscow region, has common development goals and follows the same mission.
In 2022, at the Government House of the Moscow Region, KRKA-RUS LLC was noted by the State Labor Inspectorate in the Moscow Region as employers guaranteeing compliance with the requirements of the labor legislation of the Russian Federation and was solemnly presented with a “Certificate of Trust in the Employer”. Receiving the certificate was the result of participation in the project “Declaration of the enterprise’s activities to implement the labor rights of employees and employers.”
