Tulip, 40 mg 30 pcs.

How to take, the dosage

The patient should be switched to a cholesterol-lowering diet before starting treatment. Orally, at any time of the day, regardless of meals.

The dose of the drug is varied from 10 to 80 mg once daily, adjusted for baseline LDL-C levels, the goal of therapy, and individual effect. The dose should be changed at intervals of at least 4 weeks.

Primary hypercholesterolemia and mixed hyperlipidemia

The recommended starting dose of Tulip^® is 10 mg once daily. The dose is then individually adjusted to 10-80 mg of the drug per day, depending on the target cholesterol level and the effectiveness of the drug. After 2-4 weeks after the treatment start and/or after adjusting the dose of Tulip ^® the blood lipid level should be determined and the dose of the preparation should be adjusted in accordance with it.

Familial hypercholesterolemia is heterozygous. The initial dose of Tulip^® is 10 mg per day, the dose may be increased to 80 mg per day.

Homozygous. The dose range is the same as for other types of hyperlipidemia. The initial dose is chosen individually depending on the severity of the disease. The maximum daily dose is 80 mg.

Dosages for patients with renal insufficiency. In patients with renal impairment plasma concentration of atorvastatin and its effect on LDL cholesterol levels do not change. In this regard, no dose adjustment is required for patients with renal disease.

Dosages for patients with hepatic impairment. In patients with hepatic impairment caution should be observed due to delayed elimination of the drug from the body. Clinical and laboratory parameters should be carefully monitored and if significant changes are detected, the dose should be reduced or treatment discontinued.

Patients in the older age group. No dose adjustment is required for patients over 70 years of age.

Interaction

Antacids: in concomitant administration of atorvastatin and antacids in the form of magnesium and aluminum hydroxide suspensions, plasma concentration of atorvastatin decreases by approximately 35%, while the degree of LDL cholesterol level reduction remains unchanged.

Colestipol: concomitant use of atorvastatin and colestipol decreases plasma concentration of atorvastatin by approximately 25%, with hypolipidemic effect of combination of atorvastatin and colestipol exceeding that of each drug separately.

Digoxin: Multiple concomitant administration of atorvastatin and digoxin increases plasma concentrations of digoxin by approximately 20%, therefore, the patient should be monitored.

Eritromycin: Concomitant administration of atorvastatin and erythromycin, which has an inhibitory effect on cytochrome P450 CYP3A4, increases plasma concentration of atorvastatin by approximately 40%.

Peroral contraceptives: In concurrent use of atorvastatin and oral contraceptives AUC values increase by approximately 30% for norethisterone and 20% for ethinylestradiol. These data should be considered when selecting contraceptives for patients taking atorvastatin.

Warfarin: in patients taking warfarin for a long time, atorvastatin slightly decreases prothrombin time in the first days after the beginning of its use, but after 15 days this figure is normalized. After administration of atorvastatin, patients taking warfarin should be monitored more frequently than usual.

The concomitant administration of cyclosporine, fibrates, clarithromycin, antifungal drugs (related to azoles) and nicotinamide will increase plasma concentrations of atorvastatin (risk of myopathy).

Special Instructions

Disorders of liver function. The use of HMG-CoA reductase inhibitors to reduce blood lipid levels may lead to changes in biochemical parameters reflecting liver function.

Liver function should be monitored before starting treatment, 6 weeks, 12 weeks after starting Tulip^® and after each dose increase, and periodically, such as every 6 months. Changes in liver enzyme activity are usually seen within the first three months after starting Tulip^®. Patients with elevated transaminase levels should be monitored until enzyme levels return to normal. If ALT or AST values are more than 3 times the upper limit of tolerance, it is recommended to reduce the dose of Tulip^® or discontinue treatment.

Skeletal Musculature. Patients with diffuse myalgia, muscle laxity or weakness and/or significant elevation of CPK are at risk for myopathy (defined as muscle pain with concomitant elevation of CPK levels more than 10 times the upper limit of normal).

When administering combination therapy with Tulip^® and cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, immunosuppressants, and azole antifungals and lipid-lowering doses of niacin, the potential benefit and risk of this treatment should be compared and patients who show signs or symptoms of muscle pain, lethargy, or weakness should be monitored, particularly during the first months of treatment and when the dose of any of the drugs is increased.

