Amlodipine Pharmland tablets 5mg №10×3

Name:
Amlodipine Pharmland 5mg No. 30
Description:
tablets of white or almost white color, flat-cylindrical, with a chamfer, with a cruciform risk on one side. Each tablet of Amlodipine Farmland contains 5 mg or 10 mg of amlodipine (in the form of amlodipine besylate) – the active ingredient, and excipients: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate. The notch on the tablet is intended to divide the tablet for ease of administration, but not to divide it into equal doses. This drug belongs to the group of selective calcium channel blockers with a predominant effect on the vessels. Derivatives of dihydropyridine. Taking amlodipine causes the blood vessels to dilate. The main active ingredient Amlodipine Release form tablets Dosage 5 mg Indications for use Arterial hypertension. Chronic stable angina. Vasospastic angina. Method of administration and doses Method of administration Tablets for oral administration. Tablets should be taken at the same time of day with a glass of water, regardless of the meal. Doses Adults For both hypertension and angina, the usual starting dose is 5 mg once daily. Depending on the patient’s individual response to treatment, this dose may be increased up to a maximum dose of 10 mg per day. In hypertensive patients, AMLODIPINE PHARMLAND is used in combination with a thiazide diuretic, an alpha-blocker, a beta-blocker, or an angiotensin-converting enzyme inhibitor. In patients with angina who do not respond to treatment with nitrates and / or adequate doses of beta-blockers, AMLODIPINE PHARMLAND can be used both as monotherapy and in combination with other antianginal agents. With simultaneous administration with thiazide diuretics, beta-blockers and inhibitors, dose adjustment is not required. Special patient populations Elderly When used at similar doses, AMLODIPINE PHARMLAND is equally well tolerated by both young and elderly patients. Elderly patients are recommended the usual treatment regimen, however, increasing the dose should be done with caution (see sections “Peculiarities of use” and “Pharmacokinetics”). Impaired liver function Recommended doses for patients with mild or moderate hepatic impairment have not been established. Dose selection should be carried out with caution, treatment should be started with the lowest recommended dose (see sections “Peculiarities of use” and “Pharmacokinetics”). The pharmacokinetics of amlodipine in subjects with severe hepatic impairment has not been studied. Treatment of patients with severe hepatic impairment should begin with a minimum dose of amlodipine, dose titration should be carried out gradually. Impaired renal function Changes in the concentration of amlodipine in blood plasma do not correlate with the degree of impaired renal function, so these patients are recommended to use the usual doses. Amlodipine is not excreted by hemodialysis. Pediatric patients The safety and effectiveness of amlodipine in children has not been established. If you forget to take AMLODIPINE PHARMLAND, take your tablet as soon as possible before your next dose is due. If it is time for your next dose of medication, do not take the missed dose. You can not double the dosage of the drug to compensate for the missed! Further, the drug is used according to the recommended dosing regimen. Do not stop taking AMLODIPINE PHARMLAND without first consulting with your doctor! Use during pregnancy and lactation If you are pregnant or breastfeeding, if you suspect that you are pregnant or do not rule out the possibility of pregnancy, tell your doctor about it. The safety of amlodipine in women during pregnancy has not been established. Animal studies have shown reproductive toxicity at high doses. Taking amlodipine during pregnancy can only be recommended if there is no alternative safe method of treatment if the presence of the disease poses a high risk to the mother and fetus. There is no information on the penetration of amlodipine into breast milk. A decision should be made whether nursing mothers should discontinue amlodipine or discontinue breastfeeding based on the importance of the drug to the mother or the benefits of breastfeeding. Clinical data on the possible effect of amlodipine on fertility is not enough. If you need more information, contact your doctor. Children. The safety and efficacy of amlodipine in children (under 18 years of age) have not been established. Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. Effects of other medicinal products on amlodipine CYP3A4 inhibitors: Co-administration of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) may result in a significant increase in amlodipine concentrations. Clinical manifestations of these pharmacokinetic abnormalities may be more pronounced in elderly patients. In this regard, monitoring of the clinical condition and dose adjustment may be required. CYP3A4 inducers: No data are available regarding the effects of CYP3A4 inducers on amlodipine. Simultaneous use of inducers of the CYP3A4 isoenzyme (for example, rifampicin, Hypericum perforatum preparations) can lead to a decrease in plasma concentrations of amlodipine. Caution should be exercised when prescribing amlodipine and CYP3A4 inducers at the same time. The simultaneous use of amlodipine and the use of grapefruit or grapefruit juice is not recommended, as this may lead to an increase in the bioavailability of amlodipine in some patients, which, in turn, may enhance the hypotensive effect. Dantrolene (infusion): Cases of ventricular fibrillation and cardiovascular insufficiency accompanied by hyperkalemia have been reported in laboratory animals, with a fatal outcome and collapse during the use of verapamil and intravenous administration of dantrolene. Due to the risk of developing hyperkalemia, the simultaneous use of dantrolene and slow calcium channel blockers, including amlodipine, should be avoided in patients susceptible to malignant hyperthermia, as well as in the treatment of malignant hyperthermia. Effect of amlodipine on other medicinal products. Amlodipine enhances the hypotensive effect of other drugs that have antihypertensive effects and are used to lower blood pressure Tacrolimus When tacrolimus is used together with amlodipine, there is a risk of increasing the level of tacrolimus in blood plasma. In order to prevent the development of the toxic effect of tacrolimus, it may be necessary to control the level of tacrolimus in the blood and adjust its dose. mTOR inhibitors (mammalian targets of rapamycin) mTOR inhibitors such as sirolimus, everolimus, temsirolimus are a substrate of CYP3A. Amlodipine is a weak CYP3A inhibitor. When used simultaneously with mTOR inhibitors, amlodipine may increase the concentration of mTOR inhibitors. Cyclosporine In healthy volunteers and in other populations, with the exception of those with a transplanted kidney, the interaction of cyclosporine with amlodipine has not been studied. In patients with a transplanted kidney, an increase in the minimum concentration of cilosporin in the blood was observed (by an average of 10-40%). The need to monitor ciclosporin levels in kidney transplant patients receiving amlodipine should be weighed against an appropriate dose reduction of ciclosporin. Simvastatin Co-administration of multiple doses of amlodipine 10 mg with simvastatin 80 mg resulted in a 77% increase in simvastatin concentrations compared with simvastatin alone. It is recommended to limit the dose of simvastatin in patients taking amlodipine to 20 mg per day. In clinical drug interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, or warfarin. ContraindicationsAmlodipine Farmland is contraindicated in: known hypersensitivity to dihydropyridine derivatives, amlodipine or any other component of the drug; severe arterial hypotension; shock (including cardiogenic shock); – obstruction of the outflow tract of the left ventricle (for example, severe aortic stenosis) unstable angina; hemodynamically unstable heart failure after acute myocardial infarction (within 8 weeks); severe liver dysfunction. Composition Each tablet of Amlodipine Farmland contains 5 mg of amlodipine (in the form of amlodipine besylate) – the active ingredient, and excipients: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate. Overdose Experience with overdose in humans is limited. Overdose symptoms: Existing information suggests that an overdose of amlodipine leads to excessive vasodilation and reflex tachycardia. Prolonged systemic hypotension, including fatal shock, has been reported. Treatment: Clinically significant hypotension due to amlodipine requires active cardiovascular support, including close monitoring of cardiac and respiratory function, elevating limbs, and monitoring of circulating blood volume and urination. To restore vascular tone and blood pressure, vasoconstrictor drugs can be used, taking into account their contraindications for use. The use of intravenous calcium gluconate may be useful in overdose with calcium channel blockers. In some cases, it is useful gastric lavage, the use of activated charcoal. In healthy volunteers, the use of activated charcoal within 2 hours of 10 mg administration significantly reduced its absorption. Since amlodipine is highly protein bound, the effect of dialysis is negligible. Application features The use of amlodipine during a hypertensive crisis has not been evaluated. Patients with heart failure. Amlodipine should be used with caution in this category of patients. In patients with severe heart failure degree (class III IV according to the NYHA classification), the development of pulmonary edema was more often reported with the use of amlodipine. Calcium channel blockers, including amlodipine, should be used with extreme caution in patients with decompensated heart failure, as they may increase the risk of cardiovascular disease progression and associated mortality. Patients with impaired liver function. In patients with impaired liver function, the half-life of amlodipine is prolonged, higher AUC values are observed. In these patients, amlodipine should be administered with caution, at lower starting doses. Slow dose titration and careful monitoring of patients are required. In patients with severe liver dysfunction, amlodipine is contraindicated. Patients with renal insufficiency. Amlodipine can be used at usual doses in patients with impaired renal function, with caution in renal insufficiency. Side effects If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this package insert. Adverse reactions reported with the use of amlodipine are listed below by system and organ class and frequency of occurrence: very often (? 1/10), often (? 1/100, <1/10); infrequently (? 1/1000, <1/100), rarely (? 1/10000, <1/1000), very rarely (<1/10000). From the blood and lymphatic system. Very rarely leukopenia, thrombocytopenia. From the immune system. Very rare: allergic reactions. Metabolic and nutritional disorders. Very rare: hyperglycemia. Mental disorders. Uncommon: insomnia, mood changes (including anxiety), depression. Rare: confusion. From the side of the nervous system. Often: drowsiness, dizziness, headache (mainly at the beginning of treatment). Infrequently: tremor, dysgeusia, hypesthesia, paresthesia. Very rare: hypertension, peripheral neuropathy. From the side of the organ of vision. Uncommon: visual disturbances (including diplopia). On the part of the organ of hearing and balance. Uncommon: tinnitus. From the side of the heart. Often: palpitations. Very rare: myocardial infarction, arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation). From the side of the vessels. Often: hot flashes. Infrequently: arterial hypotension. Very rare: vasculitis. Respiratory, thoracic and mediastinal disorders. Uncommon: dyspnea, rhinitis. Very rare: cough. From the digestive tract. Often: abdominal pain, nausea. Infrequently: vomiting, dyspepsia, impaired intestinal motility (including constipation and diarrhea), dry mouth. Very rare: pancreatitis, gastritis, gingival hyperplasia. From the side of the liver. Very rare: hepatitis, jaundice, elevated liver enzymes (more commonly associated with cholestasis). From the skin and subcutaneous tissue. Infrequently: alopecia, purpura, discoloration of the skin, sweating, itching, rash, exanthema. Very rare: angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Steven-Johnson syndrome, angioedema, photosensitivity. From the musculoskeletal system and connective tissue. Often: swelling in the ankles. Uncommon: arthralgia, myalgia, convulsions, back pain. From the side of the kidneys and urinary system. Infrequently: urinary incontinence, nocturia, increased frequency of urination. From the reproductive system and mammary glands. Uncommon: impotence, gynecomastia, sexual dysfunction. General disorders and condition at the injection site. Often: edema, increased fatigue. Uncommon: chest pain, asthenia, pain, malaise. Research. Infrequently: increase or decrease in body weight. Storage conditionsKeep in a place protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Amlodipine Farmland tablets 5mg No. 10x3