Nimotop is a calcium channel blocker that has a predominant effect on the vessels of the brain.
Release form and composition
- Solution for infusions: transparent, slightly yellowish (50 ml in dark glass bottles, 1 bottle in a cardboard box complete with a connecting tube; 50 ml in dark glass bottles, 1 bottle in a cardboard box bundle, with a connecting tube, on 5 packs in a film polyethylene);
- Film-coated tablets: round, convex on both sides, yellow, on one side “SK” engraving, on the other - Bayer cross (10 pieces in blisters, 3 or 10 blisters in a cardboard box).
Active ingredient - nimodipin:
- 1 ml of solution - 0.2 mg;
- 1 tablet - 30 mg.
Solution auxiliaries: sodium citrate, macrogol 400, ethanol 96%, water for injection, anhydrous citric acid.
Additional components of tablets:
- Excipients: microcrystalline cellulose, crospovidone, povidone, corn starch, magnesium stearate;
- The composition of the shell: macrogol, hypromellose, titanium dioxide, iron oxide yellow.
Indications for use
Both dosage forms of Nimotop are used to treat and prevent ischemic neurological disorders caused by spasm of the brain due to subarachnoid hemorrhage due to aneurysm rupture (in tablets, the drug is used after intravenous therapy with an infusion solution).
In tablets, Nimotop is also prescribed for the treatment of pronounced impaired brain function in elderly patients: emotional instability, decreased concentration and memory.
For both dosage forms:
- Age up to 18 years;
- Hypersensitivity to the drug.
Additionally for tablets:
- Severe abnormal liver function;
- The simultaneous use of rifampicin, antiepileptic drugs (phenytoin, carbamazepine, phenobarbital).
Nimotop should be used with caution in the following cases:
- Hypotension (systolic blood pressure less than 100 mm Hg);
- Severe bradycardia;
- Myocardial ischemia;
- Severe heart failure;
- Renal failure;
- Increased intracranial pressure;
- Generalized swelling of the brain;
- Unstable angina and the first 4 weeks after acute myocardial infarction (the drug can be prescribed only after a careful assessment of the ratio of the benefits of therapy and potential risks);
- Elderly patients with comorbidity with severe renal impairment.
Nimotop solution contains 23.7% by volume of ethanol; this should be taken into account when prescribing the drug to pregnant and lactating women, patients with epilepsy, liver diseases, and alcoholism patients with worsening alcohol metabolism.
Dosing and Administration
1. Intravenous infusion.
At the beginning of treatment, 1 mg per hour is administered over 2 hours (5 ml of Nimotop infusion solution), which corresponds to approximately 0.015 mg / kg / hour. With good portability (primarily in the absence of a noticeable reduction in blood pressure), after 2 hours, the dose is increased to 2 mg / hour (approximately 0.3 mg / kg / hour).
For patients with a body weight less than 70 kg or a labile blood pressure, the initial dose should be 0.5 mg / hour.
Nimotop infusion solution is used for continuous intravenous infusion through a central catheter using an infusion pump and a three-channel stopcock. It is administered simultaneously with one of the following solutions: 0.9% sodium chloride, 5% dextrose, Ringer's solution (including magnesium) or dextran 40 solution. Blood, human albumin or mannitol can also be used as a concomitant infusion.
Solution for infusion Nimotop can not be added to the infusion vessel and mixed with other drugs.
The introduction of nimodipine is recommended to be continued during the period of anesthesia, angiography, and surgical interventions.
To connect the polyethylene tube (through which the solution is fed), the channel of entry of the solution and the central catheter, use a three-channel stopcock.
When using Nimotop for prophylactic purposes, intravenous therapy should be started no later than the 4th day after hemorrhage and continue the entire period of having the maximum risk of developing vasospasm - approximately 10-14 days after subarachnoid hemorrhage. After the end of infusion therapy, the patient is transferred to Nimotop in the form of tablets. Assign 60 mg 6 times a day (every 4 hours) for 7 days.
If ischemic neurological disorders due to vasospasm due to subarachnoid hemorrhage already occur, Nimotope infusion therapy should be started as early as possible and performed for at least 5 days. The maximum duration of treatment is 14 days. After the end of infusion therapy, the patient is transferred to Nimotop in the form of tablets. Assign 60 mg 6 times a day (every 4 hours) for 7 days.
