Normodipine

Normodipine - a drug from the group of calcium channel blockers, intended for the treatment of hypertension. The active substance of the drug is amlodipine. He has a pronounced hypotensive and antianginal effect.

When administered orally, normodipine is slowly but surely absorbed from the digestive tract, regardless of the quantitative and qualitative composition of the food. It has a relatively high bioavailability (about 60-80%).

The peak concentration of the drug in the blood is observed after 6-12 hours after administration. Such a prolonged action of normodipin is associated with its slow release from receptor "embraces."

Clinical and pharmacological group

The calcium channel blocker.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much does Normodipine cost in pharmacies? The average price is at the level of400 rubles.

Form of issue and composition

Produced in white tablets, biconvex oblong-rounded shape, on one side there is an engraving "5". In the carton pack 30 tablets, in blisters for ten pieces.

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One tablet of Normodipine contains 5, 10 mg of amlodipine.
Excipients: 2 mg magnesium stearate, 4 mg sodium carboxymethyl starch, 63 mg calcium anhydrous hydrophosphate and 124 mg microcellulose (MCC).

Pharmacological effect

Normodipine is included in the group of blockers of "slow" calcium channels of the second generation, which have antihypertensive and anti-anginal action.

Antianginal action of the drug is associated with the expansion of the arteries. Due to this effect with angina, Normodipine improves myocardial nutrition, reducing the need for cardiac muscle in oxygen. As for the antihypertensive effect of the drug, it appears due to the expansion of peripheral vessels. Also, this drug interferes with platelet aggregation, lowers left ventricular hypertrophy, has a weak diuretic effect without causing an increase in the heart rate.

A single dose of Normodipin is able to lower the patient's blood pressure for up to 24 hours. The expected effect of the drug begins to manifest after 2-4 hours after its administration.

Indications for use

The drug is administered under the following conditions:

Arterial hypertension (a chronic disease characterized by increased pressure);
vasospastic (spontaneous) angina pectoris;
angina pectoris tension.

The drug can act as a single therapeutic drug or as part of a complex therapy. For maximum effect before using the drug, you need to undergo examination and consult with your doctor. You can not choose medicines to reduce pressure yourself!

Contraindications

Absolute:

Collapse;
Unstable angina (except Prinzmetal angina);
The period of pregnancy and breastfeeding (lactation);
Children and adolescents under 18 years of age (no clinical experience of use);
Severe arterial hypotension with systolic blood pressure (BP) below 90 mm Hg;
Cardiogenic shock;
Clinically significant aortic stenosis;
Hypersensitivity to amlodipine, as well as other dihydropyridine derivatives.

Relative (the drug is taken with caution because of the increased likelihood of complications):

Dysfunction of the liver;
Mitral stenosis;
Hypertrophic obstructive cardiomyopathy;
Acute myocardial infarction, including the period within 1 month after it;
Syndrome of weakness of the sinus node (SSSU) with pronounced bradycardia, tachycardia;
Chronic heart failure of non-ischemic etiology according to the classification of NYHA III-IV functional class;
Arterial hypotension;
Elderly age.

Dosage and route of administration

The instructions for use indicate that Normodipine is taken internally.

The initial dose for the treatment of hypertension and angina is 5 mg 1 time / day. The maximum daily dose is 10 mg. With arterial hypertension, the maintenance dose is 5 mg / day.

Do not require dose changes with simultaneous administration with thiazide diuretics, beta-blockers and ACE inhibitors.

In elderly patients, T1 / 2 amlodipine may increase and creatinine clearance may decrease. Dose changes are not required, but more careful monitoring of patients is necessary.

Patients with renal insufficiency do not require dose changes.

Side effects

When using Normodipine, there are likely to be side effects:

On the part of the organs and digestive system: aching and frequent pain in the abdomen, nausea, jaundice, hyperbilirubinemia, in rare cases, anorexia, dry mouth, constipation, vomiting, diarrhea, flatulence, dyspepsia, gingival hyperplasia, in very rare cases - increased appetite, gastritis, pancreatitis,
From the side of the central nervous system: most often excessive fatigue, spasmodic headache, drowsiness, dizziness, frequent mood changes, seizures, in rare cases - hyperesthesia, loss consciousness, tremor, paresthesia, asthenia, insomnia, malaise, depression, nervousness, anxious state, unusual dreams, ataxia, amnesia, apathy,
On the part of the urinary system: painful urge to urinate, pollakiuria, violation of sexual function, polyuria, dysuria,
From the heart and blood vessels: swelling of the ankles and feet, palpitations, flushing of blood to the face, dyspnea, in rare cases, extrasystole, migraine, increased blood pressure,
From the skin: alopecia (alopecia), purpura, xeroderma, dermatitis, and possibly the manifestation of allergic reactions in the manifestation of pruritus, rash, hives,
From the musculoskeletal and motor system: arthrosis, arthralgia, myalgia (the symptoms of these diseases are rare and only after long-term administration of Normodipin),
Other reactions: there may be problems with eyesight, pain in the eyes is noted.

