Amlodipine Teva pills 5mg N30
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Active ingredients
Amlodipine
Release form
Pills
Composition
Active ingredient: Amlodipine (Amlodipine) Active ingredient concentration (mg): 5
Pharmacological effect
Selective calcium channel blocker class II. Antihypertensive effect due to a direct relaxing effect on vascular smooth muscle. It is assumed that the antianginal effect of amlodipine is associated with its ability to expand peripheral arterioles; this leads to a decrease in OPSS, reflex tachycardia does not occur. As a result, there is a decrease in myocardial oxygen demand and energy consumption by the heart muscle. On the other hand, amlodipine, apparently, causes the expansion of large-caliber coronary arteries and coronary arterioles in both intact and ischemic myocardial regions. This provides oxygen to the myocardium during spasms of the coronary arteries.
Pharmacokinetics
When ingestion is absorbed from the gastrointestinal tract slowly and almost completely, Cmax in the blood plasma is achieved within 6-9 hours. Protein binding is 95-98%. It undergoes minimal metabolism during the first passage through the liver and a slow but significant hepatic metabolism with the formation of metabolites with negligible pharmacological activity. T1 / 2 averages 35 hours and in arterial hypertension can increase on average to 48 hours, in elderly patients - up to 65 hours and in case of abnormal liver function, up to 60 hours. It is eliminated mainly as metabolites: 59-62% by the kidneys, 20-25% through the intestines.
Indications
Arterial hypertension. Stable angina of exertion. Vasospastic angina.
Contraindications
Hypersensitivity to amlodipine, other dihydropyridine derivatives or other components of the preparation Obstruction of the outflow tract of the left ventricle. Clinically significant aortic stenosis. Age up to 18 years (efficacy and safety have not been established). Caution should be used: abnormal liver function, syn syndrome Usovogo node (marked bradycardia, tachycardia),chronic heart failure of non-ischemic etiology of III - IV functional class according to NYHA classification, arterial hypotension, aortic stenosis, mitral stenosis, acute myocardial infarction (after the first 28 days), old age, impaired renal function.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
The safety of using amlodipine during pregnancy has not been established; therefore, it is possible to use it only if the intended benefit to the mother outweighs the potential risk to the fetus. There is no data indicating the elimination of amlodipine in breast milk. However, it is known that other blockers of slow calcium channels (dihydropyridine derivatives) are excreted in breast milk. In this regard, if necessary, the use of amlodipine during lactation should decide on the termination of breastfeeding.
Dosage and administration
Inside, once a day, drinking down the required amount of water (100 ml). In case of arterial hypertension and angina: the initial dose is 5 mg 1 time per day. In the absence of a therapeutic effect within 2 to 4 weeks, the dose of the drug can be increased to 10 mg / day. once. In elderly patients: dose adjustment is not required. In patients with impaired liver function: despite the fact that T1 / 2 amlodipine, like all BMCC, increases in patients with impaired liver function, dose adjustment is usually not required. In patients with renal failure: Amlodipine-Teva is recommended to be used in usual doses.
Side effects
On the part of the central nervous system: often - headache (especially at the beginning of treatment), dizziness, fatigue, drowsiness; infrequently - general malaise, hypesthesia, neuropsychiatric asthenia, paresthesia, acrodystrophic neuropathy, intentional tremor, insomnia, emotional lability, unusual dreams, nervousness, anxiety, depression, anxiety, increased sweating; rarely - convulsions, apathy, agitation; very rarely - ataxia, amnesia, migraine. From the digestive system: often - nausea, abdominal pain; infrequently - vomiting, change of the mode of defecation (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dryness of the oral mucosa,thirst; rarely - gingival hyperplasia, increased appetite; very rarely - pancreatitis, gastritis, jaundice (usually cholestatic), hyperbilirubinemia, increased activity of hepatic transaminases, hepatitis. Cardio-vascular system: often - peripheral edema (ankles and feet), heartbeat, "flush" of blood to the skin of the face; infrequently - excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely - the development or aggravation of CHF; very rarely - fainting, shortness of breath, cardiac rhythm disturbances (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, chest pain, pulmonary edema. side of the urinary system: infrequently - pollakiuria, painful urge to urinate, nocturia; very rarely - dysuria, polyuria. From the reproductive system and mammary glands: infrequently - gynecomastia, impotence. From the respiratory system: infrequently - shortness of breath, rhinitis; very rarely - cough. On the part of the musculoskeletal system: infrequently - muscle cramps, myalgia, arthralgia, back pain, arthrosis; rarely - myasthenia. From the skin: rarely - alopecia; rarely - dermatitis; very rarely - xerodermia, cold sticky sweat, impaired skin pigmentation. Allergic reactions: rarely - pruritus, rash (including erythematous, maculopapular rash); very rarely - urticaria, angioedema, erythema multiforme. On the part of the sense organs: infrequently - tinnitus, blurred vision, diplopia, accommodation disorder, xerophthalmia, conjunctivitis, eye pain; very rarely - parosmia. From the side of metabolism: very rarely - hyperglycemia. Others: infrequently - weight loss, weight gain, taste perversion, nosebleeds, chills.
