Tablets, film coated: yellow, biconvex, round, with an engraving of a text of "SK" on one of the parties and a bayerovsky cross on another (on 10 pieces in blisters, on 3 or 10 blisters in a cardboard pack);
Solution for infusions: transparent, slightly yellowish (on 50 ml in dark glass bottles, on 1 or 5 bottles in a cardboard pack complete with a connecting tube).

Is a part of 1 tablet:

Active agent: нимодипин – 30 mg;
Auxiliary components: corn starch – 37,5 mg, microcrystallic cellulose – 142,5 mg, кросповидон – 44,4 mg, povidone – 75 mg, magnesium stearate – 0,6 mg;
Film cover: a gipromelloza – 5,4 mg, iron oxide yellow – 0,54 mg, a macrogoal – 1,8 mg, titanium dioxide – 1,26 mg.

For infusions is a part of 1 bottle of solution:

Active agent: нимодипин – 10 mg;
Auxiliary components: 96% ethanol – 10 000 mg, a macrogoal of 400 - 8500 mg, anhydrous citric acid – 15 mg, sodium citrate – 100 mg, water for injections – 31,225 mg.

Indications to use

The ischemic neurologic frustration caused by a brain vasospasm against the background of the subarachnoidal hemorrhage connected with a rupture of aneurism (for treatment and prevention);
The expressed functional disturbances of a brain at elderly patients which are shown in the form of decrease in concentration of attention and memory, emotional instability (tablet).

Contraindications

Absolute:

Age up to 18 years;
Hypersensitivity to drug components.

Additional contraindications to Nimotop's use in the form of tablets are:

Heavy functional disturbances of a liver (for example, cirrhosis);
Simultaneous use with rifampicin or antiepileptic medicines (Phenytoinum, phenobarbital, carbamazepine);
Pregnancy and period of a lactation.

Relative (Nimotop it is necessary to apply with care in the presence of the following diseases / states):

Arterial hypotension (with a systolic pressure less than 100 ml рт.ст);
Unstable stenocardia or the period of the first 4 weeks after an acute myocardial infarction (before purpose of drug it is necessary to correlate advantages of therapy to possible risk of decrease in perfusion of coronary arteries and ischemia of a myocardium);
Advanced age in combination with heavy renal failures (at glomerular filtering it is less than 20 ml in a minute (for tablets));
Alcoholism with deterioration in metabolism of alcohol, a liver disease, epilepsy, pregnancy and the period of a lactation (for infusion solution, in connection with existence in composition of drug 23,7 about. ethanol %);
The expressed bradycardia, myocardium ischemia, the expressed heart failure, increase in intracranial pressure, generalized hypostasis of a brain, liver and renal failure (for infusion solution).

The elderly patients with heavy heart failure accepting Nimotop for treatment of functional disturbances of a brain need carrying out regular inspections.

Route of administration and dosage

Tablets

Nimotop accept inside, irrespective of meal, swallowing entirely and washing down with a small amount of liquid. Breaks between receptions of single doses have to be not less than 4 hours.

At the subarachnoidal hemorrhage caused by a rupture of aneurism reception of tablets is begun in 5-14 days of intravenous therapy with infusion solution. The recommended single dose – 2 tablets (60 mg), frequency rate of reception – 6 times a day. Course duration – 7 days.

At functional disturbances of a brain by the elderly patient it is recommended to accept 3 times a day on 1 tablet.

Infusion solution

At the beginning of therapy Nimotop in the form of intravenous infusion enter for 2 hours on 1 mg (5 ml) an hour, about 0,015 mg/kg an hour. In 2 hours at good tolerance (first of all, in the absence of a noticeable lowering of arterial pressure) the dose is increased twice. The initial dose for patients with body weight to 70 kg or labile arterial pressure has to make 0,5 mg an hour.

Infusion solution of Nimotop is applied to continuous intravenous injection through the central catheter with use of the three-channel locking crane and infusional pump along with one of such solutions as: 5% of Dextrosum, 0,9% sodium chloride, solution of a dextran 40, Ringer's solution with magnesium, Ringer's solution or solution of 6% of hydroxyethylated starch in the ratio about 1:4 (Nimotop / other solution). As the accompanying infusion it is also possible to use Mannitolum, blood or human albumine.

Solution should not be mixed with other drugs or to add to an infusional vessel. It is recommended to continue Nimotop's introduction during anesthesia, an angiography and surgical interventions.

At the ischemic neurologic disturbances caused by a vasospasm because of subarachnoidal hemorrhage, infusional therapy is begun as soon as possible and out for 5-14 days then pass to administration of drug inside.

For prevention it is necessary to begin use of infusion solution not later, than in 4 days after hemorrhage. Therapy is continued throughout the entire period of the maximum risk of development of a vasospasm (10-14 days after subarachnoidal hemorrhage). Upon termination of a course treatment should be continued by Nimotop's reception inside.

If during use of drug with the therapeutic or preventive purpose surgical treatment of hemorrhage is made, intravenous administration of Nimotop needs to be continued at least for 5 days after an operative measure.

