Moxonidine-SZ, pills 0.2mg 30pcs

Composition

>

of 1 tab. contains:

Active ingredient:

moxonidine-0.2 mg;

excipients (core):

croscarmellose sodium (primellose) – 3.0 mg;

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

colloidal silicon dioxide (aerosil) – 0.5 mg;

sodium stearyl fumarate-1.0 mg;

excipients (shell):

Opadry II (polyvinyl alcohol, partially hydrolyzed is 1.32 mg; titanium dioxide E 171 – 0,6027 mg; talc – 0.6 mg; macrogol (polyethylene glycol 3350) – 0,3705 mg; soy lecithin E 322 – 0,105 mg; dye iron oxide (II) yellow 0.0003 mg; dye iron oxide (II) red – 0.0015 mg).

Pharmacological action

Moxonidine is an antihypertensive agent with a central mechanism of action. In the brain stem structures (rostral layer of the lateral ventricles) moxonidine selectively stimulates imidazoline-sensitive receptors involved in the tonic and reflex regulation of the sympathetic nervous system. Stimulation of imidazoline receptors reduces peripheral sympathetic activity and blood pressure (BP).

Moxonidine differs from other sympatholytic antihypertensive agents in its lower affinity for α2-adrenergic receptors, which explains the lower likelihood of sedation and dry mouth.

Taking moxonidine leads to a decrease in systemic vascular resistance and blood pressure.

Moxonidine improves the insulin sensitivity index by 21% (compared to placebo) in patients with obesity, insulin resistance and moderate arterial hypertension.

Indications

Arterial hypertension.

Use during pregnancy and lactation

Pregnancy There are no clinical data on the use of Moxonidine-SZ in pregnant women. In the course of animal studies, the embryotoxic effect of the drug was established. Moxonidine-SZ should be prescribed to pregnant women only after careful assessment of the risk-benefit ratio, when the benefit to the mother exceeds the potential risk to the fetus. During lactation, Moxonidine-SZ passes into breast milk and therefore should not be administered during breast-feeding. If it is necessary to use Moxonidine-SZ during lactation, breastfeeding should be discontinued.

Recommendations for use

Inside, regardless of food intake.

In most cases, the initial dose of Moxonidine-SZ 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.

Individual adjustment of the daily dose is necessary, depending on the patient’s tolerance to the therapy.

No dose adjustment is required for patients with hepatic insufficiency. The initial dose for patients with moderate or severe renal insufficiency is 0.2 mg / day.

If necessary and with good tolerability, the daily dose can be increased to a maximum of 0.4 mg.

Contraindications

– Hypersensitivity to the Active ingredient and other components of the drug;

– syndrome of weakness of the sinus node;

– severe bradycardia (heart rate of rest of less than 50 beats/min);

– atrioventricular block II and III degree;

– severe heart rhythm disorders;

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

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

– severe renal failure (CC less than 30 ml/min);

– hemodialysis;

– lactation period;

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

– age over 75 years of age;

the age of 18 (due to the lack of data on safety and efficacy).

With caution:

Special care should be taken when using moxonidine in patients with grade I atrioventricular block (risk of developing bradycardia), severe coronary artery disease, severe coronary artery disease or unstable angina (insufficient experience), chronic heart failure, severe hepatic insufficiency, and impaired renal function (creatinine clearance greater than 30 ml/min).

Side effects

The frequency of side effects listed below was determined according to the following: very common (>1/10); often (>>1/100, >><1/10); infrequently (>1/1000, <1/10); infrequently (>

From the central nervous system:

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

Infrequently: fainting*.

From the cardiovascular system:

Infrequently: marked decrease in blood pressure, orthostatic hypotension*, bradycardia.

From the gastrointestinal tract:

Very common: dryness of the oral mucosa.

Common: diarrhea, nausea, vomiting, dyspepsia.

Skin and subcutaneous tissue disorders:

Common: skin rash, pruritus.

Infrequently: angioedema.

Mental disorders:

Common: insomnia.

Infrequently: nervousness.

Hearing disorders and labyrinth disorders:

Infrequently: ringing in the ears.

Musculoskeletal and connective tissue disorders:

Common: back pain.

Infrequently: neck pain.

General disorders and disorders at the injection site:

Often: asthenia.

Infrequently: peripheral edema.

(*- the frequency is comparable to placebo).

Interaction

The combined use of moxonidine with other antihypertensive agents leads to an additive effect.

Tricyclic antidepressants may reduce the effectiveness of central antihypertensive agents, and therefore they are not recommended to be taken together with moxonidine.

Moxonidine may enhance the effects of tricyclic antidepressants, tranquilizers, ethanol, sedatives, and sleeping pills.

Moxonidine is able to moderately improve impaired cognitive function in patients receiving lorazepam.

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

Moxonidine is secreted by tubular secretion. Therefore, its interaction with other drugs released by tubular secretion is not excluded.

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

Overdose

Several cases of non-fatal overdose have been reported with simultaneous doses of up to 19.6 mg.

Symptoms:  headache, sedation, marked decrease in blood pressure, dizziness, asthenia, bradycardia, dry oral mucosa, vomiting, increased fatigue, epigastric pain, 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 animal studies.

Treatment

There is no specific antidote. In the case of a marked decrease in blood pressure, it may be necessary to restore the volume of circulating blood through the introduction of fluid and dopamine (by injection).

Bradycardia can be stopped by atropine (injection).

In severe cases of overdose, it is recommended to carefully monitor disorders of consciousness and avoid respiratory depression.

Alpha-adrenergic antagonists may reduce or eliminate the paradoxical hypertensive effects of moxonidine overdose.

Moxonidine is slightly eliminated during hemodialysis.

Special instructions

If it is necessary to cancel simultaneously taking beta-blockers and the drug Moxonidine-SZ, first cancel beta-blockers and only after a few days Moxonidine-SZ.

Currently, there is no evidence that discontinuation of Moxonidine-SZ leads to an increase in blood pressure. However, it is not recommended to stop taking Moxonidine-SZ abruptly, instead, gradually reduce the dose of the drug over two weeks.

Avoid alcohol consumption during treatment.

During treatment, regular monitoring of the heart rate and electrocardiography is necessary.

Influence on the ability to drive vehicles and fur. :

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 drowsiness, patients should exercise caution when engaging in potentially dangerous activities that require increased attention, such as driving vehicles or operating equipment that requires increased concentration of attention.

Form of production

Tablets covered with a film-coated light pink color, round, biconvex. Tablets with a break of white or almost white color (dosage of 0.2 mg).

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Moxonidine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension