Moxonidine FT tablets p/o 0.4mg №10×3

Name:
Moxonidine
Description:
Round biconvex white film-coated tablets (dosage 0.2 mg) The main active ingredient Moxonidine Form of production: film-coated tablets 10 film-coated tablets in a blister pack. 20 or 30 film-coated tablets in a polyethylene terephthalate can with a corrugation for sealing tablets and capsules and a polymer screw cap. Every 2, 3 blisters or a jar of polyethylene terephthalate, together with a leaflet, is placed in a pack of cardboard. Dosage 0.4 mg Pharmacological action Moxonidine has been shown in various animal models to be a potent antihypertensive agent. The available experimental data convincingly indicate that the place of manifestation of the antihypertensive effect of moxonidine is the central nervous system. It has been established that moxonidine selectively interacts with I1-imidazoline receptors located in the brain stem. These imidazoline-sensitive receptors are concentrated in the rostral ventrolateral medulla oblongata, an area responsible for central regulation of the peripheral sympathetic nervous system. Binding of moxonidine to I1-imidazoline receptors leads to suppression of the activity of sympathetic nerves (indicated for cardiac, visceral and renal sympathetic nerves). Moxonidine differs from other centrally acting antihypertensives in its lower affinity for central alpha2-adrenergic receptors compared to I1-imidazoline receptors; alpha2-adrenergic receptors are the molecular target through which the most common adverse reactions of centrally acting antihypertensive drugs, such as sedation and dry mouth, are mediated. In humans, moxonidine leads to a decrease in systemic vascular resistance and, consequently, blood pressure. Indications for use Arterial hypertension. Dosage and administration Inside, regardless of the meal, drinking plenty of fluids. Adults Treatment should begin with the lowest dose of moxonidine (0.2 mg) taken once in the morning. In case of insufficient effect after at least three weeks of treatment, the dose can be gradually increased to 0.4 mg taken in one or two doses (morning and evening). If there is no result of treatment after the next three weeks, the maximum daily dose can be increased to 0.6 mg, which must be divided into two doses (morning and evening). A single dose of moxonidine 0.4 mg and a daily dose of moxonidine 0.6 mg should not be exceeded. In patients with moderately reduced renal function (glomerular filtration rate 30-60 ml / min), the maximum single dose should not exceed 0.2 mg, and the maximum daily dose should not exceed 0.4 mg. In patients with severely impaired renal function (glomerular filtration rate <30 ml / min), the recommended initial dose of the drug is 0.2 mg per day. If necessary and well tolerated, the daily dose can be increased to 0.3 mg. Treatment should not be stopped abruptly, the drug should be discontinued gradually, reducing the dose within two weeks (see section "Precautions"). Special groups of patients Elderly patients Provided that renal function is preserved, the recommended doses correspond to those for adult patients. Children Moxonidine should not be given to children and adolescents under 18 years of age due to a lack of safety and efficacy data. Use during pregnancy and lactation Pregnancy There are no adequate data on the use of moxonidine in pregnant women. Animal studies have shown embryotoxic effects when used at high doses. The potential risk to humans is unknown. Moxonidine should not be used during pregnancy unless absolutely necessary. Breast-feeding Moxonidine passes into breast milk, so the drug should not be used during breast-feeding. If moxonidine therapy is absolutely necessary, breastfeeding should be discontinued. Precautions Based on post-marketing data on the use of moxonidine, it is impossible to completely exclude a causal relationship of taking the drug with slowing atrioventricular conduction. Therefore, it is recommended to exercise caution in the treatment of patients predisposed to the development of atrioventricular blockade. To avoid the development of bradycardia, special care must be taken when prescribing moxonidine to persons with atrioventricular blockade of the 1st degree. Moxonidine should not be used in patients with high-grade atrioventricular block (see section "Contraindications"). Due to the limited experience with the use of moxonidine in patients with severe ischemic heart disease and unstable angina, special care should be taken when using it in this category of patients. Due to the lack of clinical data confirming the safe use of moxonidine in patients with existing moderate heart failure, the drug should be administered to such patients with caution. When prescribing moxonidine to patients with renal insufficiency, caution should be exercised, since the drug is excreted mainly by the kidneys. Careful selection of the dose is necessary, especially at the beginning of treatment. The initial dose should be 0.2 mg per day. In case of clinical need in patients with moderate renal insufficiency (GFR from 30 to 60 ml / min), the maximum daily dose can be increased to 0.4 mg, in severe renal insufficiency (GFR less than 30 ml / min) - up to 0.3 mg moxonidine per day, provided the drug is well tolerated. If moxonidine is used in combination with a beta-blocker and it becomes necessary to stop treatment with both drugs, the beta-blocker should be discontinued first, and then moxonidine should be stopped after a few days. Although there is no evidence of an increase in blood pressure upon discontinuation of moxonidine treatment (“withdrawal effect”), abrupt discontinuation of therapy is not recommended. The dose of the drug should be reduced gradually over two weeks. The elderly may be more sensitive to the effects of antihypertensive drugs on the cardiovascular system. Therefore, treatment should be started with the lowest dose. The dose should be increased with caution to avoid