Normatens (Normatens)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspPills, coated.
Composition:Each tablet, coated with a shell, contains

Active substances:

Reserpine 0.100 mg

Dihydroergocristine mesylate, 0.580 mg

corresponds to dihydroergocristine 0.500 mg

Clopamid 5,000 mg

Excipients:

Lactose monohydrate, potato starch, povidone, talcum, magnesium stearate.

Sugar shell composition:

Sucrose crystalline, acacia gum, talc, macrogol 6000.

Description:

Round biconvex tablets, Covered with white or almost white shell, with a smooth surface.

Pharmacotherapeutic group:Hypotensive combined agent (sympatholytic + alpha-adrenoblocker + diuretic)
ATX: & nbsp
  • Reserpine and diuretics in combination with other drugs
    • Pharmacodynamics:
    Normatens is a combined antihypertensive drug containing its composition of 3 mutually complementary components.

    Reserpine - sympatholytic, penetrating the presynaptic endings of postganglionic sympathetic fibers, releases from vesicles norepinephrine with the simultaneous violation of its reverse transport and the intensification of the process of inactivation with monoamine oxidase (MAO). It causes depletion of the neurotransmitter's reserves and persistent lowering of blood pressure (BP).Helps reduce the concentration in neurons of dopamine, serotonin and other neurotransmitters, providing antipsychotic act.

    Weaken the influence of sympathetic innervation on the cardiovascular system, reduce heart rate (heart rate) and general peripheral vascular resistance; preserves the activity of the parasympathetic nervous system; deepens and intensifies physiological sleep, inhibits interoreceptive reflexes. Increases the peristalsis of the gastrointestinal tract, increases production in the stomach of hydrochloric acid; slows down metabolic processes in the body; urezhaet and deepens the respiratory movement, causes miosis, hypothermia; reduces the intensity of metabolism. Has a positive effect on lipid and protein metabolism in patients with arterial hypertension and coronary atherosclerosis; increases renal blood flow, enhances glomerular filtration.

    Dihydroergotoristin - dihydrated ergot alkaloid, blocks alpha-adrenoreceptors, causes vasodilation, reduces overall peripheral vascular resistance.

    Clopamid is a loopback sulfonamide diuretic of moderate strength, blocks the reabsorption of sodium ions at the level of the cortical segment of the Henle loop, removes sodium, potassium, chlorine and water ions.

    The hypotensive effect of the drug exceeds the hypotensive effect of each of the components individually and the effect of any combination of the two components; the onset of action - on the 4-7th day, a persistent hypotensive effect is achieved through 1- 4 weeks.

    Pharmacokinetics:
    Suction
    The individual components of Normatens are absorbed after oral administration as follows: reserpine about 30-40%, clopamid - about 90% and dihydroergocristines - less than 25%. The maximum concentration in the blood plasma is achieved respectively: for reserpine - 1-3 hours, for klopamida - about 2 hours, for dihydroergocristine - about 1 hour.

    Radistribution

    The individual components of Normatens easily spread in the body (for example, for dihydroergocristine, the volume of distribution is 52 l / kg ). Connection with plasma proteins blood: for reserpine - does not bind, clopamid - about 46% , dihydroergocristine - about 68 %. Reserpine and dihydroergocristines penetrate through the blood-brain and through the placental barrier.

    Metabolism

    Reserpine and dihydroergocristine are extensively metabolized in the liver to inactive metabolites. Clopamide does not undergo significant metabolism in the liver.
    Excretion

    The half-life (T 1/2) Normatens is long due to the presence of reserpine, for which T 1/2 is 4.5 hours in the first phase, and about 2 hours in the second phase71 hours. The output path is different for the individual components: reserpine and dihydroergocristines - inactive metabolites are excreted in urine and feces, clopamide, mainly by the kidneys.

    Indications:

    Arterial hypertension.

