Carvidil 25mg 28 tablets

Form

tableti

Dosage mg

25

Pack

28

CARVIDILOL Carvedilolum International Nonproprietary Name: Carvedilol Pharmaceutical Form. Tablets. Main Physicochemical Characteristics: 6.25 mg tablet_ round, biconvex, yellowish, with dark yellow inclusions, with a dividing line on one side. 12.5 mg tablet _ round, biconvex, light pink, with dark pink inclusions, with a dividing line on one side. 25 mg tablet _ round, biconvex, white, with a dividing line on one side. Composition. 1 tablet contains 6.25; 12.5 or 25 mg of carvedilol. Excipients. Lactose monohydrate (Pharmatose 90M), microcrystalline cellulose (Avicel PH 102), crospovidone (Polyplasdone XL), colloidal silicon dioxide, anhydrous (Aerosil 200), magnesium stearate, iron yellow oxide E 172 (in 6.25 and 12.5 mg tablets), iron red oxide E 172 (in 12.5 mg tablets). Pharmaceutical Form. Tablets Pharmacotherapeutic Group. Alpha- and beta-adrenoreceptor blocker. Indications Arterial hypertension, angina pectoris, chronic heart failure (in combination with diuretics, digoxin, and ACE inhibitors). Contraindications Hypersensitivity. Decompensated heart failure (NYHA functional class IV), grade II and III AV block, marked bradycardia, sick sinus syndrome, cardiogenic shock. Arterial hypotension (systolic blood pressure less than 85 mmHg). Liver failure. Bronchial asthma. Pregnancy, lactation. Age up to 18 years (safety and efficacy not established). Use with caution in bronchospastic syndrome, chronic bronchitis, pulmonary emphysema, Prinzmetal's angina, diabetes or hypoglycemia, hyperthyroidism, peripheral arterial disease, pheochromocytoma, depression, myasthenia gravis, psoriasis, renal failure. If you have any of the above conditions, inform your doctor before starting treatment! Caution Caution is advised in patients using contact lenses (due to reduced tear production). Withdrawal should be gradual (to avoid withdrawal syndrome), over several days (especially in patients with ischemic heart disease). Color of tablets may change when exposed to light. Symptoms of thyrotoxicosis and hypoglycemia may be masked. There is no clinical experience with the use of carvedilol in pediatric practice. In case of necessary surgery, the anesthesiologist should be informed about previous treatment with carvedilol. If heart failure progresses during treatment, the dose of diuretics should be increased; in case of renal failure, the dose is adjusted according to renal function. Ethanol consumption should be avoided during treatment. Drug Interactions It potentiates the action of insulin and sulfonylurea derivatives (simultaneously masking or weakening the symptoms of hypoglycemia, reducing hepatic glycogenolysis to glucose), hypotensive drugs (angiotensin-converting enzyme inhibitors, thiazide diuretics, vasodilators). Use with caution with antiarrhythmic drugs (increased risk of bradycardia and myocardial depression) and calcium channel blockers: increased risk of bradycardia and AV block (diltiazem), severe hypotension and heart failure (nifedipine and possibly nisoldipine), asystole, severe hypotension and heart failure (verapamil). Intravenous administration of these drugs is contraindicated during treatment with carvedilol. The drug increases serum digoxin levels. AV block and bradycardia may occur with cardiac glycosides. General anesthetics enhance its negative inotropic and hypotensive effects. Phenobarbital and rifampicin accelerate metabolism and reduce carvedilol concentration in plasma. Microsomal oxidation inhibitors (cimetidine) enhance its effect. Diuretics and angiotensin-converting enzyme inhibitors enhance the hypotensive effect of Carvidil. Before starting treatment with the drug, inform your doctor about the medications you are taking! Special Instructions If fatigue or dizziness occurs during treatment, do not drive or operate machinery. Patients with lactose intolerance should be aware that 1 tablet contains 50 mg (6.25 mg tablet), 100 mg (12.5 mg tablet), and 200 mg (25 mg tablets) of lactose. If the patient forgets to take Carvidil on time, they should take it immediately. If the next dose is approaching, do not double the dose. Continue taking the medication as prescribed at regular intervals. Dosage and Administration. For oral administration, with sufficient liquid. For arterial hypertension _ 12.5 mg once daily for the first two days, then _ 25 mg once daily, with a possible gradual increase in dose at intervals of at least 2 weeks. Maximum dose 50 mg once or in two divided doses. For angina pectoris _ 12.5 mg once daily for the first two days, then _ 25 mg twice daily (maximum _ up to 100 mg, divided into two doses). For chronic heart failure (on background therapy with digitalis, diuretics, and ACE inhibitors) _ start with 3.125 mg twice daily for 2 weeks, then (if well tolerated) increase the dose to 6.25 mg twice daily, then _ to 12.5 mg twice daily (maximum dose for body weight less than 85 kg is 25 mg twice daily, and for body weight over 85 kg _ 50 mg twice daily). If treatment is interrupted for more than 2 weeks, it should be restarted at a dose of 3.125 mg with subsequent dose increase. Overdose Symptoms: Marked decrease in blood pressure (systolic pressure _ 80 mmHg and below), bradycardia (less than 50 per minute), respiratory distress (including bronchospasm), heart failure, cardiogenic shock, cardiac arrest. Treatment: Cardiotonic agents, monitoring of cardiovascular and respiratory systems, as well as kidney function. In case of overdose, seek medical attention immediately! Side Effects Nervous system: headache, dizziness, syncope, muscle weakness (more often at the beginning of treatment), sleep disturbances, depression, paresthesia. Cardiovascular system: bradycardia, orthostatic hypotension, angina pectoris, AV block, rarely _ intermittent claudication, peripheral circulatory occlusive disorders, progression of heart failure. Digestive system: dry mouth, nausea, abdominal pain, diarrhea or constipation, vomiting, increased activity of "liver" transaminases. Hematopoietic organs: thrombocytopenia, leukopenia. Urinary system: severe renal dysfunction, edema. Allergic reactions: skin allergic reactions (exanthema, urticaria, itching, rash), exacerbation of psoriatic rash, sneezing, rhinitis, bronchospasm, shortness of breath (in predisposed patients). Other: flu-like syndrome, limb pain, reduced tear production, weight gain. Storage Conditions. In a dry, dark place, at a temperature not exceeding 25ºC. Keep the medicine out of reach of children! Do not use the drug after the expiry date indicated on the packaging! Shelf life: 3 years Conditions of dispensing. By prescription only. Release form 14 tablets in a blister. 2 blisters in a pack.