Carvedilol-vertex tab 25mg 30 pc

Description

Composition
Active substance:
1 tablet contains:
Carvedilol – 12.5 mg or 25 mg.
Excipients:
Microcrystalline cellulose, lactose (milk sugar), crospovidone (10 plasdon XL), sodium stearyl fumarate.
Description:
Tablets from white to white with cream tint color, Valium chamfered. Slight “marbling”.
Product form:
12.5 mg and 25 mg tablets. 10 tablets in blisters or 10, 20 or 30 tablets in a polymeric jar. 1, 2 or 3 blisters or each bank together with instructions for use in a stack of cardboard.
Contraindications
Hypersensitivity to carvedilol or other ingredients, acute and decompensated congestive heart failure requiring intravenously-tion administration of inotropic agents, severe hepatic failure, atrioventrikulyar Nye blockade II-III art., Bradycardia (less than 50 beats / min), weak syndrome cial-sinus node, hypotension (systolic blood pressure less than 85 mm Hg. v.), cardiogenic shock, bronchial asthma, chronic obstructive pulmonary disease, age 18 years (Efficiency and safety have not been established).
Carefully
Bronchospastic syndrome, chronic bronchitis, emphysema, angina Prince metal, thyrotoxicosis, occlusive peripheral vascular disease, pheochromocytoma-ma, psoriasis, renal failure, atrioventricular block I degree, extensive surgery and general anesthesia, diabetes mellitus, hypoglycaemia, depression, myasthenia .
Dosage
25 mg
Indications
Arterial hypertension (monotherapy or combination with a diuretic)
Chronic heart failure (in a combination therapy)
Coronary heart disease: stable angina.
Interaction with other drugs
Carvedilol may potentiate the effects of other concomitant antihypertensive agents or drugs which have an antihypertensive effect (nitrates).
If concomitant use of carvedilol and diltiazem may develop cardiac conduction and hemodynamic disturbances.
When simultaneous administration of carvedilol and digoxin increases the concentration of the latter and may increase atrioventricular conduction time.
Carvedilol may potentiate the effect of insulin and oral hypoglycemic agents, the symptoms of hypoglycemia (especially tachycardia) may be masked, so diabetic patients recommended the regular control of blood sugar.
Mikrosomalnogo oxidation inhibitors (cimetidine) increase, and inducers (phenobarbital, rifampin) weaken the antihypertensive effect of carvedilol.
Drugs that reduce the content of catecholamines (reserpine, monoamine oxidase inhibitors), increase the risk of hypotension and bradycardia.
With simultaneous use of cyclosporin increased concentration of the latter (recommended daily dose correction cyclosporin).
The simultaneous appointment of Clonidine may potentiate antihypertensive and slows the heart rate-conductive effects of carvedilol.
General anesthetics enhance the negative inotropic and hypotensive effect of carvedilol.
Overdose
Symptoms: lowering blood pressure (accompanied by dizziness or syncope), aetiology. You may experience shortness of breath due to bronchospasm and vomiting. In severe cases, possible cardiogenic shock, respiratory failure, confusion, conduction abnormalities.
Treatment: it is necessary to carry out monitoring and correction of vital parameters, if necessary – in the intensive care unit. Treatment – symptomatic. Advantageously intravenous administration of m-anticholinergics (atropine), sympathomimetics (epinephrine, norepinephrine).
pharmachologic effect
Pharmacological group:
Alpha- and beta-blocker.
Pharmacodynamics:
pharmacodynamics
Carvedilol has combined nonselective beta1-, beta2- and alpha 1 blocking action. The drug does not own sympathomimetic activity, has membrane stabilizing properties. Due to the blockade of beta-adrenergic receptors of the heart can reduce blood pressure, cardiac output, and slows the heart rate. Carvedilol inhibits the renin-angiotensin-aldosterone system by beta blockade kidney, causing a decrease in plasma renin activity. Blocking alpha-adrenoceptors, the drug can cause expansion of peripheral blood vessels, thereby reducing systemic vascular resistance. The combination of beta blockade and vasodilation provides the following effects: in patients with arterial hypertension – blood pressure reduction; in patients with coronary heart disease – anti-ischemic and anti-anginal action; in patients with left ventricular dysfunction and circulatory failure – a beneficial effect on hemodynamic parameters, improves left ventricular ejection fraction and reduces its size.
Pharmacokinetics:
Carvedilol is rapidly absorbed from the gastrointestinal tract. It has high lipophilicity. Maximum concentration in blood reached after 1-1.5 hours. The half-life of 6-10 hours. Bound to plasma proteins at 95-99%. The bio-availability of the drug 24-28%. Meal did not affect the bioavailability. It is metabolized in the liver with the formation of a number of active metabolites – 60-75% of the adsorbed drug is metabolized during the first “pass” through the liver. The metabolites possess a pronounced antioxidant and adrenoceptor blocking action. Elimination of the drug from the body occurs through the gastrointestinal tract. With impaired renal function the pharmacokinetic parameters of carvedilol did not significantly change.
