► Normodipine (amlodipine) - Practical Medicine

Normodipine (amlodipine) - tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Normodipine tablets; 10 mg; 30 tabl. Gedeon Richter 12.29 0.00
Normodipine tablets; 5 mg; 30 tabl. Gedeon Richter 6.35 0.00

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:amlodipine

The drug is available on prescription

What is Normodipine ?

A drug blocking Calcium channels. It mainly works on blood vessels causing a reduction in muscle tone of the vascular walls and vasodilation. It lowers blood pressure and reduces peripheral vascular resistance.

What does Normodipine contain and how does it work?

The active substance is Amlodipine , a dihydropyridine derivative belonging to a group of medicines called calcium channel blockers (or calcium channel blockers). Calcium antagonists act by blocking calcium channels, structures that allow the passage of calcium ions across the cell membrane. Amlodipine blocks the inflow of calcium ions from the extracellular space into the smooth muscle cells of the walls of the blood vessels and to a lesser extent into the cells of the heart muscle. Increasing the intracellular calcium concentration is necessary for the contraction of muscle cells. Amlodipine works mainly on peripheral blood vessels. Blockage of calcium channels reduces the tension of the vessel walls and vasodilation. The immediate effect of this action of amlodipine is lowering blood pressure. Enlargement of peripheral arterioles reduces peripheral vascular resistance, which relieves the heart (it reduces energy consumption by the myocardium and its oxygen demand). Coronary arteries are also likely to expand, which increases oxygen transport to the myocardium, also in patients with vasospastic angina (Prinzmetal). As a result, in patients with angina pectoris, exercise tolerance increases (the time to angina pain increases during exercise) and the incidence and severity of angina pains decreases. The clinical condition of patients with angina pectoris improves and Nitroglycerin consumption decreases.
Preparations from this group are used as medicines to lower blood pressure and to relieve symptoms of angina. In hypertensive patients, taking once daily provides a clinically significant reduction in blood pressure, both standing and lying, for 24 hours. The effect of amlodipine appears gradually, so it does not cause sudden hypotension.To obtain a stationary concentration of amlodipine in the blood requires 7.-8. days of daily use.

When should I use Normodipine?

The preparation is indicated for the treatment of:
· Chronic stable angina
· Vasospastic angina (Prinzmetal).

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients of the preparation or to dihydropyridine derivatives.
You can not use the preparation if you are present:
· Severe hypotension
· Shock, including cardiogenic shock
· Narrowing of the outflow path from the left ventricle (eg severe stenosis of the aortic valve)
Hemodynamically unstable heart failure after a heart attack.
The preparation should not be used during pregnancy unless it is absolutely necessary in the opinion of the doctor. The preparation is contraindicated during breast-feeding.

Take special care with Normodipine?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
There is no data on the safety and efficacy of the preparation in the treatment of hypertensive crisis.
Caution should be exercised in patients with heart failure, especially severe (NYHA grade III and IV); in this group of patients, there is an increased risk of pulmonary edema during the period of application.
Amlodipine should be used with caution in patients with congestive heart failure; in this group of patients, calcium antagonists may increase the risk of cardiovascular events and death.
People with hepatic impairment should be treated with caution as the effect of the preparation may be exacerbated. The doctor will start treatment with low doses, which will be gradually increased with adequate control.
There is no need to adjust the dose in patients with impaired renal function. Amlodipine is not removed during dialysis.
Elderly patients should be cautious when increasing the dose.
There are insufficient data on the effect of amlodipine on male fertility, however, sometimes these drugs may cause fertility-related adverse events, including reversible biochemical changes in sperm heads.

Does this preparation affect the ability to drive vehicles?
The preparation has minor or moderate influence on the ability to drive vehicles and operate machinery and equipment. In some people, the preparation may cause headaches, dizziness, tiredness, nausea or other symptoms that may impair psychophysical fitness and the ability to react quickly. Particular care should be taken at the beginning of treatment.

