Nimotop (Solution for infusion)

Active material: Nimodipine
When ATH: C08CA06
CCF: A calcium channel blocker with advantageous effects on the brain vessels
When CSF: 01.03.02
Manufacturer: BAYER HealthCare AG (Germany)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Solution for infusion1 ml1 fl.
nimodipine200 g10 mg

50 ml – vials of dark glass (1) complete with a connecting tube – packs cardboard.

Pills, Film-coated1 tab.
nimodipine30 mg

10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (10) – packs cardboard.

 

Pharmacological action

BMKK, 1,4-dihydropyridine derivative, provides mainly zerebrovazodilatirtee and protivojishemicescoe action. Can prevent or eliminate Vasospasm, called by various sossoudossoujiwatmi HP (for example, serotonin, PG, gistaminom). Due to its high lipophilicity GEB. Improves stability and functional ability of neurons. Selective blockade of Ca2 +-channels in certain areas of the brain, for example, the hippocampus and cerebral cortex, explain the positive impact on the ability of learning and memory (action properties). Similar molecular mechanism underlies sosudorasshiratego Nimodipine. Virtually no effect on conductivity in AV and SA nodes and airway miokrada. Reflex increases the HEART RATE in response to the expansion vessels.

 

Testimony

Cerebrovascular insufficiency (incl. acute ischemia of the brain, memory loss and the ability to focus, mood lability) – for oral dosage forms. Subarachnoid hemorrhage (incl. After surgical treatment about subarachnoid hemorrhage) – for intravenous injection.

 

Contraindications

Hypersensitivity, severe hypotension, pregnancy, lactation. Vыrazhennaya bradycardia, CHF, hepatic failure, mild or moderate arterial hypertension, myocardial infarction with LV failure, intracranial hypertension, generalized swelling of brain tissue.

 

Side effects

Side effects. From the CCC: decrease in blood pressure, bradycardia, feeling “tides” the skin of the face, heat, facial flushing, development or aggravation of available CH, arrythmia, angina, until the development of myocardial infarction (especially in patients with severe obstructive coronary artery disease), Arrhythmia (incl. transient ventricular fibrillation, the type of arrhythmia “pirouette”); rarely – excessive reduction of blood pressure, tachycardia. From the digestive system: nausea, diarrhea, gastrointestinal discomfort, activity increase “Hepatic” transaminases and alkaline phosphatase, GGT, giperplaziya right (angiostaxis, soreness, puffiness), constipation, dry mouth, increased appetite. CNS: dizziness, headache, asthenia, extrapyramidal (parkinsonian) infringement (ataxia, mask-like face, shuffling gait, stiffness in the arms or legs, tremors of the hands and fingers, difficulty weight management), symptoms of CNS excitation (insomnia, increased motor activity, excitation, aggressiveness), depression, excessive fatigue, drowsiness. The respiratory system: pulmonary edema (difficulty breathing, cough, stridor). From the hematopoietic system: asymptomatic thrombocytopenia, agranulocytosis. On the part of the musculoskeletal system: arthritis (soreness, swelling of joints). Allergic reactions: rarely – skin rash. Other: peripheral edema; increased perspiration, decreased kidney function (increasing concentrations of urea, giperkreatininemiя), transient vision loss amid Cmax, galactorrhea, the increase in body mass index. Overdose. Symptoms: marked reduction in blood pressure, tachycardia or bradycardia, vomiting, epigastric pain, CNS dysfunction. Treatment: symptomatic. First aid includes washing stomach reception activated carbons and. If there has been a significant decrease in HELL, You must enter/dopamine or norapinefrin. Specific comsp Nimodipine unknown.

 

Dosing and Administration

B /, intraventrikuljarno, vnutriserdechno, inside. Hemorrhagic and ischemic stroke (acute phase): on the first day – / drip 1 mg for 2 h speeds 15 mcg/kg/h (in 0.9% NaCl), then, with good endurance – 2 mg for 3 h speeds 30 mcg/kg/h. Infusion hold 1 once a day for 5-7 days. After 5-14-day course of parenteral treatment is recommended for 10 days of oral (by 60 mg 4 once a day). If during the therapeutic or prophylactic hemorrhage source undergoes surgery, treatment in/in the introduction of Nimodipine infusion solution should continue after the operation for a period of not less than 5 days. In/in the introduction is done in conjunction with a standard infusion therapy, the recommended size is not below 1 l / day. Introduction can be performed during general anesthesia, operations or angiography. For intraventricular introduction use solution, comprising 2 mg 20 ml 0.9% NaCl solution. Prevention of acute cerebral arteries after subarachnoid hemorrhage should start no later than, than 4 days after bleeding, and continue throughout the period of greatest risk for the development of Vasospasm, ie. up to 10-14 day. After the end of the infusion recommended ingesting during 7 next days (6 times per day 60 mg, at intervals of 4 no). When existing ischemic neurological disorders (After subarachnoid hemorrhage), caused by the spasm of blood vessels, treatment should start as soon as possible and continue for a period of not less than 5 and no more than 14 days. In elderly patients, in patients with body weight below 70 kg and/or labile HELL start infusion with half the usual initial dose. When liver or renal insufficiency dose picked individually, under the supervision of HR, Blood pressure and ECG. Inside, the tablets should be swallowed whole, drinking a small amount of liquid, regardless of the meal. The intervals between meals should not be less than 4 no. In the absence of other. appointments are advised to observe the following dosing regimen: 1. Subarachnoid hemorrhage after rupture of aneurysm. The recommended dose – 60 mg 6 once a day for 7 d (after 5-14 SUT infusion therapy solution of Nimodipine). 2. Cerebrovascular insufficiency in elderly patients. The recommended dose: 30 mg 3 once a day. In patients with severely impaired hepatic function may require dose reduction or abolition of treatment. The duration of treatment in mild neurological violations – to 8-16 Sun, at moderate – 700 days, When expressed – to 7 years. Migraine (prevention): inside, by 30 mg 3 once a day, for several months.

