Nitopin tablets are used for the prevention and treatment of ischemic neurological disorders after subarachnoid hemorrhage due to ruptured aneurysm.
The active ingredient is nimodipine (one coated tablet contains 30 mg nimodipine).
Excipients: microcrystalline cellulose, corn starch, polyvidone, crospovidone, magnesium stearate.
Sheath: hypromellose, macrogol 4000, titanium dioxide (E 171).
hypersensitivity to nimodipine or other components of the preparation;
during and within one month after myocardial infarction or an episode of unstable angina pectoris;
use in combination with rifampicin or antiepileptic preparations (phenobarbital, phenytoin, carbamazepine) due to a significant decrease in the effectiveness of the preparation"Nitopin".
Subarachnoid hemorrhage due to ruptured aneurysm
The recommended dose is two tablets. It is taken at intervals of 4 hours (total daily dose - 360 mg) with water. The application should be started within 4 days after subarachnoid hemorrhage, the duration of admission is 21 days.
In case of surgical intervention, the use of the preparation "Nitopin" should be continued (in the above dosage) until the end of the 21-day treatment period.
In the event of adverse reactions, if necessary, reduce the dose or discontinue treatment.
Subarachnoid hemorrhage due to trauma
The use of nimodipine is not recommended because a favorable benefit / risk profile has not been established.
Pregnant
Appropriate controlled studies on the use of the preparation in pregnant women have not been conducted. A study of reproductive toxicology in animals with oral administration of nimodipine showed no teratogenic effect, however, reproductive toxicity was demonstrated in animal studies. If nimodipine must be used during pregnancy, the benefits and potential risks should be carefully weighed depending on the severity of the clinical picture.
It was revealed that the concentration of nimodipine and its metabolites in breast milk in order of magnitude corresponds to the concentration in the mother's blood plasma. When using nimodipine, breastfeeding should be stopped.
In rare cases, under conditions of in vitro fertilization, calcium antagonists have been associated with reversible biochemical changes in the area of the sperm head, which can lead to dysfunction of the sperm. It is not known how significant these changes are with short-term treatment.
Children
The safety and efficacy of using nimodipine in patients under the age of 18 have not been established. The preparation is not used in children.
Drivers
The patient's ability to drive vehicles or operate other mechanisms may be impaired due to the possible occurrence of dizziness.
Symptoms
In acute overdose, severe arterial hypotension, tachycardia or bradycardia are observed, and in the case of oral administration, disorders of the gastrointestinal tract and nausea.
Treatment
In case of acute overdose, it is necessary to immediately stop using the preparation "Nitopin". When prescribing emergency care, symptomatic therapy is indicated. For oral administration of nimodipine, gastric lavage followed by the use of activated charcoal is recommended as a measure of emergency therapy. With a significant decrease in blood pressure, norepinephrine or dopamine is administered intravenously. Since the specific antidote is unknown, the most pronounced symptoms should be guided in the treatment of other adverse reactions.
Below is a list of adverse reactions identified in the course of clinical studies with the use of nimodipine for the indications of "subarachnoid hemorrhage due to rupture of aneurysm", which are distributed in frequency into the following categories: very often (≥ 1/10), often (≥ 1/100, <1 / 10), infrequently (≥ 1/1000, ≤ 1/100), rarely (≥ 1/10 000, ≤ 1/1000), very rarely (<1/10 000).
In each frequency group, adverse reactions are presented in order of decreasing severity.
On the part of the blood and lymphatic system: infrequently - thrombocytopenia.
From the immune system: infrequently - an allergic reaction, rash.
From the nervous system: infrequently - headache.
From the side of the heart: infrequently - tachycardia; rarely - bradycardia.
From the vascular system: infrequently - arterial hypotension, vasodilation.
From the digestive system: often - nausea; rarely - intestinal obstruction.
On the part of the digestive system: rarely - a transient increase in the activity of liver enzymes.
Store in its original packaging at a temperature not exceeding 25 ° C, protected from light and out of reach of children.
Shelf life is 3 years.
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