If, during prophylactic or therapeutic use of the drug, surgical treatment of hemorrhage is performed, intravenous therapy should be continued for at least 5 days after surgery.
2. Introduction to cisterns of the brain.
In the cisterns of the brain, the drug (heated to body temperature) is injected during surgery. To do this, immediately before use, 1 ml of Nimotop diluted with 19 ml of Ringer's solution.
In the event of adverse reactions, reduce the dose or stop the infusion.
In severely impaired liver function (especially in case of cirrhosis), the bioavailability of nimodipine can be increased, as a result of which its main and side effects may worsen, including the hypotensive effect. In these cases, the dose of Nimotop should be reduced depending on the degree of blood pressure reduction, and if necessary, interrupt treatment.
In tablet form, Nimotop should be taken orally, swallowing whole and squeezed with a sufficient amount of liquid. Food does not affect its effectiveness. Between doses of the drug should be observed at least 4-hour intervals.
In subarachnoid hemorrhage caused by rupture of the aneurysm, the patient is transferred to the tablet form of Nimotop after the end of intravenous infusion therapy with nimodipine. Assign 2 tablets 6 times a day for 7 days.
The recommended dose for disorders of brain function in elderly patients is 1 tablet 3 times a day.
- Cardiovascular system: infrequently - vasodilation, lowering blood pressure, tachycardia; rarely bradycardia;
- The digestive system: infrequently - nausea; rarely - a violation of the passage of intestinal contents;
- Nervous system: infrequently - headache;
- Immune system: rarely - rash, allergic reactions;
- Blood system: infrequently - thrombocytopenia;
- Hepatobiliary system: rarely - transient increase in liver enzymes;
- Local reactions when administered intravenously: rarely - reactions at the site of infusion / injection, thrombophlebitis at the injection site.
Nimodipine is absorbed by polyvinyl chloride; therefore, only systems with polyethylene pipes can be used for infusions. It is also sensitive to light, so it is necessary to avoid direct exposure to sunlight: use connecting tubes and glass syringes of yellow, brown, red or black color. In addition, it is advisable to wrap tubes and infusion sediment in light-tight paper. With artificial light and scattered daylight, the drug can be used without special protective measures for 10 hours.
Nimotop can lead to a deterioration in sperm quality.
The drug may cause dizziness, and therefore it is possible to reduce the ability to drive vehicles and work with mechanisms. When using Nimotop in the form of an infusion solution, this factor usually does not matter.
- Diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, alpha-blockers, AT1-receptor blockers, other calcium antagonists, phosphodiesterase inhibitors, methyldopa: blood pressure may decrease;
- Drugs inhibiting or inducing the activity of liver enzymes: the concentration of nimodipine in plasma changes;
- Rifampicin: accelerates metabolism and decreases the effectiveness of nimodipine;
- Antiepileptic drugs inducing CYP3A4 isoenzyme (phenytoin, phenobarbital, carbamazepine): reduced bioavailability of nimodipine;
- Formulations inducing activity isoenzyme CYP3A4, such as macrolides (e.g., erythromycin), valproic acid, antidepressants fluoxetine and nefazodone, cimetidine, kvinopristin / dalfopristin, azole antifungals (e.g., ketoconazole), HIV protease inhibitors (such as Ritonavir): concentration of nimodipine in plasma increases;
- Nortriptyline (long-term combined use): the concentration of nimodipine in the blood plasma slightly decreases;
- Fluoxetine (long-term combined use): the concentration of nimodipine in the blood increases by about 50%, the concentration of fluoxetine is significantly reduced (but the content of its active metabolite, norfluoxetine, does not change);
- Zidovudine: its clearance decreases;
- Nephrotoxic drugs (for example, furosemide, cephalosporins, amyoglycosides): possible impaired renal function;
- Calcium: decreases the effectiveness of nimodipine.
During treatment, it is recommended to avoid eating grapefruit juice, because possible increase in the concentration of nimodipine in the blood plasma.
Nimotop infusion solution contains 23.7% by volume of ethanol; therefore, possible interaction of ethanol with other medicinal substances should be taken into account.
Terms and conditions of storage
Store at a temperature up to 30 ºС in a dry, dark and out of reach of children.
The shelf life of the solution for infusion - 4 years, tablets - 5 years.