Mirium (aripiprazole) tablets 15 mg. №28

Description

Mirium composition
active substance: aripiprazole;
1 tablet contains 5 mg of aripiprazole;
Excipients:
sodium starch glycolate; microcrystalline cellulose; lactose, monohydrate; hydroxypropyl cellulose; magnesium stearate; iron oxide yellow (E 172) (for 15 mg).

Dosage form
Tablets.

Pharmacological properties
Mirium is an antipsychotic medicine. It is an atypical neuroleptic. Shows antagonism to D2 receptors (dopamine) in the mesolimbic pathway, partial agonism to the same D2 receptors in the mesocortical pathway. Shows pronounced antagonism to 5HT2a receptors (serotonin), agonism to 5HT1a receptors. At the same time, it has a small affinity for α1 (adrenergic), H1 (histamine), M1 (muscarinic) receptors.

Indications
Mirium is prescribed:

• with acute attacks of schizophrenia;
• with acute manic episodes of bipolar I disorder;
• patients with bipolar I disorder who have recently had a mixed or manic episode.

Contraindications:

• with intolerance to the components of the drug.

Mirium is prescribed with caution:

• with cardiovascular diseases (coronary artery disease, heart attack, insufficiency, conduction disturbances);
• with cerebrovascular diseases;
• with convulsive conditions;
• in conditions that predispose to hypotension (dehydration, hypovolemia, taking antihypertensive drugs);
• at risk of hyperthermia (overheating, intense physical activity, taking anticholinergics, dehydration);
• at risk of developing aspiration pneumonia;
• with obesity;
• if you have diabetes in your family.

Children
It is not used in pediatric practice.

Application during pregnancy and lactation
Sufficiently controlled studies have not been conducted. Mirium can only be prescribed during pregnancy by a doctor.
The active substance (aripiprazole) can pass into breast milk. Breastfeeding during treatment is not recommended.

Method of administration and dosage
Mirium is used internally, regardless of food.
Standard doses:

• for schizophrenia, the initial dose is 10 or 15 mg once a day, the maintenance dose is 15 mg / day;
• for manic episodes, the initial dose is 15 or 30 mg / day, the maintenance dose is 15–30 mg / day.

Overdose
Symptoms: vomiting, drowsiness, asthenia, diarrhea, tachycardia, extrapyramidal disorders, transient loss of consciousness.
In case of an overdose, maintenance therapy, effective ventilation of the lungs, oxygenation, ECG monitoring, symptomatic treatment are required.
The intake of activated carbon is recommended.

Side effects:

• Cardiovascular disorders: syncope, vasovagal syndrome, thrombophlebitis, cerebral ischemia, intracranial hemorrhage, bradycardia, myocardial infarction, palpitations, prolongation of the QT interval, hemorrhages, cardiac arrest, atrial flutter, heart enlargement, myocardial fibrillation, atrial block, and ischemia heart failure, thrombosis, extrasystole, tachycardia, orthostatic hypotension.
• Digestive disorders: esophagitis, inflammation of the tongue, bleeding gums, periodontal abscess, duodenal ulcer, intestinal bleeding, bloody vomiting, cheilitis, pancreatitis, hepatitis, liver enlargement, bowel perforation, increased appetite, difficulty swallowing, gastroenteritis, flatulence, flatulence caries, hemorrhoids, reflux, hemorrhages, fecal incontinence, swelling of the tongue, colitis, stomatitis, rectal bleeding, ulceration in the mouth, oral candidiasis, cholecystitis, fecaloma, cholelithiasis, stomach ulcer, belching, dyspepsia, nausea, vomiting, constipation, loss of appetite.
• Immune disorders: allergies (anaphylaxis, Quincke’s edema, pruritus, urticaria).
• Musculoskeletal disorders: rhabdomyolysis, increased creatine phosphokinase activity, tendinitis, rheumatoid arthritis, tendobursitis, myopathy, joint / bone pain, arthritis, myasthenia gravis, arthrosis, spasms, muscle weakness, bursitis, myalgia, convulsions.
• Neurological disorders: bucclossal syndrome, delirium, euphoria, akinesia, depression of consciousness, loss of consciousness, muscle twitching, paresthesia, obsessive thoughts, decreased reflexes, decreased / increased libido, neuroleptic malignant syndrome, dystonia, weakened concentration, impotence, tremors of the extremities, , panic reactions, increased reflexes, depressed mood, apathy, memory impairment, dyskinesia, stupor, stroke, dyskinesia, depersonalization, amnesia, hyperactivity, akathisia, myoclonus, retardation of mental function, hypotension, changes in oculomotor reaction, dizziness, extrapyramidal syndrome, psychomotor agitation, nervousness, depression, increased salivation, suicidal thoughts, hostility, confusion, manic thoughts, unsteady gait, cogwheel syndrome, insomnia, akathisia, drowsiness.
• Respiratory disorders: hemoptysis, pulmonary edema, hypoxia, aspiration pneumonia, dry nose, pulmonary embolism, apnea, pneumonia, respiratory failure, asthma, hiccups, nosebleeds, laryngitis, shortness of breath.
• Skin changes: exfoliative dermatitis, rash, hives, acne, blistering rash, baldness, eczema, psoriasis, dry skin, seborrhea, itching, sweating, ulceration.
• Sensory disorders: lacrimation, ear pain, frequent blinking, amblyopia, eye hemorrhages, deafness, diplopia, photophobia, dry eyes, ringing in the ears, eye pain, otitis media, cataracts, blepharitis, loss of taste, conjunctivitis.
• Genitourinary disorders: uterine bleeding, pain in the mammary gland, amenorrhea, galactorrhea, cervicitis, anorgasmia, glucosuria, urolithiasis, gynecomastia, painful erection, cystitis, leucorrhea, urinary frequency, hematuria, urinary retention, dysuria, premature discharge kidney disease, vaginal candidiasis, urinary incontinence, kidney stones, polyuria, albuminuria, menorrhagia, nocturia, urge to urinate.
• Others: sore throat, chills, bloating, heaviness in the head, stiffness in the back, candidiasis, Mendelssohn’s syndrome, heatstroke, facial swelling, photosensitivity, malaise, jaw pain, pelvic pain, jaw stiffness, flu-like syndrome, tension in chest, swelling, pain in the neck, chest.
• Metabolic disorders: hyperkalemia, thirst, hyponatremia, hypernatremia, iron deficiency anemia, hypoglycemic reaction, urinary acidification, dehydration, hyperglycemia, edema, hypercholesterolemia, hypokalemia, elevated ALT / AST / ALP levels, diabetes mellitus, hypoglycemia, cyanidemia, cyanidemia , obesity, weight loss, increased creatinine, lactate dehydrogenase, creatine phosphokinase.

Storage conditions and periods
At 15-30 ° C no more than 3 years.