Tenzotran, 0.2 mg 28 pcs.

Tenzotran is a hypotensive agent of central action. < br>

A selective agonist of imidazoline receptors responsible for reflex control of the sympathetic nervous system (localized in the ventero-lateral part of the medulla oblongata). < br>

It has low affinity with central alpha2-adrenoreceptors, due to interaction with which the sedative effect and dryness of the oral mucosa are mediated. < br>

Moxonidine improves insulin sensitivity index by 21% compared to placebo in obese patients and insulin-resistant patients with moderate arterial hypertension. < br>

Impact on hemodynamics: decrease of systolic and diastolic blood pressure (BP) with single and prolonged use of moxonidine is associated with decrease of sympathetic pressor action on peripheral vessels and decrease of total peripheral vascular resistance, whereas cardiac output and heart rate (HR) do not change significantly.

Indications

Arterial hypertension.

Active ingredient

Composition

Tablets, coated with a film coating.

1 tablet contains:

the active ingredient:

moxonidine 0.2 mg;

Associates:

lactose monohydrate,

povidone – K25,

crospovidone,

magnesium stearate,

Opadray Y-1-7000,

red iron oxide dye.

How to take, the dosage

Overly, regardless of meals, with plenty of fluid.

In most cases, the starting dose of Tensotran is 0.2 mg per day at a single dose, preferably in the morning hours.

If the therapeutic effect is insufficient, the dose may be increased after 3 weeks of therapy to 0.4 mg per day in 2 doses (morning and evening) or once (morning).

The maximum daily dose to 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 dosing recommendations are the same as for adult patients.

In patients with renal insufficiency (CK of 30-60 ml/min) and patients on hemodialysis, the single dose should not exceed 0.2 mg. The maximum daily dose is 0.4 mg.

Interaction

Moxonidine may be administered with thiazide diuretics, “slow” calcium channel blockers and other hypotensive agents.

The co-administration of moxonidine with these and other antihypertensive agents leads to an additive effect and increased hypotensive effect.

There is no pharmacokinetic interaction when prescribing moxonidine with hydrochlorothiazide, glibenclamide (gliburide) or digoxin.

Tricyclic antidepressants may decrease the effectiveness of centrally acting antihypertensive agents, so it is not recommended that tricyclic antidepressants be prescribed concomitantly with moxonidine.

Moxonidine moderately enhances impaired cognitive ability 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.

There is no pharmacodynamic interaction when moxonidine is co-administered with moclobemide.

Special Instructions

If it is necessary to cancel simultaneously taken beta-adrenoblockers and Tensotran, first cancel the beta-adrenoblockers and only after a few days, Tensotran.

Tricyclic antidepressants should not be prescribed at the same time as Tensotran.

During treatment, regular monitoring of BP, HR and ECG is necessary.

Moxonidine may be prescribed with thiazide diuretics, angiotensin-converting enzyme (ACE) inhibitors and slow calcium channel blockers.

Tenzotran should be discontinued gradually.

Patients with the rare hereditary pathology of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this drug.

Contraindications

High sensitivity to moxonidine and other drug components, sinus node weakness syndrome, sinoatrial and atrioventricular block of II and III degree, expressed bradycardia (heart rate less than 50 bpm).), chronic heart failure III and IV functional class according to NYHA classification, angioneurotic edema in anamnesis, unstable angina pectoris, expressed hepatic insufficiency (more than 9 points by Child-Pugh scale), chronic renal insufficiency (CK less than 30 ml/min, creatinine more than 160 μmol/l), age under 18 years (efficacy and safety not established), lactation; galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

With caution:Parkinson’s disease (severe form), epilepsy, glaucoma, depression, “intermittent” claudication, Raynaud’s disease, atrioventricular block of degree I, chronic renal failure (CK more than 30, but less than 60 ml/min.), expressed cerebrovascular disorders, after myocardial infarction, chronic heart failure class I and II, liver function disorders, hemodialysis, pregnancy.

Side effects

Especially at the beginning of therapy the most frequent adverse reactions were: dry mouth, headache, asthenia and somnolence.

The intensity of their occurrence and frequency decreased with repeated administration. 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 reports).

Cardiovascular system disorders: often – vasodilation; sometimes – marked BP decrease, orthostatic hypotension, paresthesias, Raynaud’s syndrome, peripheral circulation disorders;

Central nervous system disorders: frequent – increased fatigue, drowsiness, headache, dizziness; sometimes – insomnia, asthenia;

Gastrointestinal tract: dry mouth mucosa; frequent – nausea, constipation and other GI dysfunction; very rare – hepatitis, cholestasis;

Skin and skin side: sometimes – allergic reactions;

Urinary system: sometimes – urinary retention or incontinence, impotence, decreased libido;

Visual organ: Sometimes – dry eyes causing itching or burning sensation;

Others: sometimes – edema of various localization, weakness in the legs, angioedema, fainting, fluid retention, anorexia, pain in the parotid glands, gynecomastia.

Overdose

There have been reports of several non-fatal overdoses with doses up to 19.6 mg at a single dose.

Symptoms: headache, sedation, somnolence, marked decrease in BP, dizziness, asthenia, bradycardia, dry oral mucosa, vomiting and gastric pain, increased fatigue. Potentially also: transient BP increase, tachycardia, hyperglycemia.

Treatment: There is no specific antidote. Gastric lavage, administration of activated charcoal and laxatives, symptomatic therapy.

In case of marked BP decrease, restoration of circulating blood volume by fluid administration and dopamine administration is recommended. Bradycardia may be controlled with atropine.

Alpha-adrenoreceptor antagonists may reduce or eliminate transient arterial hypertension in moxonidine overdose.

Pregnancy use

There are no clinical data on the negative effect on pregnancy.

However, Tensotran should be administered to pregnant women only if the potential benefit to the mother exceeds the possible risk to the fetus.

Moxonidine penetrates into breast milk, it is recommended that women stop breastfeeding or discontinue the drug during treatment.

Similarities