Tulip - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Tulip

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

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Tulip is a hypolipidemic drug, an inhibitor of HMG-CoA reductase, which lowers the level of triglycerides and cholesterol in the blood serum.

Release form and composition

Dosage form - film-coated tablets: 10 mg - white or almost white film coating, engraving "HLA 10" on one side, 20 mg - light yellow film coating, engraving "HLA 20" on one side, 40 mg - white with a yellowish-brownish tint film casing, engraved "HLA 40" on one side; tablets are biconvex, round, on a cut - white (10 pcs. in blisters, in a cardboard box 3, 6, 9 blisters).

Composition of 1 tablet:

• active substance: atorvastatin (in the form of atorvastatin calcium) - 10, 20 or 40 mg;
• auxiliary components: croscarmellose sodium, lactose monohydrate, polysorbate 80, hyprolose, colloidal silicon dioxide, magnesium stearate, heavy magnesium oxide, microcrystalline cellulose;
• film shell: hyprolose, hypromellose, macrogol 6000, talc, titanium dioxide, for a dose of 20 and 40 mg additionally - iron oxide yellow.

Indications for use

• primary hypercholesterolemia, heterozygous familial and non-familial hypercholesterolemia, and combined (mixed) hyperlipidemia of type IIa and IIb according to Fredrickson's classification - Tulip is used in combination with a cholesterol-lowering diet to reduce high concentrations of total cholesterol (CS), cholesterol, lipoproteins, low-density apolites B (apoB), thyroglobulin (TG) and an increase in the concentration of high density lipoprotein cholesterol (HDL-C), when diet therapy and other non-drug methods have insufficient effect;
• homozygous familial hypercholesterolemia - to reduce elevated concentrations of LDL cholesterol and total cholesterol, when diet therapy and other non-drug methods are not effective enough;
• cardiovascular complications in patients without clinical signs of coronary heart disease (IHD), but in the presence of certain risk factors for its development, such as nicotine dependence, arterial hypertension, retinopathy, diabetes mellitus, albuminuria, low plasma concentrations of HDL-C, genetic predisposition, including against the background of dyslipidemia, age over 55 years - for primary prevention;
• cardiovascular complications in patients with coronary artery disease - secondary prevention of the condition to reduce the total mortality rate, stroke, myocardial infarction, re-hospitalization for angina pectoris and the need for revascularization.

Contraindications

Absolute contraindications:

• liver damage in the active phase;
• an increase in blood plasma activity of hepatic transaminases of unknown origin in comparison with the upper limit of normal (UHN) by more than 3 times;
• syndrome of glucose-galactose malabsorption, lactose intolerance, lactase deficiency (contains lactose);
• pregnancy and the period of breastfeeding (lactation);
• children and adolescents up to 18 years of age (the efficacy and safety of taking atorvastatin in this age group of patients has not been established);
• increased individual sensitivity to drug components.

With caution, Tulip is used in case of severe electrolyte imbalance, a history of liver disease, alcohol abuse, muscular system diseases and a history of muscle pathologies due to the use of other drugs of the group of HMG-CoA reductase inhibitors, metabolic and endocrine (hyperthyroidism) disorders, arterial hypotension, diabetes mellitus, severe acute infections (sepsis), uncontrolled epilepsy, major surgical interventions, trauma, aggressive lipid-lowering therapy (atorvastatin at a dose of 80 mg) in the secondary prevention of stroke in patients with a history of hemorrhagic or lacunar stroke.

Method of administration and dosage

Before starting the use of Tulip, the patient should be recommended a standard cholesterol-lowering diet, which must be followed throughout the entire period of drug treatment.

The tablets are taken orally, regardless of the diet.

The recommended range of daily doses of Tulip is 10–80 mg, a specific dose is selected based on data on the concentration of LDL-C, the purpose of treatment and the patient's individual therapeutic response.

The initial dose in most cases is 10 mg per day, the maximum is 80 mg per day.

At the beginning of therapy, after 14-28 days and / or at each increase in the dose of the drug, the plasma lipid concentration should be monitored and, if necessary, the dose of atorvastatin should be adjusted.

Recommended dosage regimen:

• primary (heterozygous hereditary and polygenic) hypercholesterolemia (type IIa) and mixed hyperlipidemia (type IIb): predominantly a dose of 10 mg once a day is sufficient (tablets of 10 and 20 mg can be used); if necessary, it is permissible to gradually increase the dose to 80 mg (2 tablets 40 mg each), taking into account the patient's response and observing the interval between dose increases of 14-28 days, since the therapeutic effect is noted after 14 days, and the maximum therapeutic effect is recorded after 28 days and lasts with long-term treatment;
• homozygous hereditary hypercholesterolemia: 80 mg (2 tablets 40 mg each) once a day;
• cardiovascular diseases (for prophylaxis): 10 mg once a day, if the optimal plasma concentration of LDL is not reached, it is permissible to gradually increase the dose to 80 mg (2 tablets 40 mg each), taking into account the patient's response and observing the interval between dose increases of 14 –28 days.

