Nimotop Bayer tablets and treatment of ischemia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Nimodipine

Ingredient

Composition informationContent
Nimodipine30mg

Uses

Indications

Nimotop drugs are indicated in the following cases:

Use after nimotop transmission of infusion solution, to prevent oral anemia, causing nerve disabilities due to brain spasms followed by subarly bleeding of aneurized spider.

Pharmacokological

nimodipine, the main active ingredient of Nimotop, have anti -anemia and brain vascular spasms used. The vascular contraction is activated in printing - vitro with different vascular activity (such as serotonin, prostaglandin and histamine) or by blood and regression products of blood that can be prevented or limited by nimodipine. Nimodipine also has neurological and pharmacological properties on the mental illness.

Survey in patients with acute brain blood flow disorders showed that nimodipine relaxes brain blood vessels and increases brain blood flow. As a rule, the increase in perfusion in previous brain areas with anemia or previously damaged will be more than the healthy area. Nimodipine significantly reduces neurological damage caused by anemia in patients with subarachnom hemorrhage and death rate.

pharmacokinetic

absorption

The active ingredient Nimodipine used by oral is actually completely absorbed.

Protein distribution and cohesion

97 - 99% Nimodipine is associated with plasma proteins.

After taking or intravenous injection, the concentration of nimodipine measured in brain fluid is about 0.5% of the drug measured in plasma. This is the range of measurement concentration approximately the free concentration in plasma.

Metabolism, elimination and excretion

Nimodipine is eliminated through metabolism through the cytochrome P450 3A4 system, mainly due to the hydrogen reduction of the dihydropyridine ring and the separation of oxidative esters. The combined reaction of the oxidation ester separation of hydroxylation of group 2 and 6 - methyl and glucuronide are even more important metabolic steps. The first three metabolites in plasma shows that there is no or just the remaining activity that is not important in terms of treatment.

Effects on liver enzymes through induction or inhibition are not known. In people with metabolic substances are excreted about 50% through the kidneys and 30% through bile.

Birth

Due to the high steps of nimodipine conversion through the high liver (about 85 - 95%), the absolute bioavailability is 5 - 15%.

Before taking Nimotop Bayer tablets and treatment of ischemia (3 blisters x 10 tablets)

How to use

Nimotop drugs are taken orally.

Nimotop tablets are indicated for about 7 days after the end of 5-14 days of treatment with Nimotop treatment in the form of infusion solution.

In general, the drug should be swallowed in a small amount of water, regardless of the meal.

Avoid drinking with grapefruit juice.

The distance between the next dose must not exceed 4 hours.

Dosage

Adults

Except for specific prescribed cases, the dose should be used as follows:

The process is recommended to use Nimotop injected in 5-14 days, followed by daily dose 6 x 2 nimotop tablets in the form of film bags (6 x 60mg nimodipine).

For patients with harmful reactions, the dose should be reduced or stopped.

When using simultaneously inhibited or CYP 3A4 inhibitors or induction, it may be necessary to adjust.

Drug use time:

Project: After finishing the infusion treatment, continue to take Nimotop tablets at a dose of 6 x 60 mg of Nimotop/day at a distance of 4 hours and take another 7 more days.

Use therapy: After intravenous infusion, oral orally 6 x 60 mg of nimotop/day with a distance of 4 hours and drink for another 7 days.

Patients under 18 years old

Safety and effectiveness of Nimodipine used for patients under the age of 18 has not been determined.

Patients with liver failure

Patients with serious problems of liver function, especially cirrhosis, can increase the bioavailability of nimodipine due to initial decrease in the liver metabolism as well as reduce metabolic clearance. The effects of drugs and side effects such as reducing blood pressure are also noticeable.

In the above cases depending on blood pressure, the dose should be reduced or if necessary, should consider stopping treatment with nimodipine.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms of poisoning

Symptoms of acute overdose are firstly hypotension, tachycardia or slow, and digestive and nausea complaints.

Treatment of poisoning

When an acute overdose, nimotop must be stopped immediately. Emergency measures should be conducted with each symptom. If used orally should wash stomach with activated carbon is an emergency treatment. Dopamine or noradrenalin should be indicated if there is a significant hypotension. Because it is not known for its specific anti -toxic substances, the next treatment for other side effects, focusing on the most prominent symptoms.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Nimotop, you may experience unwanted effects (ADR).

Not common, (ADR ≥ 1/1000, ADR

  • Blood and lymphatic disorders: platelets.
  • Immune system disorders: allergies, rash.
  • Nervous system disorders: headache.
  • Heart disorders: tachycardia.
  • Vascular disorders: Low blood pressure, vasodilation.

    Digestive disorders: Nausea.

    Rare, (ADR ≥ 1/10000, ADR

  • heart disorders: arrhythmia.
  • Gastrointestinal disorders: intestinal obstruction.

    Liver disorders: Increased liver enzymes.

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Nimotop drugs contraindicated in the following cases:

  • Do not take nimotop drugs in case of hypersensitivity to nimodipine or any ingredient of the drug.
  • Contrain to nimodipine with rifampicin because of the effectiveness of nimotop tablets is significantly reduced when used simultaneously with rifampicin.
  • Contrain to use Nimodipine tablets with anti -epileptic drugs such as phenobabital, phenytoin or carbamazepine because of the effectiveness of Nimotop tablets is significantly reduced.
  • Be cautious when using

    It is not recommended to use nimodipine for patients with subarly subarly dedicated hemorrhage due to trauma because they have not established the ratio of benefits on risks and have not yet identified these special groups of patients that can be effectively treated with this indication.

