Description
Release form
Film-coated tablets.
Packing
28 pcs.
Pharmacological action
Tenzotran is a central antihypertensive. Selective agonist of imidazoline receptors responsible for reflex control of the sympathetic nervous system (localized in the ventero-lateral region of the medulla oblongata). It has a low affinity for central alpha2-adrenergic receptors, due to the interaction with which the sedative effect and dryness of the oral mucosa are mediated. Moxonidine improves the insulin sensitivity index by 21% compared to placebo in obese patients and insulin-resistant patients with moderate arterial hypertension. Effect on hemodynamics: a decrease in systolic and diastolic blood pressure (BP) with a single and prolonged administration of moxonidine is associated with a decrease in the pressor effect of the sympathetic system on peripheral vessels, a decrease in total peripheral vascular resistance, while cardiac output and heart rate (HR) are not significantly changed.
Contraindications
Hypersensitivity to moxonidine and other components of the drug, sinus node syndrome, sinoatrial and atrioventricular block II and III degree, severe bradycardia (heart rate less than 50 beats / min.), functional class III and IV chronic heart failure history of angioedema, unstable angina, severe liver failure (more than 9 points on the Child-Pugh scale), chronic renal failure (CC less than 30 ml / min., creatinine olee 160 pmol / L) age up to 18 years (efficacy and safety have not been established), lactation, galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Precautions: Parkinson’s disease (severe), epilepsy, glaucoma, depression, intermittent claudication, Raynaud’s disease, grade I atrioventricular block, chronic renal failure (CC more than 30, but less than 60 ml / min.), severe cerebrovascular disorders , after myocardial infarction, chronic heart failure of the I and II functional class, impaired liver function, hemodialysis, pregnancy.
Special instructions
If it is necessary to cancel the simultaneously taken beta-blockers and Tenzotran, first beta-blockers and, only after a few days, Tenzotran are canceled.
It is not recommended to prescribe tricyclic antidepressants simultaneously with tenzotran.
During treatment, regular monitoring of blood pressure, heart rate and ECG is necessary.
Moxonidine can be prescribed with thiazide diuretics, angiotensin converting enzyme inhibitors (ACEs), and slow calcium channel blockers.
Stop taking Tenzotran should be gradual.
Patients with a rare inherited pathology of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication.
Composition
1 tablet contains:
active substance: moxonidine 0.2 mg
excipients: lactose monohydrate, povidone – K25, crospovidone, magnesium stearate, Opadry Y-1-7000, iron dye red oxide.
Dosage and administration
Inside, regardless of food intake, with plenty of fluids. In most cases, the initial dose of Tenzotran is 0.2 mg per day at a time, preferably in the morning. If the therapeutic effect is insufficient, the dose can be increased after 3 weeks of therapy to 0.4 mg per day in 2 divided doses (morning and evening) or once (in the morning). The maximum daily dose, which should be divided into 2 doses (morning and evening), is 0.6 mg. The maximum single dose is 0.4 mg.
In elderly patients with normal renal function, the dosage recommendations are the same as for adult patients.
In patients with renal failure (CC from 30-60 ml / min.) and patients on hemodialysis, a single dose should not exceed 0.2 mg. The maximum daily dose is 0.4 mg.
Side effects of
Especially at the beginning of therapy, the most frequent adverse reactions were: dry mouth, headache, asthenia, and drowsiness. The intensity of their manifestation and frequency decrease with repeated use. Frequency of development: very often (more than 1/10), often (more than 1/100, less than 1/10), sometimes (more than 1/1000 and less than 1/100), very rarely (less than 1/1000, including individual posts).
From the cardiovascular system: often – vasodilation sometimes – a marked decrease in blood pressure, orthostatic hypotension, paresthesia, Raynaud’s syndrome, peripheral circulation disorders
From the central nervous system: often – increased fatigue, drowsiness, headache, dizziness, sometimes insomnia, asthenia
From the digestive tract: dry oral mucosa often – nausea, constipation and other disorders of the gastrointestinal tract is very rare – hepatitis, cholestasis
From the skin and skin: GDS – allergic reactions
With the genitourinary system: sometimes – urinary retention or incontinence, impotence, decreased libido
part of the vision: sometimes – dry eyes, itchy or burning sensation
Other: sometimes – edema of various localization, weakness in the legs, angioedema, fainting, fluid retention, anorexia, pain in the parotid glands, gynecomastia.
Drug Interactions
Moxonidine can be prescribed with thiazide diuretics, slow calcium channel blockers and other antihypertensive drugs.
The combined use of moxonidine with these and other antihypertensive agents leads to an additive effect and an increase in the hypotensive effect.
When prescribing moxonidine with hydrochlorothiazide, glibenclamide (glyburide) or digoxin, there is no pharmacokinetic interaction.
Tricyclic antidepressants may decrease the effectiveness of central antihypertensive drugs, therefore, it is not recommended to prescribe tricyclic antidepressants simultaneously with moxonidine.
Moxonidine moderately enhances cognitive decline in patients taking lorazepam.
The administration of moxonidine together with benzodiazepines may be accompanied by an increase in the sedative effect of the latter.
Moxonidine may potentiate the effect of ethanol when used together.
When prescribing moxonidine together with moclobemide, there is no pharmacodynamic interaction.
overdose
There have been reports of multiple overdose cases with lethal doses up to 19.6 mg per dose.
Symptoms: headache, sedation, drowsiness, marked BP, dizziness, asthenia, bradycardia, dry mouth, vomiting and stomach pain, fatigue. Potentially also possible: short-term increase in blood pressure, tachycardia, hyperglycemia.
Treatment: There is no specific antidote. Gastric lavage, activated charcoal and laxatives, symptomatic therapy.
In case of marked decrease in blood pressure, it is recommended to restore the volume of circulating blood due to the introduction of fluid and the introduction of dopamine. Bradycardia can be stopped with atropine.
Alpha-adrenoceptor antagonists may reduce or eliminate transient hypertension in the case of overdose with moxonidine.
Storage conditions
At a temperature not exceeding 30 ° C.
Shelf life
2 years.
Deystvuyushtee substance
Moxonidine
Terms and conditions
prescription
dosage form
tablets
Possible product names
TENZOTRAN 0.0002 N28 TABLE P / O
TENZO TENZO 0 TENZO TENZO 0/2 TENZO TENZO 0 CAPTURE / SHELL
TENZOTRAN TAB. P.P.O. 0.2MG No. 28
TENZOTRAN TAB. P / O CAPTURE. 0.2MG No. 28
Tenzotran tab. p.p.o. 0.2 mg N28 Israel
Perrigo Israel Pharmaceuticals Ltd., Israel
