Moxonitex, 0.2 mg 14 pcs

Hypertension (high blood pressure)

– arterial hypertension.

Active ingredient

Composition

Pellets, film-coated are light pink, round, biconvex.

1 tablet moxonidine 200 mcg

Supplementary substances:

Lactose monohydrate – 94.5 mg,

povidone K25 – 2 mg,

crospovidone – 3 mg,

magnesium stearate – 0.3 mg.

Composition of the film coating:

Opadray Y 1 7000 – 3.498 mg (titanium dioxide – 1.093 mg, hypromellose – 2.186 mg, macrogol 400 – 0.219 mg), iron oxide red dye – 0.002 mg.

How to take, the dosage

Moxonitex is administered orally, regardless of meals, with plenty of fluids. Dosing regimen is adjusted individually.

The starting dose is 200 mcg in the morning. In case of insufficient therapeutic effect the dose is increased after 3 weeks to 400 mcg/day in a single dose or in two doses. The maximum daily dose is 600 micrograms, the maximum single dose is 400 micrograms.

In patients with moderate renal dysfunction (CKD 30-60 ml/min), the single dose should not exceed 200 mcg, the maximum daily dose is 400 mcg.

Interaction

When co-administration of moxonidine with other hypotensive agents there is a mutual enhancement of action.

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

Moxonidine increases the hypotensive effect of ethanol, sedatives, slow calcium channel blockers (dihydropyridine derivatives).

Moxonidine should not be used concomitantly with tricyclic antidepressants.

Tolazoline dose-dependently reduces the hypotensive effect of moxonidine.

Special Instructions

Regular monitoring of BP, HR and ECG is required during treatment.

If it is necessary to withdraw beta-adrenoblockers and Moxonitex taken simultaneously, the beta-adrenoblockers should be withdrawn first and Moxonitex only after a few days. Moxonitex should be stopped gradually.

Influence on driving and operating ability

The effect of Moxonitex on driving or operating machinery has not been studied. Taking into account the possible dizziness and somnolence, patients should be cautious when engaged in potentially dangerous activities such as driving vehicles or operating machinery requiring high concentration.

Contraindications

– history of angioedema;

– SSRI or sinoatrial block;

– grade II or III AV blockade;

– marked bradycardia (less than 50 bpm at rest./min at rest);

– expressed arrhythmia;

– chronic heart failure (functional class III-IV according to NYHA classification);

– unstable angina pectoris;

– expressed hepatic insufficiency;

– severe renal insufficiency (CKG less than 30 ml/min, serum creatinine greater than 160 µmol/l);

– age less than 18 years old;

– lactation period;

– galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

– hypersensitivity to moxonidine or any other component of the drug.

With cautiousness and under medical supervision, the drug should be used in patients after recent myocardial infarction or with peripheral circulatory disorders (intermittent claudication, Raynaud’s syndrome); In patients with moderate renal dysfunction (CK 30-60 ml/min; serum creatinine 105-160 µmol/l), with liver dysfunction, in pregnancy, depression, glaucoma, epilepsy, Parkinson’s disease.

Side effects

Frequency determination of adverse reactions: frequently (≥1%), rarely (0.01%-0.1%), sometimes (<0.01%, isolated cases).

Cardiovascular system: Rarely, symptoms of vasodilation; sometimes, marked BP decrease, syncopal states, Raynaud’s syndrome, peripheral edema.

CNS side:often – dizziness, headache, somnolence, increased fatigue, sleep disturbance; sometimes – paresthesias, depression, anxiety.

From the digestive system:often – dry mucous membrane of the mouth, nausea, anorexia, constipation.

Urogenital system disorders:sometimes – urinary retention or incontinence, impotence and/or decreased libido.

Sensory organ:sometimes – dry eyes, causing itching or burning sensation.

Allergic reactions:sometimes – hives, skin itching, exanthema, angioedema.

Others:sometimes – gynecomastia, painful parotid glands.

Overdose

Symptoms:headache, marked BP decrease, bradycardia, palpitations, weakness, drowsiness, dry oral mucosa; rarely, vomiting and epigastric pain. Paradoxical arterial hypertension and hyperglycemia are potentially possible.

Treatment:symptomatic. There is no specific antidote. In a marked decrease in BP, it is recommended to restore the blood pressure by administration of fluids. α-adrenoreceptor antagonists can reduce or eliminate transient arterial hypertension in moxonidine overdose.

Similarities