Dosage of Normodipine

The preparation is in the form of tablets. It is intended for oral use. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
The usual recommended starting dose is 5 mg once daily. Then, depending on the response to your treatment, your doctor may increase the dose up to a maximum dose of 10 mg a day. The doctor will determine whether the preparation is to be used in monotherapy or in combination with other antihypertensive or anti-anginal drugs.
Elderly patients do not need to adjust their dosage. Caution should be exercised when increasing the dose.
In people with hepatic impairment, the effect of the preparation may be increased; caution should be used and treatment should be started with the lowest possible dose.
There is no need to adjust the dose in patients with impaired renal function. Amlodipine is not removed during dialysis.
Children and youth:
Hypertension in children and adolescents 6.-17. year of life: initially 2.5 mg once daily. If necessary, after 4 weeks of use, your doctor may increase the dose to 5 mg once a day.
There is no clinical data on the use of the preparation in children under 6 years of age.

Can Normodipine be used during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
Use of the preparation in pregnancy is only allowed if the doctor deems it absolutely necessary and a safer alternative medicine can not be used and when the doctor believes that the benefits associated with the treatment clearly outweigh the risks associated with the use of the preparation.
The use of the preparation during breast-feeding is contraindicated.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Preparations that reduce the activity of cytochrome P450 3A4 isoenzyme, such as, for example, diltiazem, Verapamil , azole antifungals (ketoconazole, Itraconazole ), protease inhibitors (ritonavir), macrolide antibiotics (erythromycin, Clarithromycin ) can inhibit the metabolism of amlodipine and increase its concentration in the blood and intensifying its operation. Caution should be exercised, especially in the elderly.
Preparations that increase the activity of the cytochrome P450 3A4 isoenzyme (such as, for example, rifampicin, St. John's wort, phenobarbital, phenytoin and carbamazepine) may reduce amlodipine levels in the blood and reduce its effect. Be careful.
Parallel consumption of grapefruit juice is not recommended, because grapefruit juice may affect the effect of amlodipine and may increase blood pressure in some people.
Because of the risk of hyperkalemia (potassium increase in the blood that can cause serious heart rhythm) is recommended to avoid the use of dantrolene amlodipine in patients susceptible to malignant hyperthermia and in the treatment of malignant hyperthermia.
Due to the aggregation of the antihypertensive effect of various preparations, amlodipine may potentiate the effect of parallel antihypertensive agents (such as beta-blockers, angiotensin-converting enzyme inhibitors, alpha-blockers, diuretics).
Amlodipine does not affect the pharmacokinetics of Atorvastatin , Digoxin , Warfarin or cyclosporine.
Amlodipine may increase exposure to Simvastatin ; If simvastatin is used in concomitant treatment with amlodipine, the doctor will prescribe appropriate reduction of the dosage of simvastatin.

What side effects can occur?

Like all medicines, also Normodipine, it can cause side effects, although they will not occur in all patients using this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Common side effects include: headache, dizziness, drowsiness, fatigue, weakness, palpitations, flushing and hot flashes, nausea, indigestion, abdominal pain, swelling of the ankles. Uncommon possible: insomnia, mood disorders (including anxiety), depression, malaise, chest pain, worsening angina (early treatment), tingling or numbness (paraesthesia), trembling, fainting, altered taste, visual disturbances (including double vision), tinnitus, dry mouth, abnormal gastrointestinal motility, vomiting, diarrhea, constipation, hair loss, profuse sweating, rashes, itching, hives, skin discoloration, purpura, hypotension, dyspnea, nasal mucosa nose, headache, muscle cramps, joint pain, back pain, micturition disorders, impotence, gynecomastia, increase / decrease in body weight. Rare confusion / disorientation. Very rare: gastritis, pancreatitis, increased activity of hepatic enzymes, jaundice, hepatitis, gingival hyperplasia, cough, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in occasional cases that may cause narrowing of the air passages, impede breathing and threaten life), severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, photosensitivity), increased blood Glucose (hyperglycaemia), vasculitis, thrombocytopenia, white blood cell count (leukopenia), hypertension, peripheral neuropathy , myocardial infarction, arrhythmias (bradycardia, ventricular tachycardia, atrial fibrillation).

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