Patients with hepatic impairment systemic bioavailability of carvedilol is increased by reducing the metabolism at the first “pass” through the liver. For serious violations of the liver carvedilol is contraindicated.
Carvedilol crosses the placental barrier, excreted in breast milk.
Pregnancy and breast-feeding
Controlled studies of the use of carvedilol in pregnant women has not been, so this category of patients with use of the drug is possible only in cases where the benefit to the mother outweighs the potential risk to the fetus.
Not recommended for breast-feeding during treatment with carvedilol.
Conditions of supply of pharmacies
On prescription.
side effects
Central nervous system: dizziness, headache (usually not severe and early treatment), loss of consciousness, myasthenia gravis (usually at the beginning of the treatment), fatigue, depression, sleep disturbance, paresthesia.
From the cardiovascular system: bradycardia, atrioventricular block orthostatic hypotension II-III art, seldom – the peripheral blood circulation, the progression of heart failure (during increasing doses), lower extremity edema, angina, marked reduction in blood pressure..
On the part of the digestive tract: dry mouth, nausea, diarrhea or constipation, vomiting, abdominal pain, loss of appetite, increased activity of “liver” transaminases.
From the hematopoietic system: rarely – thrombocytopenia, leukopenia.
From the Metabolic: weight gain, impaired carbohydrate metabolism.
Allergic reactions: allergic skin reactions, exacerbation of psoriasis, nasal congestion.
The respiratory system: dyspnea, and bronchospasm (in predisposed patients).
Other: visual disturbances, reduced lacrimation, flu-like symptoms, sneezing, myalgia, arthralgia, pain in the limbs, “intermittent” claudication, rarely – a violation of urination, impairment of renal function.
special instructions
Therapy should be held for a long time and should not abruptly stop, especially in patients with ischemic heart disease, as it may lead to a worsening of the underlying disease. If necessary, the reduction in dose should be gradual, for 1-2 weeks.
At the beginning of therapy or carvedilol with increasing doses in patients, especially the elderly, may experience excessive reduction in blood pressure, especially when rising. Requires correction dose. In patients with chronic heart failure in the selection of a dose may increase the symptoms of heart failure, the appearance of edema. Thus it is not necessary to increase the dose carvedilol, recommended assignment of large doses of diuretics until stabilization of the patient.
Recommended constant monitoring of the electrocardiogram and blood pressure while appointing blocker carvedilol and “slow” calcium channels, phenylalkylamine derivatives (verapamil), and benzodiazepine derivatives (diltiazem), and – with class I antiarrhythmics.
It is recommended to monitor renal function in patients with chronic renal failure, hypotension and chronic heart failure.
In case of surgery using general anesthesia should notify the anesthesiologist of previous treatment with carvedilol.
Carvedilol has no effect on the concentration of glucose in the blood and does not cause tolerance test indicators of changes in glucose in patients with non-insulin dependent diabetes mellitus.
During treatment to avoid the use of ethanol.
Patients with pheochromocytoma before therapy is necessary to assign alpha-blockers.
Patients wearing contact lenses should take into account that the drug may cause a reduction in tearing.
It is not recommended to drive at the beginning of therapy and when increasing the dose of carvedilol. It should refrain from other activities related to the necessity of high concentration and rapid psychomotor reactions.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 C. Keep out of reach of children.
Dosing and Administration
Inside, regardless of the meal.
To ensure the below dosage regimen may use the drug carvedilol in a dosage form of a tablet of 6.25 mg.
Arterial hypertension
The initial dose is 6.25 – 12.5 mg 1 time per day in the first two days of treatment. Then 25 mg 1 time per day. When failure antihypertensive effect after 2 weeks of therapy, the dose can be increased by 2 times. The maximum recommended daily dose is 1 to 50 mg once daily (possibly divided by 2 Hour).
Coronary artery disease
The initial dose is 12.5 mg 2 times a day during the first two days of treatment. Then 25 mg 2 times a day. When failure antianginal effect after 2 weeks of therapy, the dose can be increased by 2 times. The maximum recommended daily dose is 100 mg per day, divided into 2 Hour.
Chronic heart failure
Dose picked individually, under the close supervision of a physician. The recommended starting dose of 3.125 mg two times a day for 2 weeks. With good tolerability increase dose at intervals of at least 2 weeks to 6.25 mg 2 times a day, then to 12.5 mg 2 times a day, then – to 25 mg 2 times a day. The dose should be increased to a maximum, which is well tolerated by patients. In patients weighing less than 85 kg target dose is 50 mg per day; in patients weighing more than 85 kg target dose of 75 – 100 mg per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist