Reserpine and dihydroergocristine penetrate the blood-brain and placental barrier. Metabolism reserpine and dihydroergocristine extensively metabolized in the liver to inactive metabolites.Clopamide not significantly metabolized in the liver. Elimination half-life (T 1/2) Normatensa is long due to the presence of reserpine, 1/2 T for which is in the first phase – 4.5 hours, and the second – about 271 hours. The path removal is different for the individual components: reserpine and dihydroergocristine – inactive anadrol metabolites are excreted in urine and feces, clopamide, mainly kidneys.
- hypersensitivity to any component of the drug;
- depression, epilepsy, Parkinson’s disease, epilepsy, concurrent electroconvulsive therapy;
- pheochromocytoma, concomitant treatment with monoamine oxidase inhibitors (MAOIs);
- gastric ulcer and duodenal ulcer exacerbation, erosive gastritis, ulcerative colitis;
- angina pectoris, recent myocardial infarction, congestive heart failure, bradycardia, atrioventricular block, intraventricular block;
- severe renal insufficiency (creatinine clearance below 30 ml / min), nephritis, uremia, nephrosclerosis;
- hypotension, pronounced cerebral atherosclerosis;
- severe liver function;
- Addison’s disease;
- hypokalemia, hyponatremia, chloropenia;
- hyperuricemia with clinical manifestations;
- angle-closure glaucoma;
- pregnancy and lactation;
- bronchial asthma;
- age of 18 years (effectiveness and safety have not been established).Precautions: diabetes mellitus, gout, old age.
Pregnancy and lactation
Since reserpine has teratogenic, Normatens drug during pregnancy is not recommended.
In addition, reserpine can cause a hazard to the fetus hypotension, bradycardia. In infants reserpine may contribute to edema, rhinorrhea, and nasal mucosa, leading to difficulty breathing and cyanosis.
Klopamid can cause thrombocytopenia in the fetus.
The drug should not be used during lactation. This is due, mainly, to the penetration into the milk and reserpine dihydroergocristine.
Dihydroergocristine can cause symptoms in infants, resembling ergot poisoning, and brake / weaken lactation in mothers.
Dosing and Administration
Inside, during or immediately after a meal, not liquid, squeezed small amounts of liquid.
Dose set individually. It is recommended to start treatment with 1 tablet 1 time a day, if necessary (the absence of a satisfactory therapeutic effect), you can increase the dose to 2 times a day (every 12 hours): 1 tablet, and only in exceptional cases – up to 3 times per day (every 8 hours) for one tablet. The maximum daily dose of 3 tablets.
In connection with the mechanism of drug action, the possible absence of drug efficacy can say no sooner than 2 weeks after the beginning of reception, therefore not necessary to increase the initial dose without the need for this period.
Prolonged treatment, if satisfactorily therapeutic effect, the recommended intake of 1 tablet once a day 1, and in some patients the dose can be reduced to 1 1 tablet every other day. Each reduction of the dose necessary to control blood pressure.
During the maintenance therapy should not exceed a dose – 2 tablets per day.
Side effect From the digestive system: diarrhea, dry mouth, abdominal pain, nausea, vomiting, exacerbation of peptic ulcer disease, decreased appetite. Rarely – ulceration of the mucous membrane of the stomach and duodenal ulcers, gastrointestinal bleeding when used reserpine at a dose higher than 1 mg per day (the amount contained in 10 tablets Normatensa) Since the cardiovascular system:bradycardia, decreased blood pressure, cerebrovascular disorders, orthostatic hypotension central nervous system: headache, dizziness, drowsiness, weakness, anxiety, impaired concentration, insomnia, extrapyramidal disorders (tremor, stupor, Parkinson’s syndrome); Since the drug enters reserpine should be aware of the possibility of occurrence of depressive reactions (including suicidal tendencies) and depressive syndrome; such symptoms are rare and only in cases of large doses of reserpine (more than 1 mg / day, which corresponds to the content of reserpine in more than 10 tablets Normatensa). The respiratory system: redness and swelling of the nasal mucosa. Reserpine can cause symptoms of bronchospasm, but this effect appears rarely and usually in patients with bronchial asthma or broncho-obstructive syndrome. Allergic reactions: skin rash, itching. On the part of hematopoiesis: thrombocytopenia with symptoms of hemorrhagic diathesis. Laboratory findings: hypokalemia, hypomagnesemia, hypocalcemia, metabolic alkalosis, hyperuricemia, hyperglycemia, a slight increase in triglycerides, cholesterol. Other: galactorrhea With prolonged use at high doses – paresthesias, decreased libido, reduced potency, gynecomastia, impaired urination, accommodation spasm, conjunctival hyperemia, hypothermia.
