Nitremed
Nitremed: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Nitremed
ATX code: C08CA08
Active ingredient: nitrendipine (Nitrendipine)
Manufacturer: PRO. MED. TSS Praha a.o. (PRO. MED. CS Praha as) (Czech Republic)
Description and photo update: 09.10.2019
Prices in pharmacies: from 280 rubles.
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Nitremed is a slow calcium channel blocker that has antihypertensive and antianginal effects.
Release form and composition
The drug is available in the form of tablets: yellow, round, flat, with a bevel, on one side there is a dividing line, on the other side for tablets with a dosage of 10 mg - engraving "10", for tablets with a dosage of 20 mg - "20" (10 pcs.. in blisters, in a cardboard box 2, 3 or 6 blisters and instructions for use of Nitremed).
1 tablet contains:
- active substance: nitrendipine - 10 or 20 mg;
- auxiliary components: corn starch, lactose monohydrate, povidone-25,000, microcrystalline cellulose, sodium docusate, magnesium stearate.
Pharmacological properties
Pharmacodynamics
The active substance of Nitremed is nitrendipine, a dihydropyridine derivative, a blocker of slow calcium channels. It has antianginal and antihypertensive effects by reducing the flow of extracellular calcium into cardiomyocytes and smooth muscle cells of coronary and peripheral arteries. By reducing the number of functioning channels, nitrendipine does not affect the period of their activation, inactivation and recovery. Promotes the isolation of the processes of excitation and contraction, which are mediated in the myocardium by tropomyosin and troponin, and in vascular smooth muscles - by calmodulin. Antihypertensive activity is also associated with inhibition of aldosterone secretion.
Therapeutic doses of Nitremed ensure the normalization of the transmembrane calcium current, impaired in arterial hypertension and a number of other pathological conditions.
Nitrendipine is also a calcium channel agonist with some positive inotropic effects. Its negative inotropic effect masks a reflex increase in heart rate (heart rate).
The peripheral vasodilating effect of Nitremed increases the left ventricular ejection fraction and decreases the size of the heart in patients with heart failure.
Nitrendipine does not affect venous tone. By relaxing the vascular smooth muscles, it causes expansion of both peripheral and coronary arteries, a decrease in the total peripheral vascular resistance and myocardial contractility. Reduces pre- and afterload, reduces myocardial oxygen demand. Does not suppress conduction in the myocardium. As a result of increased coronary blood flow, the blood supply to the ischemic zones of the myocardium improves without the development of the stealing phenomenon, potentiates the functioning of collaterals.
By increasing renal blood flow, it causes, especially at the beginning of treatment, a slight natriuretic effect.
Pharmacokinetics
After oral administration, nitrendipine is rapidly absorbed from the gastrointestinal tract almost in full (approximately 88%). The maximum concentration in blood plasma (C max) is reached after 1–3 hours and is 9–40 ng / ml.
Plasma protein binding (albumin) - 96–98%. In this regard, the use of hemodialysis or plasmapheresis for drug elimination is ineffective.
The volume of distribution in an equilibrium state is 5–9 l / kg.
It is metabolized in the liver as a result of oxidative processes, including 70-80% during the initial passage through the liver with the formation of pharmacologically inactive metabolites. Isoenzymes CYP3A4, CYP3A5, CYP3A7 are involved in biotransformation.
The half-life (T 1/2) of nitrendipine is 8–12 hours, in elderly patients it increases.
With cirrhosis of the liver, AUC (area under the concentration-time curve) and C max increase.
It is excreted in the form of four polar metabolites: through the kidneys - about 77%, through the intestines - 30% of the dose. Less than 0.1% of the dose is excreted unchanged in the urine. The total plasma clearance is 1.3 l / min.
Nitrendipine does not accumulate in the body.
Indications for use
The use of Nitremed is indicated for patients with arterial hypertension.
Contraindications
Absolute:
- severe arterial hypotension, if the upper blood pressure (BP) is below 90 mm Hg (Hg);
- acute period of myocardial infarction (first 28 days);
- cardiogenic shock;
- decompensated chronic heart failure;
- unstable angina;
- obstruction of the left ventricular outflow tract, which is of hemodynamic significance (including severe aortic stenosis: blood flow velocity more than 4 m / s, orifice area less than 1 cm 2, average gradient more than 40 mm Hg, valve opening area index less than 0.6 cm 2 / m 2);
- simultaneous use with rifampicin;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
- period of pregnancy;
- lactation;
- age up to 18 years;
- hypersensitivity to 1,4-dihydropyridine derivatives;
- individual intolerance to the components of the drug.
Nitremed should be taken with caution in chronic heart failure, hypertrophic obstructive cardiomyopathy, sick sinus syndrome, arterial hypotension, aortic or mitral stenosis, hepatic and / or renal failure, the need to combine with inhibitors or inducers of the CYP3A4 isoenzyme, during the period of increasing doses in elderly patients …
Nitremed, instructions for use: method and dosage
Nitremed tablets are taken orally, after meals, swallowing whole (or dividing into 2 parts according to risk) and drinking plenty of water. Do not drink grapefruit juice tablets.
The tablet should be removed from the blister just before taking it so as not to expose it to light.
The doctor determines the dose of Nitremed taking into account the severity of the disease, the treatment is carried out in a long course.
Recommended dosage:
- tablets with a dosage of 10 mg: 1 pc. 2 times a day (morning and evening). With insufficient decrease in blood pressure - 2 pcs. 2 times a day;
- tablets with a dosage of 20 mg: 1 pc. Once a day, in the morning. With an insufficient decrease in blood pressure, the daily dose can be increased to 40 mg - 1 pc. 2 times a day.
The maximum daily dose of Nitremed is 40 mg.
Do not take a double dose of the drug to compensate for an accidentally missed dose. Treatment must be continued following the prescribed dosing regimen.
In addition to monotherapy, the use of Nitremed is indicated in combination therapy with a diuretic, beta-blocker, ACE inhibitor (angiotensin converting enzyme) or angiotensin II receptor antagonist.
The initial daily dose of Nitremed for elderly patients should be 10 mg. In the absence of a sufficient clinical effect, it can be increased with caution.
In case of impaired liver function, it is recommended to start treatment with a dose of 10 mg per day, accompanied by careful monitoring of the patient's condition. If the initial dose causes a marked decrease in blood pressure, then treatment must be discontinued.
In case of impaired renal function, dose adjustment of Nitremed is not required.
Side effects
Taking Nitremed can cause the following adverse reactions [classification is made in accordance with the recommendations of the WHO (World Health Organization): very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); rarely (≥ 1/10 000 to <1/1000); very rare (<1/10 000); frequency not known (cannot be estimated from available data)]:
- from the side of the vessels: very often - transient peripheral edema (especially at the beginning of therapy); infrequently - a pronounced decrease in blood pressure; rarely - leukocytoclastic vasculitis;
- from the heart: often - tachycardia, palpitations, angina pectoris, aggravation of angina attacks; very rarely - myocardial infarction;
- from the nervous system: very often - transient headache (especially at the beginning of therapy); infrequently - increased fatigue, dizziness, nervousness, paresthesia, fainting;
- dermatological reactions: very often - transient rush of blood to the skin of the face (especially at the beginning of therapy); infrequently - itchy skin, rash, urticaria, photosensitivity; very rarely - angioedema, exfoliative dermatitis;
- from the lymphatic system and blood: very rarely - agranulocytosis, leukopenia;
- on the part of the organ of vision: infrequently - blurred vision, visual impairment;
- from the organ of hearing and labyrinth disorders: infrequently - dizziness;
- from the respiratory system, chest and mediastinal organs: infrequently - shortness of breath;
- from the hepatobiliary system: rarely - an increase in the activity of transaminases and other liver enzymes;
- from the gastrointestinal tract: infrequently - abdominal pain, nausea, vomiting, diarrhea, constipation; very rarely - gingival hyperplasia;
- from the urinary system: infrequently - polyuria, increased urge to urinate;
- from the musculoskeletal system: infrequently - arthralgia, myalgia;
- from the genitals and mammary gland: very rarely - menorrhagia, gynecomastia, erectile dysfunction;
- general disorders: infrequently - increased sweating, weight gain; very rarely - fever.
Overdose
Symptoms: a pronounced decrease in blood pressure for a long period (up to the development of collapse), hyperemia of the facial skin, headache, bradycardia, tachycardia, suppression of the sinus node function.
Treatment: immediate gastric lavage, intake of activated charcoal. The antidote of nitrendipine is calcium preparations. Shows the use of a 10% solution of calcium chloride or calcium gluconate by slow intravenous (IV) administration followed by a transition to a long-term infusion. In case of a significant decrease in blood pressure, the patient needs to administer dopamine or dobutamine intravenously, in the event of conduction disorders - atropine, isoprenaline, or install a pacemaker.
Hemodialysis is ineffective.
special instructions
The dividing line on the tablet is not intended to be divided into doses!
During the period of treatment, it should be borne in mind that the use of grapefruit juice can lead to an increase in the antihypertensive effect of Nitremed.
The combination of nitrendipine with alcohol is contraindicated.
Treatment should be discontinued by gradually decreasing the daily dose of Nitremed.
