Haloperidol-Richter solution for intravenous and intramuscular injection of 5mg 1ml N5
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Active ingredients
Haloperidol
Release form
Solution
Composition
1 ml of haloperidol decanoate 70.52 mg, which corresponds to the content of haloperidol 50 mg. Excipients: sodium hydroxide - 1.783 mg, sodium chloride - 6.9 mg, water d / and - 988.317 mg.
Pharmacological effect
Antipsychotic drug. Haloperidol decanoate is an ester of haloperidol and decanoic acid. When i / m administration during slow hydrolysis, haloperidol is released, which then enters the systemic circulation. Haloperidol decanoate is a neuroleptic, butyrophenone derivative. Haloperidol is a pronounced antagonist of central dopamine receptors and is considered a strong neuroleptic. Haloperidol is highly effective in treating hallucinations and delusions, due to the direct blockade of central dopamine receptors (probably acting on mesocortical and limbic structures), affects the basal ganglia (nigrostria). It has a pronounced sedative effect in case of psychomotor agitation, is effective in mania and other agitations. The limbic activity of the drug is manifested in the sedative effect. effective as an adjunct in chronic pain. Impact on the basal ganglia causes extrapyramidal reactions (dystonia, akathisia, parkinsonism). In socially isolated patients, social behavior is normalized. Severe peripheral antidopamine activity is accompanied by the development of nausea and vomiting (irritation of chemoreceptors), relaxation of the gastroduodenal sphincter and increased release of prolactin (blocks prolactin inhibitory factor in the adenohypophysis).
Indications
- chronic schizophrenia and other psychosis, especially when treatment with quick-acting haloperidol was effective and an effective neuroleptic of moderately sedative action is necessary. - other disorders of mental activity and behavior, occurring with psychomotor agitation and requiring long-term treatment.
Contraindications
- coma - CNS depression caused by drugs or alcohol - Parkinson's disease - damage to the basal ganglia - children's age - hypersensitivity to the drug.The drug should be prescribed with caution in decompensated diseases of the cardiovascular system (including angina pectoris, impaired intracardiac conduction, prolongation of the QT interval or susceptibility to this - hypokalemia, simultaneous use of other drugs that may cause prolongation of the QT interval), epilepsy, angle-closure glaucoma, hepatic and / or renal failure, hyperthyroidism (with symptoms of thyrotoxicosis), pulmonary cardiac and respiratory failure (including in COPD and acute in ektsionnyh disease), prostatic hyperplasia with urinary retention, alcoholism.
Use during pregnancy and lactation
Studies conducted with the involvement of a large number of patients indicate that Haloperidol Decanoate does not cause a significant increase in the incidence of malformations. In several isolated cases, congenital malformations were observed with the use of Haloperidol Decanoate simultaneously with other drugs during the period of fetal development. Prescribing a drug during pregnancy is possible only when the intended benefit to the mother outweighs the potential risk to the fetus. Haloperidol Decanoate is excreted in breast milk. Prescription drug during breastfeeding is possible only in the case when the intended benefits to the mother outweigh the potential risk to the infant. In some cases, babies experienced extrapyramidal symptoms when the drug was taken by a nursing mother.
Dosage and administration
The drug is intended exclusively for adults, only for the / m introduction. It is forbidden to introduce the drug in / in. Haloperidol Decanoate is recommended to be administered in the gluteal region. Administration in doses greater than 3 ml should be avoided to avoid the unpleasant feeling of distention at the injection site. Patients undergoing long-term treatment with oral antipsychotics (mainly haloperidol) may be advised to switch to depot injections. The dose should be selected individually due to the significant differences in responses to treatment in different patients. Selection of the dose should be carried out under strict medical supervision of the patient.The choice of the initial dose is carried out taking into account the symptoms of the disease, its severity, the dose of haloperidol or other neuroleptics administered during the previous treatment. At the beginning of treatment, every 4 weeks, it is recommended to prescribe a dose, 10-15 times higher than the dose of haloperidol for intravenous administration, which usually corresponds to 25-75 mg of the drug Haloperidol Decanoate (0.5-1.5 ml). The maximum initial dose should not exceed 100 mg. Depending on the effect, the dose can be increased in steps, 50 mg each, until the optimum effect is obtained. A maintenance dose usually corresponds to a 20-fold daily oral dose of haloperidol. If you resume the symptoms of the underlying disease during the dose selection period, treatment with Haloperidol Decanoate can be supplemented with haloperidol for oral administration. Typically, injections are given every 4 weeks, but because of large individual differences in efficacy, more frequent use of the drug may be required. Older patients and patients with oligophrenia are recommended a lower initial dose, for example, 12.5–25 mg every 4 weeks. In the future, depending on the effect of the dose can be increased.