No dose adjustment of Tulip is required for patients with renal insufficiency and elderly patients.

In case of impaired liver function, the elimination of atorvastatin from the body slows down, therefore it is recommended to use it with caution, constantly monitoring the activity of hepatic transaminases: aspartate aminotransferase (ACT) and alanine aminotransferase (ALT).

Side effects

• nervous system: often - headache; infrequently - sleep disturbance (including insomnia and nightmares), dizziness, asthenic syndrome, paresthesia, hypesthesia, weakness, memory loss / decrease, impaired taste sensitivity; rarely, peripheral neuropathy;
• sense organs: infrequently - blurred vision, tinnitus; rarely - visual impairment; extremely rare - hearing loss;
• digestive system: often - flatulence, constipation, nausea, dyspepsia, diarrhea; infrequently - vomiting, anorexia, hepatitis, pancreatitis, belching, abdominal pain; rarely - cholestatic jaundice (including obstructive); extremely rare - liver failure;
• musculoskeletal system: often - joint swelling, myalgia, arthralgia, joint pain, muscle spasm, back pain; infrequently - pain in the cervical muscles, myasthenia gravis; rarely - myositis, myopathy, rhabdomyolysis, tendinopathy (sometimes up to tendon ruptures); indeterminate frequency - cases of immune-mediated necrotizing myopathy;
• skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria, alopecia; rarely - bullous rash, angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome) and Lyell's syndrome (toxic epidermal necrolysis);
• hematopoietic system: infrequently - thrombocytopenia;
• metabolism: often - hyperglycemia; infrequently - hypoglycemia;
• respiratory system: often - sore throat, nasopharyngitis, nosebleeds;
• immune system: often - hypersensitivity reactions; extremely rare - anaphylaxis;
• laboratory parameters: often - an increase in the activity of serum creatine phosphokinase (CPK), an increase in the activity of ALT and AST; infrequently - leukocyturia; indefinite frequency - an increase in the concentration of glycosylated hemoglobin;
• other reactions: infrequently - increased fatigue, secondary renal failure, impaired potency, hyperthermia, peripheral edema, chest pain, weight gain; extremely rare - diabetes mellitus, gynecomastia; there are some data on the development of atonic fasciitis, but the exact connection with the use of atorvastatin has not been established; uncertain frequency - interstitial lung disease (especially with prolonged use), depression, sexual dysfunction.

In case of an overdose with Tulip, symptomatic therapy is necessary. Atorvastatin does not have a specific antidote, and hemodialysis is not effective due to the significant binding of the drug to blood plasma proteins.

special instructions

Tulip, like other statins (inhibitors of HMG-CoA reductase), can increase the serum activity of the liver enzymes ACT and ALT by more than 3 times compared to VGN. Therefore, it is required to monitor liver function indicators before taking the drug, after 6 and 12 weeks from the start of treatment and with an increase in its dose. Monitoring of liver function indicators is also necessary when clinical signs of liver damage appear. With an increase in the activity of ACT and ALT, the indicators should be monitored until the values normalize, if the increase is more than 3 times higher than the ULN and persists, it is recommended to reduce the dose or stop taking the drug.

The use of Tulip can cause the development of myalgia. In patients with diffuse myalgia, muscle weakness or soreness, and / or a pronounced increase in CPK activity, it is possible to assume the presence of myopathy. In this case (presence of confirmed / suspected myopathy), therapy with atorvastatin should be discontinued.

Due to the increased risk of myopathy with the simultaneous use of Tulip with immunosuppressants, fibrates, azole antifungal drugs, erythromycin, nicotinic acid (in lipid-lowering doses of more than 1 g per day), treatment with the drug begins only after a careful assessment of the ratio of the expected benefit from therapy with the likelihood of severe side effects. reactions. If combined treatment is necessary, it is recommended to consider the possibility of adjusting the initial and maintenance doses of these drugs downward.

During therapy, the activity of CPK and the concentration of glucose in the blood serum should be periodically monitored.

Patients should be informed of the need to seek immediate medical attention if any unexplained pain and / or muscle weakness occurs, especially when accompanied by a general deterioration and fever.

Rare cases of rhabdomyolysis with the development of acute renal failure due to myoglobinuria due to the use of Tulip, as well as other statins (inhibitors of HMG-CoA reductase), have been described.

If signs of possible myopathy appear or there is a risk of developing renal failure factors against the background of rhabdomyolysis (arterial hypotension, severe acute infection, trauma, extensive surgery, serious metabolic, endocrine and electrolyte disturbances, uncontrolled convulsions), atorvastatin should be suspended or treatment should be canceled.

