Moxonidine Canon, 0.4 mg 28 pcs

Pharmacotherapeutic group:

Hypotensive agent of central action

Code: C02AC05

Indications

Arterial hypertension.

Active ingredient

Composition

1 film-coated tablet, 0.4 mg contains:

the active ingredient:

moxonidine 0.4 mg;

excipients:

Hyprolose (hydroxypropylcellulose) 4.2 mg,

mannitol 95 mg,

croscarmellose sodium 4.7 mg,

Magnesium stearate 0.7 mg,

Microcrystalline cellulose 35 mg;

Composition of the film coating:

Opadray II pink 4 mg, including: polyvinyl alcohol 1.6 mg, macrogol (polyethylene glycol) 0.808 mg, talc 0.592 mg, titanium dioxide 0.9608 mg, sunset yellow dye 0.0004 mg, indigo carmine dye 0.0060 mg, crimson [Ponzo 4R] dye 0.0328 mg.

How to take, the dosage

Ingestion, regardless of meals, with plenty of fluid. In most cases, the initial dose of Moxonidine Canon is 0.2 mg per day, in one dose, preferably in the morning. If the therapeutic effect is insufficient, the dose may be increased after 3 weeks of therapy to 0.4 mg per day, which should be divided into 2 doses (morning and evening) or a single dose.

The maximum daily dose to be divided into 2 doses (morning and evening) is 0.6 mg. The maximum single dose is 0.4 mg.

In elderly patients with normal renal function, the dosing recommendations are the same as in adult patients.

In patients with renal insufficiency (creatinine clearance 30-60 ml/min) and patients on hemodialysis, the single dose should not exceed 0.2 mg and the maximum daily dose is 0.4 mg.

Interaction

Moxonidine Canon may be administered with thiazide diuretics and “slow” calcium channel blockers. Concomitant use of Moxonidine Canon with these and other hypotensive agents leads to additive effect and increased hypotensive effect.

There is no pharmacokinetic interaction when prescribing Moxonidine Canon with hydrochlorothiazide, glibenclamide (gliburide) or digoxin.

Tricyclic antidepressants may decrease the effectiveness of centrally acting hypotensive agents, therefore, their simultaneous use is not recommended.

The drug Moxonidine Canon moderately enhances impaired cognitive ability in patients taking lorazepam.

The administration of Moxonidine Canon together with benzodiazepine derivatives may be accompanied by an increased sedative effect of the latter.

Moxonidine Canon may increase depressant effects on the central nervous system of anxiolytics, barbiturates and ethanol.

Beta-adrenoblockers when combined with moxonidine increase bradycardia, the severity of negative ino- and dromotropic effects.

When prescribing Moxonidine Canon with moclobemide there is no pharmacodynamic interaction.

Special Instructions

If it is necessary to withdraw beta-adrenoblockers and Moxonidine Canon simultaneously, the beta-adrenoblockers should be withdrawn first and Moxonidine Canon only after a few days.

Tricyclic antidepressants should not be prescribed concomitantly with Moxonidine Canon.

During treatment, regular monitoring of BP, HR and ECG is necessary.

Moxonidine Canon may be used with thiazide diuretics, angiotensin-converting enzyme (ACE) inhibitors and slow calcium channel blockers.

The drug Moxonidine Canon should be discontinued gradually.

Impact on driving and operating machinery

Because of possible drowsiness and dizziness during treatment with Moxonidine Canon patients should be careful when performing potentially hazardous activities requiring increased attention such as driving a vehicle or operating machinery requiring increased concentration.

Contraindications

-high sensitivity to the drug components;

-explicit cardiac rhythm disorders;

-syndrome of weak sinus node;

-sinoatrial and atrioventricular block of II and III degree;

Side effects

WHO classification of the frequency of side effects:

very common – >1/10 appointments (>10%)

often – >1/100 to < 1/10 appointments (>1% and <10%)

infrequent – >1/1000 to <1/100 appointments (>0.1% and <1%)

rarely – >1/10000 to <1/1000 appointments (>0.01% and <0.1%)

very rarely – <1/10000 appointments (<0.01%)

Mental disorders

Often: decreased concentration. Infrequent: depression, anxiety, nervousness.

Disorders of the central nervous system

Often: increased fatigue, drowsiness, headache, dizziness.

Infrequent: paresthesias, insomnia, fainting.

Gastrointestinal tract disorders

Often: dry oral mucosa, constipation, dyspeptic disorders.

Infrequent: nausea, anorexia.

very rarely: hepatitis, cholestasis.

Skin and subcutaneous tissue disorders

Infrequent: skin rash, itching, edema of various localization.

very rarely: angioedema.

Urogenital system disorders

Infrequent: urinary retention or incontinence, impotence, decreased libido.

Hepatic and biliary tract disorders

Rarely: hepatitis, biliary congestion.

Visual disorders

Infrequent: dry eyes, causing itching or burning sensation in the eyes.

Hearing organ and labyrinth disorders

Infrequent: ringing in the ears.

Vascular disorders

Often: symptoms of vasodilation.

Infrequent: decreased blood pressure (BP), orthostatic hypotension, Raynaud’s syndrome, peripheral circulation disorders.

Endocrine system disorders

Infrequent: gynecomastia.

Skeletal, muscular and connective tissue disorders:

Often: back pain. Infrequent: pain in the neck.

General disorders and disorder at the site of administration

Often: asthenia. Infrequent: weakness in the legs, fainting, pain in the parotid glands.

Overdose

Symptoms:headache, sedation, somnolence, marked BP decrease, dizziness, general weakness, bradycardia, increased fatigue, dry mouth, vomiting and gastric pain. There is also the potential for paradoxical elevation of BP, tachycardia, and hyperglycemia.

Treatment:There is no specific antidote. Gastric lavage (immediately after ingestion), intake of activated charcoal and laxatives, symptomatic therapy. In case of marked BP decrease it is recommended to restore circulating blood volume by administration of fluids and dopamine. Bradycardia may be controlled with atropine.

Alpha-adrenoreceptor antagonists may reduce or eliminate transient arterial hypertension in overdose with Moxonidine Canon.

Similarities