    Contraindications:

    - hypersensitivity to any of the components of the drug;

    - Depression, epilepsy, Parkinson's disease, epilepsy, concomitant conduct of electroconvulsive therapy;

    - pheochromocytoma, concomitant treatment with monoamine oxidase inhibitors (MAO);

    - Stomach ulcer and duodenal ulcer in the exacerbation phase, erosive gastritis, ulcerative colitis;

    - angina pectoris, recently transferred myocardial infarction, chronic heart failure, severe bradycardia, atrioventricular blockade, intraventricular blockade;

    - severe renal failure (creatinine clearance below 30 ml / min), nephritis, uremia, nephrosclerosis;

    - arterial hypotension, expressed cerebral atherosclerosis;

    severe hepatic impairment;

    - Addison's disease;

    hypokalemia, hyponatriamthia, hypochloramand I;

    - hyperuricemia with clinical manifestations;

    - an angle-closure glaucoma;

    - violation of hematopoiesis;

    - pregnancy and lactation;

    - bronchial asthma;

    - age to 18 years (efficacy and safety of use not established).
    Carefully:Diabetes mellitus, gout, advanced age.
    Pregnancy and lactation:

    As reserpine Has a teratogenic effect, apply the drug Normatens during pregnancy is not recommended.

    Besides, reserpine can cause dangerous to the fetal arterial hypotension, bradycardia. In newborns reserpine can promote the occurrence of rhinorrhea and edema of the nasal mucosa, which leads to difficulty breathing and cyanosis.
    Clopamid can cause thrombocytesPfetus.

    The drug should not be used during lactation. This is mainly due to penetration into the milk of reserpine and dihydroergocristine.

    Dihydroergoccristine can cause in newborns symptoms resembling ergot poisoning, and in the mother to slow / loosen lactation.

    Dosing and Administration:

    Inside, during or immediately after eating, without chewing, squeezed a small amount fliquidity.

    The dose is set individually. It is recommended to start treatment with 1 tablet 1 time per day, if necessary (lack of a satisfactory therapeutic effect), you can increase the dose of the drug up to 2 times a day (every 12 hours) Pabout 1 tablet, and only in exceptional cases - up to 3 times a day (every 8 hours) Pabout 1 tablet.
    The maximum daily dose is 3 tablets.

    In connection with the mechanism of action of the drug, the possible lack of effectiveness of the drug can be talked not earlier than 2 weeks after the commencement of admission, so during this period it should not be unnecessary to increase the initial dose.

    With long-term treatment, in case of a satisfactory therapeutic effect, taking 1 tablet once a day is recommended, and in some patients the dose of the drug can be reduced to 1 tablet 1 time every other day. At each dose reduction, BP control is necessary.

    When conducting maintenance therapy, do not exceed the dose - 2 tablets per day.

    Side effects:

    From the side of the food processorьsystem: diarrhea, dry mouth, abdominal pain, nausea, vomiting, exacerbation of peptic ulcer, loss of appetite. Rarely - ulceration of the mucous membrane of the stomach and duodenum, gastrointestinal bleeding when applying reserpine in a dose of more than 1 mg per day (the amount contained in 10 tablets Normantensa);

    From the cardiovascular system: bradycardia, lowering blood pressure, cerebrovascular disorders, orthostatic hypotension;

    From the centralьNervous system: headache, dizziness, drowsiness, weakness, anxiety, impaired concentration, insomnia, extrapyramidal disorders (tremor, stupor, Parkinson's syndrome);
    Since the composition of the drug is reserpine, one should remember about the possibility of depressive reactions (including suicidal tendencies) and depressive syndrome; such symptoms appear rarely and only in cases of application of large doses of reserpine (more than 1 mg / day, which corresponds to the content of reserpine in more than 10 Normatens tablets).

    From the side of the fanьsystem: hyperemia and edema of the nasal mucosa. Reserpine can cause symptoms of bronchospasm, but such an effect appears rarely, and, as a rule, in patients with bronchial asthma or bronchial obstructive syndrome.

    Allergic reactions: skin rash, itching.

    On the part of the organs of hematopoiesis: thrombocytopenia with symptoms of hemorrhagic diathesis.

    Laboratory indicators: hypokalemia, hypomagnesemia, hypocalcemia, metabolic alkalosis, hyperuricemia, hyperglycemia, insignificant increase in triglycerides, cholesterol.

    Other: galactorrhea

    With prolonged use in high doses - paresthesia, decreased libido, decreased potency, gynecomastia, impaired urination, spasm of accommodation, conjunctival hyperemia, hypothermia.

