moxonidine | Moxonidine-SZ tablets coated.pl.ob. 0.2 mg 30 pcs.

Latin name

Moxonidine-SZ

Release form

Film-coated tablets, light pink, round, biconvex. Tablets on a fracture of white or almost white color (dosage of 0.2 mg).

Pharmacological action

Moxonidine is a hypotensive drug with a central mechanism of action. In the brain stem structures (the rostral layer of the lateral ventricles), moxonidine selectively stimulates the 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 β2-adrenergic receptors, which explains the lower likelihood of developing a sedative effect and dry mouth.

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

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

Contraindications

- Hypersensitivity to the active substance and other components of the drug

- syndrome of weakness of the sinus node

- severe bradycardia (resting heart rate less than 50 beats / min)

- atrioventricular block II and III s s cardiac rhythm - acute and chronic heart failure (III-IV functional class according to NYHA classification)

- simultaneous use with tricyclic antidepressants (see section Interaction with other medicinal products drugs)

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

- hemodialysis

- lactation period

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

- over 75 years old

- under 18 years of age (due to lack of safety and efficacy data).

Precautions:

Special care must be taken when using moxonidine in patients with grade I atrioventricular block (risk of developing bradycardia), severe coronary artery disease, severe coronary heart disease or unstable angina pectoris (insufficient experience), chronic heart failure, severe liver with impaired renal function (CC more than 30 ml / min).

Use during pregnancy and lactation

Pregnancy

Clinical data on the use of Moxonidine-SZ in pregnant women are not available. In animal studies, the embryotoxic effect of the drug was established.

Moxonidine-SZ should be prescribed to pregnant women only after a careful assessment of the risk-benefit ratio when the benefit to the mother outweighs the potential risk to the fetus.

Lactation

Moxonidine-C3 passes into breast milk and therefore should not be given during breast-feeding.

If it is necessary to use Moxonidine-SZ during lactation, breast-feeding should be discontinued.

Composition

1 tab. contains:

active substance: moxonidine - 0.2 mg

excipients (core): croscarmellose sodium (primellose) - 3.0 mg lactose monohydrate (lactopress) (milk sugar) - 95.3 mg silicon colloidal dioxide (aerosil) - 0.5 mg sodium stearyl fumarate - 1.0 mg

excipients (shell): Opadry II (polyvinyl alcohol, partially hydrolyzed - 1.32 mg of titanium dioxide E171 - 0.6027 mg talc - 0.6 mg macrogol (polyethylene glycol 3350) - 0.3705 mg soy lecithin E322 - 0.105 mg iron dye oxide (II) yellow - 0, 0003 mg iron dye oxide (II) red - 0.0015 mg).

Dosage and Administration

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. An individual correction of the daily dose is necessary depending on the patient's tolerance of the therapy.

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

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

Side effects

The frequency of side effects below was determined according to the following: very often (> 1/10) often (> 1/100, <1/10) infrequently (> 1/1000, <1/100) including individual messages.

From the central nervous system:

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

Infrequently: fainting *.

From the cardiovascular system:

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

From the gastrointestinal tract:

Very often: dry oral mucosa.

Often: diarrhea, nausea, vomiting, dyspepsia.

From the skin and subcutaneous tissue:

Often: skin rash, itching.

Infrequently: angioedema.

Mental disorders:

Often: insomnia.

Infrequently: nervousness.

On the part of the hearing organ and labyrinth disorders:

Infrequently: ringing in the ears.

From the side of musculoskeletal and connective tissue:

Often: back pain.

Infrequently: pain in the neck.

General disorders and disorders at the injection site:

Often: asthenia.

Infrequently: peripheral edema.

(* - frequency is comparable to placebo).

Drug Interactions

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

Tricyclic antidepressants can reduce the effectiveness of central antihypertensive drugs, therefore, it is not recommended to take them together with moxonidine.

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

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

Moxonidine may enhance the sedative effect of benzodiazepine derivatives when given concomitantly.

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

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



overdose There have been reports of several overdose cases with non-lethal doses up to 19.6 mg.

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

There is no specific antidote treatment for

. In the case of a marked decrease in blood pressure, it may be necessary to restore the volume of circulating blood due to the introduction of fluid and dopamine (injectable).

Bradycardia can be stopped with atropine (injection).

In severe cases of overdose, it is recommended to carefully monitor the disturbances of consciousness and to prevent respiratory depression.

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

Moxonidine is slightly excreted during hemodialysis.

Storage Conditions

In a dry, dark place at a temperature not exceeding 25 РC.

Keep out of the reach and sight of children.

Shelf life

3 years.

Do not use after the expiration date printed on the package.

Deystvuyushtee substance

Moxonidine

Terms and conditions

prescription

Dosage form

tablets

Possible product names

moxonidine-sz tablets coated film 0.2 mg 30 pcs.