Physiotens pills 0.4 mg 28 pcs
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Description
Film-coated pills Physiotens is an antihypertensive drug of central action. Moxonidine is a hypotensive agent with a central mechanism of action. In the brain stem structures (rostral layer of the lateral ventricles), moxonidine selectively stimulates imidazolin-sensitive receptors that are involved in the tonic and reflex regulation of the sympathetic nervous system. Stimulation of the imidazoline receptor decreases peripheral sympathetic activity and blood pressure (BP). Moxonidine differs from other sympatholytic antihypertensive drugs by its lower affinity for α2-adrenoreceptors, which explains the lower likelihood of developing a sedative effect and dry mouth. Acceptance of moxonidine leads to a decrease in systemic vascular resistance and blood pressure. The hypotensive effect of moxonidine was confirmed in double-blind, placebo-controlled, randomized studies. The results of a clinical study involving 42 patients with arterial hypertension and left ventricular hypertrophy (LVH) demonstrated that with a similar decrease in blood pressure, using a combination of angiotensin II receptor antagonists with moxonidine allows for a greater decrease in LVH compared with the free combination of thiazide diuretic and blocker " slow calcium channels (15% versus 11%, p˂0.05). Moxonidine improves by 21% the insulin sensitivity index (compared to placebo) in patients with obesity, insulin resistance, and a moderate degree of arterial hypertension.
Active ingredients
Moxonidine
Release form
Pills
Composition
Active ingredient: moxonidine 0.4 mg. Excipients: lactose monohydrate, povidone, crospovidone, magnesium stearate. Shell: hypromellose, ethylcellulose, macrogol, talc, iron dye red oxide (E 172), titanium dioxide (E 171).
Indications
Arterial hypertension.
Precautionary measures
Before use, consult with your doctor. The drug is available on prescription.
Use during pregnancy and lactation
Pregnancy. Clinical data on the use of fiziotenza in pregnant women are not available. In animal studies, the embryotoxic effect of the drug was established.Physiotens should be prescribed to pregnant women only after a thorough assessment of the risk-benefit ratio, when the benefit to the mother outweighs the potential risk to the fetus. Lactation period. Moxonidine passes into breast milk and therefore should not be administered during breastfeeding. If you need to use Physiotensin during lactation, breastfeeding should be stopped.
Dosage and administration
Inside, regardless of the meal. In most cases, the initial dose of Physiotens is 0.2 mg per day. The maximum single dose is 0.4 mg. The maximum daily dose, which should be divided into 2 doses, is 0.6 mg. An individual adjustment of the daily dose depending on the patient's tolerance of the therapy being performed is required. Dose adjustment for patients with liver failure is not required. The initial dose for patients on hemodialysis is 0.2 mg per day. If necessary and with good tolerance, the daily dose may be increased to 0.4 mg per day. Patients with renal failure are advised to carefully select the dose, especially at the beginning of treatment. The initial dose should be 0.2 mg per day. If necessary and with good tolerance, the daily dose of the drug can be increased to a maximum of 0.4 mg for patients with moderate renal insufficiency (CC more than 30 ml / min, but less than 60 ml / min) and 0.3 mg for patients with severe renal failure (CC less than 30 ml / min).
Side effects
The most frequent side effects in patients taking moxonidine: dry mouth, dizziness, asthenia, and drowsiness. These symptoms often decrease after the first weeks of therapy. Patients who participated in placebo-controlled clinical trials of the drug Physiotens showed the following side effects. The frequency of the side effects listed below was determined according to the following: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), including individual messages. From the central nervous system. Often: headache, dizziness (vertigo), drowsiness. Infrequently: fainting. Since the cardiovascular system. Infrequently: pronounced decrease in blood pressure, orthostatic hypotension, bradycardia. From the gastrointestinal tract.Very often: dry mouth. Often: diarrhea, nausea, vomiting, dyspepsia. From the skin and subcutaneous tissues. Often: skin rash, itching. Infrequently: angioedema. Psychiatric disorders. Often: insomnia. Infrequently: nervousness. On the part of the organ of hearing and labyrinth disorders. Infrequently: ringing in the ears. From the musculoskeletal and connective tissue. Often: back pain. Infrequently: pain in the neck. General disorders and disorders at the site of administration. Often: asthenia. Infrequently: peripheral edema.
Overdose
There are reports of several cases of overdose without fatal outcome, when doses of up to 19.6 mg were simultaneously applied. Symptoms: headache, sedation, drowsiness, marked decrease in blood pressure, dizziness, asthenia, bradycardia, dry mouth, vomiting, fatigue, pain in the epigastric region, respiratory depression and impaired consciousness. In addition, short-term increases in blood pressure, tachycardia, and hyperglycemia are also possible, as has been shown in several high-dose studies in animals. Treatment: there is no specific antidote. In the case of a pronounced decrease in blood pressure, it may be necessary to restore the circulating blood volume due to the administration of fluid and dopamine (injection). Bradycardia can be stopped by atropine (injectable). In severe cases of overdose, it is recommended to carefully monitor impairment of consciousness and avoid respiratory depression. Alpha-adrenoreceptor antagonists can reduce or eliminate the paradoxical hypertensive effects of moxonidine overdose
Interaction with other drugs
Combined use of moxonidine with other antihypertensive drugs leads to an additive effect. Tricyclic antidepressants can reduce the effectiveness of centrally acting antihypertensive drugs, and therefore they are not recommended in conjunction with moxonidine. Moxonidine may enhance the sedative effect of tricyclic antidepressants (co-administration should be avoided), tranquilizers, ethanol, sedatives and hypnotics. Moxonidine can moderately improve impaired cognitive function in patients receiving lorazepam. Moxonidine may potentiate the sedative effect of benzodiazepine produced when administered concurrently.Moxonidine is secreted by tubular secretion. Therefore, its interaction with other drugs secreted by tubular secretion is not excluded.
special instructions
Contraindications: hypersensitivity to the active substance and other components of the drug, sick sinus syndrome, severe bradycardia (heart rate (HR) rest less than 50 beats / min), atrioventricular blockade of the 2nd or 3rd degree, acute and chronic heart failure, lactation, hereditary intolerance to galactose, lactase deficiency or malabsorption of glucose-galactose, age up to 18 years (due to the lack of data on safety and efficacy). Precautions: special care must be taken when using moxonidine in patients with atrioventricular block I degree (risk of developing bradycardia), severe coronary artery disease and unstable angina (experience of use is insufficient), renal failure. In post-marketing observation, cases of atrioventricular block of varying severity were recorded in patients taking moxonidine. The relationship between taking Physiotens and slowing atrioventricular conductivity cannot be completely ruled out. Thus, in the treatment of patients with a probable predisposition to the development of atrioventricular block, caution is advised. If you need to cancel simultaneously taken beta-blockers and the drug Physiotens first cancel the beta-blockers and only a few days later Physiotens. Currently, there is no evidence that discontinuation of the drug Physiotens leads to an increase in blood pressure. However, it is not recommended to stop taking Physiotens sharply, instead, gradually reduce the dose of the drug over two weeks. Influence on ability to driving of the car and to control of cars and mechanisms. Studies on the effect of the drug on the ability to drive and other mechanisms have not been conducted. There are reports of drowsiness and dizziness during treatment with moxonidine. This should be considered when performing the above actions.