During the period of therapy with Tulip, caution is required when driving vehicles and engaging in other potentially hazardous types of work, which require an increased concentration of attention and speed of psychomotor reactions.

Drug interactions

• cyclosporine, erythromycin, clarithromycin, immunosuppressive, antifungal drugs (azole derivatives): increase the risk of myopathy in case of simultaneous use with HMG-CoA reductase inhibitors due to a possible increase in the serum concentration of atorvastatin;
• indinavir, ritonavir (HIV protease inhibitors), fibrates and nicotinic acid (in lipid-lowering doses of more than 1 g per day): increase the risk of myopathy;
• inhibitors of the isoenzyme CYP3A4 (including protease inhibitors): an increase in the concentration of atorvastatin in blood plasma is possible;
• inhibitors of the transport protein OATP1B1 (for example, cyclosporin): can increase the bioavailability of atorvastatin;
• erythromycin and clarithromycin: increase the concentration of atorvastatin in blood plasma (by 40% and 56%, respectively);
• diltiazem: at a dose of 240 mg with 40 mg of atorvastatin increases the concentration of the latter in the blood plasma;
• cimetidine: no clinically significant interaction with atorvastatin was detected;
• itraconazole: at a dose of 200 mg with 20-40 mg of atorvastatin 3 times increases the AUC value of atorvastatin;
• grapefruit juice: more than 1.2 liters per day for 5 days can cause an increase in the plasma concentration of atorvastatin;
• inducers of the CYP3A4 isoenzyme (for example, efavirenz or rifampicin): can lead to a decrease in the concentration of atorvastatin in the blood plasma, since rifampicin is an inducer of the CYP3A4 isoenzyme and at the same time an inhibitor of the transport protein of hepatocytes OATP1B1, because of such a double interaction it is not recommended to take it simultaneously with Tulip;
• antacids: combined oral administration of suspensions containing aluminum and magnesium hydroxides with atorvastatin reduce the plasma concentration of the latter by ~ 35%, but the degree of decrease in the concentration of LDL-C does not change;
• terfenadine, phenazone: atorvastatin does not affect their pharmacokinetics, therefore drug interactions are not expected;
• colestipol: reduces the concentration of atorvastatin by 25%, but enhances the lipid-lowering effect due to the synergistic effect;
• fusidic acid: there is data from post-marketing studies on the side effects of joint use on the function of the muscular system, up to the destruction of muscle tissue cells (rhabdomyolysis); careful monitoring of patients is recommended and, if necessary, the abolition of Tulip;
• colchicine: cases of myopathy have been reported (caution should be exercised when used together);
• digoxin: use with high doses of atorvastatin (80 mg per day) increases the plasma concentration of digoxin by ~ 20% (it is recommended to control this indicator);
• azithromycin, amlodipine: when used with atorvastatin in therapeutic doses, it does not interact;
• oral contraceptives: when choosing oral contraceptives, it should be borne in mind that atorvastatin significantly increases the AUC of ethinyl estradiol and norethisterone, by 20% and 30%, respectively;
• indirect coumarin anticoagulants (warfarin): simultaneous use with atorvastatin affects the anticoagulant effect (prothrombin time control is required at the beginning of joint use, when the dosage is changed and the therapy is stopped);
• other lipid-lowering agents (gemfibrozil, ezetimibe, fibrates): taking in lipid-lowering doses increases the risk of rhabdomyolysis;
• antihypertensive drugs and estrogens (as replacement therapy): there was no clinically significant interaction.

Analogs

Tulip's analogues are: Anvistat, Atomax, Ator, Atorvastatin, Atoris, Atorvox, Vasator, Lipoford, Liptonorm, Liprimar, Torvazin, Novosostat, Torvalip, Torvakard, Torvas, etc.

Terms and conditions of storage

Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Tulip: prices in online pharmacies

Drug name Price Pharmacy

Tulip 20 mg film-coated tablets 30 pcs. 162 RUB Buy

Tulip 10 mg film-coated tablets 30 pcs. 207 r Buy

Tulip tablets p.p. 10mg 30 pcs. 267 r Buy

Tulip tablets p.p. 20mg 30 pcs. 351 r Buy

Tulip 10 mg film-coated tablets 90 pcs. 450 RUB Buy

Tulip 40 mg film-coated tablets 30 pcs. 523 r Buy

Tulip tablets p.p. 40mg 30 pcs. RUB 606 Buy

Tulip tablets p.p. 10mg 90 pcs. 657 r Buy

Tulip 20 mg film-coated tablets 90 pcs. 778 RUB Buy

Tulip tablets p.p. 20mg 90 pcs. 1023 RUB Buy

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!