 

Cautions

Appointment of Nimodipine in patients of old age with lots of associated diseases, severe renal insufficiency (the value of clubockova filtering less than 20 ml / min) and severe heart disease should be carefully justified. During and after therapy these patients need regular medical supervision (including neurological). In patients with impaired liver function due to the decrease in intensity of primary metabolism and slowing the metabolic inactivation of the bioavailability of Nimodipine may increase. Consequently, the main and side effects of Nimodipine, in particular its hypotensive effect, may be aggravated by. In such cases, the dose should be reduced depending on the degree of reduction AD, and if necessary the use of Nimodipine should stop. The caution should be appointed at the same time with dizopiramidom and flekainamidom (Perhaps the increasing severity of adverse action inotropnogo). Despite its lack of BICR syndrome “cancel”, before the termination of treatment is recommended a gradual reduction in dose. If during therapy the patient required surgery under general anesthesia, You must inform the anesthesiologist about the nature of the therapy. Should be used with caution in elderly patients due to the best likelihood of age violations of kidney function. Solutions are sensitive to light, It is recommended to protect the infusion system lightproof facings. When the scattered daylight or artificial light recovery solution can be used within 10 no. During the period of treatment must be careful when driving and other lesson. potentially hazardous activities, require high concentration and speed of psychomotor reactions.

 

Cooperation

Since Nimodipine is metabolized with the participation of zitohroma CYP3A4, PM, that inhibit or induce this enzyme system, may affect the first stage of metabolism (after oral administration) or clearance of Nimodipine. Combined application of Nimodipine and Fluoxetine has been accompanied by increased concentrations of Nimodipine in plasma (on 50%), However, this concentration of fluoxetine significantly reduced, While the concentration of its active metabolita norfluoksetina remains unchanged. Prolonged use of Nimodipine with nortriptilinom leads to a slight increase in the concentration of Nimodipine in plasma; concentration nortriptilina remains unchanged. Prior to a long appointment of phenobarbital, fenitoina or carbamazepine significantly reduces the bioavailability of Nimodipine ingestion (simultaneous oral therapy nimodipinom and the anticonvulsant HP not recommended). Based on the experience of application of etc. BMKK, Nifedipine, can be expected, that rifampicin is able to accelerate the metabolism of Nimodipine, inducing the activity of liver enzymes, point O. together with the use of rifampicin and Nimodipine last efficiency can be reduced. Grapefruit juice inhibits the metabolism of oxidation digidropiridinov. Combination of Nimodipine and grapefruit juice should be avoided, tk. This can lead to increased concentrations of Nimodipine in plasma. The simultaneous use of Nimodipine with cimetidine or valproeva acid can lead to increased concentrations of Nimodipine in plasma. Ranitidine and famocidin do not have a significant impact on the metabolism of BICR. Inhibits metabolism prazosine, etc. alpha-blockers, as a result may increase the hypotensive effect. Not detected drug interaction with Nimodipine aminazin patients, located on long-term therapy aminazin. In patients with elevated AD, taking antihypertensive drugs, Nimodipine can enhance their effect. During the application of nimodipine should not be I / administered beta-blockers (the risk of a significant reduction in blood pressure). Prokaynamyd, quinidine, etc. PM, causing elongation of the Q-T interval, reinforce inotropony negative effect and may increase the risk of a significant lengthening of Q-T interval. Nimodipine increases the risk of renal dysfunction on the background of nephrotoxic drugs (aminoglycosides, cephalosporins). Enhances the arrhythmogenic effects of drugs, promote excretion of K +. It increases the risk of side effects of cardiac glycosides, xinidina, karʙamazepina, cyclosporine, teofillina, valproatov, salts of Li +. The hypotensive effect is enhanced with concomitant administration with beta-blockers, others. BMKK, inhaled anesthetics or sympatholytic medicines. The hypotensive effect of reducing sympathomimetic, NSAIDs (Pg synthesis inhibition in the kidney and delays Na + and fluid in the body), Estrogens (fluid retention). Formulations Ca2 + reduce the effectiveness of nimodipine. absorbed PVC, therefore I / O reference should only be used infusion systems made of polyethylene.

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