Composition, form of production and packaging
Tablets 1 tab.
Amlodipine (in the form of besylate) 10 mg
10 pieces. - packings cellular planimetric (3) - packs cardboard.
Tablets 1 tab.
amlodipine (in the form of besylate) 5 mg
14 pcs. - packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
The dihydropyridine derivative. Has antihypertensive, antianginal effect. It blocks the flow of calcium ions through the cell membranes into the smooth muscle cells of the myocardium and vessels.
The mechanism of hypotensive action is caused by a direct relaxing effect on the smooth muscles of the vessels. The antianginal effect of the drug is due to the ability to expand the peripheral arterioles, which leads to a decrease in the overall peripheral vascular resistance. Reducing the load on the heart leads to a decrease in myocardial oxygen demand. Under the action of the drug due to the expansion of the coronary arteries, the intake of oxygen into the myocardium increases (especially with vasospastic angina).
It has no adverse effect on the metabolism and lipids of blood plasma, has antiatherosclerotic, antithrombotic activity, increases the glomerular filtration rate, and has a weak natriuretic effect. When diabetic nephropathy does not increase the severity of microalbuminuria.
PHARMACOKINETICS
After oral administration, it is slowly absorbed from the gastrointestinal tract (90%) regardless of food intake. C max drug in the blood is achieved in 6-12 hours Bioavailability - 60-65%.
The equilibrium state in blood plasma is achieved 7-8 days after its constant intake. V d is about 20 l / kg. Binding to plasma proteins is more than 95%. Penetrates through the blood-brain barrier.
Metabolized mainly in the liver with the formation of inactive metabolites.
Less than 10% of the dose taken inside is excreted unchanged, about 60% excreted by the kidneys in the form of inactive metabolites. T 1/2 of the drug - 35-45 h, which allows you to assign it 1 time / day. 20-25% is excreted in the form of metabolites with bile and through the intestine, as well as with breast milk.
T 1/2 in patients with arterial hypertension - 48 hours, in elderly patients increases to 65 hours, with liver failure - up to 60 hours, with renal dysfunction - does not change. When hemodialysis is not removed.
INDICATIONS
- arterial hypertension (in the form of mono and combination therapy);
- Stable angina and vasospastic angina.
DOSING MODE
The initial dose: as an antihypertensive drug - 2.5 mg (especially the thin and elderly patient, the patient with a violation of liver function and as part of complex therapy); as an antianginal agent - 5 mg (recommended elderly patient and patient with impaired liver function ).
At an arterial hypertensia and a stenocardia - 5 mg / sut.
If necessary, the daily dose can be increased to 10 mg / day. The maximum daily dose is 10 mg. Any correction of the dose of Omelar Cardio with simultaneous use of thiazide diuretics, beta-blockers or ACE inhibitors is not required.
SIDE EFFECT
Cardio-vascular system: palpitation, dyspnea, marked decrease in blood pressure, fainting, vasculitis, edema (swelling of the ankles and feet), rarely - rhythm disturbances (bradycardia, ventricular tachycardia, atrial flutter), chest pain, orthostatic hypotension.
From the side of the central nervous system: dizziness, headache, flushes to the face, drowsiness, increased fatigue; rarely - a change in mood, asthenia, muscle cramps, myalgia, impaired vision, paresthesia.
On the part of the digestive system: dyspeptic disorders, nausea, abdominal pain; rarely - increased levels of hepatic transaminases and jaundice (due to cholestasis), pancreatitis, taste distortion, dry mouth, change in defecation.
From the skin: rarely - multiforme exudative erythema, discoloration of the skin.
Allergic reactions: skin rash, itching.
Other: rarely - gynecomastia, decreased potency, polyuricemia, gingival hyperplasia, increase / decrease in body weight, thrombocytopenia, leukopenia, arthralgia, pain in the extremities (with prolonged use).
CONTRAINDICATIONS
- severe arterial hypotension;
- age under 18 years (effectiveness and safety not established);
- Hypersensitivity to amlodipine and other dihydropyridine derivatives.
With caution appoint patients with impaired liver and kidney function, with chronic heart failure of II and III degree, weakness syndrome sinus node (pronounced bradycardia, tachycardia), aortic and mitral stenosis, hypercardiomyopathy with obstruction of the left ventricular outflow tract, acute myocardial infarction (and in for 1 month after), mild and moderate hypotension, elderly age.
PREGNANCY AND LACTATION
The safety of Omelar Cardio during pregnancy and lactation is not established, therefore, use the drug during pregnancy and during breastfeeding is recommended only in those cases when the risk associated with the disease itself exceeds the possible harm of treatment for the mother and fetus. If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be solved.
APPLICATION FOR FUNCTIONS OF THE LIVER
Be wary appoint patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution is prescribed to patients with impaired liver function.
APPLICATION FOR CHILDREN
Contraindication: age under 18 years (efficacy and safety not established).
APPLICATION IN ELDERLY PATIENTS
With caution appoint in old age.
SPECIAL INSTRUCTIONS
During the treatment, it is necessary to control body weight and diet, especially sodium intake, maintenance of dental hygiene and frequent visits to the dentist (prevention of soreness, bleeding, gum proliferation).
Experience with the use of Omelar Cardio in children is absent.
Impact on the ability to drive vehicles and manage mechanisms
Does not affect the ability to manage motor vehicles and moving machinery.
OVERDOSE
Symptoms: marked decrease in blood pressure, tachycardia, excessive peripheral vasodilation.
Treatment: gastric lavage, the appointment of activated charcoal, maintenance of cardiovascular function, monitoring of heart and lung performance, elevated limb position, control of bcc and diuresis. To restore the vascular tone - the use of vasoconstrictive drugs (in the absence of contraindications to their use); to eliminate the effects of calcium channel blockade - intravenous calcium gluconate administration. Hemodialysis is not effective.
DRUG INTERACTION
Compatible with thiazide diuretics, alpha and beta adrenoblockers, ACE inhibitors, nitrates, NSAIDs, antibiotics, hypoglycemic drugs for oral administration.
Inhibitors of microsomal oxidation increase the concentration in the blood plasma, increasing the risk of side effects, and inductors of microsomal enzymes of the liver - reduce.
Simultaneous application of Omelara Cardio and digoxin does not change the level of serum digoxin concentration and renal clearance of digoxin; cimetidine - does not change the pharmacokinetics of Omelara Cardio, warfarin - does not change the effects on prothrombin time in healthy male volunteers.
The hypotensive effect weakens NSAIDs, especially indomethacin (sodium retention and blockage of prostaglandin synthesis by the kidneys), sympathomimetics and estrogens (sodium retention).
Means for inhalation anesthesia (derivatives of hydrocarbons), amiodarone, quinidine, blockers of slow calcium channels can enhance the hypotensive effect.
With the joint use of lithium drugs, neurotoxicity is possible.
Thiazide and loop diuretics, beta-adrenoblockers, verapamil, ACE inhibitors and nitrates increase antianginal and hypotensive action.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store in a dry, protected from light and out of reach of children, at a temperature of no higher than 25 В° C. Shelf life - 2 years. Do not use after expiry date.