Side effects
Side effects that develop during treatment with the drug Haloperidol Decanoate are due to the action of haloperidol. Nervous system disorders: headache, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fears, akathisia, euphoria or depression, lethargy, epilepsy episodes, the development of a paradoxical reaction - exacerbation of psychosis and hallucinations. with long-term treatment - extrapyramidal disorders, including tardive dyskinesia (smacking and puckering of the lips, puffing up of the cheeks, fast and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the arms and legs), late dystonia (frequent blinking or eyelid spasms, unusual facial expression or body position, uncontrollable flexing movements of the neck, body , hands and feet) and neuroleptic malignant syndrome (difficulty or rapid breathing, tachycardia, arrhythmia, hyperthermia, increased or decreased blood pressure, increased sweating, urinary incontinence, rigidity l muscle, seizures, loss of consciousness).Since the cardiovascular system: when used in high doses - lowering blood pressure, orthostatic hypotension, arrhythmias, tachycardia, ECG changes (lengthening of the QT interval, signs of trembling and ventricular fibrillation). On the part of the digestive system: when used in high doses - loss of appetite, dry mouth, hypo-salivation, nausea, vomiting, diarrhea or constipation, abnormal liver function, up to the development of jaundice. On the part of the hematopoietic system: rarely - transient leukopenia or leukocytosis, agranulocytosis, erythropenia and a tendency to monocytosis. On the part of the urinary system: urinary retention (with prostatic hyperplasia), peripheral edema. On the part of the reproductive system and the mammary gland: pain in the mammary glands, gynecomastia, hyperprolactinemia, menstrual disorders, decreased potency, increased libido, priapism. On the part of the organ of vision: cataract, retinopathy, blurred vision. Metabolism: hyperglycemia, hypoglycemia, hyponatremia. From the side of skin and subcutaneous tissues: maculopapular and acne-like skin changes, photosensitization. Allergic reactions: rarely - bronchospasm, laryngism. Other: alopecia, weight gain.
special instructions
Side effects that develop during treatment with the drug Haloperidol Decanoate are due to the action of haloperidol. Nervous system disorders: headache, insomnia or drowsiness (especially at the beginning of treatment), anxiety, anxiety, agitation, fears, akathisia, euphoria or depression, lethargy, epilepsy episodes, the development of a paradoxical reaction - exacerbation of psychosis and hallucinations. with long-term treatment - extrapyramidal disorders, including tardive dyskinesia (smacking and puckering of the lips, puffing up of the cheeks, fast and worm-like movements of the tongue, uncontrolled chewing movements, uncontrolled movements of the arms and legs), late dystonia (frequent blinking or eyelid spasms, unusual facial expression or body position, uncontrollable flexing movements of the neck, body , hands and feet) and neuroleptic malignant syndrome (difficulty or rapid breathing, tachycardia, arrhythmia, hyperthermia, increased or decreased blood pressure, increased sweating, urinary incontinence, rigidity l muscle, seizures, loss of consciousness).Since the cardiovascular system: when used in high doses - lowering blood pressure, orthostatic hypotension, arrhythmias, tachycardia, ECG changes (lengthening of the QT interval, signs of trembling and ventricular fibrillation). On the part of the digestive system: when used in high doses - loss of appetite, dry mouth, hypo-salivation, nausea, vomiting, diarrhea or constipation, abnormal liver function, up to the development of jaundice. On the part of the hematopoietic system: rarely - transient leukopenia or leukocytosis, agranulocytosis, erythropenia and a tendency to monocytosis. On the part of the urinary system: urinary retention (with prostatic hyperplasia), peripheral edema. On the part of the reproductive system and the mammary gland: pain in the mammary glands, gynecomastia, hyperprolactinemia, menstrual disorders, decreased potency, increased libido, priapism. On the part of the organ of vision: cataract, retinopathy, blurred vision. Metabolism: hyperglycemia, hypoglycemia, hyponatremia. From the side of skin and subcutaneous tissues: maculopapular and acne-like skin changes, photosensitization. Allergic reactions: rarely - bronchospasm, laryngism. Other: alopecia, weight gain.