Moxonidine-SZ, pills 0.4mg 30pcs

Composition

of 1 tab. – moxonidine 0.4 mg. Auxiliary substances: croscarmellose sodium (primellose) – 3 mg, lactose monohydrate (lactopress) (milk sugar) – 95.1 mg, colloidal silicon dioxide (aerosil) – 0.5 mg, sodium stearyl fumarate-1 mg. Shell composition:  Opadray II (polyvinyl alcohol, partially hydrolyzed – 1.32 mg, titanium dioxide (E171) – 0.5751 mg, talc – 0.6 mg, macrogol (polyethylene glycol 3350) – 0.3705 mg, soy lecithin (E322) – 0.105 mg, aluminum varnish based on indigo carmine – 0.0018 mg, aluminum varnish based on azorubin dye – 0.0153 mg, aluminum varnish based on crimson dye [Ponso 4R] – 0.0123 mg).

Pharmacological action

An antihypertensive drug 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.

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.

The use of moxonidine leads to a decrease in OPSS 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

There are no clinical data on the use of Moxonidine in pregnant women. In the course of animal studies, the embryotoxic effect of the drug was established. Moxonidine should be given to pregnant women only after careful risk-benefit assessment, when the intended benefit to the mother outweighs the potential risk to the fetus. Moxonidine is excreted in breast milk, so the drug should not be prescribed during breast-feeding. If it is necessary to use Moxonidine-SZ during lactation, breast-feeding should be discontinued.

Recommendations for use

Contraindications

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

— severe heart rhythm disorders;

— SSSU;

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

— AV-block II and III degree

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

— simultaneous use of tricyclic antidepressants;

— hemodialysis;

— lactation period;

— age over 75 years of age;

— age up to 18 years (due to a lack of data on safety and efficacy);

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

— hypersensitivity to the Active ingredient and other components of the drug.

With caution

Special care should be taken when using moxonidine in patients with grade I AV block (risk of developing bradycardia), severe coronary artery disease, severe CHD or unstable angina (insufficient experience), chronic heart failure, severe hepatic insufficiency, 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:  often – headache*, dizziness (vertigo), drowsiness; infrequently-fainting*.

Mental disorders:  often – insomnia; infrequently-nervousness.

Hearing disorders and labyrinth disorders:  infrequently-ringing in the ears.

From the cardiovascular system:  infrequently – marked decrease in blood pressure, orthostatic hypotension*, bradycardia.

From the digestive system:  very often – dryness of the oral mucosa; often-diarrhea, nausea, vomiting, dyspepsia.

Skin and subcutaneous tissue disorders:  often – skin rash, itching.

Musculoskeletal disorders:  often-back pain; infrequently-neck pain.

Allergic reactions:  infrequently-angioedema.

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 centrally acting antihypertensive agents, and therefore their simultaneous use with moxonidine is not recommended.

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 used concomitantly.

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

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

How to take, course of use and dosage

The drug is taken orally, regardless of food intake. In most cases, the initial dose of the drug Moxonidine-SZ is 0.2 mg / 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 to 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.

Overdose

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

Symptoms:  headache, sedation, excessive lowering of 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 studies of the use of the drug in high doses in animals.

Treatment:  there is no specific antidote. In the case of an excessive decrease in blood pressure, it may be necessary to restore the BCC by injecting fluid and dopamine. 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 2 weeks.

Alcohol consumption should be excluded during treatment.

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

Influence on the ability to drive motor vehicles and manage mechanisms

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 be careful when driving vehicles and engaging in other activities that require increased concentration of attention.

Form of production

Film-coated tablets are dark pink in color, round, biconvex; at the break – white or almost white in color.

Storage conditions

The drug should be stored out of the reach of children, dry, protected from light at a temperature not exceeding 25°C.

Shelf life

3 years

Active ingredient

Moxonidine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets