Amlodipine-Teva 5 mg 30 tablets — Made in Hungary — Free Delivery

(Amlodipine-Teva)

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Description Amlodipine-Teva 5 mg 30 tablets — Made in Hungary — Free Delivery

Pharmacological properties

Pharmacodynamics. Amlodipine is a calcium antagonist (dihydropyridine derivative) that blocks the flow of calcium ions into myocardial and smooth muscle cells.

The mechanism of the hypotensive action of amlodipine is due to a direct relaxing effect on vascular smooth muscles. The exact mechanism of the antianginal effect of amlodipine is not well understood, however, the effects presented below play a role.

Amlodipine dilates the peripheral arterioles and thus reduces the systemic vascular resistance (afterload). Since the heart rate remains stable, reducing the load on the heart leads to a decrease in energy consumption and myocardial oxygen demand.

Dilation of the main coronary arteries and coronary arterioles (normal and ischemic) increases oxygen supply to the myocardium in patients with coronary artery spasm (Prinzmetal angina or variant angina).

In patients with hypertension, administration of the preparation once a day provides a clinically significant decrease in blood pressure within 24 hours in the supine and standing positions. Due to the slow onset of action of amlodipine, acute arterial hypotension is usually not observed.

In patients with angina pectoris, when using one daily dose, the time of physical activity increases, the time before the onset of an attack of angina pectoris and the time until the ST segment depression is reached by 1 mm. The preparation reduces the frequency of angina attacks and the need to take nitroglycerin.

Amlodipine is not associated with any metabolic side effects or changes in plasma lipids, and can be used in patients with AD, diabetes mellitus and gout.

Pharmacokinetics. Absorption / distribution. After oral administration in therapeutic doses, amlodipine is gradually absorbed into the blood plasma. The bioavailability of the unchanged molecule is ≈64–80%. Cmax in blood plasma is achieved within 6-12 hours after application. The volume of distribution is ≈21 l / kg, the acid dissociation constant (pKa) of amlodipine = 8.6. In vitro studies found that the binding of amlodipine to blood plasma proteins = 97.5%.

Simultaneous food intake does not affect the absorption of amlodipine.

Metabolism / excretion. T1 / 2 from plasma is ≈35-50 hours. Equilibrium concentration in blood plasma is achieved after 7-8 days of systematic use of the preparation. Amlodipine is mainly metabolized to form inactive metabolites. About 60% of the dose of amlodipine taken is excreted in the urine, of which ≈10% is unchanged.

Elderly patients. The time to reach the equilibrium concentration of amlodipine in blood plasma in elderly patients is similar to that in adult patients. The clearance of amlodipine is usually slightly reduced, which in elderly patients leads to an increase in AUC and an increase in T½ of the preparation.

Patients with impaired renal function. Amlodipine is extensively metabolized to inactive metabolites. 10% of amlodipine is excreted unchanged in the urine. The concentration of amlodipine in blood plasma does not correlate with the degree of renal dysfunction. In patients with impaired renal function, the usual doses of amlodipine can be used. It is not removed during dialysis.

Patients with impaired liver function. Information on the use of amlodipine in patients with impaired liver function is very limited. In patients with hepatic impairment, the clearance of amlodipine is reduced, which leads to an increase in the half-life and an increase in AUC by ≈40-60%.

Children. Pharmacokinetic studies were conducted with the participation of 74 children with hypertension aged 12-17 years (as well as 34 patients aged 6-12 years and 28 patients aged 13-17 years) who received amlodipine at a dose of 1.25-20 mg / day for 1 or 2 doses. Usually, when taken orally, the clearance in children aged 6-12 and 13-17 years was 22.5 and 27.4 l / h for boys and 16.4 and 21.3 l / h for girls, respectively. There is significant variability in exposure between patients. Information on patients under 6 years of age is limited.

Indications

Ag; chronic stable angina pectoris; vasospastic angina (prinzmetal angina).

Application

Inside. tablets must be taken with or without food, with a glass of liquid (eg water).

The break line is designed to better break the tablet for easier swallowing rather than splitting into two doses.

Adults. For the treatment of hypertension and angina pectoris, the initial dose of amlodipine is 5 mg once a day. Depending on the patient's response to therapy, the dose can be increased to a maximum dose of 10 mg once a day.

In patients with angina pectoris, the preparation can be used as monotherapy or in combination with other antianginal preparations with resistance to nitrates and / or therapeutic doses of β-adrenergic receptor blockers.

There is experience of using the preparation in combination with thiazide diuretics, blockers of α-adrenergic receptors, blockers of β-adrenergic receptors or ACE inhibitors in patients with hypertension.

There is no need to select a dose of the preparation when used simultaneously with thiazide diuretics, β-adrenergic receptor blockers and ACE inhibitors.

Children aged 6 years and older with hypertension. The recommended starting dose of amlodipine for this category of patients is 2.5 mg once a day. If the required blood pressure level is not reached within 4 weeks, the dose can be increased to 5 mg / day. The use of the preparation at a dose of 5 mg in this category of patients has not been studied.

Elderly patients. There is no need to select the dose of the preparation for this category of patients. Increase the dose with caution.

Patients with impaired renal function. It is recommended to use the usual doses of the preparation, since the concentration of amlodipine in the blood plasma is not associated with the severity of renal failure. Amlodipine is not excreted during dialysis.

Patients with impaired liver function. Doses of the preparation for use in patients with mild and moderate hepatic dysfunction have not been established, therefore, dose selection should be carried out with caution and the use of the preparation should be started with a low dose (see SPECIAL INSTRUCTIONS and PHARMACOLOGICAL PROPERTIES, Pharmacokinetics). The pharmacokinetics of amlodipine have not been studied in patients with severe hepatic impairment. In patients with severely impaired liver function, the use of amlodipine should be started with a minimum dose, gradually increasing it.

Contraindications

Known hypersensitivity to dihydropyridines, amlodipine or any other component of the preparation; severe arterial hypotension; shock (including cardiogenic); obstruction of the left ventricular outflow tract (eg, severe aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction.

Side effects

When using amlodipine, the most commonly reported adverse reactions were: drowsiness, dizziness, headache, heart palpitations, flushing, abdominal pain, nausea, swelling of the legs, edema and fatigue.

On the part of the blood and lymphatic system: leukopenia, thrombocytopenia.

From the immune system: allergic reactions.

Metabolic and nutritional disorders: hyperglycemia.

Mental disorders: depression, mood changes (including anxiety), insomnia, confusion.

From the nervous system: drowsiness, dizziness, headache (mainly at the beginning of treatment), tremor, dysgeusia, fainting, hypesthesia, paresthesia, hypertonicity, peripheral neuropathy.

From the side of the organ of vision: visual impairment (including diplopia).

On the part of the hearing organs and vestibular apparatus: ringing in the ears.

From the side of the cardiovascular system: tachycardia, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), myocardial infarction, hot flashes, arterial hypotension, vasculitis.

From the respiratory system, chest organs, mediastinum: shortness of breath, cough, rhinitis.

From the digestive system: abdominal pain, nausea, dyspepsia, impaired intestinal motility (including diarrhea and constipation), vomiting, dry mouth, pancreatitis, gastritis, gingival hyperplasia.

From the hepatobiliary system: hepatitis, jaundice, increased levels of liver enzymes (most often associated with cholestasis).

Skin and subcutaneous tissue disorders: alopecia, purpura, discoloration of the skin, increased sweating, itching, rash, rash, urticaria, angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke's edema, photosensitivity.

From the musculoskeletal system and connective tissue: leg edema, muscle cramps, arthralgia, myalgia, back pain.

From the kidneys and urinary tract: urinary disorders, nocturia, pollakiuria.

From the reproductive system and mammary glands: impotence, gynecomastia.

General disorders: edema, fatigue, asthenia, chest pain, pain, malaise.

Research: increase or decrease in body weight.

There have been reports of exceptional cases of extrapyramidal syndrome development.

Children. The profile of adverse reactions is similar to that observed in adults. The following adverse reactions have been reported: headache, dizziness, dilated blood vessels, epistaxis, abdominal pain, asthenia. Most of the adverse reactions were mild to moderate.

Special instructions

The safety and efficacy of amlodipine in hypertensive crisis have not been evaluated.

Patients with heart failure. In this category of patients, amlodipine should be used with caution. In patients with congestive heart failure, calcium channel blockers, including amlodipine, should be used with caution because they may increase the risk of cardiovascular events and future deaths.

Patients with impaired liver function. T½ of amlodipine and AUC parameters are higher in patients with impaired liver function; there are no dosage recommendations for the drug. Therefore, for this category of patients, it is necessary to start using the drug with a minimum dose. You should be careful both at the beginning of the use of the drug and when increasing the dose. Patients with severe hepatic impairment may require slow dose selection and careful monitoring of their condition.

Patients with renal impairment. This category of patients should take the usual doses of the drug. The concentration of amlodipine in blood plasma does not correlate with the degree of renal dysfunction. Amlodipine is not removed by dialysis.

Amlodipine does not affect laboratory test results.

Elderly patients. Increasing the dose in this category of patients should be done with caution.

Other. It is not recommended to take amlodipine in combination with grapefruit or grapefruit juice, since in some patients the bioavailability may be increased, which will lead to an increase in the antihypertensive effect of the drug.

Use during pregnancy and lactation. Pregnancy. The safety of using amlodipine in women during pregnancy has not been established.

It is recommended to use amlodipine during pregnancy only in cases where there is no safer alternative, and the risk associated with the disease itself outweighs the possible harm from treatment for the pregnant woman and the fetus.

Reproductive toxicity was observed in animal studies at high doses.

Breastfeeding period. It is not known whether amlodipine passes into breast milk. When deciding whether to continue breastfeeding or to use amlodipine, it is necessary to evaluate the benefits of breastfeeding for the child and the benefits of using the preparation for the woman.

Fertility There have been reports of reversible biochemical changes in the sperm head in some patients with the use of calcium channel blockers. There is insufficient clinical information regarding the potential effect of amlodipine on fertility.

Children. The preparation can be used in children over the age of 6 years.

It is not known how amlodipine affects blood pressure in patients under the age of 6 years.

The ability to influence the reaction rate when driving or working with other mechanisms. Amlodipine may have a slight to moderate effect on the ability to drive vehicles or operate machinery.

The reaction rate may be slowed down if symptoms such as dizziness, headache, confusion, or nausea are present.

Caution should be exercised when using the preparation, especially at the beginning of therapy.

Interactions

The effect of other preparationson amlodipine. there are data on the safe use of amlodipine with thiazide diuretics, α-adrenoreceptor blockers, β-adrenergic receptor blockers, APF inhibitors, prolonged forms of nitrates, sublingual forms of nitroglycerin, NSAIDs, antibiotics, oral hypoglycemic preparations.

The data obtained in the course of in vitro studies with human blood plasma indicate the absence of the effect of amlodipine on the binding of preparations to blood proteins (digoxin, phenytoin, warfarin or indomethacin).

Inhibitors of CYP 3A4. The simultaneous use of amlodipine and potent or moderate CYP 3A4 inhibitors (protease inhibitors, azole antifungals, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) can lead to a significant increase in amlodipine exposure and increase the risk of hypotension. The clinical significance of such changes may be more pronounced in elderly patients. Clinical observation of the patient's condition and dose selection may be necessary.

The simultaneous use of amlodipine and grapefruit or grapefruit juice is not recommended, since bioavailability may increase in some patients, which, in turn, leads to an increase in the hypotensive effect.

CYP 3A4 inductors. There is no information on the effect of CYP 3A4 inducers on amlodipine. The simultaneous use of amlodipine and preparations that induce CYP 3A4 (for example, rifampicin, St. John's wort preparations) can lead to a decrease in the concentration of amlodipine in the blood plasma, therefore, such combinations should be used with caution.

Dantrolene (infusion). In animals, the appearance of fatal ventricular fibrillation and cardiovascular collapse, which were associated with hyperkalemia, were observed after iv administration of dantrolene and verapamil. Because of the risk of hyperkalemia, it is recommended to avoid the use of calcium channel blockers such as amlodipine in patients prone to malignant hyperthermia and in the treatment of malignant hyperthermia.

The effect of amlodipine on other medicines. The antihypertensive effect of amlodipine potentiates the antihypertensive effect of other antihypertensive preparations.

Tacrolimus. There is a risk of increased blood levels of tacrolimus when used concomitantly with amlodipine, but the pharmacokinetic mechanism of this interaction has not been fully established. To avoid toxicity of tacrolimus in combination with amlodipine, regular monitoring of the concentration of tacrolimus in the blood and, if necessary, dose adjustment is necessary.

Cyclosporine. Interaction studies of cyclosporine and amlodipine have not been conducted, with the exception of use in patients with a transplanted kidney, in whom a variable increase in the residual concentration of cyclosporine was observed. In patients with a kidney transplant taking amlodipine, the possibility of monitoring the concentrations of cyclosporine and, if necessary, reducing the dose of cyclosporine should be considered.

Simvastatin. The simultaneous use of multiple doses of amlodipine (10 mg) and simvastatin at a dose of 80 mg led to an increase in simvastatin exposure by 77% compared to the use of simvastatin alone. For patients taking amlodipine, the dose of simvastatin should be limited to 20 mg / day.

It has been reported that amlodipine does not affect the pharmacokinetics of atorvastatin, digoxin, and warfarin.

The effect of amlodipine on laboratory parameters has not been identified.

Sildenafil. A single dose of 100 mg of sildenafil in patients with essential hypertension did not affect the pharmacokinetics of amlodipine. With the simultaneous use of amlodipine and sildenafil, each of the preparations showed a hypotensive effect independently of the other.

Other medicines. Clinical interaction studies have demonstrated that amlodipine does not affect the pharmacokinetics of atorvastatin, digoxin and warfarin.

Ethanol (alcohol). Single and repeated administration of 10 mg of amlodipine had no significant effect on the pharmacokinetics of ethanol.

The combined use of amlodipine and cimetidine did not affect the pharmacokinetics of amlodipine.

The combined use of aluminum / magnesium preparations (antacids) with a single dose of amlodipine did not have a significant effect on the pharmacokinetics of amlodipine.

Laboratory research data. It is not known whether amlodipine affects the results of laboratory tests.

Overdose

Experience with deliberate overdose is limited.

Symptoms: The available information suggests that a significant overdose of amlodipine will lead to excessive peripheral vasodilation and possibly reflex tachycardia. The development of significant and possibly prolonged systemic arterial hypotension, including fatal shock, has been reported.

Treatment of clinically significant arterial hypotension caused by an overdose of amlodipine requires active support for the activity of the cardiovascular system, in particular, frequent monitoring of the function of the heart and respiration, giving the patient a horizontal position with raised lower limbs, monitoring BCC and diuresis.

To restore vascular tone and blood pressure, vasoconstrictor preparations can be used, making sure that there are no contraindications to their use. The use of IV calcium gluconate may be helpful in reversing the effects of calcium channel blockade.

In some cases, gastric lavage may be helpful. The use of activated carbon in healthy volunteers within 2 hours after the administration of 10 mg of amlodipine significantly reduced the level of its absorption.

Since amlodipine binds to blood proteins to a large extent, the effect of dialysis is negligible.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° c.

Tags: Amlodipine

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