Moxonidine tablets p/o 0.4mg №10×3

Product DescriptionMoxonidine Amantismed. Forms of release Tablets. INN Moxonidine. FTGα2 is a central agonist. Description Tablets, film-coated, white (0.2 mg dose) or pink (0.4 mg dose), round, biconvex. Composition One tablet with a dosage of 0.2 mg contains: active substance: moxonidine – 0.2 mg; excipients: crospovidone, magnesium stearate, lactose monohydrate, Opadry II white; The composition of the Opadry II white shell: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol (macrogol), talc; one tablet with a dosage of 0.4 mg contains: active substance: moxonidine – 0.4 mg; excipients: crospovidone, magnesium stearate, lactose monohydrate, opadra II pink; Opadry II pink shell composition: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol (macrogol), talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). Pharmacotherapeutic group Antihypertensive agents. Antiadrenergic agents of central action. Imidazoline receptor agonists. ATC code: C02AC05. Pharmacological action Moxonidine is a strong antihypertensive agent. Moxonidine administration leads to a decrease in systemic vascular resistance and, consequently, blood pressure. Indications for use Arterial hypertension. Method of application and dosage Inside, regardless of the meal, drinking plenty of water. The usual starting dose of moxonidine is 0.2 mg daily, preferably in the morning. The maximum daily dose is 0.6 mg, which should be divided into 2 doses (morning and evening). The maximum single dose is 0.4 mg. The daily dose of the drug should be selected individually depending on the patient’s condition. If the therapeutic effect is insufficient, the dose can be increased after 3 weeks of therapy to 0.4 mg for 2 doses. Treatment should not be stopped suddenly. The drug should be stopped within 2 weeks. Patients with impaired renal function In patients with moderate renal insufficiency, the initial dose is 0.2 mg per day. If necessary, and with good tolerance, the dose may be increased to 0.4 mg per day (see section “Precautions”). Patients with hepatic impairment No studies have been conducted in patients with hepatic impairment. Moxonidine is not extensively metabolized by the liver, so little effect on pharmacokinetics is expected. Dosing in patients with mild to moderate hepatic insufficiency is the same as in adult patients. Elderly patients In elderly patients with normal renal function, the dosage regimen is the same as for adult patients. Children Moxonidine is not recommended for use in children and adolescents under 18 years of age due to a lack of safety and efficacy data. Side effect The frequency of side effects is given in the following gradation: very often (≥ 1/10); often (≥ 1/100, < 1/10); infrequently (≥ 1/1000, < 1/100); rarely (≥ 1/10000, < 1/1000); very rarely (< 1/10000); unknown (according to the available data, it is not possible to determine the frequency of occurrence). Heart disorders: infrequently - bradycardia. Hearing disorders: infrequently - ringing in the ears. Nervous system disorders: often - headache *, dizziness, vertigo, drowsiness; infrequently - fainting *. Vascular disorders: infrequently - hypotension (including orthostatic hypotension). Gastrointestinal disorders: very often - dry mouth; often - diarrhea, nausea, vomiting, dyspepsia. Skin and subcutaneous fat disorders: often - rash, itching; infrequently - angioedema. General disorders: often - asthenia; infrequently - edema. Skeletal muscle and connective tissue disorders: often - back pain; infrequently - pain in the neck. Mental disorders: often - sleep disturbances; infrequently - increased excitability. * No increase in frequency compared to placebo was observed. Contraindications hypersensitivity to moxonidine or to any of the excipients; angioedema in history; sick sinus syndrome or sinoatrial block; atrioventricular blockade of the 2nd and 3rd degree; bradycardia (less than 50 beats / min at rest); malignant arrhythmia; heart failure; severe ischemia of the heart or unstable angina; severe liver failure; chronic renal failure (CC < 30 ml / min, serum creatinine concentration > 160 μmol / l); hereditary galactose intolerance, lactase deficiency or malabsorption of glucose-galactose; pregnancy or breastfeeding; children’s age up to 18 years. Overdose Symptoms: headache, sedation, drowsiness, hypotension, dizziness, asthenia, bradycardia, dry mouth, vomiting, fatigue and epigastric pain. Potentially, a short-term increase in blood pressure, tachycardia, hyperglycemia is also possible. Treatment: There is no specific antidote. In case of hypotension, restoration of circulating blood volume by the administration of fluid and dopamine is recommended. Bradycardia can be treated with atropine. Alpha-adrenergic antagonists may reduce or eliminate transient hypertension in moxonidine overdose. Precautions A role for moxonidine in slowing atrioventricular conduction cannot be ruled out. Thus, caution is advised in the treatment of patients with a possible predisposition to the development of atrioventricular block. Special care must be taken when using moxonidine in patients with 1st degree atrioventricular block to avoid bradycardia. Moxonidine should not be used in patients with high atrioventricular block. Special care must be taken when using moxonidine in patients with severe ischemic heart disease and unstable angina, as experience with its use in this category of patients is limited. Caution is advised when prescribing moxonidine to patients with renal insufficiency, since moxonidine is excreted from the body mainly through the kidneys. When using the drug in such patients, careful dose titration is recommended, especially at the beginning of therapy. If moxonidine is used in combination with a β-blocker and treatment with both drugs must be discontinued, then the 0-blocker should be discontinued first, and moxonidine should be discontinued a few days later. At the moment, there is no evidence that discontinuation of moxonidine leads to an increase in blood pressure (“withdrawal effect”). However, abrupt discontinuation of moxonidine treatment is not recommended. The dose of the drug should be reduced gradually over two weeks. Use during pregnancy and lactation Moxonidine should not be used during pregnancy unless absolutely necessary. Moxonidine should not be used while breastfeeding as the drug passes into breast milk. Breastfeeding should be discontinued if moxonidine therapy is essential. Influence on the ability to drive vehicles or other potentially dangerous mechanisms Some side effects of the drug (hypotension, drowsiness, dizziness) may reduce the reaction and concentration of the patient, which may affect his ability to drive a car and mechanisms. This should be taken into account when driving a car or working with potentially dangerous machinery. Interaction with other drugs Simultaneous use of moxonidine with other antihypertensive drugs leads to a mutual enhancement of the antihypertensive effect. Since tricyclic antidepressants may reduce the effectiveness of antihypertensive drugs with a central mechanism of action, it is not recommended to use tricyclic antidepressants together with moxonidine. Moxonidine may increase the sedative effect of tricyclic antidepressants (their co-administration should be avoided), tranquilizers, alcohol, sedatives and hypnotics. Moxonidine moderately improved cognitive impairment in patients receiving lorazepam. Moxonidine may increase the sedative effect of benzodiazepines when used concomitantly. Moxonidine is excreted by tubular excretion. Therefore, its interaction with other drugs excreted by tubular excretion is not excluded. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the package. Upakovka10 tablets in a blister pack of pony vinyl chloride film and aluminum foil. Three blister packs, together with instructions for medical use, are placed in a cardboard pack. Conditions for dispensing from pharmacies By prescription. Buy Moxonidine tablets p / o 0.4 mg No. 10×3