    Although there is no evidence that the relationship between intracranial pressure and nimodipine treatment is needed, it is necessary to closely and carefully monitor when used in these cases or when the content in the brain tissue increases (usually brain edema).

    Caution should be cautious for patients with low blood pressure (systolic blood pressure lower than 100 mmHg).

    For patients with unstable angina or newly acute myocardial infarction in the last 4 weeks, the doctor should consider the risk of risk (such as reducing coronary perfusion, myocardial perfusion) and benefits (such as improving cerebral perfusion).

    Nimodipine is metabolized through the cytochrome P450 3A4 system. The drugs that have been known to inhibit or touch the enzyme system can change the initial transformation or clearance of nimodipine.

    Cytochrome P450 3A4 inhibitors will increase the concentration of nimodipine in the blood such as:

  • Macrolide antibiotics (erythromycine).
  • Protease inhibitors against HIV (for example: Ritonavir).
  • Azole antifungal drugs (for example, ketocozazole).
  • Nefazodone and fluoxetine antidepressants.

  • quinuprristin/dalfopristin ..
  • cimetidine.

  • Valproic Acid.
  • When used simultaneously with these drugs, it is necessary to closely monitor blood pressure, in case of necessity, the dose should be considered with nimodipine.

    The ability to drive and operate machinery

    In principle, the ability to drive and operate machinery will be reduced in the case of dizziness.

    Pregnancy

    There is no complete research and system on pregnant women. If you take nimodipine during pregnancy, you should consider carefully the benefits and risks when using the drug based on the seriousness of the clinical scene.

    Breastfeeding period

    nimodipine and its metabolites have been shown to be in breast milk with concentrations corresponding to the serum concentration of the mother, so mothers do not breastfeed during medication.

    Reproductive ability

    In some individually in vitro fertilization, the use of calcium antagonists related to the biochemical changes at the tip of sperm can recover can reduce the function of sperm.

    Drug interaction

    drugs that affect Nimodipine

    Nimodipine is metabolized through the cytochrome P450 3A4 system, found in both intestinal and liver mucosa. Therefore, these enzyme inhibitors or induction can change the initial metabolism through the liver or the clearance of nimodipine.

    It should be noted to the level and time of interaction when using simultaneously nimodipine with the following drugs:

    rifampicin

    According to experience used with other calcium antagonists, it can be seen that rifampicin increases nimodipine metabolism thanks to enzyme induction. Therefore, the effectiveness of nimodipine can be significantly reduced when used simultaneously with rifampicin. So contraindicated use combinations Nimodipine and rifampicin.

    Anti -epilepsy drugs that cause Cytochrome P450 3A4 induction such as phenobarbital, phenytoin or carbamazebine.The previous prolonged use of anti -epileptic drugs such as phenobabital, phenytoin or carbamazebine will significantly reduce the bioavailability of nimodipine oral drugs. Therefore, oral nimodipine should not be used simultaneously with these anti -epileptic drugs.

    When using simultaneously inhibitors of the following Cytochrome P450 3A4 system, it is necessary to closely monitor blood pressure and if necessary, we should consider reducing the dose of nimodipine.

    Macrolide antibiotics (for example, erythromycin)

    although azithromicin group has the same structure as macrolid antibiotics but does not inhibit CYP 3A4.

    ProtaSe anti -HIV inhibitors (for example: Ritonavir)

    No official research has been conducted on the ability to interact with drugs between Nimodipine and anti -HIV ProtaSe inhibitors.

    Azole antifungal drugs (for example, ketocozazole)

    When used simultaneously with nimodipine oral medication, nimodipine's systemic bioavailability increases significantly due to initial metabolic reduction through the liver.

    nefazodone

    When used when used simultaneously with nefazodone cannot rule out the bioavailability of Nimodipine's body significantly increased significantly due to initial metabolism through the liver.

    fluoxetin

    Nimodipine long -term use with Fluoxetin antidepressants can increase 50% of serum nimodipine levels. Fluoxitin exposure is significantly reduced while the metabolites of its activity norfluoxetin are not affected.

    quinuprristin/dalfopristin

    Based on experience with nifedipine calcium antagonists, simultaneously used with quinuprristin/dalfopristin may increase the concentration of nimodipine in serum.

    cimetidine

    H2/cimetidine antagonism simultaneously can increase the concentration of nimodipine in serum.

    Valproic acid

    Simultaneous use of Valproic acid anti -convulsions may increase the concentration of nimodipine in serum.

    Other interactions

    nortriptyline

    Nimodipine and nortripetyline long -term use lead to mitigating nimodipine exposure but does not affect the concentration of nortriptyline in serum.

    The effect of nimodipine on other drugs

    Medications that reduce blood pressure

    Nimodipine may increase the effectiveness of hypotension of hypertension treatment:

  • Diuretics.
  • Ta.
  • ACE inhibitors.
  • Agreement - α1.
  • Other antagonists.

  • Bleaners - Alpha adrenergic.
  • PDE5 inhibitors.
  • α - methyldopa.

    However, if this combination is forced to apply, it is necessary to monitor the patient in a special way.

    Interacts with food

    grapefruit juice

    Grapefruit juice inhibits Cytochrome P450 3A4. Simultaneous use of calcium dihydropyridine and grapefruit juice can increase serum levels and prolong the activity of nimodipine due to initially reduced metabolism through the liver or reduce clearance.

    As a result, hypotension can increase after drinking grapefruit juice, this effect can last for at least 4 days. Therefore, avoid grapefruit or grapefruit juice while using nimodipine.

    Storage

    Store temperatures below 30 ° C.

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