When carrying out surgical intervention the freshly cooked, warmed-up to average body temperature infusion solution (1 ml of Nimotop and 19 ml of solution of Ringer) can be entered into brain tanks. At emergence of adverse reactions to the carried-out therapy it is necessary to reduce a dose or to cancel administration of drug.

Infusion solution of Nimotop is sensitive to light influence therefore it is necessary to avoid direct hit of sunshine on drug. For this purpose use of glass syringes and connecting tubes of brown, black, red or yellow color is recommended. It is also reasonable to wrap lightproof paper of a tube and the infusional pump. At the scattered day or artificial light without holding special protective measures Nimotop it is possible to use for 10 hours.

Active agent of Nimotop – нимодипин, is absorbed by polyvinylchloride in this connection it is possible to apply to its parenteral administration only systems with polyethylene tubes.

Side effects

At treatment of ischemic neurologic frustration during Nimotop's use it can be observed development of the following disturbances (≥ 1/10 – very often; from ≥ 1/100 to <1/10 – it is frequent; from ≥ 1/1000 to <1/100 – infrequently; from ≥ 1/10 000 to <1/1000 – it is rare; <1/10 000 – it is very rare):

Alimentary system: infrequently – nausea; seldom – intestinal impassability;
Cardiovascular system: infrequently – a lowering of arterial pressure, tachycardia, a vazodilatation; seldom – bradycardia;
Nervous system: infrequently – a headache;
Gepatobiliarny system: seldom – tranzitorny increase in level of liver enzymes;
Immune system: infrequently – rash, allergic reactions;
Systems of a hemopoiesis: infrequently – thrombocytopenia;
Local reactions (at intravenous administration): seldom – reactions in the place of infusion or an injection, thrombophlebitis in an injection site.

At Nimotop's use for elderly patients during therapy of the expressed dysfunctions of a brain development of side effects is possible:

Nervous system: seldom – вертиго, a headache, a hyperkinesia, dizziness, a tremor;
Alimentary system: seldom – diarrhea, a lock, a meteorism;
Cardiovascular system: infrequently – a vazodilatation, lowering of arterial pressure; seldom – feeling of heartbeat, a faint, tachycardia, hypostases;
Immune system: seldom – rash, allergic reactions.

Special instructions

Nimotop's appointment to elderly patients with a large number of associated diseases, a serious cardiovascular illness and a heavy renal failure (at the size of glomerular filtering it is less than 20 ml in a minute) has to be especially carefully proved. Such patients during therapy and after its end need regular medical observation.

At heavy functional disturbances of a liver, especially at cirrhosis, Nimotop's bioavailability increases. Thereof aggravation of side effects of drug, including development of hypotensive action is possible. In this case, proceeding from degree of a lowering of arterial pressure, the dose of drug needs to be reduced. If necessary therapy is interrupted.

In certain cases when carrying out fertilization of in vitro against the background of Nimotop's use reversible chemical changes in a head of spermatozoa were observed that can lead to sperm dysfunction.

During therapy ability to manage motor transport can be broken in connection with developing of dizziness and a lowering of arterial pressure.

Medicinal interaction

At simultaneous use of Nimotop with some medicines there can be following effects:

Nortriptilin (long combined use): insignificant decrease in concentration of a nimodipin in a blood plasma without change of concentration of a nortriptilin;
Rifampicin: acceleration of metabolism and decrease in efficiency of a nimodipin;
Fluoxetine (long combined use): significant increase in concentration of a nimodipin in a blood plasma (as a rule, for 50%) at considerable reduction of concentration of fluoxetine and an invariance of maintenance of an active metabolite of fluoxetine (norfluoksetin);
The medicines inhibiting or inducing activity of enzymes of a liver: change of concentration of a nimodipin in plasma;
The antiepileptic drugs inducing CYP3A4 isoenzyme (Phenytoinum, phenobarbital, carbamazepine): significant decrease in bioavailability of a nimodipin (the combination of drugs is contraindicated);
Diuretics, beta adrenoblockers, inhibitors of an angiotensin-converting enzyme, blockers of AT1-receptors, other antagonists of calcium, alpha adrenoblockers, Methyldopum, phosphodiesterase inhibitors: a lowering of arterial pressure (its careful control is necessary);
The medicines inducing activity of an isoenzyme of CYP3A4 (macroleads (for example, erythromycin), azolovy antifungal drugs (for example, кетоконазол), HIV protease inhibitors (for example, ритонавир), antidepressants нефазодон and fluoxetine, dalfopristin/kvinopristin, valproic acid, Cimetidinum: increase in concentration of a nimodipin in plasma (decrease in its dose and carrying out monitoring of arterial pressure is recommended);
Zidovudine (intravenous administration): significant increase in its AUC (total concentration of drug in a blood plasma) and decrease in volume of its distribution and clearance;
Calcium drugs: decrease in efficiency of a nimodipin;
Potentially nefrotoksichny drugs (for example, aminoglycosides, cephalosporins, furosemide): a renal failure (at combined use, and also at Nimotop's appointment careful control of a state is necessary for patients with a renal failure; at development of functional disturbances of kidneys therapy is cancelled);
Grapefruit juice: increase in concentration of a nimodipin in a blood plasma.