Romazik pills p/o 20mg №10×3

Name:
Romazik tab. p / o 20 mg in bl. in pack. No. 10×3
Description:
Coated tablets are white or almost white, round and biconvex, engraved on one side. The main active ingredient rosuvastatin Product form Tablets Dosage 20 mg Special instructions Use with caution in the presence of risk factors for the development of rhabdomyolysis (including renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and a previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates), in chronic alcoholism, in patients over the age of 65, with a history of liver disease, sepsis, arterial hypotension, during extensive surgical interventions, trauma, severe metabolic endocrine or electrolyte disorders, with uncontrolled epilepsy, in people of Asian origin (Chinese, Japanese). Therapy should be discontinued if the level of CPK is significantly increased (more than 5 times compared with ULN) or if muscle symptoms are pronounced and cause daily discomfort (even if the level of CPK is 5 times lower than ULN). When using rosuvastatin at a dose of 40 mg, it is recommended to monitor indicators of kidney function. In most cases, proteinuria decreases or disappears during therapy and does not indicate the onset of acute or progression of existing kidney disease. An increase in the incidence of myositis and myopathy has been reported in patients taking other HMG-CoA reductase inhibitors in combination with fibric acid derivatives (including gemfibrozil), cyclosporine, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when co-administered with certain HMG-CoA reductase inhibitors. Thus, the simultaneous administration of rosuvastatin and gemfibrozil is not recommended. The risk-benefit ratio should be carefully weighed when using rosuvastatin and fibrates or niacin together. It is recommended to determine the parameters of liver function before the start of therapy and 3 months after the start of therapy. The use of rosuvastatin should be discontinued or the dose reduced if the level of serum transaminase activity is 3 times the upper limit of the norm. In patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome, treatment of underlying diseases should be carried out before starting treatment with rosuvastatin. Influence on the ability to drive vehicles and control mechanisms When engaging in potentially hazardous activities, patients should be aware that dizziness may occur during therapy. Indications for use Hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as an adjunct to diet when diet and other non-pharmacological treatments (eg, exercise, weight loss) are inadequate. Homozygous familial hypercholesterolemia as an adjunct to diet and other cholesterol-lowering therapy, or when such therapy is not appropriate for the patient. Dosage and administration Take orally. The recommended initial dose is 10 mg 1 time / day. If necessary, the dose can be increased to 20 mg after 4 weeks. Increasing the dose to 40 mg is possible only in patients with severe hypercholesterolemia and a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) with insufficient efficacy at a dose of 20 mg and subject to medical supervision. Use during pregnancy and lactation is contraindicated in pregnancy and lactation. Do not use in women of reproductive age who are not using reliable methods of contraception. Interaction with other drugs With the simultaneous use of rosuvastatin and cyclosporine, the AUC of rosuvastatin was on average 7 times higher than the value observed in healthy volunteers, while the plasma concentration of cyclosporine did not change. Starting therapy with rosuvastatin or increasing the dose of the drug in patients receiving concomitant vitamin K antagonists (for example, warfarin) may lead to an increase in prothrombin time and INR, and the abolition of rosuvastatin or dose reduction may lead to a decrease in INR (in such cases, monitoring of INR is recommended). The combined use of rosuvastatin and gemfibrozil leads to a 2-fold increase in plasma Cmax and AUC of rosuvastatin. The simultaneous use of rosuvastatin and antacids containing aluminum and magnesium hydroxide leads to a decrease in the plasma concentration of rosuvastatin by about 50%. This effect is less pronounced if antacids are applied 2 hours after taking rosuvastatin (clinical significance unknown). The simultaneous use of rosuvastatin and erythromycin leads to a decrease in AUC of rosuvastatin by 20% and Cmax of rosuvastatin by 30% (probably as a result of increased intestinal motility caused by taking erythromycin). The simultaneous use of rosuvastatin and oral contraceptives increases the AUC of ethinylestradiol and the AUC of norgestrel by 26% and 34%, respectively. It is impossible to exclude such an interaction with the simultaneous use of rosuvastatin and hormone replacement therapy. Gemfibrozil, other fibrates, and lipid-lowering doses of nicotinic acid (≥1 g/day) increased the risk of myopathy when used concomitantly with other HMG-CoA reductase inhibitors, possibly due to the fact that they can cause myopathy when used as monotherapy. The combined use of rosuvastatin and itraconazole (a CYP3A4 inhibitor) increases the AUC of rosuvastatin by 28% (clinically insignificant). Contraindications Liver disease in the active phase (including a persistent increase in liver transaminase activity or any increase in transaminase activity more than 3 times compared with ULN), severe renal dysfunction (CC<30 ml / min), myopathy, concomitant use of cyclosporine, pregnancy, lactation (breastfeeding), women of reproductive age who do not use adequate methods of contraception, children and adolescents under 18 years of age (since efficacy and safety have not been established), hypersensitivity to rosuvastatin. Ingredients of rosuvastatin Excipients: lactose monohydrate (type 1 and 2), microcrystalline cellulose, sodium citrate, crospovidone (type B), anhydrous colloidal silicon dioxide, magnesium stearate. Tablet shell: hypromellose, lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E171). Side effect From the side of the central nervous system: often - headache, dizziness, asthenic syndrome; possibly - anxiety, depression, insomnia, neuralgia, paresthesia. From the digestive system: often - constipation, nausea, abdominal pain; possible - a reversible transient dose-dependent increase in liver transaminase activity, dyspepsia (including diarrhea, flatulence, vomiting), gastritis, gastroenteritis. From the respiratory system: often - pharyngitis; possibly - rhinitis, sinusitis, bronchial asthma, bronchitis, cough, dyspnea, pneumonia. From the side of the cardiovascular system: possibly - angina pectoris, increased blood pressure, palpitations, vasodilation. From the musculoskeletal system: often - myalgia; possible - arthralgia, arthritis, muscle hypertonicity, back pain, pathological limb pearl (without damage); rarely - myopathy, rhabdomyolysis (simultaneously with impaired renal function, while taking the drug at a dose of 40 mg). From the urinary system: tubular proteinuria (in less than 1% of cases - for doses of 10 and 20 mg, 3% of cases - for a dose of 40 mg); possibly - peripheral edema (arms, legs, ankles, shins), pain in the lower abdomen, infections of the urinary system. Allergic reactions: possible - skin rash, skin itching; rarely - angioedema. On the part of laboratory parameters: a transient dose-dependent increase in CPK activity (with an increase in CPK activity by more than 5 times compared to VGN, therapy should be temporarily suspended). Others: often - asthenic syndrome; possibly - accidental injury, anemia, chest pain, diabetes mellitus, ecchymosis, flu-like syndrome, periodontal abscess. Buy Romazik tablets p/o 20mg No. 10x3 Price for Romazik tablets p/o 20mg No. 10x3