Fiziotenz Tab n / a film about 0.4mg 28 pc


Fiziotenz Tab n / a film about 0.4mg 28 pc

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SKU: 01933918417 Categories: , , Tags: ,


Active substance:
1 tablet contains: 0.2 mg of moxonidine, 0.3 mg or 0.4 mg.
Lactose monohydrate, povidone, crospovidone, magnesium stearate.
Sheath: hypromellose, ethyl cellulose, macrogol, talc, iron oxide red dye (E 172), titanium dioxide (E 171).
Round biconvex tablets, film-coated.
Tablets dosed at 0.2 mg – pale pink marked “0.2” on one side.
Tablets dosed at 0.3 mg – pink marked “0.3” on one side.
Tablets dosed at 0.4 mg – brownish pink color marked “0.4” on one side. At the turn of white pills.
Product form:
Film-coated tablets of 0.2; 0.3; 0.4 mg: 14 tablets in PVC / PVDC / Al blister; 1, 2 or 7 blister together with instructions for use placed in a cardboard box.
Hypersensitivity to the active substance and other ingredients; sick sinus syndrome; bradycardia (heart rate (HR) rest at least 50 beats / min.); atrioventricular block 2nd or 3rd degree; acute and chronic heart failure; lactation; hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption; age 18 years (due to lack of data on safety and efficacy).
Precautions: Special care is needed when applying Moxonidine in patients with AV block I degree (risk of bradycardia); severe coronary artery disease and unstable angina (application experience is insufficient); renal insufficiency.
Moxonidine is contraindicated in atrioventricular block II and III degree.
0.4 mg
Arterial hypertension.
Interaction with other drugs
The combined use of Moxonidine with other antihypertensives leads to additive effect.
* Complete information on the drug is presented in the medical instructions.
There are reports of a few cases of overdose with no death, when simultaneously used doses up to 19.6 mg. There is no specific antidote.
pharmachologic effect
Pharmacological group:
Centrally acting antihypertensive agent.
Moxonidine is a antihypertensive agent with a central mechanism of action. The structures of the brain stem (rostral layer lateral ventricles) moxonidine selectively stimulates imidazolin-sensitive receptors involved in tonic reflex and regulation of the sympathetic nervous system. Stimulation of imidazoline receptors reduces peripheral sympathetic activity and blood pressure (BP).
Moxonidine differs from other sympatholytic antihypertensives lower affinity for a2-adrenergic receptors, which explains the lower probability of sedation and dry mouth.
Receiving moxonidine leads to a reduction in systemic vascular resistance and BP. The hypotensive effect of moxonidine confirmed in a double-blind, placebo-controlled, randomized studies.
Moxonidine improves by 21% insulin sensitivity index (compared to placebo) in obese patients, insulinrezistentnostnostyu to moderate hypertension.
After oral administration moxonidine is rapidly and almost completely absorbed in the upper gastrointestinal tract. The absolute bioavailability is about 88%. Time to maximum concentration – about 1 hr. Meal did not affect the pharmacokinetics of the drug.
Communication plasma protein is 7.2%.
The main metabolite – dehydrogenated moxonidine. Pharmacodynamic Activity dehydrogenated moxonidine – about 10% as compared with moxonidine.
The half-life (T1 / 2) of moxonidine and metabolite of 2.5 and 5 hours, respectively. Within 24 hours over 90% moxonidine excreted by the kidneys (approximately 78% unchanged and 13% as a degidriromoksonidina, other metabolites in urine do not exceed 8% of the dose). Less than 1% of the dose is excreted through the intestines.
Pharmacokinetics in patients with hypertension:
Compared to healthy volunteers in hypertensive patients did not report changes in the pharmacokinetics of moxonidine.
Pharmacokinetics in elderly
It is noted clinically insignificant change in pharmacokinetic parameters moxonidine in elderly patients, probably due to decrease in the intensity of its metabolism and / or somewhat higher bioavailability.
Pharmacokinetics in children
Moxonidine is not recommended for use in patients younger than 18 years, and therefore in this group pharmacokinetic studies have not been conducted.
Pharmacokinetics in renal failure