    Overdose:

    Symptoms: nausea, vomiting, diarrhea, muscle weakness, dizziness, headache, marked decrease in blood pressure, bradycardia, arrhythmias, depression, hyporeflexia, confusion and coma.

    Treatment: As a first aid, if the patient is conscious, vomiting should be done, gastric lavage done and / or given Activated carbon.
    Conduction of symptomatic therapy aimed at maintaining the function of the cardiovascular system, correction of electrolyte balance.

    Reserpine, which is a part of Normatens, is not excreted from the body by dialysis.
    Interaction:

    Reduces the effectiveness of oral hypoglycemic drugs, tricyclic antidepressants, anticoagulants.

    Increases the concentration of lithium in the blood plasma (slowing its excretion).

    Weaken the action of antiepileptic drugs and levodopa, holinoblokatorov, reduces the analgesic effect of morphine.

    The effect of barbiturates, ethanol, drugs for inhalation anesthesia, antihistamines.

    Strengthens the effect of adrenomimetics.

    Barbiturates, ethanol, beta-adrenoblockers, peripheral vasodilators increase the hypotensive effect.

    Glucocorticosteroids, non-steroidal anti-inflammatory drugs, laxative drugs reduce diuretic, hypotensive effects, increase the risk of hypokalemia.

    Against the background of treatment with MAO inhibitors - an increase in the inhibitory effect on the central nervous system.

    Against the background of drug treatment, MAO inhibitors cause mild or severe hypertension, hyperreflexia.

    Antiarrhythmics - in the case of hypokalemia, which may accompany treatment, the risk of toxic effects of amiodarone, disopyramide, quinidine increases; hypokalemia weakens the effect of lidocaine, mexiletine.

    It is not recommended to combine dopamine (increased vasoconstrictor reaction).
    When combined with digoxin, the risk of bradycardia increases; In the case of hypokalemia, which may accompany treatment, the risk of increasing the adverse reactions of digoxin is increased.

    Special instructions:

    Since the Normatens effect develops relatively slowly, the dosage should not be Increase more often than once a week, due to the possibility of a pronounced decrease in blood pressure; Special care must be taken in the case of use with other antihypertensive agents; During treatment, periodically monitor the blood pressure level to determine the optimal dosage regimen.

    During the treatment period, glucose and uric acid in the serum may increase it is recommended that these parameters be periodically monitored, especially in patients with impaired glucose tolerance and hyperuricemia.

    It is necessary to monitor kidney function, especially in patients with chronic renal disease failureYu.

    In the case of bradycardia during the treatment period, the dose of the drug should be reduced or canceled.

    During treatment, potassium in the blood serum is needed. Most patients do not require potassium supplementation, provided that the diet contains a sufficient number of foods rich in potassium (fruits, vegetables, fish, low-fat cheese, etc.).

    Care should be taken in patients with bronchial asthma and bronchospasm, in case of an exacerbation, it is necessary to stop taking Normatens.

    At least 2 weeks before the planned surgery, stop taking the drug and replace it with another antihypertensive drug.
    During treatment, you should not drink alcohol.

    The dosage of Normatens should be modified accordingly in case of simultaneous application of other,interacting with it, drugs.

    7 days before the beginning of the electroconvulsive therapy, it is necessary to cancel the normatens.

    Effect on the ability to drive transp. cf. and fur:

    The normatens can disrupt the patient's ability to respond quickly, especially at the beginning of the treatment. The treatment should not drive vehicles and to engage in any activities that require high concentration and psychomotor speed reactions.

    Form release / dosage:

    The tablets are coated.

    Packaging:For 20 tablets in blisters from the film of PVC-aluminum foil. 1 or 2 blisters together with instructions for use are placed in a cardboard box.
    Storage conditions:

    In a dry, dark place at a temperature of 15 to 25 ° C.
    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N008793
    Date of registration:01.04.2011 / 22.05.2014
    The owner of the registration certificate:Meda Pharma GmbH & Co. KGMeda Pharma GmbH & Co. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspMEDA PHARMA LLCMEDA PHARMA LLC
    Information update date: & nbsp03.02.3016
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