Overdosing Symptoms: nausea, vomiting, diarrhea, muscle weakness, dizziness, headache, marked reduction of blood pressure, bradycardia, arrhythmia, depression, hyporeflexia, confusion and coma.Treatment: As first aid, if the patient is conscious, induce vomiting, gastric lavage and / or give activated charcoal. Conduct symptomatic therapy aimed at maintaining cardiovascular function, electrolyte balance correction. reserpine, which anadrol is part of Normatensa not excreted from the body by dialysis.
Interaction with other drugs
reduces the effectiveness of oral hypoglycemic drugs, tricyclic antidepressants, anticoagulants.
Increases in plasma concentration of lithium (slowing its excretion).
Weaken the effect of antiepileptic drugs and levodopa, anticholinergics, reduce the analgesic effect of morphine.
Enhances the effect of barbiturates, ethanol, medicines for inhalation anesthesia, antihistamine drugs.
Enhances the effect of agonists.
Barbiturates, ethanol, beta-blockers, peripheral vasodilators enhance the antihypertensive effect.
Corticosteroids, non-steroidal anti-inflammatory drugs, laxatives drugs reduce the diuretic, hypotensive effects, increase the risk of hypokalemia.
against . MAO inhibitors treatment – increased inhibitory action on the central nervous system
on the background of treatment with MAO inhibitors cause moderate or severe hypertension, hyperreflexia.
antiarrhythmic agents – in the case of hypokalemia, which can accompany treatment, increases the risk of toxic action of amiodarone, disopyramide, quinidine; hypokalemia weakens the effect of lidocaine, mexiletine.
Do not mix with dopamine (vasoconstrictive amplification reactions).
In a joint application with digoxin – increase the risk of bradycardia; in the case of hypokalemia, which can accompany treatment, increased risk of intensifying adverse reactions of digoxin.
Since the effect Normatensa develops relatively slowly, the dosage should not be increased more often than 1 time per week, due to the possibility of occurrence of significant decrease in blood pressure;Special care is needed in case of a joint application with other antihypertensive agents; during treatment periodically to control the level of blood pressure to determine the optimal dosing regimen.
In the period of treatment may increase the level of glucose and uric acid in the serum, it is recommended to carry out periodic monitoring of these parameters, especially in patients with impaired glucose tolerance and hyperuricaemia.
Required monitoring of renal function, especially in patients with chronic renal failure.
in the event of bradycardia during treatment, the dose should be reduced or stop the drug.
During treatment requires monitoring of potassium in the blood serum. In most patients, additional drugs potassium destination is not required, provided that a diet contains sufficient potassium rich foods (fruits, vegetables, fish, cheese and low-fat, etc.).
Use caution in patients with asthma and bronchospasm in case of acute need to stop taking Normatensa.
not less than 2 weeks before planned surgery, you should stop taking the drug and to replace it with another antihypertensive agent.
During treatment should not drink alcoholic beverages.
it is appropriate to modify the dose Normatensa in case of simultaneous use of other, interacting with them medicines.
Over the 7 days before the start of electroconvulsive therapy should be discontinued Normatens.
Effects on ability to drive vehicles and use machines
Normatens anadrol may interfere with the patient’s capacity for rapid responses, especially at the beginning of treatment. The treatment should not drive vehicles and to engage in any activities that require high concentration and speed of psychomotor reactions.