Composition, form of production and packaging
Tablets of white or almost white color, round, flat-cylindrical, with a facet and a risk; slight marbling is allowed.
1 tab.
carvedilol 6.25 mg
Excipients: calcium hydrophosphate dihydrate - 38.55 mg, giprolose (hydroxypropylcellulose) - 2.5 mg, croscarmellose sodium (impellosis) - 2 mg, lactose monohydrate (sugar milk) - 50 mg, magnesium stearate 0.7 mg.
7 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
Tablets of white or almost white color, round, flat-cylindrical, with a facet and a risk; slight marbling is allowed.
1 tab.
carvedilol 12.5 mg
Excipients: calcium hydrophosphate dihydrate - 50 mg, giprolase (hydroxypropylcellulose) - 3.5 mg, croscarmellose sodium (impellose) - 3 mg, lactose monohydrate (sugar milk) - 70 mg, magnesium stearate - 1 mg.
7 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
Tablets of white or almost white color, round, flat-cylindrical, with a facet and a risk; slight marbling is allowed.
1 tab.
carvedilol 25 mg
Excipients: calcium hydrophosphate dihydrate - 70 mg, giprolose (hydroxypropylcellulose) - 5.3 mg, croscarmellose sodium (impellose) - 4.5 mg, lactose monohydrate (sugar milk) - 93.7 mg, magnesium stearate - 1.5 mg.
7 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
7 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
28 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
The blocker? 1 -,? 1 - and? 2- adrenoreceptors, has a vasodilating, anti-anginal and antiarrhythmic effect. Carvedilol is a racemic mixture of R (+) - and S (-) stereoisomers, each of which has the same alpha-adrenoblocking and antioxidant properties. The beta-adrenergic blocking effect of carvedilol is non-selective and is due to the levorotatory S (-) stereoisomer.
Carvedilol does not have its own sympathomimetic activity, it has membrane-stabilizing properties. The vasodilating effect is associated mainly with blockade? 1-adrenoreceptors. Thanks vazodilatatsii reduced OPSS.
Blocking? -adrenoceptors, reduces the activity of RAAS, reducing the release of renin, so fluid retention, characteristic of selective alpha-blockers, occurs rarely.Carvedilol has no significant effect on the lipid profile, maintaining a normal HDL / LDL ratio.
Efficiency
In patients with hypertension, carvedilol lowers blood pressure due to a combined blockade? - and? 1- adrenoreceptors. Reduction of blood pressure is not accompanied by a simultaneous increase in OPSS, which is observed when non-selective beta-blockers are used. The heart rate somewhat decreases. Kidney blood flow and kidney function in patients with hypertension persist. It is shown that carvedilol does not change the shock volume of the blood and reduces the OPSS; does not impair blood supply to organs and peripheral blood flow, incl. in skeletal muscles, forearms, lower extremities, skin, brain and carotid arteries. Coldness of limbs and increased fatigue during exercise are rare. The antihypertensive effect of carvedilol, with arterial hypertension persists for a long time.
In patients with ischemic heart disease, carvedilol has anti-ischemic and antianginal effects (an increase in the total duration of exercise, the time until the development of ST-segment depression 1 mm in depth and the time before the onset of angina attack), which persists with prolonged therapy. Carvedilol significantly reduces myocardial oxygen demand and the activity of the sympathoadrenal system. Also reduces preload (pulmonary wedge wedge pressure and pulmonary capillary pressure) and postnagruzku (OPSS).
Carvedilol lowers the mortality rate and reduces the frequency of hospitalizations, reduces symptoms and improves left ventricular function in patients with chronic heart failure of ischemic and non-ischemic origin. The effects of carvedilol are dose-dependent.
PHARMACOKINETICS
Suction
After ingestion, carvedilol is rapidly absorbed from the digestive tract. Carvedilol is a substrate of the transporter protein for glycoprotein P, which acts as a pump in the lumen of the intestine. Glycoprotein P plays a major role in the bioavailability of certain drugs. With max in the blood plasma is achieved approximately 1 hour after ingestion. Absolute bioavailability of carvedilol is about 25%: 30% for the R-form and 15% for the S-form. Eating does not affect bioavailability.
Distribution
Carvedilol has a high lipophilicity. About 98-99% of carvedilol binds to blood plasma proteins. V d is approximately 2 l / kg. Carvedilol penetrates the placental barrier, excreted in breast milk.
Metabolism
Carvedilol undergoes biotransformation in the liver by oxidation and conjugation to form a number of metabolites. 60-75% of the absorbed drug is metabolized by the "first pass" through the liver. The existence of intestinal-hepatic circulation of the starting material is shown.
The metabolism of carvedilol by oxidation is stereoselective. The R stereoisomer is mainly metabolized by the CYP2D6 and CYP1A2 isoenzymes, and the S stereoisomer is mainly by the CYP2D9 isoenzyme and to a lesser extent by the CYP2D6 isoenzyme. Other isoenzymes of cytochrome P450 involved in the metabolism of carvedilol include isoenzymes CYP3A4, CYP2E1 and CYP2C19.
The minimum concentration of R-stereoisomer in blood plasma is approximately 2 times higher than that of the S-stereoisomer.
R-stereoisomer is metabolized mainly by hydroxylation. The "slow" metabolizers of the CYP2D6 isoenzyme may increase the plasma concentration of carvedilol, primarily the R-stereoisomer, which is reflected in the increase in alpha-adrenergic blocking activity of carvedilol.
As a result of demethylation and hydroxylation of the phenolic ring, 3 metabolites are formed (their concentrations are 10 times lower than the concentration of the starting material) with beta-adrenoblocking activity (in the 4'-hydroxyphenol metabolite it is approximately 13 times stronger than in carvedilol itself). 3 active metabolites have less pronounced vasodilating properties than carvedilol. Two of the hydroxycarbazole metabolites of carvedilol are extremely potent antioxidants, and their activity in this respect is 30-80 times greater than that of carvedilol.
Excretion
T 1/2 carvedilol is about 6 hours, plasma clearance is about 500-700 ml / min. Excretion occurs mainly through the intestines with bile. A small part of the dose is excreted by the kidneys in the form of various metabolites.
Pharmacokinetics in specific patient groups
Patients with impaired renal function
With prolonged therapy with carvedilol, the intensity of renal blood flow is maintained, GFR does not change.
In patients with arterial hypertension and impaired renal function, AUC, T 1/2 and C max do not change. Renal excretion of unchanged carvedilol in patients with renal insufficiency decreases, but changes in pharmacokinetic parameters are not very pronounced. Carvedilol is an effective treatment for patients with renovascular hypertension, incl. in patients with chronic renal failure, as well as in patients on hemodialysis or who underwent kidney transplantation. Carvedilol causes a gradual decrease in blood pressure on the day of hemodialysis, and on days without hemodialysis, and its antihypertensive effect is comparable to that in patients with normal renal function.
Carvedilol is not excreted during hemodialysis because it does not pass through the dialysis membrane, probably due to the fact that it strongly binds to blood plasma proteins.
Patients with impaired hepatic function
In patients with cirrhosis of the liver, the systemic bioavailability of the drug is increased by 80% due to a decrease in the expression of metabolism during the "first passage" through the liver. Consequently, carvedilol is contraindicated in patients with severe impairment of liver function.
Patients with chronic heart failure (CHF)
In patients with CHF, the clearance of the R- and S-stereoisomers of carvedilol was significantly lower compared to the previously observed clearance in healthy volunteers. These results indicate that the pharmacokinetics of the R- and S-stereoisomers of carvedilol in cardiac insufficiency significantly changes.
Patients of elderly and senile age
Age does not have a statistically significant effect on the pharmacokinetics of carvedilol in patients with arterial hypertension. According to clinical studies, the tolerability of carvedilol in patients with hypertension or ischemic heart disease of the elderly and senile does not differ from that in patients of a younger age.
Children
Data on the pharmacokinetics of the drug in patients under the age of 18 are currently limited.
Patients with diabetes mellitus
In patients with type 2 diabetes and hypertension, carvedilol does not affect the fasting blood glucose concentration after fasting, the level of glkkozilirovannogo hemoglobin (HbA 1 ), or the dose of hypoglycemic agents for oral administration. In some clinical studies, it has been shown that in patients with type 2 diabetes mellitus carvedilol does not cause a decrease in glucose tolerance. In patients with hypertension who had insulin resistance (syndrome X), but without concomitant diabetes mellitus, carvedilol improves insulin sensitivity. Similar results were obtained in patients with arterial hypertension and type 2 diabetes mellitus.
INDICATIONS
- arterial hypertension (in monotherapy or in combination with other antihypertensive agents, for example, blockers of slow calcium channels or diuretics);
- IHD (including in patients with unstable angina and painless myocardial ischemia);
- chronic heart failure (treatment of stable and symptomatic mild, moderate and severe chronic heart failure (NYHA class II-IV functional class) ischemic or non-ischemic genesis in combination with ACE inhibitors and diuretics, with or without cardiac glycosides (standard therapy), with absence of contraindications).
DOSING MODE
The drug is taken orally, regardless of food intake, with a sufficient amount of liquid.
In case of hypertension, the recommended initial dose is 6.25-12.5 mg (1 table by 6.25 mg or 1/2 tablets-1 tablet by 12.5 mg) 1 time / day in the first 2 days of therapy, then 25 mg 1 time / day. If necessary, in the future, the dose can be increased at intervals of not less than 2 weeks, bringing to the maximum recommended dose of 50 mg 1 time / day (or divided into 2 divided doses).
With IHD, the recommended initial dose is 12.5 mg 2 times / day in the first 2 days, then 25 mg 2 times / day. If the antianginal effect is insufficient, the dose can be increased at intervals of at least 2 weeks, bringing to a maximum daily dose of 100 mg divided into 2 doses.
With chronic heart failure, the dose is selected individually, careful monitoring of the doctor is necessary. In patients receiving cardiac glycosides, diuretics and ACE inhibitors, dosage of these drugs should be adjusted before treatment with Carvedilol Canon. The recommended initial dose is 3.125 mg (1/2 tablets at 6.25 mg) 2 times / day for 2 weeks. With good tolerability, the dose is increased at intervals of at least 2 weeks to 6.25 mg 2 times / day, then to 12.5 mg 2 times / day, then to 25 mg 2 times / day. The dose should be increased to the maximum dose, which is well tolerated by the patient. The recommended maximum dose is 25 mg 2 times / day for all patients with severe chronic heart failure and for patients with mild to moderate chronic heart failure with a body weight of less than 85 kg. In patients with mild and moderate chronic heart failure and a body weight of more than 85 kg, the recommended maximum dose is 50 mg 2 times / day.
Before every increase in the dose, a doctor's examination is necessary to detect a possible increase in the symptoms of chronic heart failure or vasodilation. When transient exacerbation of symptoms of chronic heart failure or fluid retention should increase the dose of diuretics, although sometimes it is necessary to reduce the dose or temporarily suspend it.
The symptoms can be eliminated decrease vasodilation dose diuretics. If symptoms persist, it is possible to reduce the dose of ACE inhibitor (if the patient takes his), and then, if necessary, to lower the dose carvedilol Canon. In this situation, the dose carvedilol Canon should not be increased until symptoms worsen chronic heart failure or hypotension does not improve.
If treatment with carvedilol Canon interrupted for more than 1 week, its application is restarted at a lower dose and then increased in accordance with the above recommendations.
If treatment with carvedilol Canon interrupted for more than 2 weeks, then its re-assignment should be resumed with the 3.125 mg dose (Table 1/2. At 6.25 mg), 2 times / day, then the dose is selected in accordance with the above recommendations.
In patients with renal insufficiency of moderate to severe dose adjustment is required.
Canon Carvedilol is contraindicated in patients with clinical manifestations of liver dysfunction .
The data that would have dictated the need for dose adjustment inelderly patients , no.
SIDE EFFECT
? WHO classification of frequency of side effects: very often - 1/10 appointments (> 10%), often - from 1/100 to <1/10 appointments (> 1% and <10%);? infrequently - from 1/1000 to <1/100 appointments (> 0.1% and <1%), rarely - from 1/10000 to <1/1000 appointments (> 0.01% and <0.1%), rarely - <? assignments 1/10000 (0.01%).
The frequency of certain adverse effects, such as dizziness, hypotension, bradycardia, and visual disturbances (often develops in patients with chronic heart failure) is proportional to the size of the dose. With the development of serious adverse effects of treatment with the drug should be discontinued.
From hemopoiesis system: rarely - thrombocytopenia; very rarely - leukopenia.
From endocrine system:often - in patients with pre-existing diabetes mellitus - Hyperglycemia or hypoglycemia, impaired glucose control. The presence of the drug beta-adrenoceptor blocking properties do not exclude the possibility of manifestation of latent diabetes mellitus flowing, decompensation of existing diabetes or depression kontrinsulyarnyh system.
On the part of metabolism and nutrition: often - increased body mass index, hypercholesterolemia.
From the nervous system: often - dizziness, headache (usually mild and occur more often in the beginning of treatment), depression; rarely - changes in mood / thought, sleep disturbance, paraesthesia, loss of consciousness.
From a sight organ:often - eye irritation, lacrimation decrease (which should be considered when using contact lenses); very rarely - blurred vision.
Cardio-vascular system:very often - orthostatic hypotension; often - bradycardia; rarely - violation cardiac conduction currents worsening of angina, worsening of the clinical picture of heart failure (especially with increasing dots), a marked reduction of blood pressure, palpitations, fainting, cold hands and feet, fluid retention, hypervolemia, edema (including generalized, peripheral, depending on the body position, perineal edema, edema of lower limbs); very rarely - syncope (including presinkopalnye) occlusive peripheral circulatory disorders, exacerbation of intermittent claudication syndrome and Raynaud's syndrome.