It is noted among the undesirable effects and disruption of accommodation, ringing in the ears, back pain, chills, nosebleeds, thirst, hyperhidrosis (increased sweating), taste perversion, rhinitis, cold sticky cough and hyperglycemia.

Overdose

An overdose of Normodipine can be expressed as a series of such symptoms:

development of reflex tachycardia;
a strong drop in blood pressure;
the development of excessive peripheral vasodilation (there is a risk of a pronounced and sufficiently stable hypotension, followed by the development of shock and death).

Therapy for overdose: it is necessary to appoint gastric lavage, reception of activated charcoal (preferably in the first 2 hours after taking a high dose). The patient is recommended to put it horizontally, the headboard should be low. It is necessary to prescribe drugs and procedures to actively maintain the functionality of the cardiovascular system, it is recommended to monitor lung and heart function, control diuresis and BCC. To bring the tone of the vessels in the norm, it is necessary to prescribe vasoconstrictors (provided there are no contraindications to them). To eliminate the effects of calcium channel blockade, intravenous calcium gluconate is prescribed.

When an overdose of Normodipine drug hemodialysis is ineffective.

special instructions

Before you start using the drug, read the special instructions:

The efficacy and safety of the drug for hypertensive crisis is not established.
Patients with low body weight, low growth patients and patients with severe liver function impairment may need a smaller dose.
If the liver function is also impaired, T1 / 2 of the drug may be prolonged. Therefore, such patients Normodipine should be administered with caution.
Despite the fact that the discontinuation of taking Normodipine is not accompanied by the development of withdrawal syndrome, it is advisable to discontinue treatment, gradually reducing the dose of the drug.
During the period of treatment with Normodipine, it is necessary to control body weight and sodium intake, and the purpose of the appropriate diet is indicated. It is necessary to maintain dental hygiene and supervision at the dentist (to prevent soreness, bleeding and gingival hyperplasia).

There have been no reports of the effects of Normodipine on vehicle management or work with machinery. However, some patients, mainly at the beginning of treatment, may experience drowsiness, dizziness and other side effects from the nervous system. When they occur, the patient must observe special precautions when driving and working with complex mechanisms.

Drug Interactions

In the treatment of arterial hypertension, amlodipine can be safely combined with angiotensin converting enzyme (ACE) inhibitors, beta-adrenoblockers, thiazide diuretics, alpha-adrenoblockers. In the presence of stable angina, the drug can be used in combination with other antianginal means (short-acting nitrates, beta-blockers, nitrates of prolonged action).

Also possible simultaneous reception of amlodipine with antibacterial, oral antidiabetic and non-steroidal anti-inflammatory drugs (especially with indomethacin).

It should be borne in mind that when combined with Normodipine:

Antiviral drugs (ritonavir) - increase the plasma concentration of amlodipine;
Neuroleptics, alpha1-adrenoblockers, isoflurane - increase the antihypertensive effect;
Sildenafil (with a single admission of 100 mg), cimetidine - do not affect the pharmacokinetics of amlodipine;
Beta-adrenoblockers, verapamil, ACE inhibitors, nitrates, "loop" and thiazide diuretics - can enhance hypotensive and antianginal action;
Calcium preparations - lead to a decrease in effectiveness.

Effect of amlodipine on concomitantly used substances / preparations:

Digoxin - does not affect its serum level and its renal clearance;
Warfarin - does not significantly affect its effectiveness (prothrombin time);
Indomethacin, warfarin, phenytoin, digoxin - does not affect their binding to proteins (in in vitro studies);
Lithium preparations - aggravates the manifestations of neurotoxicity (tinnitus, tremor, ataxia, diarrhea, vomiting, nausea);
Atorvastatin (in a dose of 80 mg) - does not significantly change its pharmacokinetics (with repeated use of amlodipine at a dose of 10 mg);
Antiarrhythmic drugs, leading to an extension of the QT interval (quinidine, amiodarone) - may enhance the severity of their negative inotropic effect;
Ethanol - does not affect its pharmacokinetics (with a single or repeated use of amlodipine at a dose of 10 mg).

A single dose of amlodipine in a dose of 10 mg with simultaneous consumption of 240 ml of grapefruit juice does not significantly affect the pharmacokinetics of the drug.

Reviews

We picked up some reviews of people who used the drug Normodipine:

Raisa. I take aplodipine, it holds the pressure well, but swelling of the ankles after 7-10 days after the beginning of the application. Hypotiazives do not save the situation, but it's a pity. Therefore, I take amlodipine until the moment of edema, then I take other drugs. I'm not sure I'm doing the right thing. There is no other way out-200-100.
Svetlana. At mum a hypertensia and ischemic illness of heart - is under constant supervision of doctors. Drugs that reduce pressure, a lot has been tried, but mostly they had a side effect - or the heart rate increased or the pressure or a strong diuretic effect... Normodipine - the optimal drug on which, according to doctors and moms, it was decided to stop for now.