The treatment with Tulip^® should be temporarily suspended or discontinued if a serious condition that may result from myopathy develops and if there are risk factors for acute renal failure due to rhabdomyolysis (e.g., acute severe infection, arterial hypotension, extensive surgery, trauma, severe metabolic and endocrine disorders, and electrolyte imbalances).

The patient should seek immediate medical attention if unexplained muscle pain or weakness occurs, especially if accompanied by malaise and fever. Women of reproductive age should use reliable methods of contraception.

Impact on the ability to drive vehicles and engage in other activities requiring concentration and quick psychomotor reactions

Tulip^® has no effect on the ability to drive and operate machinery.

Contraindications

• high sensitivity to atorvastatin and other excipients of the drug;
• liver disease in the active stage (including.
• Hepatic diseases in active stage (including active chronic hepatitis, chronic alcoholic hepatitis); unexplained increase of ALT or AST activity (more than 3 times of the upper limit of normal); hepatic failure (degrees A and B severity according to Child-Pugh scale);
• Women of reproductive age, not using adequate contraception methods.

With caution: history of liver disease, alcohol abuse, severe electrolyte balance disorders, endocrine and metabolic disorders, arterial hypotension, severe acute infections (sepsis), uncontrolled epilepsy, skeletal muscle disease, major surgical interventions, trauma, childhood (effectiveness and safety of use are not established).

Side effects

The digestive system: In more than 2% of cases, nausea; In less than 2% – heartburn, constipation or diarrhea, flatulence, abdominal pain, anorexia, decreased or increased appetite, dry mouth, belching, dysphagia, vomiting, stomatitis, esophagitis, glossitis, erosive and ulcerative lesions of the mouth, gastroenteritis, hepatitis, biliary colic, cheilitis, duodenal ulcer, pancreatitis, cholestatic jaundice, impaired liver function, melena, bleeding gums, tenesmus.

Respiratory system: in more than 2% of cases – bronchitis, rhinitis; less frequently – pneumonia, dyspnea, bronchial asthma, nasal bleeding.

Nervous system: in more than 2% of cases, insomnia, dizziness; in less than 2%, headache, asthenia, malaise, somnolence, unusual dreams, paraesthesia, amnesia, emotional lability, peripheral neuropathy, ataxia, facial nerve palsy, hyperkinesias, depression, hyperesthesia, unconsciousness.

Musculoskeletal system: in more than 2% of cases – arthritis; in less than 2% – leg muscle cramps, bursitis, tenosynovitis, myositis, myopathy, arthralgia, myalgia, joint contractures, neck muscle stiffness, rhabdomyolysis.

Allergic reactions: in less than 2% of cases – skin itching, skin rash, contact dermatitis; rarely – urticaria, anaphylaxis, Quincke’s edema, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), photosensitization.

Skin: in less than 2% of cases – alopecia, sweating, eczema, seborrhea, ecchymoses, petechiae.

Urogenital system: in more than 2% of cases – urogenital infections, peripheral edema; in less than 2% of cases – dysuria (including Pollakiuria, nycturia, urinary incontinence or urinary retention, imperative urge to urinate), nephritis, hematuria, vaginal bleeding, urolithiasis, epididymitis, decreased libido, ejaculation disorders, impotence, uterine bleeding.

Sensory organs: in less than 2% of cases – amblyopia, tinnitus, dry conjunctiva, accommodation disorders, bleeding in the eyes, deafness, increased intraocular pressure, parosmia, perversion of taste, loss of taste sensation.

Cardiovascular system: in more than 2% of cases, chest pain; in less than 2%, palpitations, vasodilation, orthostatic hypotension, phlebitis, arrhythmias, angina pectoris, increased BP.

Hematopoietic system: in less than 2% of cases – anemia, lymphadenopathy, thrombocytopenia.

Laboratory parameters: in less than 2% of cases – hyperglycemia, hypoglycemia, increased creatine phosphokinase (CPK) levels, albuminuria.

Others: in less than 2% of cases – weight gain, gynecomastia, worsening of gout, mastodynia.

Overdose

There is no specific treatment in case of Tulip^® overdose. Treatment is symptomatic; measures are taken to maintain vital functions and prevent further absorption of the drug (gastric lavage, intake of activated charcoal). Due to the fact that the drug is actively bound to blood plasma proteins, hemodialysis is not an effective way to accelerate its elimination from the body.

Pregnancy use

The use in pregnancy and during breastfeeding is contraindicated.

Similarities

Liprimar, Atoris, Tulip, Atorvastatin, Torvacard, Atorvastatin NW , Atorvastatin-Teva