Overdose
Overdose of the drug is not described.
Interaction with other drugs
It is possible to enhance the antianginal and antihypertensive action of blockers of slow calcium channels when used together with thiazide and loop diuretics, ACE inhibitors, beta-blockers and nitrates, as well as enhance their anti-hypertensive action when combined with alpha1-blockers,neuroleptic drugs. While in the study of amlodipine, negative inotropic effects were not usually observed, however, some blockers of slow calcium channels may increase the severity of the negative inotropic effects of antiarrhythmic drugs that cause prolongation of the QT interval (eg, amiodarone and quinidine). Simultaneous multiple use of amlodipine at a dose of 10 mg and simvastatin at a dose of 80 mg leads to an increase in the bioavailability of simvastatin by 77%. In such cases, the dose of simvastatin should be limited to 20 mg. Antiviral drugs (for example, ritonavir) increase plasma concentrations of blockers of slow calcium channels, including. amlodipine. With simultaneous use of sympathomimetics, estrogens, a decrease in the antihypertensive effect due to sodium retention in the body is possible. Neuroleptics and isoflurane increase the antihypertensive effect of dihydropyridine derivatives. With simultaneous use of drugs for inhalation anesthesia, hypotensive effect may be enhanced. With simultaneous use of amiodarone, increased antihypertensive effect is possible. With simultaneous use of lithium carbonate, manifestations of neurotoxicity are possible (including nausea, vomiting, diarrhea, ataxia, tremors, and / or tinnitus ). With the simultaneous use of orlistat reduces the antihypertensive effect of amlodipine, which can lead to a significant increase in blood pressure, the development of hypertensive crisis. At the same time Indomethacin and other NSAIDs may reduce the antihypertensive effect of amlodipine due to inhibition of prostaglandin synthesis in the kidneys and fluid retention under the influence of NPVS. Simultaneous use of quinidine may increase the antihypertensive effect. Calcium preparations can reduce the effect of slow calcium channel blockers. ) at a dose of 180 mg and amlodipine at a dose of 5 mg in elderly patients (from 69 to 87 years old) with arterial hypertension, tsya increase the bioavailability of amlodipine by 57%. The simultaneous use of amlodipine and erythromycin in healthy volunteers (from 18 to 43 years old) does not lead to significant changes in the exposure to amlodipine (an increase in AUC by 22%).Although the clinical significance of these effects is not completely clear, they may be more pronounced in older patients. Potent inhibitors of the isoenzyme CYP3A4 (for example, ketoconazole, itraconazole) can lead to an increase in the concentration of amlodipine in the blood plasma to a greater extent than diltiazem. Amlodipine and CYP3A4 isoenzyme inhibitors should be used with caution. There is no data on the effect of CYP3A4 isoenzyme inducers on the pharmacokinetics of amlodipine. Blood pressure should be carefully monitored with simultaneous use of amlodipine and CYP3A4 isoenzyme inducers.
special instructions
Caution should be used in patients with hepatic insufficiency, chronic heart failure of non-ischemic etiology of III-IV functional class according to NYHA classification, unstable angina, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and for 1 month after), SSS (severe tachycardia, bradycardia), arterial hypotension, with simultaneous use with inhibitors or inducers of CYP3A4 isoenzyme. Against the background of the use of amlodipine and in patients with chronic heart failure (NYHA class III and IV) of non-ischemic genesis, there was an increase in the incidence of pulmonary edema, despite no signs of worsening heart failure. In elderly patients, T1 / 2 may increase and clearance of amlodipine may decrease. Changes in doses are not required, but more careful monitoring of patients in this category is needed. The efficacy and safety of using amlodipine in hypertensive crisis has not been established. Despite the fact that blockers of slow calcium channels have no withdrawal syndrome, discontinuation of treatment with amlodipine is desirable gradually. Clinical data on the use of amlodipine in pediatrics are absent.