Tenzotran pills 0.2mg, 28pcs

Composition

Film-coated tablets.

1 tablet contains:

Active ingredient:

moxonidine 0.2 mg;

excipients:

lactose monohydrate,

povidone-K 25,

crospovidone,

magnesium stearate,

Opadray Y-1-7000,

iron oxide red dye.

Pharmacological action

Tensotran is a central antihypertensive agent.

Selective agonist of imidazoline receptors responsible for reflex control of the sympathetic nervous system (located in the venterolateral medulla oblongata).

It has a low affinity for central alpha-2-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 use 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) do not change significantly.

Indications

Arterial hypertension.

Use during pregnancy and lactation

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

However, Tenzotran should only be prescribed to pregnant women if the potential benefit to the mother outweighs the potential risk to the fetus.

Moxonidine penetrates into breast milk, and women are advised to stop breastfeeding or discontinue the drug during treatment.

Contraindications

Hypersensitivity to moxonidine and other components of the drug, sinus node weakness syndrome, sinoatrial and atrioventricular block II and III degrees, severe bradycardia (heart rate less than 50 beats/min), chronic heart failure of NYHA functional class III and IV, history of angioedema, unstable angina, severe liver failure (more than 9 points on the Child-Pugh scale), chronic renal failure (Creatinine clearance less than 30 ml/min, creatinine greater than 160 mmol/L), age up to 18 years (efficacy and safety have not been established), lactation period; 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 first degree of chronic renal failure (QC more than 30 but less than 60 ml/min), expressed cerebrovascular, after myocardial infarction, chronic heart failure I and II functional class, violations of liver function, hemodialysis, pregnancy.

Side effects

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

Their intensity 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 reports).

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:  dryness of the oral mucosa; often – nausea, constipation and other gastrointestinal disorders; very rarely-hepatitis, cholestasis;

From the side of the skin and integuments:  sometimes-allergic reactions.

From the genitourinary system:  sometimes – urinary retention or incontinence, impotence, decreased libido;

From the side of the visual organ:  sometimes-dry eyes that cause itching or burning sensation.

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

Interaction

Moxonidine can be administered with thiazide diuretics, slow calcium channel blockers, and other antihypertensive agents.

The combined use of moxonidine with these and other antihypertensive agents leads to an additive effect and an increase in the hypotensive effect.

When moxonidine is administered with hydrochlorothiazide, glibenclamide (glyburide) or digoxin, there is no pharmacokinetic interaction.

Tricyclic antidepressants may reduce the effectiveness of centrally acting antihypertensive agents, so it is not recommended to prescribe tricyclic antidepressants simultaneously with moxonidine.

Moxonidine modestly enhances cognitive decline in patients taking lorazepam.

The use 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 moxonidine is co-administered with moclobemide, there is no pharmacodynamic interaction.

How to take, course of use and dosage

Inside, regardless of food intake, with a sufficient amount of liquid.

In most cases, the initial dose of Tenzotran is 0.2 mg per day in one dose, 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 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 insufficiency (creatinine clearance 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.

Overdose

Several cases of non-fatal overdose have been reported when doses of up to 19.6 mg per dose were used.

Symptoms:  headache, sedation, drowsiness, marked decrease in blood pressure, dizziness, asthenia, bradycardia, dryness of the oral mucosa, vomiting and stomach pain, increased fatigue. Potentially also possible: short-term increase in blood pressure, tachycardia, hyperglycemia.

Treatment:  there is no specific antidote. Gastric lavage, taking activated charcoal and laxatives, symptomatic therapy.

In the case of a marked decrease in blood pressure, it is recommended to restore the volume of circulating blood through the introduction of fluid and the introduction of dopamine. Bradycardia can be treated with atropine.

Alpha-adrenergic antagonists may reduce or eliminate transient hypertension in the case of moxonidine overdose.

Special instructions

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

It is not recommended to prescribe tricyclic antidepressants simultaneously with Tensotran.

During treatment, regular monitoring of blood pressure, heart rate and ECG is necessary.

Moxonidine can be given with thiazide diuretics, angiotensin converting enzyme (ACE) inhibitors, and slow calcium channel blockers.

Stop taking Tensotran gradually.

Patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

2 years

Active ingredient

Moxonidine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Hypertension