Excretion Moxonidine largely correlates with creatinine clearance (CC). Patients with moderate renal impairment (creatinine clearance in the range of 30-60 ml / min) the equilibrium concentration in the blood plasma and the end of T1 / 2 of approximately 2 and 1.5 times higher than in persons with normal renal function (creatinine clearance greater than 90 mL / min.). In patients with severe renal failure (creatinine clearance less than 30 mL / min.), The equilibrium concentration in plasma and the final T1 / 2 to 3 times higher than in patients with normal renal function. Assigning multiple doses of moxonidine leads to a predictable accumulation in the body of patients with moderate and severe renal insufficiency. Patients with end-stage renal failure (creatinine clearance less than 10 mL / min) on hemodialysis, the equilibrium concentration in the blood plasma and the end of T1 / 2, respectively 4 and 6 times higher than in patients with normal renal function. In all groups, the maximum concentration of moxonidine in the plasma above 1.5 – 2 times. In patients with impaired renal function, dosage should be individualized. Moxonidine slightly displayed during hemodialysis.
Pregnancy and breast-feeding
Pregnancy: Clinical data on the use Fiziotenza® in pregnant women are not available. In animal studies embryotoxic effect of the drug was found. Physiotens should be administered to pregnant women only after careful evaluation of the risk-benefit ratio when the benefit to the mother outweighs the potential risk to the fetus. Lactation: moxonidine passes into breast milk and therefore should not be administered during breast-feeding. If necessary, use Fiziotenza® during lactation, breast-feeding should be discontinued.
Conditions of supply of pharmacies
On prescription.
side effects
Headache, dizziness (vertigo), somnolence; dry mouth; diarrhea, nausea, vomiting, dyspepsia; skin rash, itching; insomnia; backache; asthenia. A list of all side effects presented in the medical instructions.
special instructions
In post-marketing surveillance documented cases of atrioventricular block of varying severity in patients receiving moxonidine. Physiotens association between the drug and deceleration atrioventricular conduction can not be completely excluded. Thus, in the treatment of patients with probable predisposition to developing atrioventricular block recommended to proceed with caution. If necessary, cancel the concomitant beta-blockers and drug Physiotens first override beta-blockers, and only a few days Physiotens. There is currently no evidence that discontinuation Physiotens leads to increased blood pressure. However, do not stop taking the drug abruptly Physiotens instead should gradually reduce the dose of the drug for two weeks.
Effects on ability to drive a car, and to machines and management mechanisms *: there are reports of drowsiness and dizziness during treatment with moxonidine * Complete information on the drug is presented in the medical instructions.
Storage conditions
At a temperature not exceeding 25 C (for dosage 0.2 mg).
At a temperature not exceeding 30 C (for a dosage of 0.3 mg, 0.4 mg).
Keep out of the reach of children!.
Dosing and Administration
Inside, regardless of the meal. In most cases the initial dose Physiotens drug is 0.2 mg per day. The maximum single dose is 0.4 mg. The maximum daily dose to be divided into 2 doses is 0.6 mg. Requires an individual correction of the daily dose, depending on patient tolerability of the therapy. No dose adjustment for patients with hepatic impairment is not required. The starting dose for patients undergoing hemodialysis – 0.2 mg per day. If necessary and if tolerated daily dose may be increased to 0.4 mg per day. Patients with renal insufficiency, careful selection of the dose is recommended, especially at the beginning of treatment. The initial dose should be 0.2 mg daily. If necessary and if tolerated daily dose may be increased to a maximum of 0.4 mg for patients with moderate renal impairment (creatinine clearance of more than 30 ml / min, but less than 60 ml / min) and 0.3 mg for patients with severe renal failure (CC less than 30 ml / min).
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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