Nimotop^® (Tablets, Solution) Instructions for Use

ATC Code

C08CA06 (Nimodipine)

Active Substance

Nimodipine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Calcium channel blocker with a predominant effect on cerebral vessels

Pharmacotherapeutic Group

BMCC (Bone Mineral Crystal Complex)

Pharmacological Action

Selective calcium channel blocker of class II, a dihydropyridine derivative. It selectively interacts with L-type calcium channels and blocks the transmembrane influx of calcium ions.

It has a vasodilating effect primarily on the vessels of the brain. It prevents or eliminates vasospasm caused by various vasoconstrictive biologically active substances.

It causes a more pronounced increase in perfusion in areas of the brain with insufficient blood supply compared to areas with normal blood supply. It improves cerebral circulation in subarachnoid hemorrhage.

It stabilizes the functional state of brain neurons. It improves memory and the ability to concentrate.

It does not have a significant effect on systemic blood pressure, practically does not affect conduction in the AV and sinoatrial nodes and myocardial contractility.

It reflexively increases heart rate in response to vasodilation.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract; C_max in plasma is reached within 1 hour.

It undergoes intensive metabolism during the first pass through the liver. Bioavailability is low. Plasma protein binding is 95%.

T_1/2 in the initial phase is 1-2 hours, in the terminal phase is 8-9 hours.

It is excreted by the kidneys less than 1% unchanged and through the intestines.

Indications

Cerebrovascular insufficiency including acute cerebral ischemia, decreased memory and ability to concentrate, mood lability.

Treatment of residual effects of cerebrovascular accident and conditions after surgery for subarachnoid hemorrhage.

ICD codes

Dosage Regimen

For oral administration only. The dosage regimen is determined by the indication and the patient’s clinical condition.

For chronic cerebrovascular insufficiency, administer 30 mg three times daily, equivalent to 90 mg per day.

For acute conditions and during the post-stroke recovery phase, the dose may be increased to 60 mg every four hours, equivalent to 360 mg per day.

For patients with subarachnoid hemorrhage, initiate therapy within 96 hours of the bleeding event. Administer 60 mg every four hours for 21 consecutive days.

For elderly patients and patients with hepatic impairment, initiate therapy at a reduced dose of 30 mg every four hours. Adjust the dose based on tolerability and clinical response.

For patients with renal impairment, a dose adjustment is required; monitor clinical status closely.

Take tablets with a glass of water, at least one hour before or two hours after meals to ensure optimal absorption.

Do not crush or chew the tablets. Swallow them whole.

The duration of treatment is determined by the physician based on therapeutic efficacy. Continue treatment for as long as clinically warranted.

For intravenous administration, the dose must be set individually; refer to the specific parenteral formulation instructions.

Adverse Reactions

From the cardiovascular system decrease in blood pressure, bradycardia, flushing, occurrence or worsening of existing heart failure, extrasystole, angina pectoris up to the development of myocardial infarction, especially in patients with severe obstructive coronary artery disease, arrhythmias including short-term ventricular flutter, torsades de pointes arrhythmia; rarely excessive decrease in blood pressure, tachycardia, transient visual impairment.

From the digestive system nausea, diarrhea, discomfort in the gastrointestinal tract, dyspeptic symptoms, transient increase in the activity of transaminases, GGT and alkaline phosphatase in blood plasma, gingival hyperplasia bleeding, pain, swelling, constipation, dry mouth, increased appetite.

From the central nervous system dizziness, headache, asthenia, extrapyramidal disorders, symptoms of CNS excitation insomnia, increased psychomotor activity, agitation, aggressiveness, depression, fatigue, drowsiness.

From the respiratory system difficulty breathing, cough, pulmonary edema, stridorous breathing.

From the hematopoietic system thrombocytopenia, agranulocytosis.

Allergic reactions rarely skin rash.

Other joint pain and swelling, increased sweating, decreased kidney function increased urea concentration, hypercreatininemia, galactorrhea, weight gain, swelling of the feet and legs.

Contraindications

Severe arterial hypertension, pregnancy, lactation, hypersensitivity to nimodipine.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation breastfeeding period.

Use in Renal Impairment

In case of impaired renal function, dose adjustment is required.

Geriatric Use

Elderly patients require dose adjustment.

Special Precautions

Use with caution in cases of severe bradycardia, chronic heart failure, mild or moderate arterial hypotension, myocardial infarction with left ventricular failure, intracranial hypertension, and with generalized cerebral edema.

In case of impaired renal function and in elderly patients, dose adjustment is required.

Effect on the ability to drive vehicles and operate machinery

Patients taking Nimodipine should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with antihypertensive agents, an enhancement of the antihypertensive effect is possible.

With simultaneous use with beta-blockers, pronounced arterial hypotension and an increased risk of developing heart failure are possible.

With simultaneous use with aminoglycosides, cephalosporins, furosemide, impaired renal function is possible.

With simultaneous use with sodium valproate, the concentration of nimodipine in blood plasma increases; with phenobarbital, phenytoin, carbamazepine, the bioavailability of nimodipine is significantly reduced.

With simultaneous use with cimetidine, a slight increase in the concentration of nimodipine in blood plasma and an enhancement of its antihypertensive effect are possible.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.