Moxonidine-SZ, 0.2 mg 30 pcs.

Moxonidine is a hypotensive agent with a central mechanism of action. In brain stem structures (rostral layer of lateral ventricles) moxonidine selectively stimulates imidazoline-sensitive receptors involved in tonic and reflex regulation of sympathetic nervous system.

Indications

Active ingredient

Composition

1 tablet contains:

the active ingredient:

moxonidine – 0.2 mg;

auxiliary substances (core):

croscarmellose sodium (primellose) – 3.0 mg;

lactose monohydrate (lactopress) (milk sugar) – 95.3 mg;

Colloidal silica (aerosil) – 0.5 mg;

sodium stearyl fumarate – 1.0 mg;

accompanied substances (coating):

Opadray II (polyvinyl alcohol, partially hydrolyzed, 1.32 mg; E171 titanium dioxide, 0.6027 mg; talcum powder, 0.6 mg; macrogol (polyethylene glycol 3350) – 0.3705 mg; soy lecithin E322 – 0.105 mg; iron oxide (II) yellow dye – 0.0003 mg; iron oxide (II) red dye – 0.0015 mg).

Interaction

The co-administration of moxonidine with other hypotensive agents leads to additive effects.

Tricyclic antidepressants may decrease the effectiveness of centrally acting hypotensive agents, therefore it is not recommended to take them together with moxonidine.

Moxonidine may increase the effect of tricyclic antidepressants, tranquilizers, ethanol, sedatives and hypnotics.

Moxonidine may moderately improve impaired cognitive function in patients receiving lorazepam.

Moxonidine may increase the sedative effect of benzodiazepine derivatives when prescribed concomitantly.

Moxonidine is excreted by tubular secretion. Therefore, its interaction with other drugs excreted by tubular secretion cannot be excluded.

Beta-adrenoblockers increase bradycardia, the severity of negative and dromotropic effects.

Directions for use

Ingestion, regardless of meals.

In most cases, the starting dose of Moxonidine-SZ is 0.2 mg per day. The maximum single dose is 0.4 mg. The maximum daily dose to be divided into 2 doses is 0.6 mg.

An individual adjustment of the daily dose is necessary depending on the patient’s tolerance to the ongoing therapy.

Dose adjustment is not required for patients with hepatic insufficiency. The starting dose for patients with moderate to severe renal insufficiency is 0.2 mg/day.

If necessary and if well tolerated, the daily dose may be increased to a maximum of 0.4 mg.

Special Instructions

If it is necessary to withdraw beta-adrenoblockers and Moxonidine-SZ taken simultaneously, the beta-adrenoblockers should be withdrawn first and only after several days Moxonidine-SZ.

There is currently no evidence that discontinuation of Moxonidine-SZ causes an increase in BP. However, it is not recommended that Moxonidine-SZ be stopped abruptly; instead, the dose should be reduced gradually over a period of two weeks.

During treatment, avoid drinking alcohol.

Heart rate and electrocardiography should be monitored regularly during treatment.

The effect of Moxonidine-SZ on the ability to drive vehicles or operate machinery has not been studied. However, taking into account the possibility of dizziness and somnolence, patients should be cautious when engaged in potentially dangerous activities requiring increased attention, such as driving vehicles or operating machinery requiring increased concentration.

Contraindications

– hypersensitivity to the active substance and other components of the drug;

– sinus node weakness syndrome;

– expressed bradycardia (resting heart rate less than 50 beats/min);

– Atrioventricular block of II and III degree;

– expressed cardiac arrhythmia;

– acute and chronic heart failure (functional class III-IV according to NYHA classification);

– concomitant use with tricyclic antidepressants (see “Interaction with other antidepressants”).

– concomitant use of tricyclic antidepressants (see section “Interaction with other medicinal products”);

– severe renal insufficiency (CKR less than 30 ml/min);

– hemodialysis;

– lactation period;

– hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

– age older than 75 years;

– under 18 years of age (due to lack of safety and effectiveness data).

Particular caution should be exercised when using moxonidine in patients with grade I atrioventricular block (risk of bradycardia); severe coronary artery disease, severe coronary heart disease or unstable angina pectoris (insufficient experience of use), chronic heart failure, severe liver failure, with impaired renal function (CK more than 30 ml/min).

Side effects

The frequency of side effects listed below was determined accordingly as follows: very frequently (>1/10); frequently (>1/100, <1/10); infrequently (>1/1000, <1/100); including individual reports.

Anxiety to the central nervous system:

Often: headache*, dizziness (vertigo), drowsiness.

Infrequent: fainting*.

Cardiovascular system disorders:

Infrequent: marked decrease in BP, orthostatic hypotension*, bradycardia.

Gastrointestinal tract disorders:

very often: dryness of the oral mucosa.

Often: diarrhea, nausea, vomiting, dyspepsia.

Skin and subcutaneous tissue:

Often: skin rash, itching.

Infrequent: angioedema.

Mental disorders:

Often: insomnia.

Infrequent: nervousness.

Hearing organ and labyrinth disorders:

Infrequent: tinnitus.

Skeletal, muscular and connective tissue disorders:

Often: back pain.

Infrequent: pain in the neck area.

General disorders and disorders at the site of administration:

Often: asthenia.

Infrequent: peripheral edema.

(* – frequency is comparable to placebo).

Overdose

There have been reports of several non-fatal overdoses when doses up to 19.6 mg were used at one time.

Symptoms: headache, sedation, marked BP decrease, dizziness, asthenia, bradycardia, dry mouth, vomiting, increased fatigue, epigastric pain, respiratory depression and impaired consciousness. In addition, transient BP elevation, tachycardia, and hyperglycemia are also possible, as has been shown in several high-dose animal studies.

Treatment

There is no specific antidote. If there is a marked decrease in BP, restoration of circulating blood volume by administration of fluids and dopamine (by injection) may be necessary.

Bradycardia may be controlled with atropine (injection).

In severe cases of overdose, it is recommended that impaired consciousness be carefully controlled and respiratory depression avoided.

Alpha-adrenoreceptor antagonists may reduce or eliminate paradoxical hypertensive effects in moxonidine overdose.

Moxonidine is slightly excreted by hemodialysis.

Pregnancy use

Similarities