the serious consequences that these reactions may cause. Moxonidine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take moxonidine. Use in children Moxonidine is not prescribed for children and adolescents under 18 years of age due to the lack of data on safety and efficacy. Influence on the ability to drive vehicles and other complex mechanisms The effect of moxonidine on the ability to drive vehicles and other complex mechanisms has not been studied. There are reports of the occurrence of drowsiness and dizziness while taking the drug. This must be taken into account when driving vehicles and performing other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. Interaction with other drugs With the simultaneous use of moxonidine and other antihypertensive agents, there is a mutual enhancement of the antihypertensive effect. Since the effectiveness of centrally acting antihypertensive agents may be reduced when used together with tricyclic antidepressants, the simultaneous administration of the latter with moxonidine is not recommended. Moxonidine may increase the sedative effect of tricyclic antidepressants (should not be taken at the same time), tranquilizers, alcohol, sedatives and hypnotics. Moxonidine has the ability to moderately improve cognitive impairment in patients taking lorazepam. It is possible to increase the sedative effect of benzodiazepines when taken simultaneously with moxonidine. Since moxonidine is excreted by tubular secretion, its interaction with other drugs released in the same way is not excluded. Tolazoline may reduce the effect of moxonidine in a dose-dependent manner. Contraindications hypersensitivity to moxonidine or to any of the auxiliary components of the drug; sick sinus syndrome; atrioventricular blockade of the 2nd and 3rd degree; bradycardia (heart rate at rest less than 50 beats / min); heart failure; age up to 18 years. Composition Each film-coated tablet contains: tablet core: active ingredient: moxonidine - 0.2 mg, 0.3 mg or 0.4 mg; excipients: povidone, crospovidone, corn starch, magnesium stearate, microcrystalline cellulose, lactose monohydrate; tablet shell: hypromellose, macrogol 400, iron oxide red (for a dosage of 0.3 mg), titanium dioxide. Overdose There are several reports of acute non-fatal overdose of moxonidine at a dose of 19.6 mg. Signs and symptoms were observed: headache, sedation, drowsiness, hypotension, dizziness, asthenia, bradycardia, dry mouth, vomiting, fatigue and epigastric pain. Based on the pharmacodynamic properties of moxonidine, the following reactions can be expected in adult patients: headache, sedation, drowsiness, hypotension, orthostatic reactions, dizziness, asthenia, bradycardia, dry mouth, fatigue and epigastric pain. In rare cases, vomiting and a temporary paradoxical increase in blood pressure may occur. In case of severe overdose, careful monitoring of the patient is recommended, especially in case of impaired consciousness and respiratory depression. In addition, transient hypertension, tachycardia, and hyperglycemia have been observed in several animal studies with high doses of moxonidine. Treatment Treatment includes measures to reduce absorption of the drug, such as gastric lavage (shortly after ingestion), activated charcoal and laxatives, in other cases, symptomatic therapy. There is no specific antidote. If hypotension occurs, restoration of circulating blood volume by fluid administration and administration of dopamine is recommended. Bradycardia can be stopped by the introduction of atropine. Alpha-adrenergic antagonists can reduce or eliminate paradoxical arterial hypertension with an overdose of moxonidine. Side effects The most common adverse reactions when taking moxonidine are dry mouth, dizziness, asthenia and drowsiness. The severity of these symptoms decreases after the first few weeks of therapy. Adverse reactions are indicated by systemic organ classes and, depending on the frequency, are classified as follows: very often (≥ 1/10); often (from ≥ 1/100 to < 1/10); infrequently (from ≥ 1/1000 to < 1/100); rarely (from ≥ 1/10000 to < 1/1000); very rarely (< 1/10000), the frequency is unknown (it is impossible to determine the frequency from the available data). From the endocrine system: infrequently - gynecomastia, erectile dysfunction, decreased libido. Mental disorders: often - altered thought processes, insomnia; infrequently - anxiety, anorexia. From the nervous system: often - sleep disturbances, headache *, dizziness, drowsiness; infrequently - sedation, fainting *. On the part of the organ of vision: infrequently - dryness, itching or burning sensation in the eyes. On the part of the hearing organs and labyrinth disorders: infrequently - tinnitus. From the side of the heart: infrequently - bradycardia. From the side of the vessels: often - vasodilatation; infrequently - hypotension (including orthostatic), paresthesia of the extremities, peripheral circulation disorders. From the gastrointestinal tract: very often - dry mouth; often - diarrhea, nausea, vomiting, dyspepsia *, constipation and other gastrointestinal disorders. From the hepato-biliary system: very rarely - hepatic reactions. From the skin and subcutaneous tissues: often - rash, itching; infrequently - angioedema. On the part of the musculoskeletal and connective tissue: often - back pain; infrequently - pain in the neck. General disorders and disorders at the injection site: often - asthenia; infrequently - edema of various localization, weakness in the legs, fluid retention, pain in the parotid glands. * There was no increase in frequency compared to placebo If any adverse reaction occurs or worsens, whether described in this section or not, you should immediately consult a doctor. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life 3 years. The expiration date is indicated on the packaging. Do not use after the expiration date indicated on the package. Buy Moxonidine FT tablets p/o 0.4mg No. 10x3