The respiratory system: rarely - bronchospasm and dyspnoea in predisposed patients, nasal congestion; very rarely - a sneeze.
From the digestive system: often - nausea, diarrhea, abdominal pain, dryness of the oral mucosa; rarely - vomiting, loss of appetite, bloating, constipation; very rarely - increased activity of hepatic transaminases - ALT, ACT and GGT.
From the urinary system: rarely - a violation of urination, cases of urinary incontinence in women, reversible after discontinuation of the drug; very rarely - renal insufficiency and renal function in patients with diffuse vasculitis and / or renal dysfunction, edema.
On the part of genitals and mammary glands: rarely - reduced potency.
Skin and subcutaneous tissue disorders: very rarely - worsening of psoriasis flow, exfoliative dermatitis, alopecia.
On the part of the musculoskeletal system: rarely - myasthenia gravis, muscle pain, bone, spine.
Other: often - asthenia (including fatigue), weakness; rarely - hypersensitivity reactions (itching, rash, hives); very rarely - "tides" of blood to the skin, flu-like symptoms.
Adverse reactions in patients with chronic heart failure
of the nervous system: very often - dizziness, headache (usually mild and occur at the beginning of treatment), and depression.
Cardio-vascular system:often - bradycardia, postural hypotension, marked reduction of blood pressure, edema (including generalized, peripheral, depending on the body position, perineal edema, edema of lower extremities, hypervolemia, fluid retention); infrequently - syncope (including presinkopalnye), AV-block and cardiac failure during increasing doses.
From the digestive system: often - nausea, diarrhea, vomiting.
From hemopoiesis system: rarely - thrombocytopenia; very rarely - leukopenia.
On the part of metabolism and nutrition: often - increased body mass index, hypercholesterolemia; in patients with pre-existing diabetes mellitus - Hyperglycemia or hypoglycemia, impaired carbohydrate metabolism.
Other:very often - asthenia (including fatigue); often - blurred vision; rarely - renal insufficiency and renal function in patients with diffuse vasculitis and / or impaired renal function.
CONTRAINDICATIONS
- hepatic failure, severe;
- acute and chronic heart failure decompensation requiring on / in the inotropic agents;
- AV blockade II and III degree (except for patients with an artificial pacemaker);
- pronounced bradycardia (heart rate less than 50 beats per minute);
- SSS (including sinus block);
- severe hypotension (systolic blood pressure less than 85 mmHg);
- cardiogenic shock;
- severe bronchial asthma or bronchospasm (history);
- pheochromocytoma (without simultaneous application of alpha-blockers);
- lactose intolerance, lactase deficiency, malabsorption syndrome glucose / galactose;
- end stage occlusive peripheral vascular disease;
- age under 18 years (efficiency and safety not established);
- Hypersensitivity to carvedilol or any component of the formulation.
With caution should be prescribed with allergic history, COPD, depression, myasthenia gravis, hypoglycemia, AV-blockade I extent thyrotoxicosis, with extensive surgery and general anesthesia, Prinzmetal angina, diabetes, occlusive peripheral vascular disease, suspected pheochromocytoma , renal insufficiency, psoriasis.
PREGNANCY AND LACTATION
Beta-blockers reduce placental blood flow, which can lead to fetal death and premature birth. Furthermore, in the fetus and newborn unwanted reactions can occur, inter alia, hypoglycemia and bradycardia, complications of the heart and lungs. Animal studies have not revealed teratogenic effects of carvedilol.
Enough experience with carvedilol in pregnant women do not. Canon Carvedilol is contraindicated in pregnancy, unless absolutely necessary, if the expected benefit to the mother outweighs the potential risk to the fetus.
Carvedilol and its metabolites are excreted in breast milk, so if you need to use the drug during lactation, breast-feeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Precautions should be prescribed to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use of the drug in patients with hepatic insufficiency, severe contraindicated.
Canon Carvedilol is contraindicated in patients with clinical manifestations of liver dysfunction.
APPLICATION FOR CHILDREN
Use of the drug in children and adolescents under the age of 18 years is contraindicated (effectiveness and safety have been established).
APPLICATION IN ELDERLY PATIENTS
No dose adjustment in elderly patients is not required.
