Normodipine pills 5 mg 30 pcs
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Active ingredients
Amlodipine
Release form
Pills
Composition
Active ingredient: Amlodipine (Amlodipine). Concentration of active ingredient (mg): 5
Pharmacological effect
Normodipine is a so-called calcium channel blocker and is used primarily for the treatment of arterial hypertension, as well as for the treatment of coronary (ischemic) heart disease (angina pectoris).
Pharmacokinetics
After oral administration, amlodipine is slowly absorbed from the gastrointestinal tract (GIT). The average absolute bioavailability is 64%, the maximum concentration (Cmax) in serum is observed after 6-9 hours. Equilibrium serum concentrations (Css) are reached after 7-8 days of therapy. Food intake does not affect the absorption of amlodipine. The average volume of distribution is 21 l / kg body weight, which indicates that most of the drug is in the tissues, and relatively less in the blood. Most of the drug in the blood (95%) is bound to plasma proteins. Amlodipine undergoes a slow, but active metabolism in the liver in the absence of a significant effect of the first passage of a & raquo. Metabolites do not have significant pharmacological activity. After a single oral administration, the half-life (T1 / 2) varies from 31 to 48 hours, with repeated administration of T1 / 2, it is approximately 45 hours. About 60% of the ingested dose is excreted by the kidneys mainly in the form of metabolites, 10% - unchanged, and 20-25% through the intestines, as well as with breast milk. The total clearance of amlodipine is 0.116 ml / s / kg (7 ml / min / kg, 0. 42 l / h / kg). In older patients (over 65), the elimination of amlodipine is slow (T1 / 2 - 65 h) compared with younger patients, but this difference has no clinical significance. Elongation of T1 / 2 in patients with hepatic insufficiency suggests that with long-term administration cumulation of the drug in the body will be higher (T1 / 2 - up to 60 hours). Renal failure does not significantly affect the kinetics of amlodipine. The drug penetrates the blood-brain barrier. Hemodialysis is not removed.
Indications
Arterial hypertension (monotherapy or in combination with other antihypertensive drugs). Stable exertional angina and basospastic angina (Prinzmetal stenocardia) (monotherapy or in combination with other antianginal agents).
Contraindications
Hypersensitivity to amlodnpine. dihydropyridine derivative and other components of the drug.Severe arterial hypotension (systolic blood pressure less than 90 mmHg): Collapse, cardiogenic shock. Unstable angina pectoris (with the exception of princemetal angina). Clinically significant aortic stenosis. Pregnancy and lactation. Age 18 years (efficacy and safety have not been studied)
Precautionary measures
Liver dysfunction, sick sinus syndrome (SSS) (severe bradycardia, tachycardia), chronic heart failure of non-ischemic etiology of III-IV functional class according to the NYHA classification, arterial hypotension, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy (GOCP), hypertrophic obstructive cardiomyopathy (GKMP) myocardium (and within 1 month after myocardial infarction), old age.
Use during pregnancy and lactation
You need to inform your doctor about this, as the doctor must decide on the possibility of taking the drug after carefully weighing the benefit / risk ratio.
Dosage and administration
Inside, the initial dose for treatment of arterial hypertension and angina is 5 mg of the drug once a day. The maximum daily dose - 10 mg once. With arterial hypertension, the maintenance dose may be 5 mg (1 tablet, 5 mg) per day. In elderly patients, T12 amlodipine may increase and creatinine clearance (CK) may decrease. Changes in dosages are not required, but more careful observation of patients is necessary. No dose changes are required with simultaneous administration with thiazide diuretics, beta-blockers and angiotensin converting enzyme (ACE) inhibitors. No dose changes are required in patients with renal insufficiency.
Side effects
Since the cardiovascular system: often - heartbeat, peripheral edema (swelling of the ankles and feet), "tides" of blood to the skin of the face. infrequently - excessive decrease in blood pressure: very rarely - development or aggravation of the course of heart failure, rhythm disturbance (bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction, chest pain, orthostatic hypotension. vasculitis From the central and peripheral nervous system: often - headache, dizziness, fatigue, drowsiness.infrequently - asthenia, general malaise, hypesthesia, paresthesia, peripheral neuropathy, tremor, vertigo, syncope, insomnia, mood lability, unusual dreams, irritability, depression, anxiety: very rarely - apathy, ataxia, agitation, amnesia. On the part of the digestive system: often - nausea, abdominal pain. sometimes - vomiting, constipation or diarrhea, flatulence, dyspepsia, anorexia, dryness of the oral mucosa, thirst: rarely - gingival hyperplasia, increased appetite. very rarely - pancreatitis, gastritis, jaundice (due to cholestasis), hyperbilirubinemia, increased activity of “liver” transaminases, hepatitis. From the side of blood-forming organs: very rarely - thrombocytopenic purpura, leukopenia, thrombocytopenia. From the genitourinary system: rarely - frequent urination, painful urination, nocturia, impotence. very rarely - dysuria, polyuria. For the skin: rarely - dermatitis. very rarely - purpura, xerodermia, a violation of skin pigmentation. Allergic reactions: infrequently - skin itch, rash (including erythematous, maculopapular rash). very rarely - urticaria, angioedema, erythema multiforme. On the part of the musculoskeletal system: sometimes - muscle cramps, myalgia (with prolonged use), arthralgia, back pain, arthrosis. rarely - myasthenia. Others: rarely - alopecia, gynecomastia, hyperuricemia, weight loss, visual impairment, diplopia, conjunctivitis, eye pain, tinnitus, dyspnea, nasal bleeding, increased sweating. very rarely - cold sticky sweat, cough, rhinitis, parosmia, disturbance of taste sensations, disturbance of accommodation, xerophthalmia, hyperglycemia.
Overdose
Symptoms: marked reduction in blood pressure, tachycardia, excessive peripheral vasodilation (risk of severe and persistent hypotension, including the development of shock and death). Treatment: gastric lavage, the appointment of activated carbon, maintaining the function of the cardiovascular system, monitoring indicators of the function of the heart and lungs, elevated, above head level, position of the lower extremities, control of circulating blood volume and diuresis.To restore vascular tone - the use of vasoconstrictor agents (in the absence of contraindications to their use); in order to eliminate the effects of calcium channel blockade, intravenous calcium gluconate is administered. Hemodialysis is ineffective.
Interaction with other drugs
Simultaneous (accidental or regular) use of other drugs with Normodipina can lead to their interaction, therefore simultaneous use with other drugs is allowed only by the attending physician.
special instructions
During the period of treatment with the drug Normodipin, it is necessary to control body weight and sodium intake, the purpose of the appropriate diet is shown. It is necessary to maintain dental hygiene and observation at the dentist (to prevent pain, bleeding and gum hyperplasia). Patients with low body mass, patients of short stature and patients with severe liver dysfunction may require a lower dose. In elderly patients, the T1 / 2 and clearance of the drug may be lengthened. Changes in doses for elderly patients are not required: with increasing doses, more careful monitoring of patients is necessary. In violation of the liver can also be extended T1 / 2 of the drug. Therefore, normodipine should be prescribed with caution in such patients. Despite the fact that discontinuation of the drug Normodipin is not accompanied by the development of withdrawal syndrome, it is desirable to discontinue treatment, gradually reducing the dose of the drug. The efficacy and safety of the drug in hypertensive crisis has not been established.