Moksonydyn | Moxonidine-SZ tablets coated.pl.ob. 0.4 mg 30 pcs.

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BID827180
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Pharmacological action

Antihypertensive 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.

Moxonidine differs from other sympatholytic antihypertensive agents in a lower affinity for ОІ2-adrenergic receptors, which explains the lower likelihood of developing a sedative effect and dry mouth. The use of moxonidine leads to a decrease in OPSS and blood pressure.

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

Antihypertensive 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.

Moxonidine differs from other sympatholytic antihypertensive agents in a lower affinity for ОІ2-adrenergic receptors, which explains the lower likelihood of developing a sedative effect and dry mouth. The use of moxonidine leads to a decrease in OPSS and blood pressure.

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

Indications

- arterial hypertension.

Contraindications

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

- severe cardiac arrhythmias

- SSSU

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

- AV block II and III degree

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

- simultaneous use with tricyclic antidepressants

- hemodialysis

- lactation period

- over 75 years old

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

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

- hypersensitivity to the active substance and other components of the drug .

Precautions

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

Composition

1 tab. - moxonidine 0.4 mg.

Excipients: 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: Opadry 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 the dye azorubine - 0.0153 mg, aluminum varnish based on the dye crimson [Ponceau 4R] - 0.0123 mg).

Dosage and administration of

The drug is taken orally, regardless of food intake.

In most cases, the initial dose of 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. 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 to severe renal failure is 0.2 mg / day. If necessary and with good tolerance, the daily dose can 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 side of the central nervous system: often - headache *, dizziness (vertigo), drowsiness infrequently - fainting *.

Mental disorders: often - insomnia infrequently - nervousness.

On the part of the hearing organ and labyrinth disorders: infrequently - ringing in the ears.

From the cardiovascular system: infrequently - a pronounced decrease in blood pressure, orthostatic hypotension *, bradycardia.

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

From the skin and subcutaneous tissues: often - skin rash, itching.

From the musculoskeletal system: often - back pain infrequently - pain in the neck.

Allergic reactions: infrequently - angioedema.

General disorders and disorders at the injection site: often - asthenia infrequently - peripheral edema.

* - the frequency is comparable to placebo.

Overdose

There are reports of several cases of overdose without fatal outcome, when doses up to 19.6 mg were used simultaneously.

Symptoms: headache, sedation, excessive decrease in blood pressure, dizziness, asthenia, bradycardia, dry oral mucosa, vomiting, fatigue, epigastric pain, respiratory depression and impaired consciousness. In addition, a short-term increase in blood pressure, tachycardia and hyperglycemia are also possible, as has been shown in several studies on 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 due to the introduction of fluid and dopamine (injection). Bradycardia can be stopped with atropine (injection). In severe cases of overdose, it is recommended to carefully monitor impaired consciousness and prevent respiratory depression. Antagonists of β-adrenergic receptors can reduce or eliminate the paradoxical hypertensive effects of an overdose of moxonidine. Moxonidine is slightly excreted during hemodialysis.

Active ingredient

Moxonidine

lekarstvennaja form

tablets

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