In case of peripheral edema in patients with concomitant chronic heart failure, it is necessary to accurately determine the cause of their occurrence, since they can be both a side effect of Nitremed and a symptom of progression of left ventricular dysfunction.
Careful monitoring of the condition of patients with decompensated heart failure or sick sinus syndrome in the absence of a pacemaker is required.
When prescribing Nitremed to patients with coronary heart disease, it should be borne in mind that the use of slow calcium channel blockers in them can increase the frequency, duration and / or severity of angina attacks, up to the development of myocardial infarction.
Influence on the ability to drive vehicles and complex mechanisms
During the period of application of Nitremed, it is recommended to exercise caution in patients associated with potentially hazardous activities, the implementation of which requires concentration of attention and a high speed of psychomotor reactions, including driving and complex mechanisms.
Application during pregnancy and lactation
The use of Nitremed is contraindicated during pregnancy and lactation.
Pediatric use
The appointment of Nitremed to children and adolescents under the age of 18 is contraindicated due to the lack of reliable data on the safety and efficacy of the drug in this category of patients.
With impaired renal function
Nitremed should be taken with caution in case of renal failure. No dose adjustment is required.
For violations of liver function
Nitremed should be taken with caution in patients with hepatic impairment.
The initial daily dose in patients with impaired liver function should be 10 mg.
Use in the elderly
Nitremed should be taken with caution in elderly patients, especially during the period of increasing the dose of the drug.
The initial daily dose in elderly patients should be 10 mg.
Drug interactions
- quinidine, theophylline, digoxin: their concentration in blood plasma increases. So the level of digoxin almost doubles, in connection with which it is necessary to control its concentration in the blood plasma and, if necessary, reduce the dose of digoxin;
- pancuronium bromide, vecuronium bromide: increases the duration and severity of the effects of muscle relaxants;
- grapefruit juice: helps to enhance the antihypertensive effect of nitrendipine;
- drugs that inhibit or induce the isoenzyme CYP3A4 of cytochrome P 450: may have a negative effect on plasma clearance or the effect of primary passage through the liver of nitrendipine;
- calcium preparations, estrogens: help to weaken the antihypertensive action of Nitremed;
- non-steroidal anti-inflammatory drugs (NSAIDs): reduce the hypotensive effect of nitrendipine;
- inducers of liver microsomal enzymes (including rifampicin, rifampin, carbamazepine, phenobarbital, phenytoin), sympathomimetics: contribute to a significant decrease in the bioavailability of the active substance, therefore, during the period of taking anticonvulsants, the dose of nitrendipine should be increased, and after their withdrawal, return to the usual dosage regimen;
- other antihypertensive drugs, alpha and beta-blockers, inhalation anesthetics, diuretics, cimetidine, ranitidine: cause an increase in the antihypertensive effect of nitrendipine;
- tricyclic antidepressants, antifungal drugs (itraconazole, ketoconazole, fluconazole), antiviral drugs (ritonavir, amprenavir, atazanavir, indinavir, saquinavir, nelfinavir), antiepileptic drugs (valproeuristicin acid), chinopriticinitis bioavailability of nitrendipine and its concentration in blood plasma. With concomitant therapy with ketoconazole, fluconazole or itraconazole, the patient requires careful monitoring of blood pressure, if necessary, a decrease in the dose of nitrendipine;
- nefazodone: against the background of the combined use of drugs, an increase in the concentration of nitrendipine in the blood plasma is possible;
- lithium preparations, nitrates: enhance the toxic effects of nitrendipine, the symptoms of which are nausea, vomiting, diarrhea, tremor, ataxia, tinnitus;
- procainamide, quinidine: the negative inotropic effect is enhanced when combined with drugs that cause prolongation of the QT interval, which can lead to its significant prolongation.
Analogs
Nitremed's analogs are: Octidipine, Amlodipine, Amlodak, Amlodivel, Cardilopin, Veracard, Verapamil, Finoptin, Diltiazem, Lacidipine, Latsipil, Lerkamen, Nitremed, Nifedipine, Adalat, Cordaflex, Sanfidarizin, Fiedeniqifin.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Nitremed
Reviews about Nitremed are positive. Patients indicate that the use of the drug provides a stable antihypertensive effect.
Price for Nitremed in pharmacies
The price of Nitremed for a package containing 30 tablets with a dosage of 10 mg can be 207–375 rubles, with a dosage of 20 mg - 324–463 rubles.
Nitremed: prices in online pharmacies
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Drug name Price Pharmacy |
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Nitremed 10 mg tablets 30 pcs. 280 RUB Buy |
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Nitremed tablets 10mg 30 pcs. 356 r Buy |
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Nitremed 20 mg tablets 30 pcs. 381 r Buy |
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Nitremed tablets 20mg 30 pcs. RUB 515 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