SPECIAL INSTRUCTIONS
Chronic heart failure
patients with chronic heart failure in the selection period ppepapata dose can be marked increase in symptoms of congestive heart failure or fluid retention. If you experience these symptoms you need to increase the dose of diuretics or increase the dose to the stabilization of hemodynamic parameters. Sometimes it is necessary to reduce the dose of the drug Carvedilol Canon or, in rare cases, temporarily stop the drug. Such episodes do not preclude further correct selection dose carvedilol Canon.
Carvedilol Canon with care is used in combination with cardiac glycosides (possibly excessive deceleration AV-conduction).
At the beginning of therapy with carvedilol Canon or at higher doses in patients, particularly the elderly, may experience excessive reduction in blood pressure preferably at the transition from the supine position to a standing position. A dose adjustment is necessary.
Renal function in chronic heart failure
When administering the drug carvedilol Canon patients with chronic heart failure and low blood pressure (systolic blood pressure less than 100 mm Hg), ischemic heart disease, and diffuse vascular changes and / or renal insufficiency noted reversible renal impairment. Dose is adjusted depending on renal function.
It is recommended to monitor renal function in patients with chronic renal insufficiency, arterial hypertension and chronic heart failure.
COPD
Patients with COPD, including bronchospastic syndrome, not receiving oral or inhaled anti-asthma agents, Canon Carvedilol is prescribed only if the potential benefits of its use outweigh the potential risks. In the presence of the original predisposition to bronchospastic syndrome while taking the drug carvedilol Canon due to an increase of airway resistance may develop shortness of breath. At the beginning of the reception, and by increasing the dose of the drug Carvedilol Canon of such patients should be carefully observed, reducing the dose of the drug with the appearance of initial symptoms of bronchospasm.
Diabetes
Precautions Carvedilol Canon prescribed to patients with diabetes mellitus, because the drug may mask or reduce the symptoms of hypoglycemia (especially tachycardia). In patients with chronic heart failure and diabetes medication use Canon Carvedilol may be associated with impaired glycemic control.
Peripheral vascular disease
Caution is needed when administering the drug carvedilol Canon patients with peripheral vascular disease, including Raynaud's syndrome, as beta-blockers may exacerbate the symptoms of arterial insufficiency.
Thyrotoxicosis
Like other beta-blockers, carvedilol Canon may reduce the severity of symptoms of hyperthyroidism.
General anesthesia and extensive surgery
Caution is required in patients undergoing surgery under general anesthesia because of the possibility of summation of the negative effects of carvedilol and funds for general anesthesia. In the case of the need for surgery using general anesthesia is necessary to warn the anesthesiologist prior to therapy with carvedilol Canon.
Bradycardia
Carvedilol may cause bradycardia Canon. When urezhenii heart rate less than 55 bpm. / Min the dose should be lower drug.
hypersensitivity
Care should be taken when administering the drug carvedilol Canon patients with a history of instructions for severe hypersensitivity reactions or undergoing desensitization rate as beta blockers may increase the sensitivity to allergens and severity of anaphylactic reactions.
Psoriasis
Patients with a history of instructions of the occurrence or exacerbation of psoriasis when applying beta-blockers, Canon drug carvedilol can be administered only after careful analysis of the possible risks and benefits.
pheochromocytoma
Patients with pheochromocytoma before the use of any beta-blocker, you must assign an alpha-blocker. Although carvedilol has both beta and alpha-adrenoceptor blocking properties and experience of their use in such patients have, however with caution should be used in patients with suspected pheochromocytoma.
Prinzmetal angina
nonselective beta-blockers may provoke the appearance of pain in patients with angina Prinzmetal. Experience in the application of carvedilol in these patients is not. Although alpha-adrenoceptor blocking properties of carvedilol may prevent such symptoms, prescribe Carvedilol Canon in such cases should be cautious.
Contact lenses
Patients who use contact lenses should bear in mind the possibility of reducing the amount of tear fluid.
Withdrawal
Treatment with Carvedilol Canon held long. Therapy should not be stopped abruptly, poctepenno necessary to reduce the dose at intervals of 1-2 weeks. This is particularly important in patients with CAD.
In the period of treatment is necessary to eliminate the use of alcohol.
Impact on the ability to drive vehicles and manage mechanisms
Due to the possibility of dizziness, caution should be exercised when driving and other lesson potentially dangerous activities which require high concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: excessive lowering of blood pressure, bradycardia, heart failure, cardiogenic shock, cardiac arrest; possible respiratory failure, bronchospasm, vomiting, confusion, and generalized convulsions.
Treatment: in addition to the general measures necessary to carry out monitoring and correction of vital signs, if necessary - in the intensive care unit. The following measures can be used: lay the patient on his back with legs elevated; with bradycardia - atropine of 0.5-2 mg / in; to maintain heart with
